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National Haemovigilance Office
Annual Report 2004
1Annual Report
Contents
List of abbreviations 2
Foreword 4
Haemovigilance 6
An Overview: The First Five Years of the National Haemovigilance Scheme 10
Incorrect Blood Component Transfused 17
Incorrect Blood Component Transfused: Incidents involving Anti-D Immunoglobulin 49
Severe Acute Anaphylactoid or Anaphylactic Transfusion Reaction 59
Transfusion Associated Circulatory Overload 71
Delayed Haemolytic Transfusion Reaction 78
Acute Haemolytic and Other Severe Acute Transfusion Reaction: 82
Transfusion Related Acute Lung Injury 91
Suspected Transfusion Transmitted Infection 93
Pre- Deposit Autologous Donor Incidents 96
Paediatric Incidents 102
The Near Miss Project: The First Full Year of Reporting 109
Acknowledgements 115
Contacts 116
References 117
Appendix 1 120
National Haemovigilance Office2
AA Severe Acute Anaphylactoid/Anaphylactic Reaction
AAA Abdominal Aortic Aneurysm
AABB American Association of Blood Banks
ACE Angiotensin-Converting Enzyme
A&E Accident and Emergency
AHOSTR Acute Haemolytic or Other Severe Acute Transfusion
Reaction
ARDS Adult Respiratory Distress Syndrome
BCSH British Committee for Standards in Haematology
CCU Coronary Care Unit
CJD Creutzfeldt Jacob Disease
CMV Cytomegalovirus
COAD Chronic Obstructive Airways Disease
CVA Cerebro Vascular Accident
CXR Chest X-ray
CPDA1 Citrate-Phosphate-Dextrose-Adenine
DAT Direct Antiglobulin Test
DHTR Delayed Haemolytic Transfusion Reaction
DIC Disseminated Intravascular Coagulation
DM Diabetes Mellitus
DOB Date of Birth
DVT Deep Venous Thrombosis
ECG Electrocardiograph
EPO Erythropoietin
EU European Union
FBC Full Blood Count
FDA Food and Drug Authority
FFP Fresh Frozen Plasma
GI Gastrointestinal
GP General Practitioner
GTN Glyceryl Trinitrite
Hb Haemoglobin
HBV Hepatitis B Virus
HCV Hepatitis C Virus
HDN Haemolytic Disease of the Newborn
HIV Human Immunodeficiency Virus
HLA Human Leucocyte Antigen
HVO Haemovigiliance Officers
IBCT Incorrect Blood Component Transfused
IBTS Irish Blood Transfusion Service
ICU Intensive Care Unit
ID band Identity band
IgA Immunoglobulin A
IgG Immunoglobulin G
IgM Immunoglobulin M
IM Intramuscular
IMB Irish Medicines Board
INR International Normalised Ratio
ITP Immune Thrombocytopaenic purpura
ITU Intensive Therapy Unit
List of Abbreviations
IV Intravenous
JVP Jugular Venous Pressure
LDH Lactate Dehydrogenase
LOC Loss of Consciousness
LVF Left Ventricular Failure
MERS-TM Medical Event Reporting System for Transfusion
Medicine.
MRN Medical Record Number
MSBOS Maximum Surgical Blood Ordering Schedule
NAT Nucleic Acid Amplification testing
NCHCD National Centre for Hereditary Coagulation Disorders
NEQAS National External Quality Assurance Scheme
NHO National Haemovigilance Office
OPD Out Patient Department
PAD Pre-deposit Autologous Donation
PAS Patient Administration System
PBSC Peripheral Blood Stem Cell
PCC Prothrombin Complex Concentrate
PCR Polymerase Chain Reaction
PNH Paroxysmal Nocturnal Haemoglobinuria
PTP Post Transfusion Purpura
QA/QC Quality Assurance/Quality Control
RCA Root Cause Analysis
Rh Rhesus
RTA Road Traffic Accident
SD Solvent Detergent
SHOT Serious Hazards of Transfusion
SOP Standard Operating Procedure
STTI Suspected Transfusion Transmitted Infection
TACO Transfusion Associated Circulatory Overload
TA-GvHD Transfusion Associated Graft-versus-Host Disease
THR Total Hip Replacement
TRALI Transfusion Related Acute Lung Injury
TSO Transfusion Surveillance Officer
TTP Thrombotic Thrombocytopaenic Purpura
vCJD variant Creutzfeldt Jacob Disease
3Annual Report
National Haemovigilance Office4
Foreword
The 2004 Annual Report from the National
Haemovigilance Office (NHO) completes five full
years of reporting of serious adverse reactions and
events relating to blood transfusion in Ireland. In
these five years, numerous recommendations and
findings have been issued, based on analysis of the
incidents reported to the NHO. This has assisted a
growing awareness of the extent and type of adverse
events/reactions associated with transfusion practice
in Irish hospitals and the measures available to
address these.
Confidence in the scheme continues and is reflected
in increasing reporting rates. As in 2003, 100% of
transfusing hospitals in the Republic of Ireland
participated in this scheme.
Findings and recommendations for 2004 are detailed
in the relevant chapters. Of great concern are the
preventable incidents in the categories of Incorrect
Blood Component Transfused and the potentially
preventable incidences of Transfusion Associated
Circulatory Overload. These incidents, combined
with events reported to the Near Miss project,
highlight errors and areas of high-risk in the
transfusion work processes, and provide an important
opportunity to improve practice and the quality of care
for patients in the context of a no/low blame culture.
The findings and recommendations also provide a
benchmarking tool for Hospital Transfusion
Committees when reviewing practice in their own
hospitals. These committees should be in place in all
hospitals that transfuse blood and they provide an
environment within which any errors identified,
together with their root causes, can be effectively
evaluated. Appropriate actions to improve future
performance and ultimately the safety and care of
patients can also be initiated.
Hospital-based Haemovigilance Officers (HVO) are a
vital part of the haemovigilance network in Ireland.
The NHO is very grateful to HVOs for their continued
efforts in heightening awareness and in developing
mechanisms to increase transfusion vigilance and
staff consciousness in hospitals to reporting such
incidents. The input of Transfusion Medical Scientists
and Consultant Haematologists is also a central
aspect of haemovigilance.
The NHO also acknowledges the continued support
of the Medical Director and staff of the Irish
Medicines Board (IMB). In particular, the expertise
and support of the staff of the IMB’s
Pharmacovigilance Department is especially
acknowledged.
The EU Blood Directive 2002/98/EC which comes
into effect on 8th November, 2005 governs the
activities of Blood Transfusion Services and Hospital
Blood Banks and has far reaching consequences for
the regulation and management of blood transfusion
services in all EU member states. Two articles in
particular are relevant to haemovigilance in that they
provide a firm legislative basis for haemovigilance and
remove discretionary elements currently present in
relation to reporting of serious adverse reactions.
Article 14 contains specific provisions in relation to
the traceability of blood and blood components as far
as the patient and Article 15 requires that all serious
adverse reactions attributable to the quality and
safety of blood and blood components transfused are
captured and reported to the competent authority.
A number of cases in this report concern
inappropriate use of blood components. While the
risks of transmission of the known viruses HIV, HCV
and HBV are now extremely small, the emergence of
other infectious diseases such as variant Crutzfeldt-
Jakob Disease (vCJD) and West Nile Virus (WNV) as
new transfusion risks, emphasises the need to use
blood appropriately. In June 2005 an Irish blood
donor was subsequently diagnosed with vCJD,
indicating that vCJD is potentially in the blood supply.
Dr. Stefan Laspina who took over as Acting Director
of the NHO from the final quarter of 2004 to July
2005, joins with me in acknowledging the ongoing
support and efforts of the IBTS Chief Executive Mr.
Andy Kelly, National Medical Director, Dr. Willy
Murphy and the staff of the IBTS. Their efforts in the
continued recruitment of blood donors, who
consistently and voluntarily give blood donations and
in the processing and distribution of blood and blood
components to the highest safety standards are the
basic foundations of the national haemovigilance
scheme. Sincere thanks also to all those outside of
the NHO who contributed to the writing of this report.
Finally, the ongoing enthusiasm of the staff of the
NHO in their daily efforts to promote best transfusion
practice and also their patience and support in
compiling, drafting and writing this report is
personally acknowledged.
Dr. Emer Lawlor
Director,
National Haemovigilance Office
Dr. Stefan Laspina,
Acting Director,
National Haemovigilance Office
5Annual Report
The national haemovigilance scheme is a confidential
anonymised system, co-ordinated by the National
Haemovigilance Office (NHO) and dedicated to the
achievement of a national standard in practice and
quality of care for all patients, before, during and
following completion of transfusion, has similarities to
pharmacovigilance, the system for monitoring drug
safety. It is the professional responsibility of all
healthcare professionals to support the concept of
haemovigilance, which is achieved through
adherence to issued best practice guidelines and
reporting of transfusion incidents/events.
From 8th November, 2005, reporting of serious
reactions which may be attributed to the quality and
safety of blood components will be mandatory as will
serious adverse events relating to the testing, storage
and distribution of blood and blood components.
European Communities (Quality and Safety of Blood
and Blood Components) Regulations 2005 SI
360/2005.
Definition of Terms used in Haemovigilance Serious Adverse Event:Definition:
Any untoward occurrence associated with the
collecting, testing, processing, storage and
distribution of blood and blood components that
might lead to
• Death
• Life-threatening
• Disabling or incapacitating conditions for patients
which results in, or prolongs, hospitalisation or
morbidity
Serious Adverse Reaction:Definition:
An unintended response in the patient associated
with the collection or transfusion of blood and blood
component that is
• Fatal
• Life-threatening
• Disabling
• Incapacitating which results in, or prolongs
hospitalisation or morbidity
National Haemovigilance Office6
Haemovigilance
“A set of surveillance procedures,from the collection of blood and itscomponents to the follow-up ofrecipients, to collect and assessinformation on unexpected orundesirable effects resulting fromthe therapeutic use of labile blood
products, and to prevent theiroccurrence or recurrence” (FrenchLaw regulation no. 93-5, January4th 1993)
NHO Remit
The remit of the NHO is to: • Receive, collate and follow up reports from
hospitals and general practitioners of adverse
reactions/events connected with transfusion of
blood components/products and provide
feedback information to those making the report
as appropriate.
• Advise on the follow-up action necessary,
particularly with regard to suspected hazards.
• Report adverse reactions to the Irish Medicines
Board (IMB) according to an agreed procedure.
• Provide ongoing support to hospital-based TSO
and as appropriate to medical, nursing and
technical staff.
• Provide medical, scientific and nursing analyses of
reports of adverse reactions.
• Advise on improvements in safe transfusion
practice based on the data supplied by hospitals.
• Support development of clinical guidelines for
hospitals in relation to the use of blood
components/products.
• Support the audit function of hospitals in relation
to transfusion practice.
• Promote the development of fully traceable
transfusion records at hospital level.
• Report to the National Blood User’s Group on a
periodic basis with a view to developing national
best transfusion practice.
A major part of the remit of the office is education and
support in relation to best transfusion practice at
hospital level.
The NHO is located at the National Blood Centre,
(NBC) James’s St., Dublin 8 and functions under the
directorship of a Consultant Haematologist with two
and a half fulltime equivalent HVO, a Programme
Administrator and Assistant Administrator. A fulltime
HVO coordinates the ‘Near Miss Project’.
Hospital Transfusion CommitteesThe NHO actively encourages the development of
adequately resourced, multi-disciplinary Hospital
Transfusion Committees, and this is also a
recommendation of the National Blood Strategy
Implementation Group, highlighted in their report to
the Minister for Health and Children in 2004. (O’Reilly
2004) The Hospital Transfusion Committee acts as a
forum where local transfusion issues can be
discussed in a no-blame, non-punitive environment.
This multi-disciplinary approach to transfusion
supports the development of best practice. Smaller
centres may share a committee with their supplying
hospital.
Irish Medicines BoardRepresentatives of the IMB and the NHO had regular
meetings during 2004 to review reported incidents,
particularly where there was a question about the role
of concomitant medication. In addition, the IMB’s
Pharmacovigilance Unit provides a valuable resource
to the NHO, advising in relation to the overall
development of the programme.
National Blood Users GroupThe National Blood Users Group, established by the
Minister for Health and Children for the purpose of
preparing and disseminating guidelines for the use of
blood components/products in Ireland has a
membership drawn from a wide range of hospital
based transfusion disciplines, including
haematologists, medical laboratory technologists,
perfusionists, anaesthetists, surgeons and nurses,
representing a wide knowledge of transfusion
practice.
Guidelines published to date are:
• A Guideline for Transfusion of Red Blood Cells in
Surgical Patients (2000)
• A Guideline for the Use of Blood and Blood
Components in the Management of Massive
7Annual Report
Haemorrhage (2002)
• Guidelines for the Administration of Blood and
Blood Components (2004)
A number of further guidelines will be published
shortly.
Near Miss Research ProjectA three-year pilot project to capture “near miss”
events, funded by the IBTS, is currently operating,
with ten hospitals participating. Details of the results
are featured in the Near Miss Events chapter of this
report.
Education, Promotion and DevelopmentsThe NHO continues to support the development of
hospital in-service training programmes by working
closely with hospital based HVO. The office also
encourages the development of audit functions at
hospital level in an effort to promote best transfusion
practice. Support is also provided in transfusion
education for nursing and laboratory medical science
students.
All newly appointed hospital based HVO attend an
induction training programme at the NBC including
an introduction to Good Manufacturing Practice
(GMP) and an overview of the IBTS manufacturing
processes at the NBC. Smaller centres benefit from
the NHO developed ‘in-service’ education
programmes as HVO appointments are primarily in
centres with a sizeable blood usage. Nationwide
networking among HVO is also promoted by regular
correspondence through telephone/e-mail
communication and personal visits.
The NHO hosted the annual conference in Naas
entitled “Haemovigilance-from Concept to Reality” in
October 2004. Dr. Emer Lawlor, Director of the
NHO, presented a summary of the incidents reported
to the NHO in 2003. The keynote speaker was Dr.
Paul Ness, Director of Transfusion Medicine Division,
Johns Hopkins Hospital, Maryland, USA, who
presented on their haemovigilance programme, with
reference to delayed haemolytic transfusion reactions
(DHTR) incorrectly labelled samples and septic
platelet transfusion reactions. Other presentations
included:
• The Operation of the BARS System and the SATO
wristbands at Addenbrookes. by Claire Sidaway,
Specialist Practitioner of Transfusion,
Addenbrookes NHS Trust Hospital
• Safe Track by Deirdre Gough, HVO, St. James’s
Hospital
• Appropriate Blood Usage (In Neonates) by Dr.
Joan O’Riordan Consultant Haematologist, IBTS
• Review of Laboratory Implicated Errors 2003 by
Ken Gregg, Monaghan General Hospital
• A Web-based Approach to Improving Blood
Transfusion Safety by Paul O’Brien, St. Vincent’s
Hospital
• Clinical Experience with Octaplas in Ireland by Dr.
Volha Chekrizova, Medical Researcher,IBTS.
The NHO again hosted a poster competition which
was judged by Dr. Paul Ness and Ms Claire Sidaway.
The winning poster displayed details of Pre and Post
Red Cell Transfusion Haemoglobin Audit in General
and Vascular Surgery Patients and was compiled by
the haemovigilance group in St. James’s Hospital,
Dublin.
NHO AuditsTwo audits were carried out during the year to
evaluate the effectiveness of the Irish Haemovigilance
scheme. The first measured the level of satisfaction
amongst hospital based HVOs with the support
offered by the NHO. The findings were presented at
the HVO workshop in October 2004, together with
the NHO response and proposed action plan.
Staffing levels in the NHO have been improved and
National Haemovigilance Office8
the action plan will be further addressed in the
coming year.
The second audit aimed to obtain a clear picture of
requirements at hospital level for effective
haemovigilance. The findings of this audit were
presented at a workshop for HVOs in November
2004 and circulated in early 2005. Some will be
incorporated into comprehensive guidelines for
standard delivery of haemovigilance.
The NHO News, an information newsletter circulated
to all HVO, provides an informal forum for the
reporting of work carried out within the NHO and
individual hospitals, and includes local education and
training initiatives and social events which may be of
interest to other HVO. Details of events of national
and international interest are also reported. During
2004, three editions of this newsletter were
published.
Information on haemovigilance can be directly
accessed on the IBTS website @ www.ibts.org.
Reports‘Did Not Progress’
A total of 244 transfusion reactions/events were
reported. Of these, 30 did not fulfil the criteria for a
haemovigilance event, as on further investigation it
was revealed that either the patient’s underlying
condition was attributed to symptom development, or
that a serious reaction to transfusion had not
occurred. In total 214 incidents were reviewed for
this report.
‘Nil to Report’For the second successive year, 100% (81) of
hospitals participated in the scheme by returning a
‘Nil to Report Form’ in 2004. 48 of those hospitals
(59%) reported a transfusion reaction or event
compared to 47 hospitals (58%) in 2003.
9Annual Report
Table 1 NHO-Confirmed Reports by Category
Total IBCT A/A TACO AHOSTR PAD TRALI TTI DHTR Incidents
214 126 35 15 24 7 0 3 4
100% 60% 16% 7% 11% 3% 0 1% 2%
0
30
60
90
120
150
IBCT
126
TACO
15
AHOSTR
24
PAD
7
TRALI
0
TTI
3
DHTR
4
AA
35
Figure 1. Haemovigilance Incidents 2004
IBCT Incorrect Blood Component/Product Transfused.
A/A Severe Acute Anaphylactoid or Anaphylactic Transfusion
Reaction.
TACO Transfusion Associated Circulatory Overload
AHOSTR Acute Haemolytic or Other Severe Transfusion Reaction.
TRALI Transfusion Related Acute Lung Injury
TTI Suspected Transfusion Transmitted Infection.
DHTR Delayed Haemolytic Transfusion Reaction
PAD Pre-deposit Autologous Donor incident
National Haemovigilance Office10
An Overview:
The First FIVE YEARS of the NationalHaemovigilance Scheme
Findings: 2000-2004 The NHO scheme has been fully operational since
January 2000, and has published annual reports for
2000, 2001, 2002 and 2003. This year represents
the fifth year of reporting and presents an opportunity
to review the findings for the previous five years.
Approximately 875,841 blood components were
issued during the five-year period and a total of 778
adverse transfusion reactions/events were reported
to the NHO. During 2000, the first full year of
reporting, there were 85 incidents which fulfilled the
criteria for a reportable event (NHO Annual Report,
2000). By 2004, the number of events has increased
to 214 incidents fulfilling the criteria for a
haemovigilance event.
Incorrect Blood Component Transfused (IBCT) This category captured 428 of the 778 incidents and
in keeping with other haemovigilance schemes that
collect similar data, it is the largest category reported.
It also includes errors and omissions relating to blood
products such as anti–D and factor concentrates as
these also allow evaluation of the quality of systems in
place for transfusion practice. However suspected
adverse drug reactions associated with use of these
licensed medicinal products continue to be reported
to the Irish Medicines Board (IMB) as the competent
authority for licensing of medicinal products.
In 2001, in response to feedback, the IBCT incidents
were divided into levels of severity (NHO Annual
Report, 2001)
• Level 1 incidents are defined as those with the
potential for permanent injury or are life
threatening, and include wrong blood for wrong
patient and the transfusion of blood
components/products, which were not required.
• Level 2 incidents were classified as unlikely to
cause permanent harm. Between 2001- 2004,
139 (32%) of all IBCT were captured in this
group.
• Level 3 incidents have no realistic potential for
harm: During the four year period 65 incidents
(15%) were reported.
Table 2 Breakdown of NHO incidents (2000-2004) (n=778)
YEAR IBCT AA TACO DHTR AHOSTR TRALI TTI PAD Unusual TOTAL
2000 31 22 8 2 14 - 7 - 1 85
2001 69 35 16 1 12 3 2 3 3 144
2002 87 31 10 9 8 2 3 5 - 155
2003 115 23 14 9 8 1 4 6 - 180
2004 126 35 15 4 24 - 3 7 - 214
TOTAL 428 146 63 25 66 6 19 21 4 778
55% 19% 8% 3% 8% 1% 2% 3% 1% 100%
Wrong ABO Transfusion During the five-year period 2000- 2004, 20 reports
were received of incorrect ABO group red cells
transfused. In 13 of these cases, the red cells were
ABO incompatible. The total number of red cells and
whole blood issued for this period was 639,198.
Therefore, the risk of receiving a wrong ABO red cell
transfusion is about 1:31,959 units issued and of
receiving an ABO incompatible red cell transfusion is
of the order of 1:49,169 units issued. Seven of the
thirteen patients who received an ABO incompatible
red cell transfusion had symptoms of an acute
transfusion reaction. However, all recovered and no
fatalities were reported from the reaction.
11Annual Report
Table 3 Wrong ABO red cell transfusions 2000-2004
Year
20002001200220032004Total
TotalIBCT
316987115126428
IBCT Involvingincorrect ABOred cells
3645220
IBCTInvolving ABOincompatiblered cells
2415113
Units of redcells & wholeblood issued
124,797120,482127,601130,088 136,230639,198
Number per units 1:31959 1:49169issued
IBCT55%
AA19%
TTI2%
AHOSTR8%
TRALI1%
TACO8%
PAD3%
Unusual1%
DHTR3%
Figure 2 Breakdown of NHO incidents (2000-2004) (n = 778)
Prescription and Request In 152 cases (36%) the error was the first stage of
the transfusion process i.e. at prescription and
request indicating the importance of continuing
education for medical and nursing staff involved in
prescribing and ordering blood components.
Pre transfusion samplingPre transfusion sampling has been identified as the
site of first error in 32 (7 %) cases. Three of these
events were associated with the transfusion of ABO
incompatible red cells. This highlights the importance
of secure procedures for positive patient identification
and emphasises the necessity for each patient to
wear a secure ID band at the time of sampling. In one
case the transfusion was delayed because of sample
labelling problems. It is likely this delay contributed to
mortality. The introduction of automated solutions,
sample bar coding (Turner et al, 2003), extended/24
hours phlebotomy services, as well as the provision of
an ongoing transfusion education programme are key
recommendations.
Laboratory Procedures In 125 cases (29%) the first error occurred in the
laboratory. In many cases the error occurred on call
and often involved staff from other laboratory
disciplines covering the transfusion laboratories
indicating the importance of regular training of on call
staff. The use of automated grouping and automated
transmission of results would help reduce human
error through transcription and reading errors.
Site of Collection In 25 cases (6%) the first error was at the site of
collection. These resulted from absence or
inadequacy of checking procedures at the time of
collecting the component. Adequate checking
systems must be in place at the site of collection of
blood components/products from either the hospital
transfusion laboratory or the satellite fridge.
Bedside administration In 59 (14%) cases, the site of first error involved the
final bedside checking procedure with a failure to
accurately identify the patient or the
component/product pre transfusion. This resulted in
an incorrect component/product being administered.
The reasons for such errors are varied but as the final
bedside check provides the opportunity to detect and
prevent earlier errors its importance is highlighted.
The checking procedure must be performed at the
bedside and the patient should be asked to verify
their identification details. In addition, the patient must
be positively identified and an identity (ID) band must
be worn at the time of the pre-transfusion sampling
and must be in place at the time of transfusion.
The site of first error in the remaining IBCT cases
involved incidents occurring at the initial clerking
stage or at the supply centre or were unclear.
Wrong haematology values resulting inunnecessary transfusions. In 26 (6%) cases, transfusion was based on
inaccurate or absent haematology results or
inadequacy of the checking procedure. In 19 (4%) of
National Haemovigilance Office12
Laboratory(125) 29%
Prescription/Request(152) 36%
Clerking(7) 2%
Unclear(8) 2%
Collection(25) 6%
Supply Centre(19) 4%
Administration(59) 14%
Sampling(32) 7%
Figure 3 Site of first error 2000-2004 (n=427)
2006- One Anti D case not allocated a site of first error
these cases, the transfusion of red cells was involved.
Errors in communication can be minimised by using
automated transfer of laboratory information to
hospital patient identification systems. All clinical
areas should have easy access to these systems and
staff should be trained in their use so that transfusion
decisions are based on the most up-to-date and
correct results.
Inappropriate transfusionsInappropriate transfusions were reported in 48 (11%)
cases. Nineteen (4%) of these cases resulted in an
unnecessary transfusion of either SD plasma or FFP.
In addition, ten reactions captured within the A/A
category were as a result of the inappropriate use of
plasma. Adherence to national guidelines is important
to avoid inappropriate use of blood components and
unnecessary donor exposure.
All clinical staff involved in transfusion must be familiar
with guidelines for administration of components
which will help avoid unnecessary transfusions. SD
plasma or FFP is only required for reversal of over
anticoagulation in the presence of major bleeding or
emergency surgery.
BLOOD PRODUCT ADMINISTRATION (Anti D andFactor concentrates) Seventy–five of these IBCT reports related to errors
in the administration of blood products, 59 (79 %) of
which involved the administration of Anti-D. Each
hospital should have clear policies and procedures
for the prescription and administration of Anti-D and
the management of Rh D negative women during
pregnancy. Procedures for the identification of the
patient prior to Anti-D or factor concentrate
administration should be as stringent as those
performed for transfusion.
REACTIONS Severe Acute Anaphylactoid or AnaphylacticTransfusion Reactions (A/A) Severe acute anaphylactoid or anaphylactic
transfusion reactions were the largest category of
serious adverse reactions with 146 incidents (19%)
reported. In 2004 there was an increase of 52% in
these incidents compared to the 2003 figures.
Between 2000 and 2003 twenty-two cases involved
the use of fresh frozen plasma (FFP), six of which
were for warfarin reversal as a result of over
anticoagulation, which were not in compliance with
current guidelines. The numbers of reactions
associated with plasma have fallen consistently since
the first year of reporting and the introduction of SD
plasma, which is associated with a low risk of allergic
type reactions. In 2004 there were two
anaphylactoid/anaphylactic transfusion reactions
associated with the use of SD plasma. However, this
has been offset by an increase in the number of these
reactions associated with platelets. Of the 87
reactions (60%) associated with platelets, the vast
majority, 67 (77%) were associated with the
transfusion of pooled platelet concentrates. In most
cases the patients responded rapidly to treatment.
Some of these transfusions were however considered
to be inappropriate.
Acute Haemolytic or Other Severe AcuteTransfusion Reaction. (AHOSTR) There were 66 incidents (8%) reported in this
category. In 2004 there was a three fold increase in
these incidents compared to the 2003 figures. Red
cell transfusion was involved in 56 (85%). Where
there was documentation of the investigations carried
out evidence of bacterial contamination was
excluded. Only 2 cases were associated with the
detection of red cell antibodies. However, seven of
the 13 incidents involving ABO incompatible red cell
transfusions, reported in the IBCT category were
accompanied by symptoms of an acute transfusion
13Annual Report
reaction. In total therefore, of 63 red cell transfusion
reactions reported to the NHO during this period,
seven (11%) were due to ABO incompatibility. This
confirms the need to fully investigate all reactions
associated with the transfusion of red cells.
Transfusion Associated Circulatory Overload(TACO)
Transfusion associated circulatory overload (TACO)
was reported in 63 (8%) transfusions, of which 10
(15%) were associated with the use of plasma. In at
least six of these 10 (60%), the transfusion was
considered inappropriate and in two cases may have
contributed to mortality. In light of these findings, the
NHO issued an information leaflet on the use of FFP.
This leaflet outlined the firm indications for the
transfusion of FFP and highlighted the risks
associated with its use. This was updated to reflect
changes following the introduction of solvent
detergent (SD) treated pooled plasma in March
2002.
Forty-eight (76%) TACO incidents related to the
transfusion of red cells. Thirty-eight cases (60%)
involved patients aged 70 years or over. In one case
where the patient was already critically ill the
transfusion may have contributed to mortality. All
patients should be assessed pre- transfusion to
assess their likelihood to develop TACO. Particular
attention should be paid to the identification and
management of “high-risk “ patients such as the
elderly, infants and children, patients with a low body
weight and physiologically compromised patients
with a history of cardiac, respiratory or renal
insufficiency or chronic anaemia. Monitoring of the
patient’s fluid balance, transfusing as slowly as
possible and observing closely for signs and
symptoms of volume overload during and soon after
transfusion is recommended to minimise the risks.
The use of prophylactic diuretics is also
recommended.
Suspected Transfusion Transmitted Infection (TTI) There were 19 (2%) reports of suspected transfusion
transmitted infections (TTI). Investigation of these
reports confirmed one case of bacterial
contamination, which involved a pooled unit of
National Haemovigilance Office14
2000
3
1
-
3
1
8
2004
14
-
1
-
-
15
Total
48
1
1
10
3
63
2003
12
-
-
1
1
14
2002
10
-
-
-
-
10
2001
9
-
-
6
1
16
Table 4 Numbers of reports of TACO by component and reporting year
Component transfused
Red cells
Pooled Platelets
Apheresis Platelets
FFP or SD Plasma
Multi components
Total
platelets from which coagulase negative
staphylococcus was cultured from both the patient
and the unit. The patient recovered without
complications.
Eighteen reports of possible viral transmission were
investigated: six Hepatitis C virus (HCV), seven
Hepatitis B virus (HBV), four Human
immunodeficiency virus (HIV) and one case of co-
infection with both HBV and HCV. Transfusion has
been excluded as the source of infection in 16 of the
18 patients by re-testing of donors or the archived
samples from the time of donation. In one case, one
donor could not be traced and so HBV transmission
by transfusion could not be excluded. In the second,
also a case of HBV, investigations are ongoing,
however in both cases the patients had other risk
factors.
This low incidence of confirmed TTI is in keeping with
the estimated risk of transfusion transmitted viral
infection which since the introduction by IBTS of
Nucleic Acid Amplification Testing (NAT) has been
estimated at 1 in 4 million units transfused for HIV, 1
in 4 million units transfused for HCV and 1 in
200,000 units transfused for HBV (O’Riordan J.,
Personal Communication).
Delayed Haemolytic Transfusion Reaction (DHTR) There were 25 (3%) reports received which were
categorised as DHTRs during 2000-2004. There
were no fatalities. These reactions, which are largely
unavoidable, are likely to increase as our patient
population, particularly the elderly, receive more
transfusions. In 15 (60%) of the 25 cases the
patients were aged over 70 years.
Transfusion Related Lung Injury (TRALI) Six cases (1%) suggestive of transfusion related
acute lung injury (TRALI) were reported. Three cases
involved red cells , one was associated with
apheresis platelets, one with fresh frozen plasma and
one case involved multiple blood products. TRALI
was confirmed in one case and considered highly
probable in three cases, one of which was associated
with fatality. It was considered possible in one case
and unlikely in a final case. There were no incidents
which met the criteria for TRALI reported in 2004.
Post-Transfusion Purpura (PTP) and Transfusion-Associated Graft-versus Host Disease (TA-GvHD) There were no incidents reported in these categories
during the first five years.
Pre-deposit Autologous Donor Incident (PAD) In 2001 the NHO began to collect reports relating to
pre-deposit autologous donor incidents. Twenty-one
(3%) incidents were reported and one of the adverse
events involved hospitalization of the patient but none
involved rescheduling of surgery. Seven, or one third
of the incidents involved children. In a number of
cases the donated blood was not required
suggesting the importance of careful donor selection
for PAD.
CURRENT PARTICIPATION The number of incidents submitted to the NHO has
continued to rise. Because of the anonymity of the
scheme, it is difficult to determine if the increase is as
a result of an improved detection rate in hospitals that
have always participated and/or a general increase in
participation as further hospitals report to the
programme. The success of the scheme to date can
be directly attributed to the work and enthusiasm of
the hospital based TSO’s, and the support they
receive from transfusion medical scientists and
consultant haematologists. However, in order to
encourage reporting and ensure the
recommendations from the reports are adopted
further work is required.
In November 2005, the EU Blood Directive
2002/98/EC will come into effect. This directive
governs the activities of Blood Transfusion Services
and Hospital Blood Banks. Article 14 of the Directive
contains specific provisions in relation to traceability
of blood and blood components in regard to the
patient. Article 15 requires all serious adverse
reactions attributable to the quality and safety of
blood and blood components transfused are
15Annual Report
captured and reported to the competent authority.
This removes the previous discretionary element in
relation to reporting of serious adverse reactions and
gives haemovigilance a firm legislative basis.
A number of strategies are currently being examined
to improve the reporting rates, such as changes to the
“Nil to Report” form, to allow feedback to hospitals of
their reporting rates in comparison to hospitals with
similar transfusion requirements. It is hoped to
address this issue in the future.
National Haemovigilance Office16
2000
37%
31%
68%
2004
59%
41%
100%
2003
60%
40%
100%
2002
49%
44%
93%
2001
50%
27%
77%
Table 5 Hospital Participation (2000–2004)
Year
Submitted incident
Nil to Report
Participation
This category account for 60% of incidents reported(126 of 214)
There were no fatalities or major morbidity associatedwith the transfusions and all patients recoveredwithout complications. It is likely that in one casewhere transfusion was delayed because of samplelabelling problems that this contributed to mortality(Case 18).
The Site of First Error indicates the stage in thetransfusion chain where the IBCT first occurred.
Figure 4 Site of first error - IBCT Cases including Anti-D(n=125*)
17Annual Report
Incorrect Blood Component Transfused
Definition: Incorrect blood componenttransfused (IBCT) is thetransfusion of a bloodcomponent/product which did notmeet appropriate requirementsand/or was intended for anotherpatient (SHOT 1996).
Laboratory(36) 29%
Prescription/Request(48) 38%
Clerking(4) 3%
Collection(4) 3%
Supply(4) 3%
Administration(24) 20%
Sampling(5) 4%
*One Anti-D case (case 79) has not been allocated a site of
first error
Introduction
In 2001 the NHO introduced stratification ofincidents by level of severity in the IBCT category.The following classification system is used:
· Level 1 Events with the real potential for permanentinjury or to be life threatening.
· Level 2 Events that are very unlikely to causepermanent harm or have the potential forminimal or transient harm.
· Level 3 Events with no realistic potential for harm.
Level 1The transfusion of a unit of blood or blood componentor product to the wrong recipient has been taken asa major or level 1 incident, irrespective of whether theblood was by chance ABO compatible or whether ornot there were complications. This is due to thepotentially disastrous effects of the transfusion of thewrong blood to the wrong patient and the level ofsystem failure involved. Similarly, mistakes whereeither Rh D positive blood components were given toa Rh D negative female of child bearing age, or Anti-D prophylaxis was omitted in error or giveninappropriately have also been classified as level 1incidents. Inappropriate transfusions or events wherepatients who did not require a transfusion of a bloodcomponent/product but who received oneinadvertently on the basis of incorrect haematologyresults were also classified as level 1 incidents.
In 2004 there were 52 cases (42%) reported whichwere classified as Level 1 incidents.
Level 2Incidents such as failure to give cytomegalovirus(CMV) negative or irradiated cellular bloodcomponents have been classified as level 2 incidents.Although the effects of such a mistake are potentiallyvery serious, they are in fact extremely rare becauseleucodepletion of all blood components has verylargely abrogated the risks. Incidents whereguidelines were not adhered to or discrepancies inpatient identification or errors in handling bloodcomponents not meeting the criteria for a level 1incident have also been classified as level 2.
In 2004 there were 53 cases (42%) reported whichwere classified as Level 2 incidents.
Level 3Level 3 incidents on the other hand, do not pose anyrisk to patients. However, they do indicate defects inthe quality of the service delivered. Where multipleerrors have been reported in the same patient, wehave reclassified Level 3 incidents as Level 2because of the possible cumulative effects on thequality of service delivery. Those that are collectedunder the programme can be instructive and usefulfor education purposes as they are indicative of abreakdown in procedures. The National Blood UsersGroup (2002) recommends that any such breakdownshould be investigated and corrected even if therecipient of the transfusion is unharmed.
In 2004 there were 20 cases (16%) reported whichwere classified as Level 3 incidents.
*One Anti-D case (case 79) has not been levelled.
Summary of the key IBCT Findings andRecommendationsTables of all cases, selected detailed case historiesand the detailed findings and recommendations areincluded in the relevant subsections. Anti-D IBCTincidents are presented in a separate section at theend of this chapter.
National Haemovigilance Office18
Errors involving wrong ABO/Rh group,wrong blood or wrong blood to patient
Findings• There were 16 Level 1 incidents where the patient
received blood components of the wrongABO/Rh group or where the wrong blood orblood component was given. A number of theseinvolved components given to the wrong patient.
• An ABO incompatible red cell transfusion wasgiven to the wrong patient who did not require ablood transfusion (Case 116). This occurred in anA&E department where remote checking of theunit and failure to check the identity of the patientwho was not wearing an ID band wereresponsible for the error. The patient who wasGroup O, suffered a reaction after 100mls ofGroup A red cells had been transfused, by whichtime the error was discovered. The patientrecovered fully.
• A further patient (Case 76), who also did notrequire transfusion, received blood which wasfortunately ABO compatible. This error occurredbecause the wrong patient’s compatibility reportwas used to collect blood from the laboratory. Thewrong blood was therefore collected for thewrong patient. The unit was checked remotelyfrom the patient’s bedside. The nurse thenbrought the unit to the wrong patient’s bedsideand administered it without checking the patient’swristband.
• Two patients (Cases 27, 82) received red cells ofthe incorrect Rh group due to a laboratory error inrecording the results of testing.
• One patient (Case 1) was transfused with redcells crossmatched with a sample from a differentpatient of the same name because incompletedetails were taken when a telephone order wasmade. A further patient (Case 87) was transfusedwith red cells crossmatched using a frozen serum
sample from the wrong patient due to a sampletransposition. Fortunately in the two cases, bothpatients were the same ABO Rh group.
• One case (Case 57) involved the use of ABOcompatible ‘walk in’ donors to provide fresh wholeblood in a massive transfusion setting.
• Three patients (Cases 20, 23, 46) received Oplasma instead of their correct group which wasA. One case (Case 20) involved the collection,thawing and administration of unlabelled plasma inerror by nursing staff. In two cases (Cases 23, 46)the units were incorrectly issued by the laboratory.
• Two patients (Cases 53 and 78) received Oplatelets instead of their correct ABO group whichwas B and A respectively. One of these (Case 78)was an infant.
Recommendations • Staff administering transfusions must adhere
strictly to the policies and procedures fortransfusing blood.
• The checking procedure must be performed at thebedside. Remote checking is unacceptable anddangerous practice.
• The patient should be asked to verify theiridentification details and be involved in theidentification and checking process wherepossible.
• The patient identification details must always bechecked against the wristband during the bedsidecheck. The medical record alone must not beused to check patient identity.
• A check must be performed on the componentand on the identification documentation to ensurethat the correct component is selected at the siteof collection.
19Annual Report
• Electronic forms of patient and bloodcomponent/product identification are nowavailable and are recommended as they providethe highest degree of security. Where thesesystems are not in place, manual bedsideidentification procedures at sampling andadministration remain the gold standard and mustbe strictly adhered to (NBUG, 2004).
• An uninterrupted working environment should bemaintained during the crossmatch and issue ofunits, to avoid distraction and/or transposition.
• When possible written or electronic blood/bloodcomponent transfusion requests are preferred. Inthe event of telephone orders hospitals shouldhave a SOP or policy regarding the informationrequired (NBUG, 2004).
• There is no place in the current management ofmassive haemorrhage for the use of ‘walk in’donors (NBUG, 2002).
• Hospitals should have a massive transfusionprotocol in place specifically designed for theirhospital taking into account local factors such asready availability of blood and blood components.This is particularly important in obstetrichaemorrhage. This protocol should be activatedperiodically to ensure that flaws are identified andstaff are familiar with it (NBUG, 2002).
Inappropriate Transfusions
Findings
There were 17 cases reported in this category. Thesewere of two types, transfusions based on incorrectlaboratory values and transfusions based on error inclinical judgement.
Incorrect Hb result There were two cases reported (Case 31, 93) wheretransfusion was based on the wrong Hb result. One
(Case 93) arose because of a communication errorbetween the clinical area and the laboratory and in thesecond (Case 31), the sample was unsuitable due tohaemolysis and should not have been processed.
Errors in clinical judgement There were 15 cases reported where the transfusionwas based on error in clinical judgement. Seveninvolved red cells and eight involved plasma.
Red Cells• Seven cases (Cases 4, 15, 33, 64, 70, 99, and
122) were reported where transfusion wasconsidered inappropriate because the Hb was notchecked between transfusions and the patientreceived more units than necessary. All sevenpatients were elderly and six were female.
• In two cases (Case 122 and 33), the Hb resultswere known. In Case 122, the Hb result of12.0g/dl was known, but the transfusion wasprescribed regardless.
• In the other case (Case 33), the Hb results werealso available but not checked and an elderlyfemale was over transfused. The Hb posttransfusion was 16.8 g/dl.
• In one case (Case 99), two units were prescribedand subsequently transfused where the patientwas stable and the clinical picture did not warranttransfusion.
PlasmaSeven Level 1 cases involved the inappropriate use ofplasma.
• In one case (Case 22), plasma was given tocorrect a low serum protein.
• In five cases (Cases 38, 62, 67, 71 and 120),plasma was given to reverse anticoagulants inpatients who were not bleeding. In Case 38, thepatient was scheduled for elective surgery.
National Haemovigilance Office20
• In case 119, plasma was administered to manageintra-operative bleeding, which had stopped.Coagulation studies were not performed.
Recommendations• Red cell transfusion must be administered on a
unit by unit basis in the non-emergency setting.
• Plasma is not indicated for the correction of a lowserum albumin.
• Plasma is not indicated for elective anticoagulantreversal. Plasma should only be given whereemergency reversal of anticoagulant therapy isindicated and where prothrombin complexconcentrates which are now licensed for thisindication are unavailable.
Failure to give Antigen Negative Blood
FindingsIn two cases (Case 63 and 110), antigen negativeblood was not supplied when requested. In one ofthese cases (Case 63), the patient had a pre-existingRh antibody documented, but this information wasnot clearly available from either the poorly organisedmanual records or the incomplete computer recordsin the laboratory. In the second case (Case 110),incorrectly antigen typed blood was issued in error inan emergency.
Recommendations• Consideration should be given to issuing antibody
cards to all patients with clinically significantantibodies (NBUG, 2002).
• The possibility of a national patient antibodyregister for patients with red cell antibodies shouldalso be evaluated.
• Once a clinically significant red cell antibody hasbeen detected in the past, the patient shouldalways receive antigen negative blood, eventhough the antibody is no longer detectable,except in an emergency situation where antigennegative blood is not available.
Failure to supply special requirements inCMV negative and/or irradiatedcomponents
Findings• Fifteen cases involved failure to administer CMV
negative and/ or irradiated components topatients requiring them.
• Fourteen cases involved failure to prescribe thecorrect component and as in all but one case(Case 88), clinical details were not entered on therequest form, the laboratory was not alerted to theerror.
• Three cases (Cases 51, 89 and 91) involvedtransfusion in an emergency but in one case(Case 51) although the patient had stabilised andthe need for specialised requirements wasrecognised, two of the remaining units were notwithdrawn but were transfused on subsequentdays.
• In two cases (Cases 107, 108) the patient wasreceiving shared care between centres but thepatient had not been transfused in that centrebefore. In three cases (Cases 89, 91 and 17), thepatient was admitted to a different facility and thenecessity for specialised components was notrecognised.
• In three cases (Cases 50, 88 and 123), the errorinvolved the laboratory. In one case (Case 88),the requirements on the request form wereoverlooked. In two cases (Cases 50 and 123), thelaboratory system alert was not noticed on oneoccasion (Case 123) and had not been activatedin the other (Case 50), although previoustransfusions had been CMV negative andirradiated.
• One case (Case 98) involved failure to prescribeCMV components to a pregnant woman.
• The final bedside check did not detect any of theerrors.
21Annual Report
Recommendations • The importance of providing clinical details to
laboratories is re-emphasised. In all but one case,clinical details which would have alerted thelaboratory were not supplied.
• Blood transfusion request forms should be fullyread at processing with particular attention to anyspecial requirements.
• Blood transfusion laboratory computer systemalerts which draw attention to the need forspecialised components should be used whereverpossible.
• Hospitals must put in place systems to ensure thatpatients who require specialised products receivethe correct component wherever possible.
• These systems should include labelling of thepatient’s medical record. As some of the incidentsinvolved shared care or admission to differenthospitals, issuing of a patient card should beconsidered.
• There are situations where CMV negativecomponents cannot be supplied, as in the case ofspecialised components such as HLA matched orHPA 1a negative apheresis platelets where onlysmall suitable numbers of donors are available, orin cases of blood shortage. In these cases, theuse of non CMV negative product is appropriateand as the product is leucodepleted, the risk ofCMV infection is very small and is outweighed bythe risks of failure to transfuse.
Patient/sample identification problems
Findings• In a number of cases, samples were not properly
labelled with the correct patient details. In onecase (Case 18), an elderly patient with severeanaemia had an unidentified antibody which led todelay in obtaining the correct blood. The patientdied before transfusion and this delay probably
contributed to mortality.
• There were two cases where an incompletetelephone order to the laboratory led to problemsin patient identity where there were two patientswith the same names in the hospital. In one casealready described, (Case 1), the blood wascrossmatched against a sample from the wrongpatient.
• In Case 28, although the correct blood was issuedon the crossmatch sample from this patient, thepatient’s identity was incorrectly assigned in thelaboratory because the incorrect patient with thesame name was selected from the computerdatabase.
• In one case (Case 35), the patient who had beentransfused earlier expressed concern when henoticed he had an incorrect ID band. However thecorrect blood was transfused as the correct IDband had been on at sampling and the ID bandwas not checked prior to transfusion.
Recommendations
• A secure patient identification procedure shouldbe in place in all hospitals and the ID wristbandshould be worn from the taking of the crossmatchsample right through the transfusion. This IDwristband should contain three unique identifiers,which include the patient’s full name, date of birthand unique identification number (NBUG, 2004).
• It is the professional responsibility of the personwho removes the ID wristband to replace it.
• Sample tubes should be handwritten correctly andlegibly immediately after sampling at the patientsside. Until automated systems are available,identification procedures must be strictly adheredto at the bedside to reduce sample errors. Wherepossible the patient should be involved.
• Hospital laboratories should have SOP or policies
National Haemovigilance Office22
for the acceptance or rejection criteria forincorrectly labelled samples. Such policies shouldcover amendments, which are acceptable, andthose, which are unacceptable and require a freshsample to be taken.
• In an emergency where there is insufficient time toobtain results from a fresh sample, the policyshould include the use of emergency Group O Rhnegative blood until the patient has beenregrouped.
• It is important that existing policies are fullyunderstood and regularly updated. It is critical toensure that on going education highlights to allmedical, nursing and laboratory staff, especiallythose not regularly working in transfusion orreturning from leave, the importance of strictcompliance.
Errors surrounding the Collection,Storage and Handling of BloodComponents
Findings• There were four cases (Cases 109,114, 121 and
127) where units were not correctly stored beforetransfusion, three involving red cells and oneinvolving SD plasma.
• These cases were Level 2 and Level 3 incidentsand are described in the appropriate tables.
• Case 121 involved a paedipack aliquot and isdescribed in the paediatric chapter.
Recommendations
• Documentation including the prescription shouldbe completed prior to collection of components inthe non-emergency setting.
• Should an unforeseen delay in thecommencement of the transfusion occur, it is
necessary to return the unit to controlled storagewithin 30 minutes and inform the laboratory toensure the unit is being returned to theappropriate fridge.
IBCT due to problems with infusion
FindingsThere were eight cases involving problems withinfusions.
• One case (Case 126), involved the transfusion ofantibiotics into the same line as a red celltransfusion via a three way tap. The patient whowas septic developed a fever and hypertensionpost transfusion. It is likely that this was relatedto his underlying condition rather than thetransfusion.
• In one case (Case 111), the second of two unitsof blood prescribed over three hours wasadministered in 50 minutes. The patient, a youngpost partum female, showed an increase in pulserate and blood pressure and chest tightnesssuggestive of fluid overload but recovered quicklywithout therapy.
• Four cases involved the use of a fluid giving setwithout an integral filter instead of a blood givingset (Cases 42, 58, 66 and 113). In two cases(Case 42, 113), the incident involved a newmember of staff. In one of these, the staff memberthought all fluids in theatre were administeredthrough a blood giving set as in the hospitals shehad previously worked in and presumed she wasusing a filtered set. In the second case, theperson was unfamiliar with the different packagingof the sets.
• One case (Case 66) arose because the fluidgiving sets and the blood administration sets werestored together and the wrong set was selected.
23Annual Report
Recommendations• No fluids other than normal saline should be
added to blood due to risk of haemolysis orclotting.
• It is recommended that blood administration setsbe stored separately to fluid administration sets.
• In the non-bleeding patient, infusion rates dependon the clinical context, age and cardiac status ofthe patient. Except for patients in the massivetransfusion setting, transfusion rates for bloodshould not exceed 2-4 mls/kg/hr (NBUG, 2004).
• The use of calibrated infusion pumps to ensurecorrect infusion rates should be evaluated.
Unit labelling Errors
Findings• There were three incidents (Cases 6, 24 and
105), where red cell units issued for transfusionwere mislabelled. In one of these cases (Case24), blood for two patients was labelled at thesame time and the unit labels were transposedbetween patients. Both were fortunately Group ORh negative and the patients suffered no harm.
Recommendations • There should be a dedicated area in the laboratory
for labelling products. At the time a unit is issued,there shall be a final check of transfusion recordsand each unit of blood or component (Brecher etal, 2003).
• Processing should be performed on samples fromthe beginning of the process to the endindividually and by one person, wherever possible.
• Where possible, two people should read andinterpret results in the laboratory.
• Wherever possible, only the units from one
crossmatch should be labelled and issued at anygiven time to avoid errors.
Blood Centre Supply problems Findings• Three incidents involved the supply centre, (Cases
25, 77, 110), where there was difficulty insupplying the correct component or where theincorrect component was issued in error.
• In one case (Case 77) there were no in-date Rhnegative platelets available to treat emergencyobstetric haemorrhage. A clinical decision wasmade to use Rh D negative platelets which hadexpired a few hours earlier in preference to Rh Dpositive platelets with Anti D.
• In Case 25, the product of choice for plasmaexchange was group B Octaplas. Due, however,to a shortage of group B Octaplas, Uniplas wasused.
• In another case (Case 110), an incompletelyantigen typed unit of red cells was selected andlabelled manually as antigen negative and issuedin error in an emergency, when in fact it wassantigen positive.
MiscellaneousFindings• There were a number of incidents where errors
occurred during issuing and administration ofblood where the possibility of patient harm waslow but which reflected failure to adhere to bestpractice.
• These included incidents where units had expiredpre-transfusion (Cases 39, 77), where more than72 hours had elapsed between the crossmatchsample being taken and the transfusion beingadministered (Case 5, 9, 54, 69, 80 and 117) orthe units were given too slowly (Case 13, 59, 100and 101).
National Haemovigilance Office24
Recommendations• While blood stock management to avoid wastage
due to outdating of units is an important aspect oflaboratory practice, laboratories should try toensure that blood close to expiry is not releasedfor patients who are unlikely to be able tocomplete the transfusion within the expiry period.
• Where blood isused near to expiry date the AABB2002 recommends that transfusion should becompleted prior to component expiration. Inindividual cases, a medical decision may be madeto continue the transfusion. The risk of stopping anecessary transfusion particularly when suppliesare short, coupled with the risk of exposing thepatient to another donor, must be balancedagainst the remote risks of completing atransfusion shortly beyond the expiry time.
• From starting the infusion to completion, infusionof the pack should take a maximum of four hours(NBUG, 2004).
• A repeat crossmatch sample is required if morethan 72 hours have elapsed since the time oftaking the pre-transfusion sample or betweentransfusions.
Incorrect Factor ConcentrateadministeredThe risk of errors when administering factorconcentrate therapy to patients is a constant hazard,particularly if staff are unfamiliar with the differentproducts. To minimise this, secure systems need tobe put in place to ensure the administration of thecorrect product to the correct patient. The NationalCentre for Hereditary Coagulation Disorders(NCHCD) has produced a standard protocol for staffadministering factor concentrates. This is availablefrom the NCHCD, located at St James Hospital,Dublin 8.
FindingsSix adverse events were reported involving factorconcentrates.
• In one case (Case 73), where recombinant factorVIII concentrate was given to the wrong patientwho was not a haemophilia patient, theprescription and drug were checked away fromthe bedside. When the patient’s first name wascalled, another patient with the same first namereplied and the patient’s ID wristband was notchecked.
• One patient (Case 112) who did not normallyrequire factor concentrate for control of his VonWillibrand’s disease received plasma derivedfactor concentrate in error through communicationfailure.
• Inadequate dosage was reported in two cases(Cases 19, 81).
• The wrong make of factor VIII concentrate wasadministered in one case (Case 21), and inanother (Case 115), the patient who requiredtreatment received the correct dose ofprothrombin complex which however had beenissued for a different patient.
Recommendations• The same precautions and identification proce-
dures need to be followed for factor concentratesas are for blood components.
• The importance of the bedside check is reiterated.
• Clear communication between treating centres isparamount in preventing error, as Case 112demonstrates.
• Except in the emergency situation, transfusion offactor concentrate products should only beadministered on the basis of a written prescription.
25Annual Report
National Haemovigilance Office26
Leve
l
1 1 1 1 1 1 1 2
Case
Num
ber
IBCT
Case
116*
IBCT
Case
76*
I BCT
Case
87*
IBCT
Case
1*
IBCT
Case
27*
IBCT
Case
57
IBCT
Case
82*
IBCT
Case
49
ABO
and
RhD
Grou
pof
Patie
ntGr
oup
ORh
Dpo
sitive
Grou
pA
RhD
posit
ive
Grou
pO
RhD
nega
tive
Grou
pO
RhPo
sitive
Grou
pA
RhD
nega
tive
Grou
pA
RhD
posit
ive
Grou
pO
RhD
posit
ive
Grou
pO
RhD
nega
tive
ABO
and
RhD
Grou
pof
IBCT
Grou
pA
RhD
posit
ive
Grou
pO
RhD
posit
ive
Grou
pO
RhD
nega
tive
Grou
pO
Rhpo
sitive
Grou
pA
RhD
posit
ive
Two
units
ARh
Dpo
sitive
One
unit
ORh
Dpo
sitive
Grou
pO
RhD
nega
tive
Grou
pO
RhD
posit
ive
Volum
eof
IBCT
10m
lsof
red
cells
70m
lsof
red
cells
Thre
eun
itsof
red
cells
One
unit
ofre
dce
lls
Two
units
ofre
dce
lls
Thre
eun
itsof
red
cells
Two
units
ofre
dce
lls
One
unit
ofre
dce
lls
Sym
ptom
sand
Outc
ome
Hype
rtens
ion,t
achy
card
ia,dy
spno
ea,w
heez
e,re
stles
snes
sand
anxie
ty.
Noco
mpli
catio
nsas
are
sult
ofth
istra
nsfu
sion.
Noco
mpli
catio
nsas
are
sult
ofth
istra
nsfu
sion.
Noco
mpli
catio
nsas
are
sult
ofth
istra
nsfu
sion.
Noco
mpli
catio
nsas
are
sult
ofth
istra
nsfu
sion.
Dono
rssu
bseq
uent
lyte
sted
nega
tive
forv
iralm
arke
rs.No
com
plica
tions
asa
resu
ltof
this
trans
fusio
n.
Noco
mpli
catio
nsas
are
sult
ofth
istra
nsfu
sion.
Noco
mpli
catio
nsas
are
sult
ofth
istra
nsfu
sion.
Caus
eof
Erro
r
ABO
incom
patib
leblo
odad
mini
stere
dto
the
wron
gpa
tient
due
tore
mot
ech
eckin
gat
the
nurse
ssta
tion
and
failu
reto
chec
kpa
tient
’sID
atth
ebe
dside
.Pa
tient
wasn
otwe
aring
awr
istba
nd.
Com
patib
ility
form
from
the
wron
gpa
tient
sent
toth
elab
orat
ory
and
aun
itof
red
cells
wasc
ollec
ted.
The
unit
wasr
emot
elych
ecke
din
the
treat
men
tro
om.
The
patie
nt’s
IDwa
snot
chec
ked
atth
ebe
dside
prior
totra
nsfu
sion.
Seru
msa
mple
incor
rect
lylab
elled
.W
rong
patie
nts’
seru
mcr
ossm
atch
ed.
Thre
eun
itsof
the
wron
gblo
odtra
nsfu
sed
which
happ
ened
tobe
Grou
pO
RhD
nega
tive.
Telep
hone
requ
estt
olab
orat
ory
forb
lood
forp
atien
t.Th
eon
lyde
tail
requ
este
dby
the
labor
ator
ywa
sthe
patie
nt’s
nam
e.Th
ere
were
two
patie
nts
with
simila
rnam
esin
the
hosp
itala
ndblo
odwa
scro
ssm
atch
edan
diss
ued
onth
ewr
ong
patie
nt’s
sam
ple.
This
wasn
otde
tect
edat
the
beds
idech
eck
asth
eun
itwa
snot
chec
ked
again
stth
ewr
istba
nd.
RhD
grou
pre
cord
edinc
orre
ctly
byon
call
med
icals
cient
istdu
ring
chan
geov
erof
shift
.
Thre
eun
itsof
whole
blood
take
nfro
m“w
alkin
dono
rs”an
dtra
nsfu
sed
durin
ga
mas
sive
haem
orrh
age.
Patie
ntinc
orre
ctly
grou
ped
asRh
Dne
gativ
e,dis
cove
red
onre
chec
king
asRh
Dpo
sitive
.
RhD
posit
iveun
itgiv
ento
RhD
nega
tive
patie
ntbe
caus
ean
incor
rect
com
men
twas
atta
ched
toth
eun
itwh
ichre
ad“U
nitgr
oup
diffe
rent
from
patie
ntbu
tOK
totra
nsfu
se”i
nste
adof
“Use
only
inEm
erge
ncy”.
TABL
E:6:
Erro
rsin
volvi
ngW
rong
ABO/
RhGr
oup,
Wro
ngBl
ood
orBl
ood
toW
rong
Patie
nt(R
edCe
lls)(
N=11
)
*Inc
luded
asfu
llca
sehis
tory
27Annual Report
Leve
l
2 2 2
Case
Num
ber
IBCT
Case
94*P IB
CTCa
se96
*P IBCT
Case
97*P
ABO
and
RhD
Grou
pof
Patie
ntGr
oup
ORh
Dpo
sitive
Grou
pO
RhD
posit
ive
Grou
pO
RhD
posit
ive
ABO
and
RhD
Grou
pof
IBCT
Grou
pO
RhD
posit
ive
Grou
pO
RhD
posit
ive
Grou
pO
RhD
posit
ive
Volum
eof
IBCT
One
aliqu
otof
paed
ipack
red
cells
One
aliqu
otof
pead
ipack
red
cells
One
aliqu
otof
paed
ipack
red
cells
Sym
ptom
sand
Outc
ome
Noco
mpli
catio
nsas
are
sult
ofth
istra
nsfu
sion.
Noco
mpli
catio
nsas
are
sult
ofth
istra
nsfu
sion.
Noco
mpli
catio
nsas
are
sult
ofth
istra
nsfu
sion.
Caus
eof
Erro
r
Thre
eali
quot
sofr
edce
llswe
reinc
orre
ctly
cros
smat
ched
and
trans
fuse
dfro
ma
paed
ipack
which
wasc
ross
mat
ched
and
alloc
ated
fora
noth
erba
byof
the
sam
ena
me.
Thre
eali
quot
sofr
edce
llswe
reinc
orre
ctly
cros
smat
ched
and
trans
fuse
dfro
ma
paed
ipack
which
wasc
ross
mat
ched
and
alloc
ated
fora
noth
erba
byof
the
sam
ena
me.
Thre
eali
quot
sofr
edce
llswe
reinc
orre
ctly
cros
smat
ched
and
trans
fuse
dfro
ma
paed
ipack
which
wasc
ross
mat
ched
and
alloc
ated
fora
noth
erba
byof
the
sam
ena
me.
TABL
E:6:
Erro
rsin
volvi
ngW
rong
ABO/
RhGr
oup,
Wro
ngBl
ood
orBl
ood
toW
rong
Patie
nt(R
edCe
lls)(
N=11
)(Co
nt)
*PInc
luded
asfu
llca
sehis
tory
inPa
ediat
ricCh
apte
r
Errors involving wrong ABO/Rh group orblood to wrong patient
A number of these cases are discussed in detail.
ERRORS INVOLVING BLOOD TO WRONGPATIENT: Case Histories (Red Cells)
Level 1 IBCT Case 116This elderly patient was being assessed in the A&Edepartment and was not prescribed for blood. Twostaff members checked a unit of Group A positive redcells, which was intended for another patient,remotely at the nurse’s station against thecompatibility label. One staff member then went tothis patient who was not wearing a wristband. Thestaff member did not ask the patient to identify herselfor check that she had a wristband. The transfusionwas commenced and following administration of 10mls of blood the patient developed symptoms ofhypertension, tachycardia, dyspnoea, wheeze,restlessness and anxiety. The staff member was stillat the bedside and realised that the wrong patienthad been selected. The unit was discontinued andchlorpheniramine, hydrocortisone IV, salbutamolnebuliser and oxygen at 4 L/min were administered.Intravenous NaCL was also commenced. The patientsettled shortly after the medication had beenadministered with resolution of symptoms within 24hours. The laboratory investigations showed that thepatient was Group O positive. The post transfusionDAT was positive but Hb, LFT’s , renal function testsand coagulation screen were normal and the patientrecovered fully.
Level 1 IBCT Case 76This incident involved the transfusion of 70 mls ofGroup O Rh D negative red cells to a group A Rh Dpositive patient who was not scheduled fortransfusion. The error occurred because a compatibility form foranother patient was sent to the laboratory requestingone unit of red cells. The laboratory provided acrossmatched unit for this request and it was
collected and brought to the clinical area. Twopeople checked the unit in the treatment room againstthe patient’s medical record. The nurse then went tothe wrong patient’s bedside. The patient was notasked to identify themselves and the details on thepatient’s wristband were not checked against the unitbefore the transfusion was commenced. The nursediscovered the error after 70 mls had been transfusedwhen it was noted that the compatibility form, whichwas now in the medical record, contained a differentname to that on the patient’s medical record. The unitwas immediately discontinued and the patientsuffered no complications as a result of thistransfusion.
Level 1 IBCT Case 87This female patient required a transfusion of threeunits of red cells for a perioperative bleed. A phonerequest for blood was made on-call to the laboratory.This patient had already been group and screenedand the medical scientist regularly working in bloodtransfusion thawed the specimen for crossmatch. Inerror, another patients frozen serum sample was usedfor this crossmatch. This occurred because thesample tube was incompletely labelled and while itcontained a similar unique number to that of thepatient, there were no other patient details. Also thesample tubes were normally stored in numerical orderbut on this occasion were out of sequence. Thepatient grouped as O Rh D negative. Three units ofgroup specific crossmatched red cells were issuedfor the patient. All three units were transfuseduneventfully. The error was discovered during aroutine check of all on-call work. The ward staff wereimmediately alerted and a sample was taken whichconfirmed the patient group as O Rh D negative.Laboratory investigations showed no evidence ofhaemolysis as the sample processed was the samegroup as the patient. As a result of this incident allserum samples are now bar-coded and must bescanned electronically prior to crossmatch.
Level 1 IBCT Case 1This elderly ITU patient, Patient X, with multi organ
National Haemovigilance Office28
failure required a transfusion. A telephone call wasmade to the laboratory asking if a group and hold hadbeen performed on this patient and this wasconfirmed. Later, a further telephone call was maderequesting red cells for this patient. The telephonelog was not filled in, and no other details other thanthe patients name were requested by the laboratory.There were two patients with the same name in thehospital and the blood was crossmatched and issuedfor the wrong patient, Patient Y. When the blood wascollected from the fridge, only name details werechecked. During the bedside check, the compatibilitylabel was checked against Patient Y’s details on thecompatibility form. Patient’s X ID wristband waschecked against his medical records. However theunit of blood, labelled with Patient Y details, was notchecked against Patient X’s wristband. Onretrospective crossmatch it was found by fortunatecoincidence that the unit was the same group as therecipient.
Errors involving blood of wrong Rh group:Case histories (Red Cells)
Level 1 IBCT Case 27This elderly male patient, admitted for investigation ofsymptomatic anaemia, required a transfusion of twounits of red cells. The patient had no historical recordof transfusion in this hospital. The group andcrossmatch were done during the on call period. Twomedical scientists were covering the session from17.00 hrs to midnight and one of these had startedthe procedure. The other medical scientist, whowould not normally work in blood transfusion,completed the procedure. The blood group wasdone using gel cards and the result was recorded asgroup A Rh D positive. The actual result was Group ARh D negative. Two A Rh D positvie units were issuedand transfused uneventfully when the error wasdiscovered the following day, during a routine audit ofon call work. This incident highlighted that as far aspossible the person starting the group andcrossmatch should also complete the procedure.
Level 1 IBCT Case 82This group O Rh D positive female required atransfusion of two units of red cells for anaemia Hb6.3g/dl. A medical scientist not normally working intransfusion did the crossmatch during the on callperiod over a weekend. No historical group wasavailable for the patient. The patient’s group wasidentified and recorded as O Rh D negative. Twounits of compatible red cells were issued andtransfused. Three days later when a furthertransfusion was required the patient grouped asgroup O Rh D positive which was confirmed ontesting a second sample. Retrospective testing of theoriginal pre transfusion sample also confirmed thepatient as O Rh D positive. Investigation of theincident has shown that an error occurred whenrecording the results of the grouping procedure. Asecond medical scientist reviewing on call work thenext day failed to identify the error. As a result of thisincident it is now recommended that a second groupmust be processed to confirm all on call work if ahistorical group is not available.
Errors involving wrong ABO/Rh group:Case histories (Plasma)
Level 1 IBCT Case 20This male patient on warfarin therapy, required anemergency transfusion of solvent detergent (SD)plasma following a fall. The pre-transfusion samplewas processed on call and the patient grouped as ARh D positive. In error four units of Group O SDplasma instead of Group A SD plasma were collectedfrom the storage fridge by nursing staff and signedout of the central plasma log, thawed by the nursingstaff and brought unlabelled to the ITU for this patient.There was no compatibility form and the nursing staffthought this was the product of choice. The errorwent unnoticed during the bedside checkingprocedure. The patient suffered no complications asa result of this transfusion. The error was identifiedduring routine retrospective audit by the HVO. Thisincident has highlighted the necessity for a medicalscientist to be involved in the issue of bloodcomponents.
29Annual Report
Level 1 IBCT Case 23This elderly male patient with multiple medicalproblems on warfarin had suffered an internalhaemorrhage. Three units of SD Plasma wereprescribed for emergency anticoagulant reversal. Thepatient was Group A Rh D negative. A medicalscientist who normally works in this area issued threeunits of Group O SD Plasma in error. Two membersof staff checked the units at the bedside but the errorremained undetected. The error was discovered on aroutine check of the issued plasma several days later.A software change on the laboratory computer hasbeen requested to include a warning if SD Plasmawhich is not the same ABO blood group of thepatient is requested for issue.
National Haemovigilance Office30
31Annual Report
Level
1
1
1
CaseNumber
IBCT Case 20*
IBCT Case 46
IBCT Case 23*
ABO and RhD Group ofPatient
Group A Rh Dpositive
Group A Rh Dpositive
Group A Rh Dnegative
ABO and Rh DGroup of IBCT
Group O SD Plasma
Group O SD Plasma
Group OSD Plasma
Volume ofIBCT
4 units of SD Plasma
Two units of SDPlasma
Three units of SDPlasma
Symptoms andOutcome
No complications as a resultof this transfusion.
No complications as a resultof this transfusion.
No complications as a resultof this transfusion.
Cause of Error
Group O SD Plasma was issued bynursing staff in error instead ofgroup A Octaplas.
Group O SD Plasma issued by thelaboratory to a group A patient.
Incorrect group SD Plasma issuedin laboratory in error for a group Apatient.
Table 7: Errors involving wrong ABO/Rh group Plasma (N=3)
Level
1
1
CaseNumber
IBCTCase 53
IBCT Case 78*P
ABO and RhD Group ofPatient
Group B Rh Dnegative withimmune anti D
Group A Rh Dpositive
ABO and Rh DGroup of IBCT
Group O Rh Dpositive
Group O Rh Dpositive
Volume ofIBCT
One unit of pooledplatelets
15mls of apheresisplatelets x 2
Symptoms andOutcome
No complications as a resultof this transfusion.
No complications as a resultof this transfusion.
Cause of Error
Group O Rh D positive plateletsissued to a Group B Rh D negativepatient due to incorrect groupselection in laboratory.
Group O platelets issued from thelaboratory for a Group A infant.
Table 8: Errors involving wrong ABO/Rh group platelets (N=2)
* Included as full case history
*P Included as full case history in Paediatric Chapter
National Haemovigilance Office32
Level
1
1
1
1
1
1
1
CaseNumber
IBCT Case 4*
IBCT Case 15
IBCT Case 33*
IBCT Case 64*
IBCT Case 70*
IBCT Case 99
IBCT Case122*
Volume ofIBCT
At least one unitof red cells
One unit of redcells
Two units of redcells
One unit of redcells
Three units of redcells
Two units of redcells
Two units of redcells
Symptoms and Outcome
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
Cause of Error
The patient received four units of red cells over atwo-day period but the Hb was not checkedbetween transfusions. Post transfusion Hb was13.4g/dl.
Hb prior to transfusion was 7.9 g/dl. Followingtransfusion of second unit of red cells Hb was9.7.g/dl. Third unit of red cells was inappropriatelytransfused. The post transfusion Hb was 13.5g/dl.
Two units of red cells prescribed although the Hbwas 12.8g/dl. Post transfusion Hb was 16.8g/dl.
Inappropriate transfusion of red cells. Posttransfusion Hb 14.4g/dl.
Three units of red cells transfused to a patient onweekly erythropoietin therapy without checking theHb between units. Post transfusion Hb 13.3g/dl.
Inappropriate transfusion. Patient had frankhaematuria but was haemodynamically stable. Hb12.4g/dl pre transfusion.
Communication error regarding updated Hb result.Two units of red cells transfused with a Hb of12.0g/dl.
INAPPROPRIATE TRANSFUSIONS (N=17)Table 10: Transfusion based on error in clinical judgement (Red cells) (N=7)
Level
1
1
CaseNumber
IBCT Case 31
IBCT Case 93
Volume ofIBCT
One unit of redcells
Two units of redcells
Symptoms and Outcome
No complications as a result of thistransfusion.
No complications as a result of thistransfusion
Cause of Error
Patient admitted with breathlessness. Phone resultmisheard as Hb 8.2g/dl, actual result 10.8g/dl.Post transfusion Hb 13.9g/dl.
Pre transfusion FBC specimen haemolysed.Haemolysis of the U/E specimen identified whichshould have prompted inspection of the FBCspecimen.
INAPPROPRIATE TRANSFUSIONS (N=17)Table 9: Transfusion based on incorrect result (Red Cells) (N=2)
* Included as full case history
Inappropriate Transfusion: Red Cells
Transfusion based on incorrect result: Casehistories
Level 1 IBCT Case 31This elderly male patient with malignancy wasadmitted for investigations for shortness of breath.The patient had been discharged from hospital twoweeks earlier when the Hb was 10.8g/dl. On thisoccasion following admission to the ward, a phonedHb result from the A&E department was misheard as8.2g/dl. Two unit of red cells were prescribed and thefirst was administered uneventfully. A repeat Hb priorto the second unit was 10.8g/dl and therefore thisunit was not transfused. Subsequent investigationsshowed that the shortness of breath was actuallycaused by a chest infection.
Level 1 IBCT Case 93 This elderly female patient with a history ofcardiovascular disease received a perioperativetransfusion of two units of red cells for a reported Hb6.5g/dl. The medical scientist processed the urea,electrolytes and the FBC samples on call. The U/Eresult showed serum potassium of 10mmols/L as thespecimen was haemolysed. While this should haveraised the suspicion of a problem with the FBCspecimen, this was not repeated. Two units of redcells were crossmatched and transfused uneventfullywith no Hb measurement on a unit by unit basis. Thepost transfusion Hb was 13.9g/dl which wasdiscovered during a routine audit by thehaemovigilance officer.
Transfusion based on error in clinical judgement: -Case histories
Level 1 IBCT Case 4 This elderly female patient with a history of gastricbleeding was transfused for anaemia, Hb. 6.7 g/dl.The patient received a total of four units of red cellson consecutive days - two units on the first day andtwo on the following day. During this two day period
there had been no further evidence of active bleeding.The Hb was not checked between transfusions. Onthe next day, the patient’s Hb was 13.4 g/dl,therefore, at least one unit of red cells wasinappropriately transfused. The patient suffered nocomplications as a result of this transfusion. Theincident was picked up by the HVO on retrospectiveaudit.
Level 1 IBCT Case 33 This elderly female patient with chronic medicalproblems including malignancy and generalisedweakness was prescribed a transfusion of four unitsof red cells. The pre transfusion Hb. was 9.5 g/dl. Twounits were transfused and the repeat Hb was 12.8g/dl. Despite this, two further units were transfused.On the day following transfusion the Hb was 16.8g/dl. The laboratory staff detected the error when theHb results were being issued.
Level 1 IBCT Case 64 This elderly female patient with underlying ischaemicheart disease and severe rheumatoid arthritis wastransfused with three units of red cells. The unitswere prescribed for a Hb of 9.5g/dl. The patient’shaemoglobin post transfusion of two units was11.9g/dl and following the third unit was 14.4g/dl.Subsequent investigation into the cause of thedyspnoea revealed pulmonary fibrosis with asuspected respiratory tract infection and thetransfusion of these units was consideredinappropriate. While the guideline in the hospitalstates the need to assess transfusion on a unit by unitbasis, this was not done.
Level 1 IBCT Case 70 This female patient with chronic renal failure,hypertension and underlying malignancy wasreceiving weekly erythropoietin therapy for chronicanaemia. On this admission the Hb was 5.8g/dl andthree units of red cells were prescribed. Thetransfusion took place over a weekend perioduneventfully but the Hb was not checked on a unit byunit basis. On routine audit the HVO discovered the
33Annual Report
patient’s post transfusion Hb was in fact 13.3g/dl.The patient suffered no complications as a result ofthis transfusion. It is likely that there was a problemwith the pre transfusion Hb sample although itappeared to be from the correct patient.
Level 1 IBCT Case 122 This patient with an underlying cardiac disease andother medical problems was awaiting surgery. Thesurgical procedure had been cancelled on a previousoccasion due to anaemia Hb 10.2 g/dl. The GPcontacted the consultant and requested that thepatient be admitted for transfusion prior to surgery inorder to avoid a further cancellation. The consultantthought this was the current Hb result but in fact itwas from a month before. On admission theconsultant left instructions that the patient was fortransfusion of three units of red cells. The patient hada FBC drawn on admission and the result was Hb12.0 g/dl. The medical officer did not convey thisresult to the consultant and the transfusionproceeded as directed. The patient received twounits of red cells but the third was cancelled when thepre-transfusion result was reviewed. This error wasdiscovered during routine audit by the HVO.
National Haemovigilance Office34
Inappropriate transfusion: Plasma
Transfusion based on error in clinical judgement:Case histories
Level 1 IBCT Case 38 This elderly patient was admitted in the afternoon foran elective procedure the following morning. Thepatient had taken 3mg warfarin in the morning prior toadmission. There was no documentation regarding
stopping warfarin prior to the procedure in thepatient’s medical record. The target range for INRprior to the procedure was 1.2 to 1.7. Vitamin K 2mgIV was administered in order to reverse theanticoagulation. The INR following this was 2.2. Oneunit of SD treated plasma was transfused and threehours later a further 2mg of Vitamin K wasadministered. The INR prior to the procedure was1.6.
35Annual Report
Level
1
1
1
1
1
1
1
2
CaseNumber
IBCT Case 22
IBCT Case 38*
IBCT Case 62*
IBCT Case 67*
IBCT Case 71*
IBCT Case 119*
IBCT Case120*
IBCT Case 52
Volume ofIBCT
One unit of SDplasma
One unit of SDplasma
Four units of SDplasma
Six units of SDplasma
Two units of SDplasma
Two units of SDplasma
Two units of SDplasma
Two units of SDplasma
Symptoms and Outcome
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
Cause of Error
Prescribed to treat hypoalbuminemia, contrary toguidelines for use of plasma.
SD plasma given to reverse anticoagulation due towarfarin prior to procedure.
SD plasma given to an elderly patient over 30minutes when vitamin K had already corrected theINR.
SD plasma given for warfarin reversal to a nonbleeding patient awaiting surgical review for kneeinjury INR 2.9.
SD plasma given for reversal of overanticoagulation with warfarin in non bleedingpatient.
Inappropriate transfusion of SD plasmapostoperatively to correct intraoperative bleeding,which had stopped. No coagulation studies hadbeen carried out.
SD plasma used to correct anticoagulation in nonbleeding patient.
SD plasma administered without a prescription.
INAPPROPRIATE TRANSFUSIONS (N=17)Table 11: Transfusion based on error in clinical judgement (Plasma) (N = 8)
* Included as full case history
Level 1 IBCT Case 62This elderly female patient on warfarin therapy, INR4.4, was admitted and was due to have an invasiveprocedure. Vitamin K 10mgs was given IV onadmission. A repeat INR ten hours later was 1.37.Two units of SD plasma were then prescribed statwith a further two units prescribed over 13 minuteseach for the reversal of oral anticoagulation. Inaddition to the unnecessary transfusion, the entirefour unit transfusion was completed within 30minutes which was against hospital policy whichstates that each individual unit should be transfusedover 30 minutes. The patient suffered nocomplications as a result of this transfusion. Theincident was discovered during a routine audit.
Level 1 IBCT Case 67 This patient with a history of cardiovascular diseaseand pulmonary embolus following previous surgery,was admitted for investigation of a knee injury. Thepatient was taking oral anticoagulants and the INRwas 2.8 with no associated bleeding. Six units of SDplasma were administered and the transfusion wascompleted prior to surgical review when it wasdecided that surgical intervention was not required. Atrial of Vitamin K was not considered. The patientsuffered no complications as a result of thisunnecessary transfusion.
Level 1 IBCT Case 71This elderly patient on warfarin therapy who was oneweek post surgery when the INR was found to be 7.4.There was no associated bleeding. A clinicaldecision was taken to administer two units of SDplasma to reverse this instead of administeringVitamin K despite being aware of current nationalguidelines regarding the use of SD plasma. Thefollowing day the INR was recorded at 5.7. Thepatient suffered no complications as a result of thisunnecessary transfusion.
Level 1 IBCT Case 119Two units of SD plasma were prescribed postoperatively for a patient following an elective surgical
procedure. No coagulation studies requested on thispatient. During a routine audit, the haemovigilanceofficer could not find a documented reason for thistransfusion as no other products were prescribed.When the prescription was questioned, theprescribing clinician felt that the patient bledexcessively during surgery although this appears tohave settled when the patient returned to the ward.The patient suffered no sequelae as a result of thisunnecessary transfusion.
Level 1 IBCT Case 120This patient admitted for medical investigations with ahistory of cardiac, respiratory and vascular disease,required treatment for raised INR of 17. The patientwas on warfarin therapy but there were no signs ofactive bleeding. One mg of vitamin K wasadministered and two units of SD plasma wereordered. The medical scientist queried the requestbut the two units were transfused overnight. The INRthe following day was 5.8. This transfusion did notcomply with national and local recommendations formanagement of excessive anticoagulation. The HTChas recommended that a consultant approve allrequests for plasma in future.
National Haemovigilance Office36
Failure to give antigen negative red cells:Case History
Level 1 IBCT Case 63This elderly patient with underlying malignancy andcardiac disease required a transfusion for anaemia5.5 g/dl. The patient had an anti C antibody presenton a previous occasion but the current antibodyscreen was negative. Manual and computer recordswere checked prior to transfusion but failed to detectthis history. On the manual records, two cards werestuck together, on the computer records twoepisodes were present but only one contained a fullhistory, so this information was missed. Three units ofred cells were transfused uneventfully. The error wasdiscovered during a training session. Post transfusionthe units were screened and one of the units wasfound to be C antigen positive. Post transfusiontesting showed the patient to be antibody screennegative, DAT negative.
37Annual Report
Level
1
1
CaseNumber
IBCT Case 63*
IBCT Case 110 This case isalso included inthe supplycentreproblemssection.
Antibodyspecificity
Anti-C
Possible anti Jka-detectedpreviously
Volume of redcells transfused
Three units of redcells
One unit of red cells
Symptoms andOutcome
No complications as aresult of this transfusion.
No complications as aresult of this transfusion.
Cause of Error
Antigen positive blood transfused to anantigen negative patient.Details missed during manual andcomputer record checking.
Patient with previous history of anti Jkaantibodies. Unit of red cells issued as anemergency from the supply centre wasincorrectly selected and labelled as antigennegative when in fact it was antigenpositive.
Table 12: Failure to give antigen negative red cells (N = 2)
* Included as full case history
National Haemovigilance Office38
Level
2
2
2
2
2
2
2
2
2
2
CaseNumber
IBCT Case 2
IBCT Case 17
IBCT Case 50*P
IBCT Case 51
IBCT Case 55
IBCT Case 85
IBCT Case 86
IBCT Case 88
IBCT Case 89
IBCT Case 91
Volume ofIBCT
Two units of redcells.Two units of plateletconcentrate
Two units of redcells
One unit of red cells
Five units of redcells
Four units of redcells Two units of platelet concentrate
Four units of redcells
Three units of redcells, one unit ofapheresed platelets,one unit of plateletconcentrate
Two units of redcells
Two units of redcells
Two units of redcells
Symptoms and Outcome
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
Cause of Error
CMV negative and irradiated blood not requested.
Failure to request CMV antibody negative andirradiated red cells for post solid organ transplantpatient in a different facility.
CMV negative and irradiated red cells not orderedand error not detected on processing in laboratoryas this requirement had not been flagged on aprevious transfusion.
CMV negative and irradiated red cells notprescribed in emergency setting.
Patient on list for solid organ transplant. CMVnegative and irradiated products not ordered.
CMV negative and irradiated red cells required butnot prescribed.
CMV negative and irradiated components requiredbut not prescribed. No clinical details included onthe request form, which could have alertedlaboratory staff.
CMV negative and irradiated units were prescribedbut not issued from the laboratory and the unitswere subsequently transfused without specialrequirements being noticed.
During an emergency admission CMV negative andirradiated units were not requested and with notransfusion history, the units were issued andtransfused without special requirements being metin this different facility.
Failure to prescribe CMV negative or irradiated redcells for an emergency transfusion for anaemiafollowing a solid organ transplant in a differentfacility.
Table 13: Error in CMV negative and irradiated component administration (N=15)
*P Included as full case history in paediatric chapter
Error in CMV negative and irradiatedcomponent administration: Case History
Level 2 IBCT Case 98 This young female patient required a transfusion oftwo units of red cells Hb 6.4g/dl for an ante partumhaemorrhage at 21 weeks gestation. Theprescription did not specify that CMV negative bloodwould be required and the request form did notindicate that this was an antenatal patient thus thelaboratory were not prompted to issue according tohospital policy. Two units of red cells were issuedand transfused uneventfully and the error was notdiscovered until a further request was made to thelaboratory specifying that this was an antenatal
patient. Of the two units that had been transfusedone was CMV positive. The patient has suffered nosequelae to date as a result of this transfusion.
39Annual Report
Level
2
2
2
2
2
CaseNumber
IBCT Case 98*
IBCT Case 102
IBCT Case 107*P
IBCT Case 108
IBCT Case 123
Volume ofIBCT
Two units of redcells
One unit of redcells
One unit of redcells
60 mls of red cells
One unit of redcells
Symptoms and Outcome
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
Cause of Error
Failure to prescribe CMV negative red cells for antenatal patient.
Patient with haematological malignancy, onchemotherapy, was not prescribed CMV negative orirradiated red cells.
Failure to prescribe CMV negative or irradiated redcells for a patient with a malignant haematologicaldisorder. Patient was receiving shared carebetween two different centres.
Failure to request and prescribe irradiated bloodproducts for a patient with a malignanthaematological disorder. Patient was receivingshared care between two different centres.
Failure to prescribe CMV negative or irradiated redcells for a potential solid organ transplant patient.Requirement for special needs flagged in computerfrom previous transfusions but not noted.
Table 13: Error in CMV negative and irradiated component administration (N=15) (cont)
* Included as full case history*P Included as full case history in paediatric chapter
Level
1
1
2
2
3
3
3
3
3
3
3
CaseNumber
IBCT Case 18*
IBCT Case 35*
IBCT Case 28*
IBCT Case 43
IBCT Case 14
IBCT Case 16
IBCT Case 29
IBCT Case 45
IBCT Case 47
IBCT Case 74
IBCT Case 75
Volume ofIBCT
Units nottransfused
Three units of redcells over two days
Three units of redcells
One paedi-pack
One unit of redcells
Two units of redcells
One unit of redcells
One unit of redcells
Three units of redcells
Eight units of redcells
One unit of redcells
Symptoms and Outcome
Failure to transfuse.Possible contribution to mortality.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
Cause of Error
Patient’s name, date of birth, and hospital numberincorrect on sample referred to reference centre.Patient had an unidentified antibody. Delay inproviding compatible red cells.
Patient expressed concern that he had received thewrong blood as he was wearing a wristbandbelonging to another patient. However he hadreceived the right blood as the ID band was correctduring sampling. Incorrect ID band not checked attime of transfusion.
Patient selection error during laboratory processingresulted in an incorrect compatibility label beinggenerated. The name and date of birth wereidentical but the hospital number and address wereincorrect.
Incorrect date of birth was transcribed from notesonto request form and sample tube.
Crossmatch sample without MRN number sent infrom GP. Transfused in hospital but the patient’sMRN number did not appear on either the sampletube, the crossmatch form, the compatibility label,the issue voucher or the wristband.
Surname incorrectly spelled on both request formand sample tube, leading to the issue andtransfusion of two units with surname incorrectlyspelled on both units and the collection slip.
One digit error in date of birth on pre transfusionsample request form and on unit transfused.
Incorrect date of birth inadvertently entered on thepatient’s ID wristband and sample tube.
Incorrect date of birth given by patient whenextremely unwell. Correct date of birth in previousrecords. Computer system in laboratory andhospital information system not linked.
Units transfused with incorrect DOB not confirmedduring bedside checking procedure.
Mother of patient stated patient’s date of birthincorrectly, i.e month, day, year instead of day,month, year.
Table 14: Patient/sample identification problems (N=11)
National Haemovigilance Office40
* Included as full case history
Patient/sample identification problems:Case Histories
Level 1 IBCT Case 18This elderly male patient with a symptomatic anaemia,Hb 3.1g/dl, was admitted from a care facility forevaluation and treatment. The patient had a history ofa CVA. The pre-transfusion sample was taken duringroutine working hours. A positive antibody screen wasdiscovered and a further sample was taken and sentto a reference laboratory for confirmation andcompatibility testing. The sample was incorrectlylabelled with respect to name and date of birth and arepeat sample was requested. A transfusion historywas not recorded on the request form and the carefacility was contacted but there was a delay in gettingthe information. A Chido antibody was identified inthe reference centre and compatible red cells wereissued. The patient became extremely unwell,suffered a cardiac arrest and died before receivingthe blood. The post mortem result revealed a severechest infection with bilateral pleural effusions,however, the delay in providing compatible red cellsmay have contributed to the patient’s death.
Level 1 IBCT Case 35 This male patient with a history of malignancyrequired a transfusion of three units of red cells forpostoperative anaemia. He had a previous transfusionhistory on file in this hospital. Two days following thetransfusion a relative approached the clinical staffconcerned that the wrong blood may have beenadministered as the patient was wearing an identitywristband that belonged to a different patient.Subsequent investigation has revealed that thepatient actually received the correct units intended fortransfusion. During pre transfusion sampling thepatient was wearing the correct identity wristband butthis was removed in theatre and replaced by a handwritten identity band. Following transfer to the ward itwas noted that the identity band was hand writtenand this was replaced with a printed identitywristband from the patient’s medical record, takenfrom the wrong record. The final bedside checkingprocedure pretransfusion involved verbal confirmation
of identity with the patient but did not include the stepto confirm the identity wristband. The patient sufferedno complications as a result of this incident.
Level 2 IBCT Case 28 This patient was prescribed a transfusion of threeunits of red cells for anaemia and a sample was sentto the laboratory for group and crossmatch. Thelaboratory computer system does not require thepatient details for processing. The user was given achoice of two patients on the system with the samename and the same date of birth; one was not an in-patient. The user selected the wrong patient and therequest was processed using the incorrect addressand hospital number. Thus the compatibility form andcompatibility labels were generated with incorrectdetails. Each unit was collected as requiredseparately and on each occasion the error was notdetected during collection of the units from thelaboratory. Two members of staff carried out thepretransfusion check at the bedside but failed todetect the error as each unit was checked against theblood compatibility form only and the patient’s identityband had been removed to gain IV access and notreplaced. When the last unit was collected a memberof the staff noticed the incorrect details on the unit.
41Annual Report
National Haemovigilance Office42
Level
1
1
2
2
2
2
2
2
2
2
CaseNumber
IBCT Case 111*
IBCT Case126*
IBCT Case 30
IBCTCase 40
IBCT Case 42*
IBCT Case 58
IBCT Case 66
IBCT Case 113
IBCT Case 124
IBCT Case 125
Volume ofIBCT
One unit of redcells
One unit of redcells with ivantibiotics
One unit of CMVantibody negativeand irradiated redcells
One unit ofapheresed platelets
Four units of redcells
Two units of redcells
One unit of redcells
Half a unit of redcells
90 mls of red cells
100 mls of red cells
Symptoms and Outcome
Chest tightness 40 minutesfollowing transfusion.
Pyrexia >1.5°C Hypertension.Chlorpheniramine andhydrocortisone administered.Recovered within 24 hours.Reaction probably related topatient’s underlying condition.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
Cause of Error
One unit of red cells prescribed over 3 hoursinfused in error within 50 minutes.
Antibiotics administered through a three-way tapinto the same line as the blood transfusion.
Unit of red cells transfused using an IVadministration set that had been used for aprevious platelet transfusion.
Platelets infused via an unsuitable pump.
Four units of red cells administered through a nonfiltered giving set because the staff memberpresumed that all fluids in the operating theatrewere transfused through blood administration sets.
Two units of red cells inadvertently administeredthrough a non filtered giving set.
Unit of red cells administered through a nonfiltered administration set. Blood administrationsets and regular administration sets are storedtogether.
Incorrect administration set used inadvertently bynew staff member.
Incorrect administration set inadvertently used.
Transfusion not checked against writtenprescription, blood warmer not used as indicated.
Table 15: IBCT due to problems with infusion (N=10)
* Included as full case history
43Annual Report
IBCT due to problems with infusion:Case histories
Level 1 IBCT Case 111 This young female patient required a transfusion ofred cells for postnatal anaemia -Hb 6.1g/dl. Two unitswere prescribed, each over a three hour period. Thefirst unit was given uneventfully however the secondunit had been infused in error within 50 minutes.Forty minutes following transfusion the patientcomplained of chest tightness and the heart rate andblood pressure were elevated from the baseline andthe patient required medical review. The examinationwas unremarkable and no specific medication wasprescribed. The patient recovered from this incidentwithin four hours. The incident was discovered whenthe HVO was asked in the ward about the need forinfusion pumps to avoid transfusion beingadministered too quickly and the incident of theinadvertent transfusion was described. As a result ofthis incident a report is currently being prepared intothe use of infusion pumps for transfusion.
Level 1 IBCT Case 126 This elderly male patient with underlying sepsis wasreceiving a transfusion of red cells for anaemia. Thepatient was prescribed IV antibiotics, which werechecked by two members of staff. The antibioticswere administered through a three-way tap into thesame line as the blood transfusion. Later anothermember of staff noticed the empty antibiotic bag insitu. The antibiotics were completed and theremainder of the transfusion was completed.Immediately following completion the patientdeveloped a rise in temperature of 1.2°C and a rise inblood pressure. Two and half-hours post transfusionthe temperature had further increased by 2.7°Cabove base line. Chlorpheniramine andhydrocortisone IV were administered. Posttransfusion the DAT and antibody screen wasnegative. The patient recovered fully within 24 hours.
Level 2 IBCT Case 42 This patient with a malignancy required a transfusionof four units of red cells for an intra-operative bloodloss. All four units were administered through a givingset without an integral filter. A new member of thestaff thought that all fluids in the operating theatrewere transfused through a blood giving set, as wasthe practice in other hospitals and she had worked inand presumed she was using a filtered set. Anotherstaff member detected the error. The patient sufferedno complications as a result of this transfusion
Unit Labelling Errors: Case histories
Level 1 IBCT Case 24 This female patient with a history of cardiac diseasewas prescribed a unit of red cells for anemia. In thelaboratory, the crossmatch was conductedsimultaneously with a crossmatch for another patientwho was prescribed two units of red cells. Bothpatients typed as Group O Rh D negative and hadnegative antibody screens. The unit numbers for eachpatient were transposed and subsequently incorrectlyentered on the computer system. One of the unitswas issued from the laboratory and the transfusioncommenced. One hour after the product had beencollected, laboratory staff detected the error duringroutine audit. The transfusion was discontinued. Onretrospective crossmatch the unit was confirmedcompatible with the recipient.
Level 2 IBCT Case 105 This female patient with an underlying malignancywas admitted via A&E and required a transfusion ofred cells for symptomatic anaemia Hb 5.8g/dl. Thepatient regularly attended the day ward fortransfusion. On this occasion, three units of red cellswere prescribed during the on call period. Duringissue of the units, however, a problem was
encountered with the computer printer and only twoissue labels were printed. These two labels werereversed and then fixed to crossmatch compatible butincorrect units. The third unit was returned to stockat that time. During the collection of the first unit,which was labelled with the details for the unit putback into stock, the incorrect label went unnoticed.The unit was checked at the bedside but the unitnumber was not checked. The unit was transfuseduneventfully. The ward phoned the laboratory for thesecond and third units and at this point, the error wasdiscovered. A new label was generated for thesecond unit which was correct. However, during thecollection process the unit was signed out of thelaboratory against the wrong unit. The unit wastransfused uneventfully and the third unit, nowcorrectly labelled was also administered. The errorrelating to the transfusion of the second unit wasdiscovered when the medical scientist on call wascarrying out an audit of units remaining in the fridgeand discovered that one unit signed out actuallyremained in the fridge. The patient suffered nocomplications as a result of this transfusion but theincident has highlighted the importance of checkingboth the unit number and the compatibility label onthe back of the pack.
National Haemovigilance Office44
Level
1
2
2
3
CaseNumber
IBCT Case 24*
IBCT Case 105*
IBCT Case 6
IBCT Case 41
Volume ofIBCT
One unit of redcells
Two units of redcells
One unit of redcells
24 units of SDPlasma
Symptoms and Outcome
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
Cause of Error
Unit numbers for two different crossmatchedpatients transposed on compatibility slip.
Unit labels for crossmatched units attached to theincorrect units. Undetected during the final bedsidechecking procedure.
The medical scientist crossmatched three units forthis patient. The labels for two of the intendedunits were transposed.
Incorrect batch number and group on SD Plasmaon label in error in emergency due to incorrectselection of batch number from computer.
Table 16: Unit labelling errors (N=4)
* Included as full case history
45Annual Report
Level
1
1
2
CaseNumber
IBCT Case 77
IBCT Case 110IBCT
Case 25*P
ABO and RhD Group ofPatientGroup A Rh Dnegative
Group O Rh Dpositive
Group B Rh Dnegative
ABO and RhD Group ofIBCT
Rh D negative
Group O Rh Dpositive
Uniplas - SDPlasma
Volume ofIBCT
Two units ofplatelet concentrate
One unit of redcells
Plasma exchangedon four occasionswith 12 units ofUniplas
Symptoms andOutcome
No complications as aresult of this transfusion.
Significant rise in BPduring transfusion, whichresolved on cessation oftransfusion and withoutmedication. Unlikely tobe related to thetransfusion.
Positive DAT.No other complications asa result of thistransfusion.Subsequently transfusedwith group B FFP.
Cause of Error
No in-date Rh negativeproduct available. Expiredunits issued and transfused inemergency obstetrichaemology.
Unit of red cells issued as anemergency from the supplycentre was incorrectlyselected and labelled asantigen negative when in factit was antigen positive.
Inability of supply centre tosupply group B SD plasma forlarge volume exchange.
Table 17: Blood supply centre problems (N=3 )
*P Included as full case history in paediatric chapter
Level
2
2
3
3
CaseNumber
IBCT Case 114
IBCT Case 121*P
IBCT Case 109
IBCT Case 127
Volume ofIBCT
Two units of SDplasma
One aliquot of redcells
One unit of redcells
One unit of redcells
Symptoms and Outcome
No complications as a result of thistransfusion
No complications as a result of thistransfusion
No complications as a result of thistransfusion
No complications as a result of thistransfusion
Cause of Error
SD Plasma transfused 12 hours after it wasthawed.
Last aliquot of paedipack red cells removed fromfridge in error and wasted. Stock neonatal red cellsused.
Blood out of controlled storage for 1 hour and 25minutes, then returned to fridge. Later transfused.
Unit recalled by blood issue centre as thetemperature of the blood storage area on thevehicle during delivery was not within specificationon one probe, although van temperature chart waswithin specification.
Table 18: Errors surrounding collection, storage or improper handling of components (N=4)
*P Included as full case history in paediatric chapter
National Haemovigilance Office46
Level
3
CaseNumber
IBCT Case 39
Volume ofIBCT
Two units of redcells
Symptoms and Outcome
No complications as a result of thistransfusion.
Cause of Error
Two units transfused which had expired. Due to abank holiday the day before ward staff checkingthe unit had mixed up the date and thought it wascorrect. It is not clear why short-dated blood wasissued from the laboratory.
Table 20: Expired units transfused (N=1)
Volume ofIBCT
One unit of redcells
One unit of redcells
One unit of redcells
One unit of redcells
One unit of redcells
Two units of redcells
Cause of Error
Crossmatch sample should have been repeated asmore than 72 hours had elapsed since the originalcrossmatch had been taken The patient had beentransfused within that time.
Patient needed three units of red cells. Third unitgiven outside 72 hours from the collection of thecrossmatch sample. A new sample would havebeen required.
A unit of red cells was collected from the issuefridge more than 48 hours after the first unit wastransfused outside hospital policy.
Unit issued using a crossmatch specimen whichwas 58 hours old when the patient had beentransfused within this period outside hospital policy.
Transfusion >72 hours from time of sample.Failure by laboratory to remove blood from thefridge.
An on call medical scientist crossmatched 2 unitsof red cells outside the 48 hour period required byhospital policy.
Miscellaneous (n=14) Included in this category are reports of:• Expired pre-transfusion sample/units (6)• Expired units transfused (1)• Transfusion time exceded (5) • Unit inappropriately checked (1)• Failure to prescribe transfusion (1)
Table 19: Expired pre-transfusion sample/units (N=6)
Symptoms and Outcome
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
CaseNumber
IBCT Case 5
IBCT Case 9
IBCT Case 117
IBCT Case 69
IBCT Case 54
IBCT Case 80
Level
2
2
2
2
3
3
47Annual Report
Level
2
CaseNumber
IBCT Case 90
Volume ofIBCT
Half a unit of redcells
Symptoms and Outcome
No complications as a result of thistransfusion.
Cause of Error
In a busy, short staffed ward, collection slip usedto cross check unit instead of compatibility reportform.
Table 22: Unit inappropriately checked prior to transfusion (N=1)
Level
3
CaseNumber
IBCT Case 118
Volume ofIBCT
One unit of redcells
Symptoms and Outcome
No complications as a result of thistransfusion.
Cause of Error
Red cells documented in patients notes but nottranscribed into the transfusion prescription chart.
Table 23: Failure to prescribe transfusion (N=1)
Level
3
3
2
3
3
CaseNumber
IBCT Case 13
IBCT Case 59
IBCT Case 83
IBCT Case 100
IBCT Case 101
Volume ofIBCT
One unit of redcells
One unit of redcells
One unit of redcells
One unit of redcells
One unit of redcells
Symptoms and Outcome
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
Cause of Error
Transfusion time exceeded four hours and resultedin some of the product being transfused aftermidnight on the date of expiry.
One unit of red cells transfused over 5 hours and10 mins following removal from fridge.
One unit of red cells transfused over 6 hours.
.
Unit transfused over 6 hours.
Unit transfused over 5 hours and 10 minutes.
Table 21: Transfusion time exceeded (N=5)
Wrong component transfused - Factorconcentrate: Case history
Level 1 IBCT Case 73 This patient with an underlying malignancy receivedrecombinant factor VIII in error. The product hadbeen prescribed for a patient with factor VIIIdeficiency. The patient was sharing a room with threeother patients and the product was checked againstthe prescription by two people in the clinic room,away from the patient’s bedside. When the patient’sfirst name was called in the ward, the incorrect patientanswered and the ID band or the mandatory three
identifiers were not confirmed. The product was givento this patient. The error was discovered followingadministration when the patient was again called bythe first name and replied that was not his name. Thecorrect patient was then identified and factor VII wasthen given to the correct patient.
National Haemovigilance Office48
Level
1
1
1
2
2
2
Volume ofIBCT
RecombinantFactor IX
RecombinantFactor VIII given towrong patient
Plasma derivedFactor VIIIConcentrate
One vial of theincorrect type ofrecombinant factorVIII
Recombinant factorVIII
One vial ofprothrombincomplexconcentrate
Cause of Error
An error was made in calculating the dose ofFactor IX required and an inadequate dose wasgiven.
Lack of communication between the primary carefacility and the prescribing hospital led to thisincident.
Remote checking and patient not formallyidentified. Factor VIII given to the wrong patient.
Only one person checked the register. The wrongpatient was selected when checking the registerand incorrect information passed on to theprescriber.
Patient with severe factor FVIII deficiency requiredrecombinant Factor VIII. The correct product but anincorrect dose was prescribed and administered.
Vial labelled for another patient was collected fromthe blood bank.
Table 24: – Wrong component transfused - Factor concentrate (N=6)
Symptoms and Outcome
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
Unnecessary exposure to bloodproduct.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
No complications as a result of thistransfusion.
CaseNumber
IBCT Case 19
IBCT Case 73*
IBCT Case 112
IBCT Case 21
IBCT Case 81
IBCT Case 115
* Included as full case history
Findings There were 25 incidents involving Anti-D. Thirteen(54%) were classified as serious or level 1 incidents.Nine (38%) were classified as level 2 and 2 (8%)were classified as level 3. One case was not levelledas it occurred outside the control of the hospital.
Errors in administration (N=7) • Six level 1 incidents involved the administration of
Anti-D in error (Cases 37, 48, 60, 92, 95 and106). Three involved administration of Anti-D toRh positive women.
• Two of these cases involved administration to thewrong patient (Cases 37 and 106), one of whomwas Rh D positive, because of failure to followcorrect identification procedures.
• In two further cases, patients were given Anti-Dbecause of a transcription error in the patient’schart in one case (Case 60), and a faxed report ofan incomplete laboratory investigation enteredonto the computer in the second case (Case 95).
Both patients were Rh D positive.
• In two cases (Case 48 and 92) the patient wasalready alloimmunised and therefore did notrequire Anti-D immunoglobulin prophylaxis.
Omission/Delay (N=12)Anti-D was omitted in six cases (Cases 3, 10, 26, 56,103 and104).
The reasons for failure to give Anti-D include:
• In one case, due to a laboratory transcription error,a test result was recorded incorrectly (Case 103).
• In another case (Case 3), there was an incorrectphoned result from the laboratory and the correctreport was only received five days post discharge.
• In a further case (Case 56), the patient hadsuffered a fall and a due to failure to review theKleihauer result prior to discharge, administrationof Anti-D was omitted. Subsequently the patient
Incorrect Blood Component TransfusedIncidents involving Anti–D Immunoglobulin
Incidents involving errors or omissions relating to Anti-D are collected by the NHO as they also relate totransfusion practice. Adverse reactions to theadministration of Anti-D are reportable directly to theIMB under the Pharmacovigilance Scheme, and ifreceived by the NHO are forwarded to them. Therefore,these are not covered in this report.
was readmitted to the hospital five weeks later forbleeding and received Anti-D on that admission.
• In another case (Case 104), Anti-D was not givenfor a large vaginal bleed at 35 weeks by the GP orat a routine hospital visit one week later. Thepatient was found to be alloimmunised at delivery.
In six cases Anti-D administration was delayed frombetween four to 11 days (Cases 7, 8, 12, 36, 84, and79).
The causes of the delay include:
• Failure to take a cord blood sample and thesubsequent transfer of the mother to anotherhospital (Case 8).
• Failure to prescribe Anti-D at time of receipt of thecord blood result and subsequently the result wasincorrectly transcribed into the chart (Case 84).
• In one case (Case 7), the result was only availableafter discharge. The patient was booked to returnfor a procedure which would have been within 72hours of delivery. A decision was made toadminister the Anti-D at this visit and while it wasissued it was not administered at that time.
• In three cases (Cases 12, 26, and 79), the patientcould not be contacted/failed to return to receiveAnti-D. However in one of these cases (Case 26)the delay was originally caused by the fact that theinitial blood group sample was incorrectly labelledand had therefore not been processed.
Recommendations• Procedures for the identification of the patient
prior to Anti-D administration should be asstringent as those performed for transfusion, i.e.checking of the records at the bedside andcorrect patient identification as per nationalguidelines (NBUG 2004).
• There should be easy access to current laboratoryresults, either in written or electronic format. Boththe prescriber and the person administering Anti-D should always check the most recent report ofthe patient’s RhD and antibody screen to assessthe need for the product prior to administration.Transcribed RhD results must not be accepted;the original reports must always be consulted.Wherever possible, these written results ratherthan telephone results should be used toprescribe and administer Anti-D.
• Anti–D results should not be entered into thecomputer/released before the result has beenconfirmed.
• Effective communication between clinical andlaboratory staff relating to antibody screening andthe issuing of Anti-D, both in the ante and postnatal period is vital in preventing errors. This isparticularly important where patients are receivingshared care between their GP and Obstetrician.
• Where mothers or babies are being nursedoutside the normal clinical areas or in a differenthospital, it should be the responsibility of thereferring unit to follow up these patients andensure that clinical staffs are aware of specificrequirements.
• Medical and Nursing staff working in all clinicalareas where RhD negative women are beingtreated should be familiar with Anti-D guidelines inorder to avoid errors or delay in the administrationof Anti-D.
• Where Anti-D has not been administered withinthe 72 hour period every effort should still bemade to administer the Anti-D within nine to tendays of the sensitising event as this may affordsome protection (BCSH,1999).
National Haemovigilance Office50
Problems with weak RhD groups ormisinterpretation of RhD status (n =4)
There were four cases in this category (Cases 11, 34,61 and 65)
• It is debatable whether some of these should beregarded as true errors as appropriatereagents/techniques were used and thedifficulties in identification of weak D types reflectthe limitations of the technology.
• In one case (Case 11), Anti-D was administeredon the basis of historical records and thesignificance of the weak D type (RhDu) was notrecognised by the laboratory or the administeringstaff.
• In two reports (Case 61 and 65), Anti-D wasissued and administered while awaiting aconfirmatory result from a reference centre whichshowed the patient to be RhD positive (weak Didentified). The administration of Anti-D in thesecases was in fact appropriate as the practice is inline with BCSH guidelines (2004).
• In one case (Case 34), a patient who had beenpreviously been classified as Rh D negative andhad received Anti-D, was now reclassified as RhDpositive (weak D) using different technology. Thisnew result was misfiled resulting in unnecessaryadministration of Anti-D.
Recommendations for weak RhD typing• The use of Du terminology is no longer
recommended. The phrase Du was originally usedfor D antigens detected by only some Anti-Dreagents. High grade Du cells are those that aredirectly agglutinated by some Anti-D reagents andlow grade Du refers to D antigens only detectedusing the indirect antiglobulin technique (IAT). TheBCSH Guidelines (2004) for compatibility testingrecommend that the IAT should not be used for D
typing of patients to reduce the potential formistyping partial D variants as Rh D positive.
• RhD variants may be divided into those that reflecta quantitative change or a qualitative change in theRhD antigen.
• Partial RhD variants are qualitatively different. TheRhD antigen is a mosaic of epitopes and partialRhD variants lack a proportion of these epitopes.People whose red cells lack part of the RhDmosaic can then form antibodies to the missingepitope which behave like Anti–D when testedagainst normal RhD types. The most commonpartial D type associated with risk ofalloimmunization to RhD is DVI.
• Weak D variants are considered to have all the Depitopes present but expressed weakly i.e. fewerD antigen sites per cell.
• Partial weak D cells have some epitopes missing,the remainder being expressed weakly.
• Most examples of weak D can be easily detectedby selecting high affinity monoclonal reagents forroutine RhD typing. The reagents/techniques usedshould not detect partial DVI types.
• Patients should not be regarded as RhD positivewhere a weak positive result has been obtainedusing only a single Anti-D reagent (or a pool ofmore than one reagent). It is safer to regard thepatient as RhD negative until confirmatorygrouping has been performed by a referencelaboratory
• Where verification checks against historicalresults reveal a discrepancy of an RhD group(previous RhD negative – now RhD positive) itshould not be assumed that this was due to failureof previous technology to identify a weak RhDphenotype. Confirmatory typing should be
51Annual Report
performed on a new sample to exclude a sampleidentification error.
• Investigation of discrepancies may require involvereferral to a reference serology laboratory. As Anti-D should be given as soon as possible after thesensitizing event and always within 72 hours,administration should not be delayed pendingavailability of results.
• The BCSH guidelines on compatibility testing(BCSH 2004) which includes RhD typing advisethat where uncertainty arises regarding a patient’sRhD status that the patient is treated as RhDnegative pending further investigation, as in Case61 and 65.
• Because it may be difficult or impossible todistinguish between passive Anti-D resulting froma previous Anti-D injection during pregnancy andweak Anti-D resulting from early immunisation,Anti D immunoglobulin should be given to anyeligible woman with weak Anti-D antibody atdelivery unless it has been clearly confirmed thatshe is already immunised (BBTS/RCOG 1999).
• Patients identified as having a partial D antigenshould be regarded as RhD negative and thesignificance should be explained to the patientand her clinician.
• Patients who are confirmed as weak RhD positiveshould be regarded as RhD positive fortransfusion and Anti-D prophylaxis purposes. If thepatient was treated as RhD negative in the pastthen the findings should be explained to both thepatient and the clinician and the patient’s fileclearly marked to indicate the change in status sothat confusion does not arise when sensitizingevents occur.
National Haemovigilance Office52
53Annual Report
Level
1
1
1
1
1
1
3
Volume of IncorrectBlood Component orProduct Transfused
One dose of Anti-D
One dose of Anti-D
One dose of Anti-D
One dose of Anti-D
One dose of Anti-D
One dose of Anti-D
One dose of Anti-D
Cause of Error
Anti-D given in error to a RhD positive motherbecause of remote checking and failure toconfirm positive patient identification prior toadministration.
Two group RhD negative patients with the samename and same address delivered babies within48 hours. One baby was RhD positive and theother RhD negative. Anti-D was given to thewrong mother.
Patient’s blood group incorrectly transcribed asO RhD negative on to the inside front cover ofthe patient’s record based on a report from adifferent hospital.
Blood group report faxed to ward, fromcomputer results which had been enteredbefore testing was complete on sample.
Anti-D detected in mother’s blood from previoussensitising incident, unknown cause.Laboratory instruction not to administer Anti-D.During medical follow up Anti-D ordered andadministered in error.
One unit of Anti-D given to an alreadysensitised mother following delivery.
PV bleeding during the first trimester, hospitalpolicy specifies half the normal dose to begiven in this case i.e. 626 iu. Full dose wasgiven.
Table 25: Administration of Anti-D in error (N=7)
Symptomsand Outcome
No complicationsreported to date.Unnecessaryexposure to bloodproduct
No complicationsreported to date.Unnecessaryexposure to bloodproduct.
No complicationsreported to date.Unnecessaryexposure to bloodproduct
No complicationsreported to date. Unnecessaryexposure to bloodproduct
No complicationsreported to dateUnnecessaryexposure to bloodproduct
No complicationsreported to date.Unnecessaryexposure to bloodproduct
No complicationsreported to date.
RhD Group of Patient
RhD positive
RhDnegative
RhD positive
RhD positive
RhDnegative
RhDnegative
RhDnegative
CaseNumber
IBCTAnti-D Case 106
IBCT Anti-D Case 37*
IBCTAnti-D Case 60*
IBCTAnti-D Case 95*
IBCTAnti-DCase 92*
IBCT Anti-D Case 48
IBCT Anti-D Case 32
WRONG IDENTITY
TRANSCRIPTION/RECORDING ERROR
ALLOIMMUNISED
INCORRECT DOSAGE
* Included as full case history
National Haemovigilance Office54
Level
1
1
1
1
2
2
Volume of IncorrectBlood Component orProduct TransfusedAnti-D omitted
Anti-D omitted
Anti-D omitted
Anti-D omitted
Anti-D omitted
Anti-D omitted
Cause of Error
An incorrect phone result was given by thelaboratory to the ward, stating that baby wasRhD negative. Baby was in fact RhD positive.Mother did not receive Anti-D. The official resultwas only received after discharge of the motherand was not acted on.
Administration delayed pending Kleihauer result.Kleihauer test showed occasional cells but notreviewed and Anti-D not administered.
Patient miscarried; the blood group testing wasperformed correctly but recorded incorrectly.Patient should have received Anti-D at thattime. Error detected on subsequent pregnancy.
Ante natal patient with a PV bleed at 35 weeksattended GP. Anti-D was not given. Routine antenatal visit one week later Anti-D notadministered. At delivery it was noted thatAnti-D antibodies had developed.
Failure to administer Anti-D following bleed in13th week of pregnancy. Previousgroup/records not checked
Patient presented post trauma at 36 weeksgestation. Specimen incorrectly labelled, repeatsample requested. Patient contacted and didnot return for 10 days. Patient refused Anti-D.
Table 26: Omission in administration of Anti-D (N= 6)
Symptomsand Outcome
No complicationsreported to date.
No complicationsreported to date.
No complicationsreported to date.
Anti-D antibodydeveloped
No complicationsreported to date.
No complicationsreported to date.
RhD Group of Patient
RhD Negative
RhD Negative
RhD Negative
RhD Negative
RhD Negative
RhD Negative
CaseNumber
IBCT Anti-D Case 3
IBCT Anti-D Case 56
IBCTAnti-D Case 103
IBCT Anti-D Case 104
IBCTAnti-D Case 10
IBCT Anti-D Case 26
55Annual Report
Level
1
1
1
2
n/a
2
Volume of IncorrectBlood Component orProduct TransfusedOne dose of Anti-Dadministered four days afterthreatened miscarriage.
One dose of Anti-Dadministered eight days postdelivery
Anti-D given >100 hoursfollowing delivery
One dose of Anti-D 5 days after bleed
Anti-D givenat 96 hours
Anti-D given 11 days post firstbleed
Cause of Error
Patient had a threatened miscarriage, 17 weeksgestation. Sample processed the following dayby which time the patient had been discharged.Patient scheduled to return for a procedurewithin the 72 hours Anti-D was issued foradministration at this visit but it was notadministered at this time.
Cord blood not taken from baby prior tomothers transfer to another hospital followingcaesarean section. The need for Anti-D for themother not identified.
Cord blood incorrectly transcribed into medicalnotes as RhD negative. Patient had beendischarged when the error was noted
Delay in administering Anti-D post sampletaking as the patient had been discharged andhad given an incorrect telephone number.
Patient discharged herself early. Did not returnfor Anti-D until >72 hours in spite of fourtelephone calls
Attended emergency room on two occasionswith heavy bleeding prior to 12th week ofpregnancy. Previous group records not checked.
Table 27: Delay in administration of Anti-D (N=6)
Symptomsand Outcome
No complicationsreported to date.
No complicationsreported to date.
No complicationsreported to date.
No complicationsreported to date.
No complicationsreported to date.
Unknown
RhD Group of Patient
RhD Negative
RhD Negative
RhD Negative
RhD Negative
RhD Negative
RhD Negative
CaseNumber
IBCTAnti-D Case 7
IBCTAnti-D Case 8*
IBCTAnti-D Case 84
IBCT Anti-D Case 12
IBCT Anti-D Case 79
IBCT Anti-D Case 36
* Included as full case history
National Haemovigilance Office56
Level
2
2
2
2
Volume of IncorrectBlood Component orProduct TransfusedOne dose of Anti-D
One dose of Anti-D
One dose of Anti-DReviewed and Anti-Dregarded as appropriate
One dose of Anti-D Reviewed and Anti-Dregarded as appropriate
Cause of Error
Anti-D was administered on the basis issued ofan historical records (A Rh negative, Dupositive) Most recent sample was not testeduntil the next working day and was reported asRh D positive. Both the laboratory and theadministering staff were unaware of thesignificance of Du positivity.
Patient previously grouped as A RhD negativeand received Anti-D in previous pregnancies.Although initial sample in current pregnancytested in reference laboratory suggested shemay have a partial D antigen, further testing ona new sample confirmed she was RhD positive(weak D). The new result was misfiledresulting in unnecessary Anti-D administration.
Patient grouped RhD negative, however,confirmation RhD status from reference centreshowed the patient was RhD weak D positive.
Patient grouped RhD negative by on callmedical scientist not normally working intransfusion. Scientist unaware of confirmatorytesting required for weak D group patients.
Table 28: Failure to identify weak RhD groups or misinterperation of RhD status (N=4)
Symptomsand Outcome
No complicationsreported to date.
No complicationsreported to date.
No complicationsreported to date.
No complicationsreported to date.
RhD Group of Patient
RhDpositive(weak Dpositive)
RhD positive (weak Dpositive)
RhD positive(weak Dpositive)
RhD positive (weak Dpositive)
CaseNumber
IBCT Anti-D Case 11
IBCT Anti-DCase 34
IBCT Anti-DCase 61
IBCTAnti-D Case 65
Level
3
2
Volume of IncorrectBlood Component orProduct TransfusedOne dose of Anti-D
One dose of Anti-D
Cause of Error
Incorrect batch number on the issue label andbox label of Anti-D as the batch numberselected was that of the next batch which wasin stock but not in use.
Vial of Anti-D labelled for one patient given to adifferent patient who also needed Anti-D.
Table 29: Anti-D batch number/labelling incorrect (N=2)
Symptomsand Outcome
No complicationsreported to date.
No complicationsreported to date.
RhD Group of Patient
RhDnegative
RhDnegative
CaseNumber
IBCT Anti-DCase 44
IBCTAnti-DCase 72
A number of case histories are described in moredetail
Wrong Patient
Level 1 IBCT Anti-D Case 37 Two RhD negative mothers with the same first namesurname and same address gave birth within 48hours. One baby grouped as RhD positive and theother as RhD negative. Anti-D was prescribed andrequested correctly for the RhD negative mother whohad delivered the RhD positive infant. Two healthcare professionals checked the documentation,which included the mother and infant’s RhD status,prescription and product, at the nurse’s station. TheAnti-D was administered at the bedside using themothers name as confirmation only and wasadministered to the incorrect patient. Followingadministration a midwife highlighted the presence oftwo patients with the same name and address to theperson who had administered the Anti-D and the errorwas realised. The correct patient received Anti-Dsubsequently.
Recording Errors
Level 1 IBCT Anti-D Case 60 This young group RhD positive patient delivered aRhD positive baby. An old report which originatedfrom another hospital was filed in the patient’s chart,where the result was recorded as RhD negative. Thisresult was transcribed on the inside front cover of thepatients current chart and Anti-D was prescribed,issued and administered to the patient based on thisresult. There were in fact more recent resultsavailable from the admitting hospital which showedthe patient to be Rh D positive. The error remainedundetected prior to issue from the laboratory whichdid not check their own Anti-D typing results. Theerror was discovered while checking the medicalnotes for other information.
Level 1 IBCT Anti-D Case 95 This antenatal patient presented to hospital at 11weeks gestation with a PV bleed and bloods weresent for routine antenatal screening to a laboratoryoff- site. The patient was aware that her blood groupwas RhD positive and she was discharged later thatevening. The patient’s blood group result was faxedto the ward later that weekend and the report showedthe group was O RhD negative. The patient wascontacted and requested to attend for administrationof Anti-D. When she presented she again repeatedthat in fact she was RhD positive and refused Anti-D.At this point the midwife contacted the laboratory andexplained the lady’s concern. The medical scientistchecked the computer records and said that thecorrect result had been faxed to the clinical area andAnti-D was administered by the midwife. Thelaboratory telephoned the ward some time later andstated that the result, which had been faxed to theward, was in fact incomplete and incorrect and thepatient’s blood group was O RhD positive. On postevent analysis it appears that a result had beenentered on the laboratory computer system prior tothe complete result being available and confirmed.
Alloimmunised
Level 1 IBCT Anti-D Case 92This RhD negative primigravida delivered a RhDpositive baby. Anti-D was detected in the mother’sblood. The reason for this sensitisation was unclear.The laboratory requested a further sample of bloodfrom the mother for Anti-D quantitation. Followingreview the laboratory result forms and the nursingnotes clearly stated that the mother was not for Anti-D immunoglobulin administration. The patient wasdischarged home. The mother attended a follow upmedical appointment and in error was referred backto the maternity hospital for Anti-D administration.The product was prescribed and administered asordered.
57Annual Report
Omission/delay in administration of Anti-D: Case history
Level 1 IBCT Anti-D Case 8 This lady was transferred to another hospital followinga caesarean section delivery. The baby did not havecord blood taken immediately post delivery althoughthe baby was subsequently grouped as RhD positive.On transfer of the mother back to the maternityhospital medical staff realised that the mother wasgroup RhD negative and the baby was group RhDpositive. Anti-D had not been administered to themother. Anti-D was administered eight days postdelivery.
National Haemovigilance Office58
This category captures acute allergic andanaphylactic reactions. All allergic type reactionsexcept for mild rashes and localised urticaria arecollected by the NHO as are such reactionsoccurring despite premedication cover.
As allergists are moving away from the term‘anaphylactoid‘, the European HaemovigilanceNetwork are proposing that the term ‘anaphylacticreaction’ which covers both anaphylactoid reactionsand anaphylactic shock should replace it. The NHOproposes to change the title of this category in 2006to Acute Allergic and Anaphylactic Reactions.
The cause of these allergic type reactions is not fullyelucidated (Gilstead, 2003). Severe IgA deficiency ispresent in about 1:700 blood donors and a smallnumber of individuals who are IgA deficient developanti IgA antibodies which can be associated withsevere and occasionally fatal reactions. In theJapanese population, where haptoglobin deficiency ismuch more common than IgA deficiency, anti-haptoglobin antibodies have been associated withallergic/anaphylactoid reactions. (Koda et al 2000)
In the majority of patients, however, no underlyingcause is found in the patient to explain the reactions.Reactions may not be triggered by the bloodproducts per se but rather by other concurrentaspects of patient treatment or parallel drugadministration. It is now appreciated thatangiotensin–converting enzyme (ACE) inhibitorsblock kininase II allowing accumulation of plasmakinins and increasing the risk of an anaphylactoidreaction (Unsworth 2005).
Plasma constituents in the product may beresponsible. Since the replacement of FFP by SDplasma which is associated with a low risk of allergictype reactions, increasing numbers of these reactionshave been reported to the NHO associated withplatelets. The majority are associated with pooledplatelets but cases have also been reported withapheresis platelets. Release of cytokines/chemokines in stored platelets such as C3a and C5a,have been suggested as a cause (Boehlen 2001)(Gilstad 2003) . In a small series of patients, removalof plasma from platelet concentrates andreplacement by platelet storage medium reduced the
Severe Acute Anaphylactoid orAnaphylactic Transfusion Reaction
DefinitionAllergic, anaphylactoid and anaphylactic transfusion reactions span a range ofsymptoms of varying severity. The symptoms encompass simple allergic-typereactions such as urticaria/pruritis associated with or without gastrointestinaldiscomfort, to more severe reactions such as stridor, wheeze, bronchospasm,laryngeal oedema and hypotension. The onset of intractable hypotension or shockwith loss of consciousness is commonly designated as an anaphylactic reaction. Inits severest form anaphylaxis can be fatal. (Vamvakas, 2001)
59
incidence of allergic type reactions, although it didnot have a significant effect on the incidence of febrilenon haemolytic type reactions. (Heddle 2002).
Serum tryptase is a marker of anaphylaxis whichpeaks in one to two hours and may return to normal inthree to four hours, but it can remain elevated for upto 48 hours. It has been suggested serum tryptasedeserves further study as a potential marker forsevere allergic transfusion reactions, with or withoutanaphylaxis. (Domen, and Hoeltge, 2003)
Findings
This category accounted for 16% (35 of 214) of theincidents reported during the reporting year. Thisrepresents an increase of 50% of submitted reportsbased on the 2003 figures due to increased reactionsassociated with platelets.
• The incidence of A/A was 1:651 units of plateletsissued,.1:22705 units of red cells/whole bloodissued and 1:12424 units of SD plasma issued.
• As in previous years, the majority of A/A reactionsinvolved platelets. Twenty one involved pooledplatelets and six involved apheresis platelets.
• Six (17 %) of the reports were associated with redcell transfusions.
• Two reports (6%) involved SD plasma (Cases 16and 31). In one case (Case 16), it appears thatthe transfusion was inappropriate as SD plasmainstead of vitamin K was used for warfarin reversal.
• Paediatric patients (under 18 years old) wereinvolved in seven reports (20%). The samepaediatric patient, however, was involved in threeof the reports (Cases 21, 22, and 23).
• As three patients were involved in more than onereport, a total of 31 patients were involved. Of the31 patients, 26 had an underlying malignantcondition.
• In eight reports, the patient had had a previoustransfusion reaction. In five cases, the patient hadreceived premedication prior to transfusion butwent on to develop a reaction nonetheless. Theseverity of the reaction however may havelessened. In one further report (Case 35), thepatient had a previous reaction to medication andwas receiving regular chlorpheniramine but did notreceive premedication before the transfusion.
• In 27 reports, recommendations were made tomanage future transfusions. In 12 reportspremedication cover prior to future transfusionswas recommended. In nine reports apheresisplatelets were recommended associated withpremedication. Washed components wererecommended in six cases.
• The majority of cases responded well to treatmentwith chlorpheniramine or a combination ofchlorpheniramine and hydrocortisone, within twohours. However in ten reports further treatmentwas required. One case (Case 34) associatedwith red cells required glyceryl trinitrate (GTN)spray, oxygen and IV fluids and transfer to atertiary centre for further management, althoughfuture transfusions have been uneventful.
• In the majority of reports there were cutaneousmanifestations, but in seven, these were notpresent. In one of these cases (Case 8), overloadwas also present and it is unclear if the reactionwas actually A/A. In one report (Case 30) the mainsymptoms were nausea and vomiting.
National Haemovigilance Office60
Recommendations
• Even mild allergic reactions should be reported tothe hospital blood bank and haemovigilanceofficer as subsequent reactions may be moresevere.
• Most allergic/anaphylactic transfusion reactionsrespond to chlorpheniramine. Steroids should bereserved for the more severe reactions.
• Prophylaxis with antihistamine should be given ifthere is a previous history of allergy or repeatedreactions.
• Protocols and training for the management ofsevere A/A reactions should be in place in eachhospital and all staff involved in transfusion shouldbe familiar with them. The National Blood UsersGroup (NBUG) has produced recommendationsfor the Management of an Acute TransfusionReaction (NBUG 2004) (See Appendix 1)
• Patients who have experienced an anaphylactoidreaction during a blood component transfusionshould have a label placed on their chart alertingclinical staff to their history of transfusionreactions and to ensure that appropriatepremedication is given prior to future transfusions.
• Where patient are receiving shared care, systemsmust be in place so that all relevant details relatingto transfusion such as history of reaction/allergyand/or premedication requirements can becommunicated between centres effectively.
• IgA deficiency (<0.05mg/dl) with anti IgAantibodies can cause severe anaphylactoidreactions and anaphylaxis.
• Patients with severe or repeated reactions shouldhave IgA levels performed.
• Since the transfused product may contain
appreciable quantities of IgA, where possible,samples taken pre-transfusion should be used tocheck for IgA levels.
• If anti IgA antibodies are present these patientswill require special transfusion managementincluding the use of saline washed cellularcomponents for future transfusions.
• Washed components for the management of A/Areactions are only appropriate for patients with ahistory of anaphylactic or severe anaphylactoidtransfusion reactions uncontrolled bypremedication. A poorly justified requirement forwashed components may cause undue delayswhen transfusions are needed in the future. Inaddition, washing of platelets can affect plateletyields with loss of platelet numbers and viabilityfrom the washing process and poor in vivoincremental rises.
• Before prescribing washed platelets for patientswith a history of transfusion reactions to pooledproducts, a trial of apheresis platelets should beundertaken as patients who react to pooledplatelets may often tolerate apheresis platelets.
• Classical allergic or anaphylactoid reactions donot routinely require culture of the unit or pack orserological investigations. However, whereatypical symptoms such as fever are present in asuspected A/A reaction or where skinmanifestations are absent, it is important to culturethe implicated unit/s and the patient, to rule outunderlying sepsis and/or bacterial infection in theunit and in the case of red cells to undertakeserological tests to exclude incompatibility.
61Annual Report
National Haemovigilance Office62
Case
No.
AA Case
1 AA Case
2 AA Case
3 AA Case
4 AA Case
5 * AA Case
7
Age
yrs
Gend
er
52 F 46 M 43 F 22 F 51 M 68 M
Com
pone
nt
One
unit
poole
dpla
telet
conc
entra
te
T wo
units
HLA
mat
ched
plate
letco
ncen
trate
One
unit
poole
dpla
telet
conc
entra
te
One
unit
poole
dpla
telet
conc
entra
te
One
unit
ofpo
oled
plate
letco
ncen
trate
One
unit
ofpo
oled
plate
letco
ncen
trate
Reas
onfo
rTra
nsfu
sion
Plat
eletc
ount
15x1
09/L
Malig
nanc
y.
Plat
eletc
ount
14x1
09/L
Haem
atolo
gical
Malig
nanc
y.
Plat
eletc
ount
34x1
09/L
Haem
atolo
gical
mali
gnan
cy,
activ
eble
eding
.
Plat
eletc
ount
17x1
09/L
Malig
nanc
y.
Plat
eletc
ount
76x1
09/L
Malig
nanc
y,ac
tive
bleed
ing.
Plat
eletc
ount
28x1
09/L
Malig
nanc
y.
Sym
ptom
s
Urtic
aria,
GIsy
mpt
oms
includ
ingcr
amps
.
Bilat
eral
perio
rbita
loe
dem
a.
Dysp
noea
,fall
ingO 2
satu
ratio
nsch
ills.
Dysp
noea
,sub
-ste
rnal
disco
mfo
rt,ta
chyc
ardia
(170b
pm),
fallin
gO 2
satu
ratio
ns,c
hills.
Urtic
aria,
dysp
noea
,GI
sym
ptom
s,ta
chyc
ardia
,fall
ingO 2
satu
ratio
ns.
Flush
ing,ur
ticar
ia.
Inves
tigat
ions
Unit
cultu
red
nogr
owth
.IgA
levels
notc
heck
ed.
Unit
cultu
red,
nogr
owth
.IgA
levels
notc
heck
ed.
IgAlev
elsno
rmal.
Cultu
reof
unit
and
patie
ntno
grow
th.
Patie
ntcu
lture
d,no
grow
th,u
nitno
tcult
ured
.IgA
levels
notc
heck
ed
Cultu
reof
both
unit
and
patie
nt,n
ogr
owth
.IgA
levels
notc
heck
ed.
None
Stag
eTra
nsfu
sion
Reac
tion
Deve
loped
Follo
wing
com
pletio
nof
trans
fusio
n.
Follo
wing
com
pletio
nof
trans
fusio
n.
Follo
wing
com
pletio
nof
trans
fusio
n.
Follo
wing
com
pletio
nof
trans
fusio
n.
Follo
wing
com
pletio
nof
trans
fusio
n.
Follo
wing
com
pletio
nof
trans
fusio
n.
Treat
men
t
Hydr
ocor
tison
ean
dch
lorph
enira
mine
IV.
Hydr
ocor
tison
ean
dch
lorph
enira
mine
IV.
Chlor
phen
iram
ineIV.
Hydr
ocor
tison
ean
dch
lorph
enira
mine
IVan
dsa
lbuta
mol
nebu
lizer
.
Hydr
ocor
tison
ean
dch
lorph
enira
mine
IV.
Hydr
ocor
tison
ean
dch
lorph
enira
mine
IV
Sequ
elae/
Reco
mm
enda
tions
forf
utur
etra
nsfu
sions
Reco
very
with
inon
eho
ur.
Subs
eque
nttra
nsfu
sions
have
been
unev
entfu
l.
Reco
very
with
inm
inute
s.No
reco
mm
enda
tions
docu
men
ted.
Reco
very
with
in30
minu
tes.
Aphe
resis
plate
letsh
ave
been
reco
mm
ende
dfo
rfu
ture
trans
fusio
ns.
Reco
very
with
in20
minu
tes.
Aphe
resis
plate
letsh
ave
been
reco
mm
ende
dfo
rfu
ture
trans
fusio
ns.
Reco
very
with
in45
minu
tes.
Patie
ntsu
bseq
uent
lyha
da
mild
urtic
arial
reac
tion
follo
wing
aphe
resis
plate
lets
and
isno
wbe
ingtra
nsfu
sed
with
wash
edpla
telet
s.
Reco
very
with
inon
eho
ur.
Prem
edica
tion
ofch
lorph
enira
mine
and
para
ceta
mol
have
been
reco
mm
ende
dfo
rfut
ure
trans
fusio
ns.
Tabl
e30
:AA
Case
sAs
soci
ated
with
Plat
elet
s(n
=27)
*Inc
luded
asa
full
case
histo
ry*P
Includ
edas
afu
llca
sehis
tory
inpa
ediat
ricch
apte
r
63Annual Report
Case
No.
AA Case
8 AA Case
9 AA Case
10 AA Case
11 AA Case
12 AA Case
13 *
Age
yrs
Gend
er
82 M 20 F 12 F 11 F 45 F 58 M
Com
pone
nt
One
unit
ofpo
oled
plate
letco
ncen
trate
One
unit
ofap
here
sispla
telet
conc
entra
te
One
unit
Poole
dpla
telet
conc
entra
te
One
unit
poole
dpla
telet
conc
entra
te
One
unit
poole
dpla
telet
conc
entra
te
One
unit
ofap
here
sispla
telet
conc
entra
te
Reas
onfo
rTra
nsfu
sion
Plat
eletc
ount
6x1
09/L
Haem
atolo
gical
mali
gnan
cy.
Plat
eletc
ount
<10x
109 /L
Malig
nanc
y.
Plat
eletc
ount
54x
109 /L
Haem
atolo
gical
mali
gnan
cy,
seps
is.
Plat
eletc
ount
18X1
09/L
Haem
atolo
gical
mali
gnan
cy.
Plat
eletc
ount
18x1
09/L
Haem
atolo
gical
mali
gnan
cy.
Plat
eletc
ount
<10x
109 /L
Haem
atolo
gical
mali
gnan
cy.
Sym
ptom
s
Hype
rtens
ion,
tach
ycar
dia,c
hills
rigor
s,fa
llin
O 2sa
tura
tion
and
rise
inPC
O 2,E
CGch
ange
s.
Dysp
noea
,sub
stern
aldis
com
fort,
fallin
gO 2
satu
ratio
ns,
restl
essn
essa
ndan
xiety
.
Urtic
aria
desp
itepr
emed
icatio
nwi
thhy
droc
ortis
one
and
chlor
phen
iram
ineIV.
Urtic
aria,
itch
and
disco
mfo
rtde
spite
prem
edica
tion
with
hydr
ocor
tison
ean
dch
lorph
enira
mine
IV.
Urtic
aria,
chills
rigor
s,vo
mitin
g,co
ugh
and
tight
ness
inth
roat
.
Urtic
aria,
dysp
noea
,str
idor,
whee
ze,a
ndfa
lling
O 2sa
tura
tions
.
Inves
tigat
ions
Cultu
reof
pack
and
patie
nt,n
ogr
owth
.
IgAlev
elno
rmal.
Cultu
reof
the
patie
ntan
dun
it,no
grow
th.
None
None
ABO
incom
patib
ility
exclu
ded.
IgAlev
elsno
rmal.
None
Stag
eTra
nsfu
sion
Reac
tion
Deve
loped
Follo
wing
trans
fusio
nof
50m
ls.
45m
inute
sint
oth
etra
nsfu
sion
when
190
mls
had
been
trans
fuse
d.
Follo
wing
com
pletio
nof
trans
fusio
n
45m
inute
safte
rco
mm
encin
gtra
nsfu
sion.
One
hour
follo
wing
com
pletio
nof
trans
fusio
n.
Twen
tym
inute
sint
oth
etra
nsfu
sion
when
160
mls
had
been
trans
fuse
d.
Treat
men
t
Hydr
ocor
tison
e,ch
lorph
enira
mine
,ad
rena
line
IV,sa
lbuta
mol
nebu
lizer
.Tran
sfusio
ndis
cont
inued
Hydr
ocor
tison
ean
dch
lorph
enira
mine
IV.Tra
nsfu
sion
disco
ntinu
ed.
None
Hydr
ocor
tison
eIV.
Hydr
ocor
tison
ean
dch
lorph
enira
mine
IV.
Hydr
ocor
tison
ean
dch
lorph
enira
mine
IVox
ygen
and
salbu
tam
olne
buliz
er.
Sequ
elae/
Reco
mm
enda
tions
forf
utur
etra
nsfu
sions
Died
unre
lated
totra
nsfu
sion.
Reco
very
with
intw
enty
minu
tes
Aphe
resis
plate
letsa
ndpr
emed
icatio
nha
vebe
enre
com
men
ded
forf
utur
etra
nsfu
sions
.
Reco
very
with
inth
irty
minu
tes.
Was
hed
com
pone
ntsh
ave
been
reco
mm
ende
dfo
rfut
ure
trans
fusio
ns.
Reco
very
with
inth
irty
minu
tes.
Was
hed
com
pone
ntsh
ave
been
reco
mm
ende
dfo
rfut
ure
trans
fusio
ns.
Reco
very
with
info
urho
urs.
Reco
mm
enda
tions
notd
ocum
ente
d.
Reco
very
with
in10
minu
tes.
Subs
eque
nttra
nsfu
sions
with
prem
edica
tion
ofch
lorph
enira
mine
have
been
unev
entfu
l.
Tabl
e30
:AA
Case
sAs
soci
ated
with
Plat
elet
s(n
=27)
(con
t)
*Inc
luded
asa
full
case
histo
ry*P
Includ
edas
afu
llca
sehis
tory
inpa
ediat
ricch
apte
r
National Haemovigilance Office64
Case
No.
AA Case
14 * AA Case
19 AA Case
20,2
4Sa
me
patie
nt
AACa
se21
,22&
23Sa
me
patie
nt*P
Age
yrs
Gend
er
26 F 20 M 62 F 6 M
Com
pone
nt
One
unit
ofap
here
sispla
telet
conc
entra
te
One
unit
ofpo
oled
plate
letco
ncen
trate
Two
units
ofap
here
sispla
telet
conc
entra
te(1
sttra
nsfu
sion)
Two
units
aphe
resis
plate
letco
ncen
trate
(2nd
trans
fusio
n)
One
unit
ofpo
oled
plate
letco
ncen
trate
(1st
trans
fusio
n)
Reas
onfo
rTra
nsfu
sion
Plat
eletc
ount
67x1
09/L
Haem
atolo
gical
mali
gnan
cy,
activ
eble
eding
.
Plat
eletc
ount
15x1
09/L
Haem
atolo
gical
mali
gnan
cy.
Plat
eletc
ount
<10x
109 /L
Haem
atolo
gical
mali
gnan
cy.
Plat
eletc
ount
<10x
109 /L
.Ha
emat
ologic
alm
align
ancy
.
Plat
eletc
ount
10x1
09/L.
Malig
nanc
y.
Sym
ptom
s
Hype
rtens
ion,d
yspn
oea,
subs
tern
aldis
com
fort
desp
itepr
emed
icatio
nof
chlor
phen
aram
ine.
Exte
nsive
rash
onall
limbs
.Dy
spno
eastr
idor,
whee
ze,
tach
ycar
dia,
hype
rtens
ion,
anxie
tyan
dpe
riorb
italo
edem
a.
Feeli
ngof
sunb
urn
onbo
thleg
sand
naus
ea.
Diar
rhoe
afo
llowi
ngda
y.
Rash
onan
terio
rasp
ect
offo
otan
dsw
ollen
foot
.
Urtic
aria
Inves
tigat
ions
IgAlev
elno
rmal,
HLA
antib
ody
scre
enne
gativ
e.
IgAlev
elspo
sttra
nsfu
sion
norm
al.
HLA
antib
ody
scre
enne
gativ
e.
IgAlev
elsno
rmal.
None
Stag
eTra
nsfu
sion
Reac
tion
Deve
loped
Two
hour
sFoll
owing
com
pletio
nof
trans
fusio
n.
Post
trans
fusio
n
Post
trans
fusio
nfo
llowi
ngda
yat
hom
e.
Post
trans
fusio
nat
hom
e.
Post
trans
fusio
n
Treat
men
t
Chlor
phen
iram
ine.
Hydr
ocor
tison
ean
dch
lorph
enira
mine
IV
None
,pat
ientw
asat
hom
e.
None
Sequ
elae/
Reco
mm
enda
tions
forf
utur
etra
nsfu
sions
Reco
very
with
infiv
em
inute
s.Pr
emed
icatio
nwi
thch
lorph
enira
mine
and
aphe
resis
plann
ed.
Ifun
succ
essfu
lsa
line
wash
edpla
telet
sto
beus
ed.
Reco
very
with
info
urho
urs.
Subs
eque
nttra
nsfu
sions
using
aphe
resis
plate
letsh
ave
been
unev
entfu
l.
Reco
very
time
uncle
ar.
Subs
eque
nttra
nsfu
sions
with
aphe
resis
plate
letsa
ndpr
emed
icatio
nof
chlor
phen
iram
ineha
vebe
enun
even
tful.
Reco
very
with
inon
eho
ur.
Tabl
e30
:AA
Case
sAs
soci
ated
with
Plat
elet
s(n
=27)
(con
t)
*Inc
luded
asa
full
case
histo
ry*P
Includ
edas
afu
llca
sehis
tory
inpa
ediat
ricch
apte
r
65Annual Report
Case
No.
AACa
se25 AA
Case
26,2
7Sa
me
patie
nt
AAca
se28
Age
yrs
Gend
er
46 M 68 F 49 F
Com
pone
nt
One
unit
ofpo
oled
plate
letco
ncen
trate
(2nd
trans
fusio
n)
One
unit
ofpo
oled
plate
letco
ncen
trate
(3rd
trans
fusio
n)
Two
units
poole
dpla
telet
conc
entra
te
One
unit
poole
dpla
telet
conc
entra
te(1
sttra
nsfu
sion)
One
unit
poole
dpla
telet
conc
entra
te(2
ndtra
nsfu
sion)
One
unit
poole
dpla
telet
conc
entra
te
Reas
onfo
rTra
nsfu
sion
Plat
eletc
ount
14x1
09/L.
Malig
nanc
y.
Plat
eletc
ount
19x1
09/L.
Malig
nanc
y.
Plat
eletc
ount
27x1
09/L.
Haem
atolo
gical
mali
gnan
cy.
Plat
eletc
ount
16x1
09/L.
Haem
atolo
gical
mali
gnan
cy.
Plat
eletc
ount
6x10
9 /L.
Haem
atolo
gical
mali
gnan
cy
Plat
eletc
ount
11x1
09/L.
Haem
atolo
gical
mali
gnan
cy.
Sym
ptom
s
Urtic
aria,
coug
han
dlum
pin
thro
at.
Whe
eze,
coug
h,lum
pin
thro
atan
ditc
hde
spite
prem
edica
tion
with
hydr
ocor
tison
ean
dch
lorph
enira
mine
IV.
Perio
rbita
loed
ema,
redn
essa
ndex
trem
eitc
hing
ofbo
thpa
lms.
Urtic
aria,
rise
inte
mpe
ratu
reof
1°C.
Urtic
aria,
dysp
noea
,wh
eeze
,che
sttig
htne
ssan
dco
ugh
desp
itepr
e-m
edwi
thhy
droc
ortis
one
and
chlor
phen
iram
ineIV.
Urtic
aria,
tach
ycar
dia,
dysp
noea
.
Inves
tigat
ions
None
None
None
None
None
Cultu
reof
patie
ntan
dpa
ck,n
ogr
owth
.
Stag
eTra
nsfu
sion
Reac
tion
Deve
loped
Post
trans
fusio
n.55
minu
tesa
fter
com
men
cing
trans
fusio
n
Post
trans
fusio
n.30
minu
tesa
fter
com
men
cing
trans
fusio
n
45m
insaf
ter
com
men
cing
first
unit
and
10m
insint
oth
ese
cond
unit.
16m
lsha
dbe
entra
nsfu
sed
140
mls
had
been
trans
fuse
d
Follo
wing
com
pletio
nof
trans
fusio
n
Treat
men
t
None
Salbu
tam
olne
buliz
er.
Hydr
ocor
tison
ean
dch
lorph
enira
mine
IV.
Hydr
ocor
tison
ean
dch
lorph
enar
mine
IV.Tra
nsfu
sion
disco
ntinu
ed.
Hydr
ocor
tison
eO 2
adm
iniste
red.
Hydr
ocor
tison
ean
dch
lorph
enira
mine
IV.
Sequ
elae/
Reco
mm
enda
tions
forf
utur
etra
nsfu
sions
Reco
very
with
inon
eho
ur.
Prem
edica
tion
prior
tofu
ture
trans
fusio
nsre
com
men
ded.
Reco
very
with
inon
eho
ur.S
ubse
quen
ttra
nsfu
sions
with
wash
edpla
telet
shav
ebe
enun
even
tful.
Reco
very
with
ineig
htho
urs.
Prev
ious
reac
tion
topla
telet
s.W
ashe
dpla
telet
san
dpr
emed
icatio
nwi
thhy
droc
ortis
one
and
chlor
phen
iram
inefo
rfut
ure
trans
fusio
nsha
vebe
enre
com
men
ded.
Reco
vere
dwi
thin
seve
nho
urs.
Pre-
med
with
hydr
ocor
tison
ean
dch
lorph
enira
mine
reco
mm
ende
d.
Reco
very
with
intw
oho
urs.
Prem
edica
tion
with
chlor
phen
iram
inean
dap
here
sispla
telet
shav
ebe
enre
com
men
ded
forf
utur
etra
nsfu
sions
.
Reco
vere
dwi
thin
two
hour
s.Pr
emed
icatio
nof
antih
istam
inepr
iorto
plate
lettra
nsfu
sion
hasb
een
reco
mm
ende
dfo
rfut
ure
trans
fusio
ns.
Tabl
e30
:AA
Case
sAs
soci
ated
with
Plat
elet
s(n
=27)
(con
t)
*Inc
luded
asa
full
case
histo
ry*P
Includ
edas
afu
llca
sehis
tory
inpa
ediat
ricch
apte
r
National Haemovigilance Office66
Case
No.
AAca
se29 AA Ca
se30 AA Ca
se33
AA Case
35
Age
yrs
Gend
er
54 F 73 M 55 M 30 M
Com
pone
nt
One
unit
poole
dpla
telet
conc
entra
te
One
unit
ofA
poole
dpla
telet
conc
entra
tePa
tient
O
One
unit
ofpo
oled
plate
letco
ncen
trate
One
unit
poole
dpla
telet
conc
entra
te
Reas
onfo
rTra
nsfu
sion
Plat
eletc
ount
16x1
09/L.
Haem
atolo
gical
mali
gnan
cy,p
ost
BMT.
Plat
eletc
ount
2x10
9 /L.
Haem
atolo
gical
mali
gnan
cy.
Plat
eletc
ount
57x1
09/L.
Liver
biops
y.
Plat
eletc
ount
10x1
09/L.
Haem
atolo
gical
mali
gnan
cy,
post
BMT.
Sym
ptom
s
Dysp
noea
,whe
eze,
thro
atsw
elling
,fall
inO 2
satu
ratio
ns.
Naus
eaan
dvo
mitin
g
. Urtic
aria,
dysp
noea
,GI
sym
ptom
sand
perio
rbita
loed
ema.
Ches
ttigh
tnes
s,na
usea
,vom
iting,
feeli
ngof
appr
ehen
sion
and
doom
,fac
ialsw
elling
.
Inves
tigat
ions
None
Cultu
reof
the
patie
nt,n
ogr
owth
.Pac
kcu
lture
,Co
agula
sene
gativ
esta
phylo
cocc
us,p
roba
bleco
ntam
inatio
n.
Cultu
reof
the
patie
ntan
dun
itno
grow
th.
IgAlev
elsno
rmal.
Stag
eTra
nsfu
sion
Reac
tion
Deve
loped
With
in15
minu
teso
fco
mm
encin
gtra
nsfu
sion
when
150
mls
had
been
trans
fuse
d.
Afte
rfou
rminu
teso
ftra
nsfu
sion
Follo
wing
com
pletio
nof
trans
fusio
n
Afte
r20
minu
teso
ftra
nsfu
sion.
150
mls
trans
fuse
d.
Treat
men
t
Hydr
ocor
tison
e,ch
lorph
enira
mine
IVan
dO 2
adm
iniste
red.
None
None
Hydr
ocor
tison
ean
dch
lorph
enira
mine
IV.
Sequ
elae/
Reco
mm
enda
tions
forf
utur
etra
nsfu
sions
Reco
vere
dwi
thin
30m
inute
s.Pr
emed
icatio
nan
dpla
telet
aphe
resis
have
been
reco
mm
ende
dfo
rfut
ure
trans
fusio
ns.
Reco
vere
dwi
thin
minu
tes.
Subs
eque
ntpla
telet
trans
fusio
nswi
thch
lorph
enira
mine
prem
edica
tion
have
been
unev
entfu
l.
Reco
vere
dwi
thin
one
hour
.Pr
emed
icatio
nof
chlor
phen
iram
ineha
sbe
enre
com
men
ded.
Reco
vere
dwi
thin
20m
inute
s.Pr
emed
icatio
nof
hydr
ocor
tison
e,ch
lorph
enira
mine
and
wash
edpla
telet
sha
vebe
enre
com
men
ded
forf
utur
etra
nsfu
sions
.
Tabl
e30
:AA
Case
sAs
soci
ated
with
Plat
elet
s(n
=27)
(con
t)
67Annual Report
Case
No.
AA Case
6 AA Case
15 P* AA Case
17 AA Case
18 AA Case
32 AA Case
34 *
Age
yrs
Gend
er
19 M 5 M 83 M 11 M 50 F 62 F
Com
pone
nt
One
unit
red
cells
One
unit
red
cells
One
unit
red
cells
One
unit
red
cells
One
unit
red
cells
One
unit
red
cells
Reas
onfo
rTra
nsfu
sion
Anae
mia
Hb7.7
g/dl
Haem
atolo
gical
mali
gnan
cy.
Anae
mia
Hb7.6
g/dl
Haem
atolo
gical
mali
gnan
cy,
activ
eble
eding
.
Anae
mia
Hb7.4
g/dl
Card
iacdis
ease
,m
ultipl
em
edica
lpr
oblem
s.
Anae
mia
Hb8.1
g/dl
Haem
atolo
gical
mali
gnan
cy.
Anae
mia
Hb8.1
g/dl
Vasc
ulard
iseas
e,ac
tive
bleed
ing.
Anae
mia
Hb8.6
g/dl
Malig
nanc
y.
Sym
ptom
s
Dysp
noea
,itch
ing,
naus
ea,g
ener
alise
djoi
ntpa
in.
Urtic
aria,
pero
rbita
loe
dem
a.
Oede
ma
ofup
perl
ip
Urtic
aria,
feve
rrise
of1.9
°C,c
hills,
rigor
s,ta
chyc
ardia
.
Urtic
aria
and
puffy
eyes
.
Urtic
aria,
tach
ycar
dia,
strido
r,wh
eeze
,fa
lling
O 2sa
tura
tion,
flush
ing,s
ubste
rnal
disco
mfo
rtan
da
rise
inte
mpe
ratu
reof
1.3°C
.
Inves
tigat
ions
ABO
incom
patib
ility
exclu
ded.
Post
trans
fusio
nan
tibod
ysc
reen
nega
tive.
Cultu
reof
patie
ntan
dun
it,no
grow
th.
None
ABO
incom
patib
ility
exclu
ded,
IgAlev
elno
rmal.
ABO
incom
patib
ility
exclu
ded.
Cultu
reof
patie
ntan
dun
it,no
grow
th.
ABO
incom
patib
ility
exclu
ded.
Cultu
reof
the
unit,
nogr
owth
.
Stag
eTra
nsfu
sion
Reac
tion
Deve
loped
Afte
r10
minu
teso
ftra
nsfu
sion.
50m
lstra
nsfu
sed.
Follo
wing
com
pletio
nof
trans
fusio
n.
With
intw
oho
urso
fco
mm
encin
gtra
nsfu
sion.
With
inth
ree
hour
sof
com
men
cing
trans
fusio
n.24
0mls
had
been
trans
fuse
d.
Afte
rone
hour
and
20m
inute
soft
rans
fusio
n.10
0m
lstra
nsfu
sed.
One
hour
forty
minu
tes
afte
rcom
men
cing
trans
fusio
n.24
0m
lstra
nsfu
sed.
Treat
men
t
Antie
met
icgiv
enfo
rna
usea
.Tra
nsfu
sion
disco
ntinu
ed.
Chlor
phen
iram
ine
Trans
fusio
ndis
cont
inued
.No
treat
men
tgive
n.
Hydr
ocor
tison
eIV,
para
ceta
mol.
Trans
fusio
ndis
cont
inued
.
Hydr
ocor
tison
ean
dch
lorph
enira
mine
IV.
Trans
fusio
ndis
cont
inued
.Hy
droc
ortis
one
chlor
phen
iram
ineIV,
adre
nalin
e,GT
Nsp
ray
oxyg
enan
dIV
fluids
.Tra
nsfe
rred
tote
rtiar
yce
ntre
foro
bser
vatio
n.
Sequ
elae/
Reco
mm
enda
tions
forf
utur
etra
nsfu
sions
Reco
very
with
in30
minu
teso
fre
ceivi
ngtre
atm
ent.
Furth
ertra
nsfu
sions
have
been
unev
entfu
l.
Reco
vere
dwi
thin
two
and
aha
lfho
urs
Subs
eque
nttra
nsfu
sions
with
prem
edica
tion
ofch
lorph
enira
mine
have
been
unev
entfu
l.
Reco
very
with
in30
minu
tes.
Prem
edica
tion
ofan
tihist
amine
has
been
reco
mm
ende
dfo
rfut
ure
trans
fusio
n.
Reco
very
with
in4-
5ho
urs.
Prem
edica
tion
ofan
tihist
amine
has
been
reco
mm
ende
dfo
rfut
ure
trans
fusio
n.
Reco
very
time
notd
ocum
ente
d.Su
bseq
uent
trans
fusio
nswi
thpr
emed
icatio
nof
chlor
phen
iram
ineha
vebe
enun
even
tful.
Unkn
own
reco
very
time.
Care
ful
obse
rvat
iondu
ring
subs
eque
nttra
nsfu
sions
which
were
unev
entfu
l.
Tabl
e31
:AA
Case
sAs
soci
ated
With
Red
Cells
(n=6
)
*Inc
luded
asa
full
case
histo
ry*P
Includ
edas
afu
llca
sehis
tory
inpa
ediat
ricch
apte
r
National Haemovigilance Office68
Case
No.
AA Case
16 * AA Case
31
Age
yrs
Gend
er
83 M 22 F
Com
pone
nt
Two
units
SDpla
sma
Thre
eun
itsSD
plasm
a
Reas
onfo
rTra
nsfu
sion
INR
3.8Ha
emat
oma
seco
ndar
yto
traum
a,ca
rdiac
disea
se.
INR
1.6Ma
jortra
uma.
Sym
ptom
s
Dysp
noea
,ras
hon
arm
san
dsto
mac
h,py
rexia
,ris
eof
2°C
inte
mpe
ratu
re.I
gAlev
elsno
tche
cked
.
Urtic
aria,
mar
ked
hypo
tens
ion,
bron
chos
pasm
.
Inves
tigat
ions
Cultu
reof
both
pack
s,no
grow
th.P
atien
tnot
cultu
red.
None
Stag
eTra
nsfu
sion
Reac
tion
Deve
loped
With
in30
minu
tes
follo
wing
com
pletio
nof
trans
fusio
n.
Follo
wing
com
pletio
nof
thre
eun
itsof
SDpla
sma.
Treat
men
t
Hydr
ocor
tison
e,ch
lorph
enira
mine
IVan
dox
ygen
ther
apy.
Hydr
ocor
tison
e,ch
lorph
enira
mine
IV,no
radr
enali
nean
dge
lofus
in.
Sequ
elae/
Reco
mm
enda
tions
forf
utur
etra
nsfu
sions
Reco
vere
dwi
thin
two
hour
s.Su
bseq
uent
trans
fusio
nsof
SDpla
sma
with
hydr
ocor
tison
ean
dch
lorph
enira
mine
prem
edica
tion
have
been
unev
entfu
l.
Patie
ntdie
dfiv
eda
yslat
erun
relat
edto
trans
fusio
n.
Tabl
e32
:AA
Case
sAs
soci
ated
With
Plas
ma
(n=2
)
*Inc
luded
asa
full
case
histo
ry*P
Includ
edas
afu
llca
sehis
tory
inpa
ediat
ricch
apte
r
Severe Acute Anaphylactoid orAnaphylactic Transfusion Reaction. CaseHistories:The following stories are described in detail as theyshow the problems encountered. (Cases 15, 21, 22and 23 are discussed in the Paediatric Chapter)
AA Case 5 This male patient with a newly diagnosed malignanthaematological disorder was actively bleeding. Hewas prescribed a transfusion of one unit of CMVantibody negative and irradiated pooled platelets for aplatelet count of 76x109/L. The patient’s primary careteam had indicated that the platelet count should bemaintained above 70x109/L. On completion of theunit the patient developed symptoms of urticaria,dyspnoea, tachycardia and falling oxygen saturations.Chlorpheniramine and hydrocortisone wereadministered intravenously and the patient recoveredwithin 45 minutes. Bacteriological investigations ofboth the patient and the unit isolated no microorganism, IgA levels were not done. One subsequenttransfusion with apheresis platelets resulted in a mildurticarial reaction and as a result, future needs havebeen managed with saline washed plateletsuneventfully.
AA Case 13 This male patient with a malignant haematologicaldisorder required a transfusion of one unit of plateletsfor a low platelet count. The patient had receivedprevious transfusions of pooled and apheresisplatelets uneventfully. On this occasion, following160 mls of apheresis platelets, the patient developedurticaria, dyspnoea, stridor, wheeze and falling oxygensaturations. The transfusion was initially continued ata slower rate and then discontinued completely andchlorpheniramine, hydrocortisone and salbutamolnebulizers were administered. The patient recoveredwithin ten minutes without complications.Subsequently the patient has had severaltransfusions of apheresis platelets with premedication of chlorpheniramine withoutcomplications.
AA Case 14 This young female patient with a newly diagnosedmalignant haematological disorder was administereda transfusion of one unit of platelets for a plateletcount of 67X109/L as she was actively bleeding. Thepatient had received a previous transfusion of pooledplatelets and developed a mild urticarial reaction andas a result, had been subsequently transfused withpooled platelets with pre medication ofchlorpheniramine. On this occasion following premedication and 180 mls of platelet apheresis, thepatient developed hypertension, dyspnoea andsubsternal discomfort. The transfusion wasdiscontinued and chlorpheniramine and oxygenadministered. The patient recovered within fiveminutes without complications. The HLA antibodyscreen was negative and IgA level pre transfusionwas within normal limits. Future transfusions willinclude a further attempt at pre medication andapheresis platelets and should the patient reactagain, saline washed platelets will be recommended.
AA Case 16This elderly patient with underlying cardiac diseasewas on multiple medication including warfarin andantibiotic therapy. The patient was transfused withtwo units of SD plasma over a three-hour period for ahaematoma secondary to trauma, INR 3.8. Warfarintherapy had been discontinued the day prior totransfusion but vitamin K was not given. Thirtyminutes following the transfusion the patientdeveloped symptoms of dyspnoea, a rash on botharms and abdomen and a rise in temperature of 2°Cto 38.2°C. Oxygen was given and IV hydrocortisoneand chlorpheniramine were administered. Symptomsresolved within two hours. Both packs were culturedand found to be negative. The patient was notcultured. IgA level not checked. The patient receivedsubsequent transfusions of SD treated plasma totreat further bleeding with antihistamine and steroidcover which were uneventful. Vitamin K was notadministered.
69Annual Report
AA Case 34 This female patient required a transfusion of one unitof red cells for symptomatic anaemia of malignancyHb 8.6g/dl. One hour and 40 minutes into thetransfusion when 240 mls had been transfused thepatient became flushed and developed symptoms ofurticaria, tachycardia, stridor/wheeze, falling oxygensaturation and substernal discomfort. The transfusionwas discontinued and IV chlorpheniramine,hydrocortisone, epinephrine and glycerine trinitratespray (GTN) was given. Bacteriological culture of theunit showed no growth. The patient required transferto a tertiary centre for further observation andmanagement. Investigations of the reaction wereinconclusive and the IgA level was not checked.Further transfusions were required following transferto the tertiary facility and were uneventful.
National Haemovigilance Office70
IntroductionTransfusion–associated circulatory overload (TACO)occurs when the transfusion rate or volume exceedsthe capacity of a compromised cardiovascular system(Zhou et al, 2005). Pulmonary complications (eitherTACO or TRALI) are now among the most frequentlynoted life threatening hazards of transfusion. TACOis often under-recognised (Popovsky, 2004,Andrzejewski and Popovsky 2005) and consequentlycan be under-reported. The incidence for thisreporting year in the NHO is 0.01% (1: 9730 units ofred cells issued) and TACO accounts for 7% of theincidents reported. Popovsky (2004) suggests thatthe incidence of TACO occurring in a patientundergoing transfusion is more likely to be in theregion of 1-8% (Popovsky, 2004).
TACO can result from over-transfusion to individualsat risk, often the elderly or the very young, in whomfluid infusion engulfs the capacity of the left ventricle,causing congestive cardiac failure and ultimatelypulmonary oedema (Bux, 2005). However whilethese patient populations are particularly susceptible,no recipient of blood is resistent (Stack et al, 1996).
Patients with severe chronic anaemia are also at riskof TACO resulting from rapid changes in circulatingvolume. Such patients should be transfused slowly toavoid acute changes in blood volume which mayprecipitate heart failure (Stack et al, 1996).Transfusion should not be required in the vast majorityof patients with chronic anaemia due to underlyinghaematinic deficiencies of iron, B12 or folate. Thesepatients respond quickly to specific replacementtherapy (Saxena et al1993). Where compliance ispoor, parenteral iron should be used to treat irondeficiency. Iron sucrose preparations are associatedwith less side effects than iron dextran preparations(Bailie et al 2005).
Anaemia in the context of cardiac disease presentsparticular problems. It is found to be present in 25-50% of this patient group and its presence in heartfailure is associated with a poorer prognosis (Anandet al, 2005). The causes of the anaemia appear to bemulti-factorial and include decreased erythropoiesis,hemodilution and inhibition of erythropoietin synthesisby ACE inhibitors. Iron deficiency due to nutritional
Transfusion Associated CirculatoryOverload (TACO)
DefinitionTransfusion Associated CirculatoryOverload (TACO) is characterised by thedevelopment of acute pulmonaryoedema secondary to congestive cardiacfailure. Signs and symptoms canmanifest during, or within some hours of
transfusion and can include any or all ofthe following: dyspnoea, orthopnoea,cyanosis, tachycardia, hypertension andpulmonary and/or pedal oedema. Chestauscultation reveals the presence ofrales (Popovsky, 2001).
71
anaemia, malabsorption and gastrointestinal bleedingmay also be important. (Anand 2005). There isencouraging evidence that the anaemia of heartfailure, not due to other causes, may be improved bytreatment with erythropoieitin and iron therapy. Thistreatment may improve symptoms and reduce the riskof hospitalisation for worsening heart failure (NHS,Clinical Guideline 5, Silverberg et al, 2001, Manciniet al 2003). Transfusion in patients with acutecoronary syndromes who develop bleeding oranaemia during their hospitalisation, may beassociated with higher mortality rates (Rao et al,2004).
TACO can manifest itself during or within hours of thetransfusion. Non-specific symptoms frequentlyreported include chest tightness, headache and drycough.TACO in patients can often be readily identified.Occasionally, however, symptoms associated withother transfusion reactions or medical conditions canoverlap making it difficult to diagnose. Zhou et al(2005) suggest that measurement of B-natriureticpeptide (BNP), which is secreted from the cardiacventricles in response to volume expansion andoverload, is useful in evaluation of patients withsuspected transfusion related respiratory distress. Itmay be considered as a useful adjunct marker indiagnosing overload.
Findings• The cases included in this chapter illustrate the
difficulty of managing anaemia in patients with pre-existing cardiac disease.
• 14 out of 15 cases (93%) of TACO casesreported involved the transfusion of red cells.
• One case, (Case 15) was difficult to categorise asdefinitely TACO and was initially reported as anAA. It is not possible to be sure whether thesymptoms and signs in the patient who had pre-existing cardiac disease were due to the
transfusion or were coincidental. However thedevelopment of cardiac arrhythmias andsubsequent myocardial infarction is suggestive ofa cardiac cause for the symptoms and the incidenthas been captured as a TACO.
• One case, (Case12) was associated with atransfusion of apheresis platelets. Although thevolume of apheresis platelets is only 220-250 mls,the transfusion was given over 15-20 minutes.
• All but one of the patients were aged between 60-88 years and all were at risk of TACO, due to theirunderlying medical conditions.
• In six out of 15 cases, TACO occurred on the firstunit, and in two cases the patient received 100mlsor less of the transfusion before developingsymptoms.
• In a number of cases, the patient was either inpositive fluid balance or had evidence ofperipheral oedema prior to transfusion.
• In seven cases, records show that a fluid balancechart was either not kept, or was inaccurate due toincontinence. In two cases other fluids wereinfusing simultaneously with the red cells. In bothof these cases the fluid balance chart was notedto be inaccurate due to incontinence.
• Most patients responded quickly to diuretictherapy, but in one case (Case 11), where thepatient was already critically ill with underlyingmalignancy, the transfusion may have contributedto mortality.
• In nine cases, the patients were on regular diuretictherapy. In one case, (Case 13) this was stoppedthree days earlier due to dehydration. In three ofthese cases, additional diuretics were givenbefore transfusion or between units.
• In four cases, pre-transfusion diuretics were
National Haemovigilance Office72
administered but proved insufficient in preventingTACO.
• In one case (Case 6), two units prescribed overtwo days were inadvertently given on the sameday resulting in TACO. However in two furthercases (Cases 3 & 7), where the transfusion wasgiven over two days, the patients still developedTACO.
• In one of these two cases (Case 3), furthertransfusions were administered uneventfully withdiuretic cover.
Recommendations• As no patient is immune, all patients should be
reviewed pre-transfusion to assess their risk ofdeveloping TACO. Particular attention should bepaid to the identification and management of‘high-risk’ patients which include:
• Patients of low body weight,
• Elderly
• Infants and children,
• Physiologically compromised patients,especially with a history of cardiac, respiratoryor renal insufficiency or chronic anaemia.
• At risk patients should be transfused slowly at arate of 1 ml/kg/hour (Popovsky 1985) and closeattention, where possible, should be paid to thepatient’s fluid balance status not only during thetransfusion but also in the 24 hour period prior totransfusion. Single unit transfusions can result inTACO and therefore should be monitored asclosely as multiple unit transfusions (Andrzejewskiand Popovsky, 2005).
• Transfusion should be on a unit-by-unit basis, with
a medical assessment of the patient prior tocommencing transfusion and before administeringany further component. This assessment shouldinclude:
• A careful estimation of the patient’s hydrationstatus prior to transfusion.
• Thorough review of the patient’s fluid balanceduring transfusion of any blood component.
• The possible need for ‘prophylactic’ diuretictherapy.
• The risk of TACO can be reduced by theadministration of pre-transfusion diuretics. Thismay also be necessary for those on regulardiuretic therapy.
• In very low weight/ at-risk patients, it may beadvisable to transfuse units with 24 hoursbetween each unit in combination with pretransfusion diuretics. Some subjects take as longas 24 hours to readjust blood volume particularlyin those patients whose venous pressure is raisedpre-transfusion (Mollison et al 1998).
• Where possible, simultaneous infusion of otherfluids during transfusion should be avoided inpatients at risk of TACO.
• In cases of iron-deficiency anaemia, transfusionshould only be considered when the anaemia issymptomatic. (Saxena et al, 1993). Where oraliron is not tolerated or compliance is poor,parenteral iron therapy should be considered.
73Annual Report
National Haemovigilance Office74
Case
No.
TACO
Case
1
TACO
Case
2
TACO
Case
3*
TACO
Case
4
TACO
Case
5
Age
yrs
Gend
er
63 M 88 M 56 F 64 F 63 M
Weig
htkg 68 Un
k
55 Ukn
Ukn
Volum
eTra
nsfu
sed
One
com
plete
unit
and
>100
mls
ofth
ese
cond
unit
ofre
dce
lls
>10
0mls
red
cells
over
two
hour
s
Two
units
ofre
dce
lls
One
unit
red
cell
conc
entra
te
One
unit
ofre
dce
lls
Rate
ofTra
nsfu
sion
90m
lspe
rhou
r
Two
units
over
four
hour
seac
h
Thre
eun
itsov
erfo
urho
urse
ach
over
two
days
One
unit
over
four
hour
s
Over
four
hour
s
Pre-
exist
ingPr
oblem
s
Myoc
ardia
linf
arct
ionan
dlef
tve
ntric
ularf
ailur
e.Hb
7.2g/
dlPo
sitive
fluid
balan
ceof
1512
mls
Seve
reco
nges
tive
card
iacfa
ilure
,isc
haem
iche
artd
iseas
e,re
nal
impa
irmen
t.Hb
7.7g/
dlPo
sitive
fluid
balan
ceof
122m
ls
Carc
inom
aof
the
lung.
Histo
ryof
myo
card
ialinf
arct
ion,
hype
rtens
ion,p
eriph
eral
vasc
ular
disea
sean
dep
ileps
y.Hb
6.5g/
dl
Haem
atolo
gical
mali
gnan
cyRe
curre
ntpn
eum
onia
Perip
hera
loed
ema
Hb8.6
g/dl
Sym
ptom
s&Ou
tcom
e
Deve
loped
dysp
noea
and
pulm
onar
yoe
dem
adu
ring
the
seco
ndun
it.Tre
atm
ent:
Frus
emide
IVad
mini
stere
dan
dsy
mpt
oms
reso
lved.
Noco
mpli
catio
ns.
Dysp
noea
,tac
hyca
rdia,
expir
ator
ywh
eeze
,dec
reas
edair
entry
both
base
s,ra
ised
JVP
Treat
men
t:hy
droc
ortis
one,
fruse
mide
,neb
ulise
rsy
mpt
omsr
esolv
ed.
Noco
mpli
catio
ns
Tach
ypno
ea,c
ough
ingan
dvo
mitin
g.Tre
atm
ent:
oral
diure
ticsg
iven
with
good
resp
onse
.Dy
spno
eaan
dsy
mpt
omsr
esolv
ed.
Noco
mpli
catio
ns
Dysp
noea
,tac
hyca
rdia,
bilat
eral
crep
sand
whee
ze,l
ower
edO 2
satu
ratio
nsan
dch
estt
ightn
ess.
Treat
men
t:fru
sem
ide,g
lycer
yltrin
itrat
e–fu
llre
cove
ryNo
com
plica
tions
Dysp
noea
,clam
my,
pale,
swea
ty.
Ches
tx-ra
ysh
owed
exte
nsive
alveo
larsh
adow
ingTre
atm
ent:
hydr
ocor
tison
e,fru
sem
ide,O
2ne
bulis
ers
Died
days
later
unre
lated
totra
nsfu
sion
Com
men
ts
Nodiu
retic
prior
totra
nsfu
sion
Regu
lardiu
retic
ther
apy
and
diure
ticpr
iorto
trans
fusio
n.
Eject
ionfra
ction
10%
-pat
ient
susc
eptib
leto
over
load.
First
unit
given
over
4ho
urs,
seco
ndgiv
enne
xtda
yov
er3
hour
sand
40m
inute
s.Flu
idba
lance
wasn
otre
cord
edpr
iorto
ordu
ring
the
trans
fusio
n.Di
uret
icgiv
enpr
iorto
3rd
unit
–tra
nsfu
sed
unev
entfu
lly
Haem
acel
infus
ingsim
ultan
eous
ly.No
regu
laror
prop
hylac
ticdiu
retic
.Flu
idba
lance
char
tina
ccur
ate.
Reac
tion
occu
rred
when
only
60-8
0mls
had
trans
fuse
d90
minu
tesa
fter
com
men
cem
ento
ftra
nsfu
sion.
Onre
gular
diure
tics.
Fluid
balan
ceina
ccur
ate
prior
toth
etra
nsfu
sion
Tabl
e33
:TAC
OCa
ses
(n=1
5)
*Inc
luded
asa
full
case
histo
ry
75Annual Report
Case
No.
TACO
Case
6*
TACO
Case
7
TACO
Case
8
TACO
Case
9
TACO
Case
10
Age
yrs
Gend
er
74 F 74 F 60 F 80 F 76 M
Weig
htkg 37 Uk
n
46 <70
Unk
Volum
eTra
nsfu
sed
One
unit
and
150
mls
red
cells
Two
units
and
300m
lsof
third
unit
ofRe
dCe
lls
220m
lsof
red
cells
One
unit
and
200m
lsof
red
cells
60m
lsof
first
unit
ofre
dce
lls
Rate
ofTra
nsfu
sion
Two
units
over
four
hour
seac
hov
ertw
oda
ys.
Thre
eun
itsov
ertw
oda
ys
Over
four
hour
s
Over
four
hour
seac
h
Four
units
over
4ho
urs
each
Pre-
exist
ingPr
oblem
s
Malig
nanc
y.Lo
werl
imb
oede
ma.
Hb8g
/dl
Malig
nanc
ywi
thlun
gse
cond
aries
and
unde
rlying
infec
tion.
Rena
lfail
ure
Hb6.6
g/dl
Post
oper
ative
anae
mia,
hype
rtens
ionHb
6.3g/
dl
Card
iacco
nditio
n,pe
riphe
ral
vasc
ulard
iseas
ean
dan
aem
iaHb
7.4g/
dlPo
sitive
fluid
balan
ceof
1000
mls.
GIble
eding
,con
gesti
veca
rdiac
failu
reHb
4.3g
Sym
ptom
s&Ou
tcom
e
Dysp
noea
fallin
gox
ygen
satu
ratio
nTre
atm
ent:
Oxyg
en,d
iscon
tinue
dun
it–
full
reco
very
Noco
mpli
catio
ns.
Pyre
xia,t
achy
card
ia,hy
perte
nsion
,ba
ckpa
in,dy
spno
eaan
dwh
eeze
.Tre
atm
ent:
Frus
emide
,par
acet
amol
–re
cove
ryin
6ho
urs
Noco
mpli
catio
ns.
Hype
rtens
ion,t
achy
card
iaTre
atm
ent:
Disc
ontin
ued
trans
fusio
n,fru
sem
idean
dox
ygen
Noco
mpli
catio
ns
Atria
lfibr
illatio
n,hy
perte
nsion
tach
ycar
dia,d
yspn
oea
fallin
gox
ygen
satu
ratio
ns,u
rtica
ria,
Treat
men
t:fru
sem
ide40
mgs
given
with
anef
fect
ivediu
resis
of19
60m
lsNo
com
plica
tions
Brad
ycar
dia,d
yspn
oea,
and
fallin
gO 2
satu
ratio
nsTre
atm
ent:
Frus
emide
,cyc
lomor
ph,i
soso
rbide
dinitr
ate
infus
ion,o
xyge
nNo
com
plica
tions
Com
men
ts
Both
units
inadv
erte
ntly
given
onth
esa
me
day.
Onre
gular
diure
ticsa
ndals
obe
twee
nun
its
Pallia
tive
care
patie
nt.
Frus
emide
given
follo
wing
seco
ndun
it.Fo
llowi
ngfir
stun
itwa
sin
nega
tive
fluid
balan
ceof
200m
ls.
Nore
gular
diure
tics.
Noflu
idba
lance
reco
rded
prior
toth
etra
nsfu
sion.
Onre
gular
diure
tics.
First
unit
trans
fuse
dun
even
tfully
.No
pre-
trans
fusio
ndiu
retic
.
Onre
gular
diure
tics
OnNa
Clinf
usion
simult
aneo
usly.
Inacc
urat
eflu
idba
lance
prior
totra
nsfu
sion
Trans
fusio
nre
com
men
ced
and
othe
runit
sgiv
enwi
thfu
rther
fruse
mide
and
mor
phine
Tabl
e33
:TAC
OCa
ses
(n=1
5)(c
ont)
*Inc
luded
asa
full
case
histo
ry
National Haemovigilance Office76
Case
No.
TACO
Case
11
TACO
Case
12
TACO
Case
13
TACO
Case
14
TACO
Case
15
Age
yrs
Gend
er
63 M 66 M 85 F 80 M 81 F
Weig
htkg 69 72 38 Un
k
Unk
Volum
eTra
nsfu
sed
Two
units
ofre
dce
lls
One
unit
ofap
here
sispla
telet
s
One
unit
ofre
dce
llsan
d20
0m
lsof
seco
ndun
it.(re
ceive
don
eun
itof
red
cells
the
prev
ious
day)
150
mls
ofre
dce
llsov
ertw
oho
ursa
nd20
minu
tes
One
unit
ofre
dce
lls
Rate
ofTra
nsfu
sion
Over
4ho
urse
ach
Over
30m
inute
s
Over
four
hour
seac
h
Over
sixho
urs
Give
nov
er40
minu
tes
Pre-
exist
ingPr
oblem
s
Card
iomyo
path
y,ca
rcino
ma
ofth
elun
gHb
8g/d
l
Haem
atolo
gical
disor
der,
anae
mia
Cong
estiv
eca
rdiac
failu
re,o
ther
med
icala
ndga
stroin
testi
nal
cond
itions
Hb6.5
g/dl
Chro
nicob
struc
tive
pulm
onar
ydis
ease
,car
diac
disea
se,d
iabet
es,
hype
rtens
ion.
Hb8.9
g/dl
Posit
iveflu
idba
lance
of37
0mls
prior
totra
nsfu
sion
Perip
hera
lvas
cular
disea
se,h
istor
yof
mali
gnan
cy,c
ereb
rali
nfar
ctan
dhy
perte
nsion
Hb9.9
g/dl
Sym
ptom
s&Ou
tcom
e
Hype
rtens
ion,f
alling
oxyg
ensa
tura
tions
.Tre
atm
ent:
Diur
etic
with
good
resp
onse
Patie
ntdie
d24
hour
spos
ttra
nsfu
sion
poss
ibly
relat
edto
trans
fusio
n,alt
houg
hth
epa
tient
wasv
ery
ill.
Incre
ased
hear
trat
e,dy
spno
eaTre
atm
ent:
Hydr
ocor
tison
e,ch
lorph
enam
ine–
reco
very
inon
eho
urNo
com
plica
tions
Dysp
noea
,fall
inO 2
satu
ratio
n,fa
lling
urina
ryou
tput
Treat
men
t:fru
sem
idean
dox
ygen
Noco
mpli
catio
ns
Dysp
noea
,hyp
erte
nsion
,fall
inur
inary
outp
utTre
atm
ent:
fruse
mide
,res
pons
eun
clear
Patie
ntdie
d2
mon
thsl
ater
unre
lated
totra
nsfu
sion.
Supe
rven
tricu
larta
chyc
ardia
,hyp
oten
sion
facia
lras
h,Tre
atm
ent:
gelof
usin,
chlor
phen
iram
ine,h
ydro
corti
sone
,ad
enos
ine,f
ruse
mide
and
oxyg
enPa
tient
died
10da
yslat
erun
relat
edto
the
trans
fusio
n
Com
men
ts
Onre
gular
diure
ticth
erap
yan
dpr
e-tra
nsfu
sion
diure
tic.
Plat
elets
given
over
15-2
0m
inute
s.No
regu
lardiu
retic
s.No
fluid
balan
ce
Stop
ped
regu
lardiu
retic
ther
apy
thre
eda
yspr
iorto
trans
fusio
n.Ina
ccur
ate
fluid
balan
ce.
Onre
gular
diure
tics
Myoc
ardia
linf
arct
ionfo
llowi
ngda
y
Tabl
e33
:TAC
OCa
ses
(n=1
5)(c
ont)
TACO Case Histories
We describe 2 of the case reports in detail toillustrate some of the issues highlighted:
TACO Case 3 This low weight female patient (weight 55kg) with ahistory of malignant lung disease and a Hb of 7.6g/dlrequired a transfusion of three units of red cells. Oneunit was transfused without incident. The next day,immediately following the administration of thesecond unit over 3 hours and 40 minutes, the patientdeveloped symptoms of dyspnoea, increasedrespiratory rate (40/min), excessive coughing andvomiting. Oral diuretics were prescribed andadministered with a good diuretic response. Thesymptoms improved quickly with full resolution withinfour hours. Eight hours after the completion of thesecond unit, a third unit of red cells was prescribedand administered uneventfully. An oral diuretic wasadministered prior to this transfusion.
TACO Case 6 This elderly low weight female patient withmalignancy required a transfusion of two units of redcells. Her Hb level was 8g/dl. The patient had nodocumented underlying history of cardiac orrespiratory disease but was receiving regular diuretictherapy for limb oedema. The two units wereprescribed over four hours each and were to be givenon two separate days. Inadvertently both units wereadministered on the same day. The patient receivedher regular diuretic that morning and the first unitinfused uneventfully over three hours. Oral frusemide20 mgs was given between the first and second units.Within 30 minutes of commencing the second unit,following transfusion of approximately 150 mls, thepatient developed symptoms of dyspnoea and fallingoxygen saturations. The transfusion wasdiscontinued completely. Nasal oxygen therapy wascommenced and no further diuretics wereadministered. The patient recovered withoutsequelae and although the timeframe is unclear anote in the patients chart four hours after the eventsuggests she had recovered at that stage.
77Annual Report
This category accounted for 2% of the incidentsreported (4 of 214), down from nine cases in thepreceding two years. This type of reaction is thoughtto occur at a frequency of 1:400-1:700 transfusions.It is therefore, likely that a number of these reactionsgo undiagnosed. This is possibly due to the fact thatmost of the patients receiving transfusions are alreadyvery ill and the symptoms are attributed to theirunderlying condition. Typically patients present withfalling haemoglobin and other signs of haemolysisincluding a raised bilirubin and possibly renalimpairment a few days (usually 4-10) aftertransfusion. On the vast majority of occasions theantibody screen prior to the transfusion is found to benegative for the antibody responsible. The antibodiesusually involved belong to the Rh and Kidd families.
Findings: • There were four cases reported this year, down
from nine in the previous two years.
• Grading: Group 1: Asymptomatic with ‘antibody only’ detected
(with or without a positive antiglobulin test(DAT)). Two cases; Case 2 and Case 4.
Group 2: Evidence of haemolysis measured by fallinghaemoglobin and positive DAT. None
Group 3: Falling Hb with jaundice with or without apositive DAT. Two cases; Case 1 and Case 3.
Group 4: As for Group 3, but with renal impairment.None.
• As in previous years, the antibodies implicatedbelong to the Rh, Kidd and Duffy families.
• There were no fatalities associated with thesereactions.
• In Case 1, the patient presented ten days after atransfusion with a rising bilirubin but this wasthought to be due to the underlying condition or to
Delayed Haemolytic Transfusion Reaction
DefinitionDelayed haemolytic transfusion reactionsare defined, for the purpose of thisreport, as those occurring more than 24hours following the transfusion of a bloodcomponent. A haemolytic transfusionreaction occurs when antigen-positive
red blood cells are transfused to apatient who develops an alloantibody tothat antigen. It results in the lysis oraccelerated clearance of red blood cellsdue to immunologic incompatibilitybetween the blood donor and therecipient (Boehlen & Clemeston, 2001)
78
the patient's medication. It was only at asubsequent stage during DAT testing that thediagnosis was made.
• In Case 2, allo-absorption studies were not carriedout prior to transfusion with the result that some ofthe units of blood transfused were positive for anantigen to which the patient already had anantibody.
Recommendations• It is likely that there is under-diagnosis or under-
reporting of this condition. It is essential that anypatient presenting with any signs of haemolysis ora positive DAT, some days after a transfusionshould be investigated for a DHTR. Thesuccessful diagnosis depends also on accuratehistory taking and the elicitation of a history ofrecent transfusion.
• Use of red cell panels in sensitive antibodyscreening techniques, adequate training andproficiency testing of all staff involved in cross-matching and participation by all concerned inexternal quality assurance schemes shouldcontribute to the minimisation of this complication.
• Patients with Autoimmune Haemolytic Anaemiawith strong autoantibody reactions present aparticular problem. In non emergenciesabsorption studies should be carried out toexclude the presence of an underlying clinicallysignificant antibody prior to transfusion of thesepatients. If emergency transfusion is required thenRh phenotype compatible, K negative bloodshould be provided and the clinician advised ofthe potential incompatibility. Patients withtransfusion dependent autoimmune haemolyticanaemia should be monitored at regular intervalsso that transfusion requirements are anticipated,providing sufficient time for extended compatibilitytesting procedures to be performed prior totransfusion. Absorption studies should be carriedout prior to transfusion wherever possible.
However, urgent treatment should not be delayed.
• Undue delay in transfusion rather than the delayedreaction itself may lead to fatalities (SHOT 2002).Urgent transfusion should not be delayedunnecessarily and in the case of a DHTR,specialist advice should be sought for futuretransfusion management.
• There is a need for the on-call facility to performcomplex serological investigations such asabsorption studies in autoimmune haemolyticanaemia out of hours.
• Local policies/procedures should be in place forthe management of emergency transfusion whereunidentified antibody(ies) or difficulties inprovision of compatible blood occur.
• Consideration should be given to issuing antibodycards to patients with clinically significantantibodies (NBUG 2002) and the possibility of anational patient antibody register for patients withred cell antibodies should also be evaluated.(Lariat & Fisher 2005)
79Annual Report
National Haemovigilance Office80
Case
No.
DHTR
Case
2*
DHTR
Case
4
Age
yrs
88yr
s
75yr
s
Gend
er
F F
Pre-
exist
ingco
nditio
n
Auto
imm
une
haem
olytic
anae
mia
with
mult
iple
med
icalp
roble
ms.
Sym
ptom
soff
alling
Hb,r
aised
biliru
bin,d
eter
iorat
ingre
nal
func
tion,
apo
sitive
DAT
and
evide
nce
ofsp
hero
cyto
sis
COAD
,CVA
,hyp
erte
nsion
,Ad
dison
’sdis
ease
with
unde
rlying
mali
gnan
cyan
dwi
desp
read
met
asta
sis
Inter
valb
etwe
entra
nsfu
sion
and
onse
tof
sym
ptom
s/sig
ns
Multip
letra
nsfu
sions
adm
iniste
red
over
thre
em
onth
s.
Anti
Ch/R
g18
days
afte
rtra
nsfu
sion
Treat
men
t
None
None
Findin
gs
Allo
anti-
Jka
dete
cted
afte
rem
erge
ncy
trans
fusio
nof
thre
eun
itsof
blood
that
were
later
foun
dto
beJk
apo
sitive
.
Bilir
ubin,
LDH,
GTT
allra
ised
pre
trans
fusio
n.Re
nalf
unct
ionte
stsab
norm
alpr
e-tra
nsfu
sion
Outc
ome
Patie
ntdie
dse
vent
een
days
later
unre
lated
totra
nsfu
sion.
Leas
tinc
ompa
tible
blood
wasi
ssue
dan
dtra
nsfu
sed
unev
entfu
lly.
Tabl
e34
:Del
ayed
Haem
olyt
icTr
ansf
usio
nRe
actio
n(D
HTR)
(n=4
)Gr
oup
1
Case
No.
DHTR
Case
1*
DHTR
Case
3
Age
yrs
51yr
s
79yr
s
Gend
er
F F
Pre-
exist
ingco
nditio
n
Post
majo
rGIs
urge
ryan
dre
nal
failu
re.
Anae
mia,
GIble
ed-H
aem
atem
esis
and
mela
ena
Treat
men
t
None
None
Findin
gs
Anem
ia,ra
ised
biliru
bin,D
ATpo
sitive
Anti
-E,-
c,-J
kade
tect
ed
Raise
dbil
irubin
Anti-
Jkb ,
and
poss
ibly
anti-
Ean
dan
ti-s
Outc
ome
Patie
ntdie
don
em
onth
afte
rtra
nsfu
sion
–de
ath
unre
lated
toth
ere
actio
n.
Trans
fuse
dwi
thco
mpa
tible
antig
enne
gativ
eblo
od.R
ecov
ered
with
intw
owe
eks.
Noco
mpli
catio
ns
Tabl
e35
:Del
ayed
Haem
olyt
icTr
ansf
usio
nRe
actio
n(D
HTR)
(n=4
)Gro
up3
Inter
valb
etwe
entra
nsfu
sion
and
onse
tof
sym
ptom
s/sig
ns
11da
ys.
8da
ys
*Inc
luded
asa
full
case
histo
ry
Delayed Haemolytic Transfusion Reaction(DHTR). Case Histories:
DHTR Case 1 This acutely ill patient required transfusion due tointraoperative bleeding. The patient had fivetransfusion episodes over a period of eleven days,totalling 15 units RCC, 16 units of plasma and threepacks of platelets. The antibody screen was negativeon two occasions. Despite continued transfusiontherapy her Hb remained consistently low. Ten daysafter the first transfusion episode it was noted that thepatient’s bilirubin level had raised but it was felt thatthis might be related to the patient’s condition andmedication. At the same time the DAT (previouslynegative) was found to be positive and subsequentantibody screening showed the patient haddeveloped anti-E, anti-c and anti-Jka. The patient dieda month later, although the death was deemedunrelated to the transfusion reaction.
DHTR Case 2 This elderly patient required a transfusion for longstanding warm AIHA. The Hb level at transfusion was5.4 g/dl. Previously the patient had been referred tothe IBTS and was shown to have an autoantibody aswell as an allo anti-Cw. On a previous admission overa weekend, the patient required an urgent transfusionfor a low Hb 5.8 g/dl, and three units of genotypedmatched blood were transfused withoutcomplications. A pre-transfusion sample confirmedthe continuing presence of the auto-antibody,however no allo anti-Cw was detected. The patientcontinued to have Cw negative blood. On the nextadmission, again on a weekend, the patient wassymptomatic with a Hb of 7.2g/dl and blood wasurgently needed. The transfusion went ahead withoutfull absorption studies. Although further sampleswere requested for full work up at the IBTS, thesewere not taken. The next admission occurred onemonth later, once again at a weekend. The Hb levelwas 5.4 g/dl and the patient received a transfusion offour units of red cells. No absorption studies werecarried out prior to the transfusion. These were
carried out on the next working day and they revealedan allo anti-Jka. All four packs transfused were testedand three units were found to be Jka positive. Sinceno absorption studies were performed on theprevious occasion, it is unclear when the allo anti Jka
developed. The patient died unrelated to thetransfusion seventeen days post transfusion.
81Annual Report
This category accounted for 11% of incidentsreported (24 of 214). The differential diagnosis forthese reactions will always include red cellincompatibility and bacterial infection and an effortshould be made to exclude both these possibilities.As in reports in previous years, it has been noted thatit is not always possible to establish the cause of thereaction and that symptoms caused by the patient’sunderlying condition may have contributed to thepresentation.
Findings 2004
• There was a sharp rise in the number of reactionsin this category as compared to previous years.Apart from increased awareness and thereforeincreased reporting, no specific reason wasidentified to explain this increase.
• 20 out of the 24 cases occurred after transfusionof red cell units. 16 out of the 24 patients had anunderlying history of malignancy. Of the 18patients where information was available about
patient recovery, 11 recovered within four hoursand the remainder, except for one patient whoserecovery was delayed, recovered within 24 hours.Of the cases where treatment is recorded, 17patients received treatment that includedparacetamol, chlorpheniramine and hydro-cortisone. Five patients received no treatment andrecovered spontaneously.
• The haemoglobin prior to transfusion ranged from5 g/dl to 8.8 g/dl. Most of these patients wereelderly and had multiple underlying problems.Only one patient was transfused at a Hb of 10g/dl.The patient had a history of multiple medicalproblems and was on antibiotics and had receivedtwo units of red cells on the previous day withoutproblems.
• In the majority of the 14 cases where atemperature rise of >1.5°C was documented,either the patient or the unit or both were cultured.However, only two out of the four cases involvinga platelet transfusion were cultured.
Acute Haemolytic and Other Severe AcuteTransfusion Reaction: (AHOSTR)
DefinitionAcute Transfusion Reactions are definedas those occurring within twenty fourhours of transfusion. The major concernin evaluating these reactions is toexclude bacterial contamination of theunit or haemolysis due to incompatiblered cells (Heddle & Kelton, 2001).
For the purpose of the NHO report,Acute Haemolytic Transfusion Reactionsoccurring due to incorrect bloodtransfused are captured in the ‘IncorrectBlood Component Transfused’ chapter.Anaphylaxis/Anaphylactoid transfusionreactions are also reported within aseparate chapter
82
Positive cultures were found in four cases – in threeof them, the patient sample cultured positive and inthe fourth, culture of the unit was positive. On furtherevaluation, however, these results were notconsidered to be associated with the transfusion butwere due to the patient’s underlying condition orcontamination.
• Red cell incompatibility was excluded in 13 cases.In one case (Case 1) associated with fever andrigors, anti-Fya antibody was detected 5 days afterthe transfusion and in another, (Case 26) wherethe patient showed evidence of haemolysis, ananti-Lua antibody was identified. However, an antiLua antibody is not usually of significance and wasnot considered to be the cause of the patient’sreaction, which remains unexplained. In the rest ofthe cases, no serology investigations werereported.
• In one case (Case 11), a reaction to platelets, thepatient had developed HLA antibodies whichwere probably responsible for the reaction.
Recommendations:
• Every patient should be carefully monitored duringtransfusion with special emphasis placed on thestart of each new unit. Individual units should becommenced slowly, and the patient observedclosely for the first 15 minutes/50 mls as severereactions are most likely to occur within this time.(BCSH 1999).
• Each hospital must have a policy in place for themanagement of an acute transfusion reaction.This should include the medical and nursingmanagement of the patient’s symptoms and theinvestigations necessary to complete thetransfusion reaction analysis. Following a severetransfusion reaction, the transfusion should bediscontinued completely and no further units fromthis crossmatch should be transfused until anABO incompatible transfusion has been excluded
and the blood has been re-crossmatched.
• Investigations should include: -
- Re-confirming the identification of the patientand the unit
- Re-confirming the ABO and Rh D group of thepatient and the unit
Blood samples for:- Repeat group, antibody screen and
crossmatch to exclude an ABO or red cellincompatible transfusion including a clottedsample for antibody identification using serum
- full blood count (FBC)- direct antiglobulin test (DAT)- coagulation screen- biochemistry analysis to include serum bilirubin
and LDH (NBUG 2000)- blood cultures
• Where antibody is detected in the post transfusionsample taken within 24 hours of the transfusionwhich was not detected in the pre-transfusionsample, the pre-transfusion sample should betested by a different technique and/or referred toa reference laboratory for investigation as it islikely that the antibody was present pre-transfusion but was not detected.
• It is essential to carry out adequate serologicalinvestigations in patients with multiple antibodieswho present with an acute reaction.
• If possible, further transfusions should be delayeduntil completion of the transfusion reaction work-up.
• In AHOSTR, particularly where there is fever andchills/rigors, both the patient and the transfusedunit(s) should be cultured to exclude bacterialcontamination of the unit. This is particularlyimportant when the reaction occurs in platelet
83Annual Report
transfusion as platelet concentrates are stored at20°C and the incidence of bacterial contaminationis highest in platelet concentrates. To reduce thisrisk, the IBTS has undertaken bacteriologicalscreening of all platelet concentrates before issuesince the last quarter of 2004.
• A protocol for culturing of the blood component isavailable by writing to the QA/QC Department ofthe IBTS. This protocol outlines the procedure tobe followed when culturing a unit implicated in afebrile transfusion reaction.
• Specimens e.g. urine, sputum, necessary toexclude other possible sources of infection shouldalso be cultured.
National Haemovigilance Office84
85Annual Report
Case
No.
AHOS
TRCa
se1*
AHOS
TRCa
se2
AHOS
TRCa
se3
AHOS
TRCa
se5
AHOS
TRCa
se6
AHOS
TRCa
se8*
AHOS
TRCa
se9
Com
pone
ntPr
escr
ibed
Two
units
ofre
dce
lls
Two
units
ofre
dce
lls
Two
units
ofre
dce
lls
Four
units
ofre
dce
lls
One
unit
ofre
dce
lls
One
unit
ofwa
shed
red
cells
One
unit
ofre
dce
lls
Age
Yrs
Gend
er
78 F 74 F 83 F 89 F 72 F 42 F 60 F
Unde
rlying
cond
ition
Seps
isse
cond
ary
toga
stric
surg
ery
Haem
atolo
gical
mali
gnan
cy
Ischa
emic
Hear
tDi
seas
e
Pulm
onar
yem
bolus
.Ch
ronic
anae
mia
Malig
nanc
ypo
stope
rativ
ean
aem
ia,se
psis
Paro
xysm
alNo
ctur
nal
Haem
oglob
inuria
Haem
atolo
gical
mali
gnan
cy
Volum
etra
nsfu
sed
onse
t
Follo
wing
trans
fusio
nof
150
mls
ofre
dce
lls.
Patie
ntha
dre
ceive
da
trans
fusio
n1
mon
thpr
eviou
sly.
150
mls
ofse
cond
unit
100m
lsre
dce
lls
100m
lsof
4th
unit.
One
unit
ofre
dce
lls
150
mls
ofre
dce
lls.
120
mls
ofre
dce
lls
Sym
ptom
s/sig
ns
Patie
ntco
mpla
ined
ofrig
orsa
ndfe
ver.
Risin
gbil
irubin
post
trans
fusio
nwi
thin
6ho
urs.
Urine
posit
ivefo
ruro
bilino
gen
Agita
tion,
feeli
ngof
impe
nding
doom
and
tach
ycar
dia.
Tem
pera
ture
rise
>1.5
°C,c
hills,
rigor
s,re
stles
snes
s,an
xiety
,ta
chyc
ardia
and
feeli
ngof
impe
nding
doom
Tem
pera
ture
>1.5
°C,c
hills
and
rigor
s
Hype
rtens
ion,
tach
ycar
dia.
Tem
pera
ture
rise
>1.5°
C
Tem
pera
ture
rise
of2.5
°C,
hype
rtens
ion,n
ause
aan
dge
nera
lac
hes.
Tem
pera
ture
rise
0.6°C
,chil
lsan
drig
ors,
rise
inblo
odpr
essu
rebu
tre
main
edno
rmot
ensiv
e
Inves
tigat
ions
The
DAT
wasp
ositiv
ein
IgGin
pre
and
post
trans
fusio
nsa
mple
s.An
tibod
ysc
reen
wasp
ositiv
e.Su
bseq
uent
inves
tigat
ions5
days
later
show
edan
ti-Fy
a .
Pack
cultu
red
–no
orga
nism
siso
lated
.Re
dce
llinc
ompa
tibilit
yex
clude
d.
Patie
ntno
tcult
ured
.Unit
cultu
red
-no
orga
nism
siso
lated
.Re
dce
llinc
ompa
tibilit
yex
clude
d.
Patie
ntcu
lture
dpo
sitive
for
staph
yloco
ccus
aure
us-p
roba
bleco
ntam
inant
.Un
itno
tcult
ured
.
Patie
ntan
dun
itcu
lture
d-n
oor
ganis
miso
lated
Bact
eriol
ogica
lscr
eenin
gof
the
unit
wasn
egat
ive.
Histo
ryof
prev
iousr
edce
llan
tibod
iesan
dhis
tory
ofpr
eviou
stra
nsfu
sion
reac
tion.
Red
cell
incom
patib
ility
exclu
ded.
Bact
eriol
ogica
lscr
eenin
gof
both
patie
ntan
dun
itwa
sneg
ative
Treat
men
t&Ou
tcom
e
Non
stero
idala
nti-i
nflam
mat
ory.
Patie
ntre
cove
red
with
noill
effe
cts
with
in6
hour
s.
Oxyg
enth
erap
y.Sp
onta
neou
srec
over
yaf
ter1
0to
15m
inute
s.
Trans
fusio
ndis
cont
inued
com
plete
ly.Hy
droc
ortis
one
given
.Re
cove
red
with
inon
eho
ur.
Unit
disco
ntinu
edco
mple
tely.
Para
ceto
mol
given
.Re
cove
red
fully
with
inon
eho
uran
dre
main
edap
yrex
ial.
Para
ceto
mol
given
.Obs
erve
dre
cove
rywi
thin
two
hour
s.
Para
ceta
mol
given
.Re
cove
red
with
out
com
plica
tions
.
Trans
fusio
ndis
cont
inued
com
plete
ly.Hy
droc
ortis
one
and
chlor
phen
iram
inegiv
en.
Patie
ntre
cove
red
with
inon
eho
ur
Tabl
e36
:AHO
STR
case
s(n
=24)
*Inc
luded
asa
full
case
histo
ry
National Haemovigilance Office86
Case
No.
AHOS
TRCa
se10
AHOS
TRCa
se12
AHOS
TRCa
se13
AHOS
TRCa
se14
AHOS
TRCa
se15
AHOS
TRCa
se16
*
AHOS
TRCa
se26
*
Com
pone
ntPr
escr
ibed
One
unit
ofre
dce
lls
Red
cells
One
unit
ofre
dce
lls
One
unit
ofre
dce
lls
One
unit
ofre
dce
lls
One
unit
ofre
dce
lls
Thre
eun
itsof
red
cells
Age
Yrs
Gend
er
43 F 86 M 58 M 27 M 32 M 72 M 65 F
Unde
rlying
cond
ition
Haem
atolo
gical
mali
gnan
cy
Haem
atolo
gical
mali
gnan
cy
Malig
nanc
y
Multip
leinj
uries
follo
wing
RTA
Malig
nanc
y
Haem
atolo
gical
disor
der,
card
iacdis
ease
Intra
oper
ative
blood
loss
Volum
etra
nsfu
sed
onse
t
150
mls
ofre
dce
lls
150m
ls
Few
mls
With
in40
minu
teso
fco
mm
encin
gtra
nsfu
sion
With
in30
minu
teso
fco
mm
encin
gtra
nsfu
sion.
Sym
ptom
socc
urre
dth
ree
hour
safte
rtra
nsfu
sion.
Next
day.
Sym
ptom
s/sig
ns
Hype
rtens
ion,t
achy
card
ia,dy
spno
ea,r
estle
ssne
ss,a
nxiet
yan
da
feeli
ngof
impe
nding
doom
Tem
pera
ture
rise
of2.9
°C,
tach
ycar
dia,c
hills,
naus
ea,
vom
iting
Tem
pera
ture
rise
>1.5
°C.
Chills
and
rigor
s.Hy
perte
nsion
Tach
ycar
dia,c
hills,
rigor
s,ap
preh
ensio
n.
Hypo
tens
ion,
restl
essn
ess,
anxie
ty,f
eelin
gof
impe
nding
doom
,ting
ling
inbo
thar
ms
Tem
pera
ture
rise
>1.5°
C,ta
chyc
ardia
,rigo
rs,hy
perte
nsion
,dy
spno
eaan
dta
chyp
noea
,flus
hed
and
incon
tinen
t.
Haem
atur
ia,hy
pote
nsion
,fall
ingha
emog
lobin
sligh
tcya
nosis
,na
usea
.Ra
ised
biliru
binan
dLD
H
Inves
tigat
ions
Red
cell
incom
patib
ility
exclu
ded.
Cultu
reof
the
patie
ntan
dth
eun
itne
gativ
e
Red
cell
incom
patib
ility
exclu
ded.
Cultu
reof
unit
nega
tive,
patie
ntsh
owed
coag
ulase
nega
tive
staph
lococ
ci-co
incide
ntal
cont
amina
tion
Red
cell
incom
patib
ility
exclu
ded.
DAT
post
trans
fusio
nne
gativ
e
Red
cell
incom
patib
ility
exclu
ded
and
patie
ntan
dun
itcu
lture
dne
gativ
e.
Red
cell
incom
patib
ility
exclu
ded.
Post
trans
fusio
nIgA
level
norm
al.
Red
cell
incom
patib
ility
exclu
ded.
Patie
ntno
tcult
ured
.Un
itcu
lture
dne
gativ
e.
Pre
trans
fusio
nan
tibod
ysc
reen
had
ident
ified
anan
ti-Lu
a
antib
ody,
which
wasa
lsoide
ntifie
dpo
stop
erat
ively
and
conf
irmed
ata
refe
renc
ece
ntre
.No
tcon
sider
edca
use
ofre
actio
n.
Treat
men
t&Ou
tcom
e
Initia
llyth
eun
itwa
ssto
pped
tem
pora
rily
afte
r150
mls
had
been
infus
edan
dth
enco
ntinu
edat
aslo
werr
ate.
Subs
eque
ntly
disco
ntinu
edco
mple
tely.
Sym
ptom
sim
med
iately
reso
lved
with
outt
reat
men
t.
Hydr
ocor
tison
e20
0mg
IV,pa
race
tam
ol1g
,m
etoc
lopra
mide
IV.Re
cove
red
with
inon
eho
urwi
thno
illef
fect
s.
Trans
fusio
ndis
cont
inued
.Par
acet
omol
given
.Ri
gors
subs
ided
with
in20
minu
tes.
Tem
pera
ture
norm
alwi
thin
four
hour
s.
Trans
fusio
ndis
cont
inued
,par
acet
omol
given
.Re
cove
red
with
intw
oho
urs.
Trans
fusio
ndis
cont
inued
.No
spec
ifictre
atm
entg
iven.
Reco
vere
dwi
thin
one
hour
O 2,I
Vch
lorph
enira
mine
and
hydr
ocor
tison
e.Pa
tient
reco
vere
dwi
thin
48ho
urs
Subs
eque
nttra
nsfu
sions
with
prem
edica
tion
unev
entfu
l.
Futu
retra
nsfu
sion
will
bem
anag
edus
ingRh
phen
otyp
edKe
llne
gativ
ecr
ossm
atch
com
patib
lere
dce
lls.
Tabl
e36
:AHO
STR
case
s(n
=24)
(Con
t)
*Inc
luded
asa
full
case
histo
ry
87Annual Report
Case
No.
AHOS
TRCa
se19
AHOS
TRCa
se20
*P AHOS
TRCa
se21
AHOS
TRCa
se22
AHOS
TRCa
se23
AHOS
TRCa
se24
Com
pone
ntPr
escr
ibed
One
unit
ofre
dce
lls
One
unit
ofJK
b
antig
enne
gativ
ere
dce
lls
One
unit
ofCM
Vne
gativ
ere
dce
lls
One
unit
ofre
dce
lls
Two
units
ofre
dce
lls
One
unit
ofre
dce
lls
Age
Yrs
Gend
er
82 M 3 M 50 F 83 F 38 F 85 M
Unde
rlying
cond
ition
Malig
nanc
y
Haem
atolo
gical
mali
gnan
cy
Auto
imm
une
haem
olytic
anem
ia
Multip
lem
edica
lpr
oblem
s
Treat
men
tfor
post
oper
ative
com
plica
tion
Malig
nanc
y
Volum
etra
nsfu
sed
onse
t
100
mls
ofre
dce
lls
. 93m
ls
300
mls
Appr
oxim
ately
80m
lsof
red
cells
.
Durin
gse
cond
unit
ofre
dce
lls.
Two
hour
sand
45m
insint
oth
etra
nsfu
sion.
(230
mls)
Sym
ptom
s/sig
ns
Tem
pera
ture
rise
>1.5°
C
Tem
pera
ture
rise
>1.5°
Cba
ckac
he,n
ause
a
Tem
pera
ture
rise
>1.5°
C,ha
emog
lobinu
riaan
dvo
mitin
g.
Pyre
xia,r
igors,
tach
ycar
dia,
naus
ea,v
omitin
gan
dre
spira
tory
prob
lems.
Tem
pera
ture
rise
>1.5°
C
Tem
pera
ture
rise
>1.5°
C,Hy
perte
nsion
,GI
sym
ptom
s,rig
ors
Inves
tigat
ions
Patie
ntan
dun
itcu
lture
dne
gativ
e.
Patie
ntcu
lture
d–
noor
ganis
ms
isolat
ed.
Noinv
estig
ation
sca
rried
outa
lthou
ghpa
tient
had
histo
ryof
Anti-
Jkb
antib
odies
.
Red
cell
alloa
ntibo
dyex
clude
d.Un
itcu
lture
d-n
ogr
owth
.Pat
ient
cultu
red
-Sta
phCi
treus
(not
cons
idere
dre
lated
totra
nsfu
sion)
Patie
nt,u
nitan
dse
gmen
tline
cultu
red
-no
grow
th.
Red
cell
incom
patib
ility
exclu
ded.
Patie
ntan
dun
itcu
lture
d-n
ogr
owth
.Red
cell
incom
patib
ility
exclu
ded.
Histo
ryof
tem
pera
ture
rise
onpr
eviou
stra
nsfu
sion
-not
inves
tigat
ed.
Red
cell
incom
patib
ility
exclu
ded.
Unit
cultu
red
-no
grow
th.
Patie
ntno
tcult
ured
.
Treat
men
t&Ou
tcom
e
Chlor
phen
iram
inean
dan
tipyr
etic
adm
iniste
red.
Patie
ntdie
dun
relat
edto
trans
fusio
nse
ven
days
later
.
Trans
fusio
nwa
sdisc
ontin
ued,
patie
ntre
cove
red
fully
with
outs
pecif
ictre
atm
ent
Para
ceto
mol
and
proc
hlorp
eraz
inegiv
en,
reco
vere
dwi
thno
illef
fect
s.
Chlor
phen
iram
ine,
hydr
ocor
tison
ean
dox
ygen
ther
apy.
Patie
ntha
dalr
eady
rece
ived
para
ceta
mol.
Nofu
rther
treat
men
tgive
n,re
cove
red
quick
ly.
P ara
ceto
mol
given
and
trans
fusio
nco
ntinu
edini
tially
.Tra
nsfu
sion
disco
ntinu
edwh
ensy
mpt
omsw
orse
ned.
Patie
ntre
cove
red
with
in12
hour
s.
Tabl
e36
:AHO
STR
case
s(n
=24)
(Con
t)
*PInc
luded
asa
full
case
histo
ryin
paed
iatric
chap
ter
National Haemovigilance Office88
Case
No.
late
lets
AHOS
TRCa
se4
AHOS
TRCa
se11
*
AHOS
TRCa
se18
*
AHOS
TRCa
se25
Com
pone
ntPr
escr
ibed
One
unit
ofap
here
sispla
telet
s
One
unit
ofpo
oled
plate
lets
One
unit
ofap
here
sispla
telet
s
One
unit
ofpo
oled
plate
lets
Age
Yrs
Gend
er
79 M 51 F 62 F 75 F
Unde
rlying
cond
ition
Haem
atolo
gical
mali
gnan
cy
Haem
atolo
gical
mali
gnan
cy.
Malig
nant
haem
atolo
gical
disor
der.
Malig
nanc
y
Volum
etra
nsfu
sed
onse
t
150m
ls
45m
inute
sfoll
owing
trans
fusio
n
222m
ls(1
unit)
.Re
actio
noc
curre
don
eho
urpo
sttra
nsfu
sion
One
hour
post
trans
fusio
n
Sym
ptom
s/sig
ns
Hype
rtens
ion,
light
head
ed,n
ause
a,vo
mitin
gan
dtre
mor
Tem
pera
ture
rise
>1.5
°C.C
hills,
rigor
sand
tach
ycar
dia
Feve
r,ta
chyc
ardia
,dys
pnoe
a,fa
lling
oxyg
ensa
tura
tions
,chil
lsan
drig
ors,
naus
ea,v
omitin
gan
dbr
onch
ospa
sm
Hype
rtens
ion,t
achy
card
ia,dy
spno
ea,f
ever
,chil
lsan
drig
ors.
Inves
tigat
ions
Patie
ntcu
lture
d-n
oor
ganis
ms
isolat
ed.
Unit
cultu
red
posit
ivefo
rco
agula
sene
gativ
esta
phylo
cocc
iaf
ter3
1ho
urs.
(Dee
med
cont
amina
nt)
Posit
iveDA
Tpr
ean
dpo
sttra
nsfu
sion
Patie
ntfo
und
tobe
HLA
alloim
mun
ised.
Bloo
dcu
lture
san
dse
gmen
tline
cultu
res-
nega
tive.
Patie
ntcu
lture
dne
gativ
e.Re
actio
nno
tinv
estig
ated
due
toco
mm
unica
tion
prob
lem.T
RALI
exclu
ded.
Dono
rinv
estig
ation
sne
gativ
e.
Susp
ecte
dre
actio
nno
tinv
estig
ated
Treat
men
t&Ou
tcom
e
IVhy
droc
ortis
one
and
chlor
phen
iram
inegiv
en.
Reco
vere
dwi
thin
one
hour
and
disch
arge
dlat
erth
atda
y.
Hydr
ocor
tison
ean
dch
lorph
enira
mine
.Re
cove
red
with
inon
eho
ur
Oxyg
en,h
ydro
corti
sone
,chlo
rphe
niram
ine,
and
proc
hlorp
eroz
inead
mini
stere
d.Pa
tient
reco
vere
dfro
mth
ere
actio
nwi
thin
24ho
urs.
Subs
eque
nttra
nsfu
sions
have
been
unev
entfu
l.
Chlor
phen
iram
ine
Tabl
e36
:AHO
STR
case
s(n
=24)
(Con
t)
*Inc
luded
asa
full
case
histo
ry
Acute Haemolytic or Other SevereTransfusion Reaction (AHOSTR)
Detailed case histories (Red Cells)
AHOSTR Case 1This elderly patient, who was in ICU and on antibiotictherapy for sepsis, was prescribed two units of redcells for anaemia secondary to gastric surgery. Thepatient had received a number of transfusions themost recent of which was one month previously. Onthis occasion, having received one hundred and fiftymls of red cells, the patient developed fever andrigors. The patient was treated with a non-steroidalantiflammatory and the transfusion was discontinuedcompletely. She recovered with no ill effects withinsix hours. The DAT was positive in IgG pre and posttransfusion but the eluate was negative. The initialpost transfusion antibody screen was weakly positivebut no specificity was detected. A urine sampleshowed raised urobilinogen and she was found tohave a rising bilirubin. Subsequent investigations fivedays later at the reference centre showed thepresence of anti-Fya and HLA antibodies. Culture ofthe unit was negative .
AHOSTR Case 8This young female patient with Paroxysmal NocturnalHaemoglobinuria required a transfusion of red cellsfor Hb of 7.5 g/dl. She had suffered a severetransfusion reaction in 2001 in another hospital andsince then was to be transfused with washed redcells. In 2001 the serology on this patient hadrevealed anti-C, anti-S, anti-K. The patient hadreceived several washed red cell transfusions, whichwere compatible, without incident. During atransfusion of washed cells in 2002 the patientdeveloped symptoms of pyrexia, rigors andhypotension, the unit was discontinued andparacetamol was administered. A further unit wastransfused with no complications following thatincident. On this occasion 3hrs and 15 mins into thetransfusion, 150 mls of washed antigen negative redcells had been infused. Symptoms of a temperature
rise of 2.5°C, rigors, hypotension, tachycardia,nausea, and general aches developed. The unit wasdiscontinued, the patient received paracetamol andsymptoms resolved. The unit subsequently culturednegative.
AHOSTR Case 16 This elderly male patient with underlyingmyelodysplasia, cardiovascular disease andcongestive heart failure was prescribed one unit ofred cells for symptomatic anaemia -Hb 8.8g/dl. Thepatient had been transfused with three units of redcells over the previous month uneventfully. Thepatient received his regular diuretic medication thatmorning and the unit infused over four hours. Threehours following the transfusion, the patient becameextremely flushed and developed a pyrexia (39.2°C)and symptoms of dyspnoea, tachypnoea, tachycardia,hypertension, falling O2 saturations, rigors andagitation developed. Following medical reviewoxygen, hydrocortisone, and chlorpheniramine wereadministered. The patient’s symptoms improved buthe still remained short of breath with wheezing for 24hours which had completely resolved within 48 hours.The patient was reviewed for future transfusionmanagement by the consultant haematologist.Subsequent transfusions have been covered bypremedication with hydrocortisone, chlorpheniramineand have been uneventful. Investigations of thereaction excluded red cell incompatibility. The patientwas not cultured but culture of the unit was negative.
AHOSTR Case 26 This female patient required a transfusion of one unitof red cells intra operatively for a blood loss of about1 litre. Two days post operatively the patient had afurther blood loss of 1340 mls from surgical drains.The Hb was 6.1g/dl and an additional two units of redcells were administered. The following day her urinebecame dark, concentrated and was positive ++ forblood. The patient was very pale with a slightcyanosis and developed symptoms of hypotensionand nausea. At that time this was attributed to asuspected drug interaction. The patient’s Hb was
89Annual Report
7.1g/dl and a further two units of red cells wereprescribed. Investigations for the cause of thehaematuria, revealed no abnormalities and the causeof the bleeding was not established. Duringtransfusion of the second unit when there was againfrank haematuria, the unit was discontinued andinvestigation of a suspected transfusion reaction wasinitiated.
Post transfusion investigations included re-grouping,cross match and antibody screen. The pre-transfusion antibody screen had identified an anti-Luaantibody, which was also identified post operativelyand confirmed at a reference centre. Crossmatchcompatible blood was provided but antigen negativeblood is not required for patients with anti-Lua. Thebilirubin was 32.2, the LDH was 6130 (Norm 230-460) the DAT was weakly positive. Both units fromthat transfusion were cultured negative. Tests forparoxysmal nocturnal haemoglobinuria (PNH) werenegative. Haemosiderin was negative immediatelypost transfusion but positive one week latersuggestive that haemolysis had occurred. Therecommendation from the reference centre was thatfuture transfusions should be managed with Rhphenotyped K negative compatible blood. Duringinvestigation of this reaction it emerged that thepatient had been transfused over 20 years ago withfour units of red cells. At that time she also developed“black urine” which was treated by her GP. Earlierthis year she was admitted to a different hospital withsymptomatic anaemia and received four units of redcells, which was followed by the occurrence of darkurine five days later. Investigations into the cause ofthe anaemia were inconclusive.
Detailed Case histories - Platelets
AHOSTR Case 11 This patient with a malignant haematological disorderrequired a transfusion of one unit of pooled plateletsfor a low platelet count. The patient had receivedthirty seven units of platelets and sixteen units of redcells over the previous two months and had a slight
reaction following the last transfusion of platelets, butrecovered without medication. On this occasion,forty-five minutes following transfusion, the patientdeveloped pyrexia 39.2°C, chills, rigors andtachycardia. Hydrocortisone and chlorpheniraminewere administered IV and the patient recovered withno ill effects within one hour. Patient blood cultureswere negative, the segment line cultures werenegative but as the pack and administration set wereopen to air these were not cultured. Investigationsshowed that the patient had developed HLAantibodies.
AHOSTR Case 18This patient with thrombocytopenia, secondary to amalignant haematological disorder, was prescribedone unit of apheresis platelets. The transfusion wascompleted uneventfully. However, one hour posttransfusion the patient developed fever with chills andrigors, tachycardia, dyspnoea, bronchospasm andfalling oxygen saturations. Oxygen, hydrocortisone,chlorpheniramine and prochlorperazine were givenand the patient recovered from the reaction within 24hours. The patient’s chest x-ray post reaction showeda mild cardiomegaly with prominence of the upperlobe veins but no evidence of an active process.Bacteriological culture of the patient isolated noorganisms, however due to a misunderstandingbetween clinical and laboratory staff, the implicatedunit was not cultured. The transfusion laboratory wasnot informed of the reaction and transfusion reactioninvestigations were not carried out. Futuretransfusions for this patient using pre medicationcover with chlorpheniramine have been uneventfulfollowing this regimen. This case was originallyreported as a possible case of TRALI but donorinvestigations carried out were negative.
National Haemovigilance Office90
INTRODUCTION
Although a number of suspected cases werereported and investigated during this reportingperiod, there were no reported cases fulfilling thecriteria for TRALI. Two reports were originallyconsidered. One case was reported as a suspectedcase of TRALI but this was excluded on the basis ofclinical findings, and this case was re-categorised asAHOSTR. A second case, originally reported asTRALI, was subsequently outruled based on clinicaland autopsy findings.
It is very difficult to distinguish TRALI from othercauses of acute lung injury which also causedyspnoea, hypoxia, interstitial and alveolar infiltrateson chest X ray. Patients may also present withhypo/hypertension. Symptoms begin within six hoursof transfusion and in the majority of cases the patientoutcome is good. However, as systems are put inplace to tackle fatal outcomes from other adverseevents, TRALI is slowly coming to increasedprominence.
The true incidence is unknown and may range from1:5000 to 1:100,000 units of plasma containingblood components transfused. Underreporting andthe lack of prospective data complicate the issuefurther. However, it is important to recognise thatTACO is much more common than TRALI and wherethere is evidence of fluid overload or cardiac failure,the diagnosis is very unlikely to be TRALI (NHO2002).
The presence of white cell antibodies (including HLAclass I and II antibodies, granulocyte-specificantibodies and anti-monocytic antibodies) has beenreported to be associated in about 80% of cases andcorrespondence between the donor antibody andpatient antigen is found in up to 50% of these. Thereare, however, a number of cases where no antibody isfound. It has been proposed that non-immunologicmechanisms may play a part in causing TRALIwhereby two insults to the lung are necessary, thefirst one being a predisposing event such as traumaor sepsis and the second, transfusion of a biologicallyactive substance such as lipids found in storedcellular blood products.
Transfusion Related Acute LungInjury
DefinitionTransfusion Related Acute Lung Injury(TRALI) is a clinical combination of acuterespiratory distress, hypotension, feverand rigors associated with bilateralpulmonary oedema with no evidence ofcardiac failure or fluid overload.Symptoms typically begin within 1-2hours of transfusion and always within 6hours (Popovsky, 2001)
91
It is important that the condition is recognisedpromptly and timely intervention with oxygen, ifnecessary, mechanical ventilation and other supportmeasures are fundamental to a successful outcome.
A great deal of consideration has been given to thedefinition of TRALI. A proposal put forward by theCanadian Consensus Conference suggests thatTRALI should be divided into TRALI and possibleTRALI based on the clinical symptoms/signs(adapted from Klienman et al, 2004)
Recommendations • To prevent TRALI, it is important to underline the
need for vigilance in the appropriate use of bloodand blood components, as transfusion relatedadverse events can be associated with fatalities.
• It is important that hospital staff be made moreaware of this complication of transfusion in orderfor it to be recognised and dealt with in anappropriate fashion. This would also facilitateprompt investigation and case review.
• The IBTS has put in place a number of measureswith a view to minimising the risk from TRALI.These include avoiding the use of plasma fromfemale donors both for suspension of pooledplatelets and as FFP and from early 2004,deferring new and lapsed female plateletpheresisdonors with a history of pregnancy. Moreover, aspart of the vCJD Policy, SD Plasma has becomethe standard plasma product. To date, SD treatedplasma has not been convincingly implicated inTRALI.
National Haemovigilance Office92
TRALI
Acute Lung Injury (ALI) is characterised by1. Acute onset2. Hypoxemia Sp02 <90% on room air or other
evidence of hypoxemia3. Bilateral infiltrates on frontal chest Xray4. No evidence of circulatory overload5. No pre-existing acute lung injury (ALI) before
transfusion or during or within six hours oftransfusion.
6. No alternate risk factors for Acute Lung Injurypresent
Possible TRALI
1. ALI as above2. No pre-existing ALI before transfusion or during or
within six hours of transfusion.3. Alternative risk factors for Acute Lung Injury
present (see table below)
Symptoms of dyspnoea, tachypnea, tachycardia, fever,hypotension or hypertension are present in somecases but are not sufficiently specific to be included inthe definition of TRALI or possible TRALI
Risk Factors for ALI
Direct Lung Injury Indirect Lung InjuryAspiration Severe sepisPneumonia ShockToxic inhalation Multiple traumaLung contusion Burn injuryNear drowning Acute pancreatitis
Cardiopulmonary bypassDrug overdose
The incidence of ALI varies considerably among theseconditions and may be as high as 40 percent forintensive care unit-related cases of septic shock andaspiration or as low as 2 percent for cases ofcardiopulmonary bypass and intensive care unit-related drug overdose.
Figure 5
This category accounted for 1% of incidents reported(3 of 214) in 2003. The NHO collects andinvestigates reports of all suspected transfusion-transmitted viral infections relating to bloodcomponents which have been transfused after theintroduction of mandatory testing for that virus. Viralinfections which not covered by mandatory testing,e.g. Hepatitis A virus, CMV and Parvovirus, but arereported to the NHO and suspected to be associatedwith a blood transfusion during the current reportingyear will be recorded as an NHO incident andinvestigated appropriately. The NHO also collectsand investigates reports of transfusion-transmittedbacterial and parasitic infections.
The onset of symptoms related to a transfusion-transmitted viral infection may occur several weeks toyears after the date of transfusion. Bacterial orparasitic infections are usually associated with acutesymptoms and come to clinical attention soon aftertransfusion. Viral diseases however, may not beassociated with any symptoms until some years later.Therefore, reports received within this category arenot necessarily the result of components transfusedduring this reporting year.
Infections presenting weeks, months or years after atransfusion are termed post-transfusion infections.These may indeed be due to the transfusion of aninfected or contaminated unit, but equally, infectionmay have been acquired from another source.Investigation of markers of infection in an implicateddonation, or in subsequent samples from the donorsof implicated donations, can confirm transfusion asthe probable cause of infection, or identify the need toinvestigate other possible sources (SHOT, 1999).Such investigations may involve microbiologicaltesting of many donors and may take many months tocomplete.
A post transfusion infection is confirmed astransfusion-transmitted once investigations arecomplete and the following criteria are fulfilled:(SHOT, 1999)
The recipient had evidence of infection following thetransfusion, with no evidence of infection prior to thetransfusion
and, either
Suspected Transfusion TransmittedInfection
93
A donor who had evidence of the same transmissibleinfection donated at least one component received bythe infected recipientor
At least one component received by the infectedrecipient was shown to have been contaminated withthe same infectious agent.
Much concern has been voiced in recent yearsregarding the risk of transfusion-transmitted infectionand much quality assurance effort has been directedtowards appropriate testing and handling of bloodafter collection. There is very good evidence that withcontinuous improvements in the donorselection/testing procedures and manufacturingprocesses used in Ireland, the risk of transfusion-transmitted infection is very small.
The current estimated risks for HIV and HCV are lessthan 1 per 4 million components transfused(O’Riordan J., personal communication). Theseresidual risk estimates are based on serologicaltesting and nucleic acid amplification testing (NAT)for HCV and HIV.
Even prior to the introduction of NAT testing, the riskfor Hepatitis C for screened blood was estimated tobe 1-500,000.
The risk for HBV has been estimated at approximately1:200,000 since the introduction of testing forantibody to Hepatitis B core in January 2002(O’Riordan J., personal communication).
Hepatitis B infection is not uncommon in thecommunity and in up to 40% of cases no risk such assexual exposure, intravenous drug abuse ortransfusion is present. Evidence of past clearedinfection in blood donors, a highly selectedpopulation was found in 0.17% i.e. 17 in 10,000donors in the first year of testing. In many of thesecases, nosocomial risks in the past may beresponsible. Such cleared infection does not pose a
risk to recipients and in a number of countries, suchindividuals are acceptable as donors. In Ireland, weintroduced core antibody testing in 2002 to reducethe possible risk of donors donating before HBVinfection was fully cleared i.e. in the second windowperiod when HbsAg is no longer detectable in bloodbut before an adequate (>100miu/l) antiHbs antibodyis found. Because hepatitis B core antibodies are amandatory test, donors with cleared infection foundreactive for the marker are also deferred.
Investigations into suspected transfusion transmittedinfections are difficult. They can involve considerableupset to donors who often have to be recalled andoffered testing and they are resource intensive.Where pre-transfusion samples are available, thesesamples can provide significant help in investigation.Patients such as haematology patients who willrequire ongoing transfusion should be offered testingbefore therapy and at regular intervals with storage ofsamples wherever possible for further testing ifnecessary.
The risk of receiving an incorrect blood component isin fact much greater than the risk of receiving atransfusion-transmitted infection. Over the seven yearperiod since the United Kingdom Serious Hazards ofTransfusion (SHOT) began reporting, confirmedreports of TTI accounted for 2.2% of incidents incomparison to reports in the IBCT category, whichaccounted for almost 63.9% (SHOT 2003)
Findings • Three incidents, which fit the criteria of suspected
transfusion-transmitted infection, were reported tothe NHO during this reporting year.
• There were two reports of suspected HIV infectionand one of HBV.
• In all cases, transfusion was excluded as the likelycause.
National Haemovigilance Office94
95Annual Report
CaseNumber
TTI Case 1
TTI Case 2
TTI Case 3
Viral Marker
HIV
HIV
HBV
Outcome
Transfusion excluded
Transfusion excluded
Transfusion excluded
Table 37: Suspected Transfusion Transmitted Infection (n=3)
Number ofdonorsinvolved
53
3
16
Gender
F
F
M
Year ofTransfusion
2004
2004
2004
Adult orChild
Adult
Adult
Adult
Adverse incidents or reactions during the donationare reported in this section. Incidents occurringduring the transfusion of autologous blood arecaptured elsewhere in this report under the relevantcategory.
These adverse reactions accounted for 3% of thetotal incidents reported (7 of 214).
The majority of autologous donors tolerate thedonation procedure without incident, but adversereactions occur occasionally (Brecher et al, 2002).The most common reaction is vasovagal in nature(Yomtovian and Praprotnik, 2001). However, severereactions are up to 12 times more likely in autologousdonors than allogeneic donors. (Popovsky et al,1995) High risk autologous donors include thosewith coronary artery disease or congestive cardiacfailure or uncontrolled hypertension or on medicationwhich affects the haemodynamic response of thecardiovascular system (Vamvakas and Pineda, 2000).Haemodynamic monitoring in high risk patientsundergoing autologous blood donation has detected
a significant number of adverse changes in responseto blood donation not detectable by simpleobservation (Spiess et al, 1992).
Pre Autologous Donation (PAD) is an option forsuitable patients where transfusion is anticipatedduring surgery (BCSH, 1993). One application forPAD has been in the field of elective orthopaedicsurgery. Advances in anaesthesia and surgicaltechnique, however, combined with reducedtransfusion thresholds have diminished the need fortransfusion in such patients. Politis and Richardson(2004) undertook a survey to determine the incidenceof PAD throughout Europe and report almost onethird of autologous units donated are not used.
The technique became popular during the 1980’s asa result of public concern regarding transfusion safetybut has declined with the increasing safety of bloodtransfusion for the main transfusion transmittedviruses HIV, Hepatitis B & C. However othertransfusion transmitted infection agents are emergingincluding West Nile Virus and vCJD. A case of vCJD
Pre- Deposit Autologous DonorIncidents
Definition
An adverse or unforeseen event, which isexperienced by the donor during orfollowing a pre-deposit autologousdonation procedure. (SHOT, 2001)1
96
in a transfusion recipient was reported in the UK inlate 2003 (Llewelyn et al, 2004) and the reportedfinding of abnormal prions at post mortem in thespleen of a second recipient who died of unrelatedcauses but who had received a unit of blood from adonor who developed vCJD supports thetransmission of vCJD through transfusion (Peden etal, 2004). In 2005, an Irish blood donor developedsymptoms considered to be due to vCJD. While anumber of precautionary measures have been put inplace to reduce the risk of transmitting vCJD by bloodtransfusion in Ireland, no universally effective measureexists to prevent its transmission and reducedexposure to transfusion and appropriate blood usageremain the most important measure.
The benefits to the patient of autologous transfusioninclude elimination of the risk of transmission ofinfectious diseases and alloimmunization and otherimmunological effects of allogeneic transfusion(Politis and Richardson, 2001).
Innerhofer et al (2005) in a prospective study reportthat despite universal white blood cell (WBC)filtration, recipients of allogeneic blood transfusionare still at greater risk of developing postoperativeinfections in comparison to autologous recipients.
However, Linden and Kruskall (1997) point out thatalthough autologous blood is considered safer thanallogeneic blood, it is not without risk. Bacterialcontamination, febrile non-haemolytic reactions andallergic reactions have all been reported followingautologous transfusion (Goldman et al, 2002). Otherdisadvantages associated with PAD are the necessityfor a definite date for surgery, increased likelihood ofreceiving a transfusion, bacterial contamination, riskof error, volume overload, and additional cost. Biliotte et al (2002) demonstrated that pre- operativeautologous donation increased the likelihood oftransfusion at the time of surgery.
According to Carless et al, (2004) in a systematicanalysis of autologous blood techniques the
advantages of autologous transfusions arecounteracted by lower pre-operative Hb levels andhigher overall transfusion rates, and they suggestusing other techniques such as antifibrinolytic drugsin conjunction with conservative transfusionthresholds to reduce the need for allogeneic blood.
Other forms of autologous transfusion in particularintraoperative cell salvage may reduce the need forallogeneic transfusion. (National Blood ConservationStrategy for NBTC and NBS Working Party Report,2004). An audit commissioned by the National BloodStrategy Implementation Group (NBSIG) in 2001found the use of autologous transfusion techniques inIreland is low and has recommended that cell salvageprogrammes be established in major hospitals as theyconsider this is the most effective alternative toallogeneic blood transfusion.
Regulatory aspects
Hospitals collecting pre-deposit autologous bloodwill now be considered blood establishments inrespect of the collection of autologous units and assuch subject to the same scrutiny as a bloodtransfusion service under Article 29 of the EuropeanDirective 2002/98/EC, which came into effect inNovember 2005.
Detailed requirements covering autologous donationsare detailed in Commission Directive 2004/33/ECwhich addresses technical requirements for blooddonors including autologous donors. It coversinformation to be given to donors, storage, andtransport and distribution requirements.
These directives can be downloaded fromhttp://europa.eu.int.
Findings:
• Six of the seven incidents involved PAD fororthopaedic surgery. The remaining incident wasassociated with PAD for urological surgery.
97Annual Report
Symptoms reported were generally vasovagal innature and ranged from feeling light-headed,nauseated and faint to actually fainting. Onset ofsymptoms ranged from during the procedure up totwenty-four hours post donation.
• One donor developed a generalized body rash 24hours after donating one unit and a severeurticaria on the torso, arms, legs and handsimmediately following the donation of a secondunit. This resolved with treatment the next day.The patient was on ACE inhibitors and it is notclear whether the reaction was related to the drugor the PAD although a sibling had had a similarreaction after blood donation.
• Six of the donors were discharged the same day.However, one donor required overnighthospitalisation. This patient was onantihypertensive medication.
• Three of the donors had each donated a unitpreviously, one of whom had felt nauseated andweak post donation but three of the donorsinvolved were donating blood for the first time.
• Four of the donors were under sixteen years ofage and three weighed less than 50 kgs. In one ofthese cases, although the donor completed apredonation questionnaire, she did not disclosethat she felt faint and weak at the sight of blood orneedles.
• Simultaneous volume replacement was notundertaken during the donations. However, two ofthe donors who experienced symptoms at the endof or following the donation were given fluids IV.
• All of the donors recovered without complicationsand one successfully donated a second unituneventfully seven days later.
• The blood collected was transfused in six of theseven cases. Two donors received allogeneic
blood in addition to the PAD blood. In one of thecases re-assessment post-transfusion after thefirst allogeneic unit might have obviated the needfor further transfusions.
Recommendations
• Paediatric patients and adult patients weighingless than 50 kg need special consideration, andcare should be taken to ensure the volume drawndoes not exceed 12% of the estimated bloodvolume. (BCSH, 1994)
• All PAD clinics should monitor the donations usinga digital scales. This would ensure that donationson children or lower weight adults could bestopped at < 450mls. Patients less than 16 yearsmay require to be bled into smaller bags assuggested by the BSCH guidelines (1994).
• Donors receiving antihypertensive medicationshould be carefully monitored. Volumereplacement should be considered for patients ontreatment with beta-blockers and/or angiotensinconverting enzyme (ACE) inhibitors as their abilityto respond to a reduction in blood volume may becompromised by their treatment.
• Careful selection of patients for PAD, such asyoung, fit adolescents may reduce the need forallogeneic transfusions in these patients anddecisions to transfuse additional allogeneic bloodpost-operatively should be based on carefulclinical assessment.
National Haemovigilance Office98
99Annual Report
Case
No.
PAD
Case
1 PAD
Case
2 PAD
Case
3 *
Plan
ned
Proc
edur
e
Rem
oval
ofsp
inalr
ods
Ganz
oste
osto
my
Elect
iveor
thop
aedic
surg
ery
15 F 14 F 43 F
50 49 60
Hb g/dl
14.7
13.1
14.4
&12
.0
Curre
ntMe
dicat
ion
Oral
iron
Oral
analg
esia
ACE
inhibi
tor
/thiaz
idediu
retic
and
oral
analg
esics
.
Com
plica
tions
Naus
eaan
dhy
pote
nsion
post
dona
tion.
Light
-hea
ded
and
naus
eaat
end
ofdo
natio
n.
24ho
ursf
ollow
ing1s
tdo
natio
nur
ticar
iaov
erbo
dy.
Follo
wing
2nd
dona
tion
seve
rera
shov
erto
rso,
hand
s,an
dba
ck.
Reac
tion
Dona
tion
Histo
ry
On1s
t
On1s
t
On2n
d.1s
tun
even
tful.
Com
men
ts
Past
histo
ryof
naus
eaan
dfe
eling
weak
.50
0mls
ofIV
fluids
adm
iniste
red.
Reco
vere
dwi
thno
com
plica
tions
.Di
scha
rge
Hb10
.3.g/
dl.
Past
histo
ryof
need
leph
obia.
500m
lsof
IVflu
idsad
mini
stere
d.Re
cove
red
with
noco
mpli
catio
ns.
Disc
harg
eHb
8.9g/
dl.
Requ
ired
anti-
hista
mine
table
tsan
dcr
eam
toea
sera
sh.R
ecov
ered
with
noco
mpli
catio
ns.
Disc
harg
eHb
9.7g/
dl.
PAD
unit
(s)
trans
fuse
d
None
.
Auto
logou
sunit
trans
fuse
dan
d1u
nitof
allog
eneic
blood
adm
iniste
red.
Both
units
trans
fuse
d
Tabl
e38
:Pr
e-op
erat
iveAu
tolo
gous
Dono
rInc
iden
ts(N
=7)
Age YrsGender
Weight kg1 1 2No Planned
Donations
*Inc
luded
asa
full
case
histo
ry
National Haemovigilance Office100
Case
No.
PAD
Case
4 PAD
Case
5 * PAD
Case
6 PAD
Case
7 *
Plan
ned
Proc
edur
e
Orth
opae
dicsu
rger
y
Orth
opae
dicsu
rger
y
Urolo
gical
surg
ery
Orth
opae
dicsu
rger
y
13 F 61 M 61 M 15 M
44 101
80 66
Hb g/dl
14.6
13.5
16.1
15.4
Curre
ntMe
dicat
ion
Oral
iron
Card
iosele
ctive
beta
-bloc
ker,
class
IIca
lcium
anta
gonis
t.Br
onch
odil
ator
sora
llyan
dvia
inhala
tion.
Oral
analg
esia
None
Bron
chod
ilato
rinh
aler
Com
plica
tions
Naus
eaan
dvo
mitin
g30
mins
post
dona
tion.
Brad
ycar
dia,
hypo
tens
ion,
losso
fcon
sciou
snes
sFa
inted
follo
wing
dona
tion
of50
0mls
Light
-hea
dedn
ess,
felt
faint
20m
inspo
stdo
natio
n.
Light
-hea
dedn
ess.
Faint
ed25
mins
post
dona
tion
Reac
tion
Dona
tion
Histo
ry
On1s
t.2n
dun
even
tful
On2n
d.1s
tun
even
tful.
On2n
d1s
tun
even
tful
On2n
d.1s
tun
even
tful.
Com
men
ts
Reco
vere
dwi
thno
com
plica
tions
.Di
scha
rge
Hb7.9
g/dl.
Requ
ired
over
night
adm
ission
.Re
cove
red
with
noco
mpli
catio
ns.
Disc
harg
eHb
10.6
g/dl.
Reco
vere
dwi
thno
com
plica
tions
.Di
scha
rge
Hb10
.9g/
dl.
Reco
vere
dwi
thno
com
plica
tions
.Po
st-tra
nsfu
sion
Hb7.4
g/dl.
Disc
harg
eHb
.10.4
g/dl.
PAD
unit
(s)
trans
fuse
d
One
unit
trans
fuse
d.
2un
itstra
nsfu
sed.
2un
itsof
trans
fuse
d.
2un
itsof
auto
loguo
usan
d2
units
ofall
ogen
eicblo
odad
mini
stere
d.
Tabl
e39
:(Co
ntin
ued)
Pre-
oper
ative
Auto
logo
usDo
norI
ncid
ents
(N=7
)
Age YrsGender
Weight kg3 2 2 3No Planned
Donations*
Includ
edas
afu
llca
sehis
tory
Pre-operative Autologous Donor (PAD)Incidents (n=7) Case Histories
PAD Case 3 This female patient was pre-donating two units ofblood for elective orthopaedic surgery. Assessmentof donor fitness was carried out and the patient’sweight was 60 kgs and Hb 14.4g/dl prior to the firstunit and 12.0 g/dl prior to donation of the secondunit. The patient had a history of hypertension, whichwas well controlled with the ACE inhibitor /thiazidediuretic, Capozide. The collection of the first unit wasuneventful. However, the following day the patientwent on holiday and developed a generalised bodyrash, which she attributed to a change in the sheetsin the hotel. Within one hour following donation of thesecond unit, however, the patient developed a virulenturticaria on torso arms legs and hands that requiredan antihistamine cream and tablets to alleviate theitch. This settled within 24 hours. The patient’s Hblevel prior to transfusion was 9.3g/dl. and the patientreceived the two pre-deposited units followingsurgery. No further allogeneic units were required ondischarge the Hb was 9.7g/dl. Further investigationof this incident revealed that a sibling had a similarreaction when donating blood. The patient denied anysimilar previous rash.
PAD Case 5 This male patient was scheduled to pre-donate twounits of blood prior to a total hip replacement forwhich the MSBOS recommended two units of blood.His pre-donation Hb was 13.5g/dl. The donor had ahistory of asthma and hypertension and his currentmedications included a cardioselective beta- blocker,a class II calcium antagonist, a bronchodilator,salbutamol inhaler and oral analgesics. Immediatelyfollowing the second donation of 500mls (includinganticoagulant) of whole blood, the donor felt faint hadsymptoms of bradycardia, hypotension and loss ofconsciousness. The donor was reviewed by themedical team and remained in hospital overnight andwas referred to a cardiologist for review, which wasnormal. The patient’s haemoglobin prior to transfusion
was 10.1 g/dl and the two units, which had beencollected, were administered based on theintraoperative blood loss. No extra allogeneic unitswere required. Prior to discharge home the patientsHb was 10.9g/dl.
PAD Case 7 This young boy was pre-donating his second unit ofblood for elective orthopaedic surgery. He haddonated one unit previously. Between 450-460 mlsof blood were collected uneventfully and the patientrested in the donation facility for 20 minutes. Shortlyafterwards he became lighted-headed and fainted.He returned to the donation facility and rested for afurther hour and had some fluids orally. He recoveredwithout incident from this event. A third unit was nottaken. Peri-operatively when the patient had reachedhis maximum allowable blood loss (MABL), bothautologous units were transfused. The patient’shaemoglobin post transfusion was 7.4 g/dl and hisvital signs were within normal limits. However, on daythree post-operatively the patient becamesymptomatic complaining of dizziness and feelinglight-headed on getting out of bed and two furtherunits of allogeneic red cells were administered. In thiscase, reassessment after the first allogeneic unitmight have obviated the need for a further transfusion.The patients discharge haemoglobin was 10.4g/dl.
101Annual Report
Paediatric patients form an important sub group oftransfusion patients. This chapter summarises thefindings on the 24 paediatric cases reported, whichaccount for 11% of the total reports received. Themajority of reports were in the IBCT category, seveninvolved acute reactions and four were reactionsassociated with PAD.For the purpose of this report, paediatric patients aredefined as age 18 years or under.
Findings IBCT• There were 12 reports in the IBCT category. The
majority of errors were similar to those found in theadult patients.
• In one case (Case 78) a group A baby receivedgroup O platelets due to a request error to thesupply centre by a medical scientist on call notnormally working in the transfusion laboratory.
• One patient was involved in three reports (Cases94, 96 & 97) where three paedipack aliquots wereincorrectly crossmatched and transfused from a
paedipack which was crossmatched and allocatedfor another baby of the same name.
• In three cases (Cases 50, 107 & 108) there wasa failure to prescribe CMV negative/irradiatedcomponents. Two of these (Cases 107 and 108)involved shared care between facilities and as noclinical details were provided, the laboratory wasnot aware of the requirements. In the third case,(Case 50) although the patient had receivedprevious CMV negative/irradiated components,the alert on the laboratory computer had not beenactivated so the error was not detected.
Findings Reactions There were 12 reports in the reaction category.
• The most common reaction reported was in theAA category with seven reports. Pooled plateletswere involved in five cases and red cells in two.
• Three of the AA cases occurred despite theadministration of premedication of
Paediatric Incidents
102
chlorpheniramine and hydrocortisone.
• Further transfusion was managed usingpremedication alone in three cases and washedcomponent in three cases. One of these whorequired washed components was a patient whohad three separate reactions to pooled platelets(Case 21, 22, 23).
• Cutaneous manifestations were present in all ofthe AA reports.
• There was one report in the AHOSTR category.
• Four cases involved reactions associated with pre-deposit autologous donations and are discussedin the PAD chapter.
Recommendations.• On going training should be provided for medical
scientists providing on call cover who do notnormally work in transfusion to highlight specialrequirements for neonates.
• Each aliquot of a paedipack dedicated to aspecific infant should be individually labelled forthe intended infant to reduce the chance ofissuing it to another infant.
• Medical staff must be aware of guidelines forprescribing irradiated products in paediatricpatients.
• Alert stickers should be placed on charts wherepatients have special requirements e.g.irradiated/CMV negative components.
• Blood transfusion laboratory computer systemalerts which draw attention to the need forspecialised components should be used whereverpossible.
• As some of the incidents involved shared care oradmission to different hospitals, issuing of apatient card should be considered.
• A/A reactions are distressing for both the patientand the clinical team and washed componentsmay be indicated for serious repeated reactions.However, poorly justified requirements for washedcomponents may cause undue delays whentransfusions are needed in the future. In addition,washing of platelets can affect platelet yields withloss of platelet numbers and viability from thewashing process and poor in vivo incrementalrises.
• Before prescribing washed platelets for patientswith a history of transfusion reactions to pooledproducts, apheresis platelets (which areassociated with a lower rate of reactions) withpremedication cover should be tried first.
• It is important to ensure that the patient has apatent IV cannula and that all documentation iscorrect prior to collection of the unit. Should therebe a delay in the commencement of thetransfusion it is necessary to return the unit tocontrolled storage within thirty minutes and informthe laboratory to ensure the unit is being returnedto the appropriate fridge.
103Annual Report
National Haemovigilance Office104
Level
1
2
2
2
2
2
2
2
3
3
Volume of IncorrectBlood Component orProduct Transfused15mls of apheresis plateletsx 2
Plasma exchanged on fouroccasions with 12 units ofUniplas.
One paedi-pack
One unit of red cells.
One aliquot of red cells
One aliquot of red cells
One aliquot of red cells
One unit of red cells
Discovered when 60 mls ofred cells transfused ,discontinued.
One aliquot of red cells
One unit of red cells
One unit of red cells
Cause of Error
Group O platelets requested and issued toGroup A baby.
Inability of supply centre to supply group B SDPlasma for large volume plasma exchanges.
Incorrect date of birth was transcribed fromnotes onto request form and sample tube.
CMV negative and irradiated red cells notordered as required and error not detected onprocessing as this requirement had not beenflagged on a previous transfusion.
Paedipack aliquot incorrectly crossmatchedand transfused from a paedipack which wascrossmatched and allocated for another babyof the same name.
Paedipack aliquot incorrectly crossmatchedand transfused from a paedipack which wascrossmatched and allocated for another babyof the same name.
Paedipack aliquot incorrectly crossmatchedand transfused from a paedipack which wascrossmatched and allocated for another babyof the same name.
Failure to prescribe CMV negative or irradiatedred cells for a patient with a malignanthaematological disorder.
Failure to request and prescribe irradiatedblood products for a patient with a malignanthaematological disorder.
In error last aliquot of paedipack removedfrom and left out of fridge too long andwasted.
One digit error in date of birth on pretransfusion sample request form and on unittransfused.
Mother of patient stated patient’s date of birthincorrectly, i.e. month, day, year instead ofday, month, year.
TABLE 40: IBCT Paediatric Incidents (N=12)
Symptoms andOutcome
No complications as a resultof this transfusion.
Positive DAT. Nocomplications as a result ofthis transfusion.Subsequent transfusionswith Group B FFP.
No complications as a resultof this transfusion.
No complications as a resultof this transfusion.
No complications as a resultof this transfusion
No complications as a resultof this transfusion
No complications as a resultof this transfusion
No complications as a resultof this transfusion.
No complications as a resultof this transfusion.
No complications as a resultof this transfusion
No complications as a resultof this transfusion.
No complications as a resultof this
Age
1 wk
1yr
39 days
18 months
5 wks
3 yrs
15 yrs
22 days
3 yrs
7 yrs
CaseNumber
IBCT Case 78*P
IBCTCase 25
IBCTCase 43
IBCT Case 50*P
IBCT Case 94,96, 97samepatient*P
IBCT Case 107*P
IBCT Case 108
IBCTCase 121*P
IBCT Case 29
IBCT Case 75
*P Included as a full case history in this chapter
Wrong Platelet ABO group
Level 1 IBCT Case 78 This premature neonate with sepsis required atransfusion of platelets for thrombocytopenia. Thepatient’s blood group was A Rh D positive. A Rh Dpositive platelets should have been requested. Inerror, group O Rh D positive platelets were requestedby an on-call medical scientist not normally working inblood transfusion. The supply centre did not detectthe error as the information about the patient’s bloodgroup was incorrect. The platelets were administeredin two doses of 15 mls uneventfully and bothtransfusions were checked at the bedside by twoclinical staff; however the group discrepancy wentunnoticed. A medical scientist normally working inblood transfusion discovered the error the followingday during a routine audit of on-call work. The patientsuffered no complications as a result of thistransfusion.
Problems with Paedipacks
Level 2 IBCT Case 94, 96, 97 This neonate required a top up transfusion foranaemia of prematurity. There were three infants withthe same surname being nursed in the ITU at thistime. On call a medical scientist not normally workingin transfusion issued an aliquot crossmatched for thisbaby, from a paedipack which had been allocated andcrossmatched for one of the other babies of the samename. Both babies were of the same blood group.The error occurred due to a failure to confirm correcthospital number and date of birth on the babyintended for transfusion. In the hospital, the unit,which is split into aliquots, is labelled with the baby’sdetails but each aliquot is not individually labelled.However the crossmatch form contains the donornumber, which is on each aliquot and used forconfirmation during the final bedside checkingprocedure. The error went unnoticed and wasrepeated on the same baby on two further occasions.All transfusions were uneventful and a senior medicalscientist discovered the error during a routine audit.
Both babies required further transfusions and newaliquots were assigned.
Level 2 IBCT Case 121 This premature neonate required a transfusion of redcells for anaemia. The baby had already receivedthree of the five neonatal aliquots available at thehospital. On this occasion the baby required onefurther aliquot but two units were removed from thefridge in error. One aliquot was transfused but theother one had to be discarded as it had been out ofcontrolled storage for too long. The following dayhaving reviewed the patient a decision was made totransfuse a further unit of red cells. A new paedipackof red cells was ordered but due to the baby’scondition a decision was made to transfuse the babyimmediately using the stock red cells for neonatal use.
CMV / Negative Irradiated componentsnot prescribed
Level 2 IBCT Case 107 This child with a malignant haematological disorderrequired a transfusion of two units of CMV negativeand irradiated red cells for anaemia. The child wasreceiving shared care between two facilities. Theprescription however did not state the need forspecial requirements and the first unit was issuedfrom the laboratory and transfused. When thelaboratory staff contacted the clinical area to see ifthe second unit was required they were informed ofthe shared care programme and it was then realisedthat CMV negative and irradiated components shouldhave been prescribed. As this was the firsttransfusion outside the primary care facility notransfusion history was available.
Level 2 IBCT Case 50 This young child with a malignant disorder required ared cell transfusion. The patient had receivedprevious transfusions of CMV negative and irradiatedblood products. On the previous transfusion, theappropriate product was issued but the alert which
105Annual Report
would have indicated the special requirements forfuture transfusions was not activated on the laboratorysystem. On this occasion, one unit of red cells wasprescribed but the requirement for CMV negative andirradiation was not specified. The laboratory staff werenot alerted by the IT system as the alert had not beenactivated previously. One unit of red cells wastransfused. By chance the unit was CMV negative butwas not irradiated. The patient suffered nocomplications as a result of this incident. The error wasdetected on a subsequent transfusion. As a result ofthis incident all computer records of paediatriconcology patients have been flagged as requiring CMVnegative and irradiated products. All new cases withspecial transfusion requirements have a sticker placedon the front of the chart.
Transfusion Reactions
AA Case 15This five-year-old male patient with a malignanthaematological disorder required a red cell transfusionfor anaemia. The unit of red cells was administered asprescribed over three and half-hours. Two hours aftertransfusion the patient developed symptoms ofurticaria and periorbital oedema. Chlorpheniraminewas given and the patient recovered fully within twoand half-hours. The patient suffered no furthercomplications as a result of this transfusion. Noinvestigations were carried out. Pre-medication ofchlorpheniramine for future transfusions wasrecommended and the patient has had receivedsubsequent transfusions with no complications usingthis regime.
AA Case 21, 22 & 23 This young male child with a malignancy requiredseveral transfusions of platelets in the day care settingfollowing chemotherapy. Following transfusion of a unitof pooled platelets, the patient developed an urticarialrash which did not require treatment and whichsubsided within 30 minutes. During a subsequenttransfusion of pooled platelets one week later, thepatient developed urticaria, a cough and a lump in his
throat. No medication was prescribed. One unit of redcells was then transfused uneventfully and the childwas discharged. On the third occasion, one week later,premedication of chlorpheniramine and hydrocortisonewas given prior to a further transfusion of pooledplatelets. Following transfusion, the patient developeda cough, wheeze and itch which required treatmentwith a salbutamol nebulizer. The symptoms resolvedwithin one hour and future recommendations fortransfusion of this child include the administration ofwashed platelets. Subsequent transfusions using thisprotocol have been successful.
AHOSTR case 20This young male child with a malignant haematologicaldisorder required one unit of CMV negative red cellsfor anaemia. The patient grouped as O Rh D positive,the historical antibody screen was positive for Anti Jkb
which was not detected on this occasion. Antigennegative blood was crossmatched and issued. Duringtransfusion, when 93 mls had been transfused, thepatient developed symptoms of fever (>1.5°C) withbackache and nausea. The transfusion wasdiscontinued completely and no medication was given.A full recovery was made but the recovery timeframewas not specified in the case notes. The patient wascultured and no organisms were isolated. However thesuspected reaction was not investigated and the unitwas not cultured.
National Haemovigilance Office106
107Annual Report
Case
No.
AACa
se10 AA
Case
11 AACa
se15 *P AA
Case
18 AACa
se21
,22
&23
*P
Com
pone
nt
One
unit
poole
dpla
telet
conc
entra
te
One
unit
poole
dpla
telet
conc
entra
te
One
unit
red
cells
One
unit
red
cells
One
unit
ofpo
oled
plate
letco
ncen
trate
(1st
trans
fusio
n)
One
unit
ofpo
oled
plate
letco
ncen
trate
(2nd
trans
fusio
n)
One
unit
ofpo
oled
plate
letco
ncen
trate
(3rd
trans
fusio
n)
Age
Yrs
Gend
er
12 F 11 F 5 F 11 F 6 M
Reas
onfo
rtra
nsfu
sion
Plat
eletc
ount
54x1
09/L
Haem
atolo
gical
mali
gnan
cy,
seps
is.
Plat
eletc
ount
18x1
09/L
Haem
atolo
gical
mali
gnan
cy.
Anae
mia
Hb7.6
g/dl
Haem
atolo
gical
mali
gnan
cy,
activ
eble
eding
.
Anae
mia
Hb8.1
g/dl
Haem
atolo
gical
mali
gnan
cy.
Plat
eletc
ount
10x1
09/L
Malig
nanc
y.
Plat
eletc
ount
14x1
09/L
Malig
nanc
y.
Plat
eletc
ount
19x1
09/L
Malig
nanc
y.
Sym
ptom
s
Urtic
aria
desp
itepr
emed
icatio
nwi
thhy
droc
ortis
one
and
chlor
phen
iram
ineIV.
Urtic
aria,
itch
and
disco
mfo
rtde
spite
prem
edica
tion
with
hydr
ocor
tison
ean
dch
lorph
enira
mine
IV.
Urtic
aria,
perio
rbita
loe
dem
a.
Urtic
aria,
feve
rrise
of1.9
°C,c
hills,
rigor
s,ta
chyc
ardia
.
Urtic
aria
Urtic
aria,
coug
han
dlum
pin
thro
at.
Whe
eze,
coug
h,lum
pin
thro
atan
ditc
hde
spite
prem
edica
tion
with
hydr
ocor
tison
ean
dch
lorph
enira
mine
IV.
Inves
tigat
ions
None
None
None
ABO
incom
patib
ility
exclu
ded.
Cultu
reof
patie
ntan
dun
it,no
grow
th.
None
.
Stag
eTra
nsfu
sion
Deve
loped
Follo
wing
com
pletio
nof
trans
fusio
n
45m
inute
safte
rco
mm
encin
gtra
nsfu
sion.
Follo
wing
com
pletio
nof
trans
fusio
n.
With
inth
ree
hour
sof
com
men
cing
trans
fusio
n.24
0mls
had
been
trans
fuse
d.
Post
trans
fusio
n
Post
trans
fusio
n.55
minu
tesa
fter
com
men
cing
trans
fusio
n
Post
trans
fusio
n.30
minu
tesa
fter
com
men
cing
trans
fusio
n
Treat
men
t
None
Hydr
ocor
tison
eIV.
Chlor
phen
iram
ine
Hydr
ocor
tison
eIV,
para
ceta
mol.
Trans
fusio
ndis
cont
inued
.
None
.
None
.
Salbu
tam
olne
buliz
er.
Sequ
elae/
Reco
mm
enda
tions
forf
utur
etra
nsfu
sions
Reco
very
with
inth
irty
minu
tes.
Was
hed
com
pone
ntsh
ave
been
reco
mm
ende
dfo
rfu
ture
trans
fusio
ns.
Reco
very
with
inth
irty
minu
tes.
Futu
retra
nsfu
sions
with
wash
edco
mpo
nent
sha
vebe
enre
com
men
ded.
Reco
vere
dwi
thin
two
and
aha
lfho
urs
Subs
eque
nttra
nsfu
sions
with
prem
edica
tion
ofch
lorph
enira
mine
have
been
unev
entfu
l.
Reco
very
with
in4-
5ho
urs.
Prem
edica
tion
ofan
tihist
amine
hasb
een
reco
mm
ende
d.
Reco
very
with
inon
eho
ur.
Reco
very
with
inon
eho
ur.P
rem
edica
tion
prior
tofu
ture
trans
fusio
nsre
com
men
ded.
Reco
very
with
inon
eho
ur.W
ashe
dce
llsha
vebe
enre
com
men
ded
forf
utur
etra
nsfu
sions
.
TABL
E41
:AA
Paed
iatri
cIn
cide
nts
(N=7
)
*PInc
luded
asa
full
case
histo
ryin
this
chap
ter
National Haemovigilance Office108
Case
No.
AHOS
TRCa
se20
*P
Com
pone
ntPr
escr
ibed
One
unit
ofre
dce
llsJk
ban
tigen
nega
tive
red
cells
.
Age
Yrs
Gend
er
3 M
Unde
rlying
cond
ition
Haem
atolo
gical
mali
gnan
cy
Volum
etra
nsfu
sed
onse
t
93m
ls
Sym
ptom
s/sig
ns
Tem
pera
ture
rise
>1.5°
C,ba
ckac
he,n
ause
a.
Inves
tigat
ions
Patie
ntcu
lture
d,no
orga
nism
siso
lated
.No
furth
erinv
estig
ation
sca
rried
out.
altho
ugh
patie
ntha
da
histo
ryof
prev
iousa
ntibo
dies.
Treat
men
t&Ou
tcom
e
Trans
fusio
nwa
sdisc
ontin
ued,
patie
ntre
cove
red
fully
.No
treat
men
twas
given
.
TABL
E42
AHOS
TRPa
edia
tric
Inci
dent
s(N
=1)
Case
No.
PAD
Case
1 PAD
Case
2 PAD
Case
4 PAD
Case
7 *
Plan
ned
Proc
edur
e
Rem
oval
ofsp
inalr
ods
Ganz
oste
osto
my
Orth
opae
dicsu
rger
y
Orth
opae
dicsu
rger
y
15 F 14 F 13 F 15 M
5 0 49 44 66
Hb g/dl
14.7
13.1g
/
14.6
15.4
Curre
ntMe
dicat
ion
Oral
iron
Oral
analg
esia
Oral
iron
Bron
chod
ilato
rinh
aler
Com
plica
tions
Naus
eaan
dhy
pote
nsion
post
dona
tion.
Light
-hea
ded
and
naus
eaat
end
ofdo
natio
n.
Naus
eaan
dvo
mitin
g30
mins
post
dona
tion.
Light
-hea
dedn
ess.
Faint
ed25
mins
post
dona
tion
Reac
tion
Dona
tion
Histo
ry
On1s
t
On1s
t
On1s
t.2n
dun
even
tful
On2n
d.1s
tun
even
tful.
Com
men
ts
Past
histo
ryof
naus
eaan
dfe
eling
weak
.50
0mls
ofIV
fluids
adm
iniste
red.
Reco
vere
dwi
thno
com
plica
tions
.Di
scha
rge
Hb10
.3.g/
dl.
Past
histo
ryof
need
leph
obia.
500m
lsof
IVflu
idsad
mini
stere
d.Re
cove
red
with
noco
mpli
catio
ns.
Disc
harg
eHb
8.9g/
dl.
Reco
vere
dwi
thno
com
plica
tions
.Di
scha
rge
Hb7.9
g/dl.
Reco
vere
dwi
thno
com
plica
tions
.Po
st-tra
nsfu
sion
Hb7.4
g/dl.
Disc
harg
eHb
.10.4
g/dl.
PAD
unit
(s)
trans
fuse
d
None
.
Auto
logou
sunit
trans
fuse
dan
d1u
nitof
allog
eneic
blood
adm
iniste
red.
One
unit
trans
fuse
d.
2un
itsof
auto
loguo
usan
d2
units
ofall
ogen
eicblo
odad
mini
stere
d.
TABL
E43
:Pre
-Dep
osit
Auto
logo
usDo
norI
ncid
ents
(N=4
)
Age YrsGender
Weight kg
1 1 3 3No PlannedDonations
*PInc
luded
asa
full
case
histo
ryin
this
chap
ter
*Inc
luded
asa
full
case
histo
ryin
appr
opria
tech
apte
r
IntroductionA three year pilot project in Near Miss event reportingcommenced in November 2002. The objectives of theproject were to improve the safety of transfusion byanalysing the incidence of Near Miss events and theirroot causes so that changes could be introducedwhere weaknesses in the transfusion chain wereidentified.
The Medical Event Reporting System for TransfusionMedicine (MERS-TM), a system specificallydesigned to collect, classify and analyse events withpotential for compromising blood transfusion safetywas used to collect and analyse the data.
Ten hospital sites nationwide have been contributingto the project since it commenced and reporting rateshave been steadily growing. During 2004, the first fullyear of reporting, a total of 467 Near Miss eventswere received and analysed. The total number ofreports received within the IBCT category from thesame ten hospital sites during 2004 was 42,confirming that Near Miss events are occurring onaverage, 11 times more frequently than adverseevents causing harm.
The distinguishing difference between a Near Missevent and an adverse event causing harm, is that in aNear Miss event there is always a ‘recovery’ step that
prevents harm to the patient. Recovery can either bein the form of a planned checking step in the workprocess or, an event can be simply caught by chance.Information about recovery within an organisation canprovide us with insight about which barriers to errorare effective or which are weak or missing.
The risk index of each event was calculated using therisk assessment tool provided by MERS-TM. Eachevent was classified into either high medium or lowrisk depending on the degree of risk the event posedto either the patient or the organisation.
Root causes were divided into Human,Organisational, Technical or Patient Related Failures.Most events involved more than one root cause; onlysignificant root causes where patterns or trends inerror emerged will be discussed in this report.
By analysing Near Miss event data, we can identifyhigh risk clinical areas and steps in the work processin addition to many other factors that contribute toerror. By studying the circumstances surroundingeach event, we can gain vital insight into the realreasons why errors occur in the transfusion setting.Most importantly, as the lessons we can learn fromNear Miss event data do not involve the patient beingexposed to harm, we can improve the safety oftransfusion in a way that benefits both the patient and
The Near Miss Project The First Full Year of Reporting
109
the organisation.
RESULTS
Fig 6: Near Miss Events versus Adverse Eventsreported in the 10 Project SitesJan - Dec 04
Near Miss events in the 10 project sites are occurringon average 11 times more frequently than adverseevents causing harm
Fig 7: Risk Index of Events
There were 353 events that were classified as lowrisk, 81 as medium risk and 33 as high risk.
Fig 8: Step in the Work Process where Eventswer Discovered N = 467
The majority of events 273 (58%) were discovered atthe Sample Handling step in the laboratoryhighlighting this step as an effective barrier to error.There were 66 (13%) events that were notdiscovered until Unit Transfusion ie: at some pointafter the unit was issued, but before it was transfusedto the patient. These relate to events discovered ateither collection from site of storage or the finalbedside check. A further 60 (13%) events werediscovered at some point outside recognisedchecking steps in the work process, these eventswere classified as being discovered at‘miscellaneous’ steps.
National Haemovigilance Office110
0
100
200
300
400
500
Actual Errors Reported
42
Near Miss Events Reported
467
0
50
100
150
200
250
300
350
400
Low Risk Medium Risk
353
81
High Risk
33
Sampling Handling273 (58%)
Selection1 (1%)
Storage2 (1%)
Unit Transfusion66 (14%)
SampleCollection
21 (4%)
Miscellaneous60 (13%)
Issue9 (2%)
Check In6 (1%)
Avail for Issue5 (1%)
Pres. Req.3 (1%)
Testing21 (4%)
Fig 9: 1st Site of Error
Sample Collection was the first site of error in 300(64%) events, identifying it as the highest risk step inthe work process. There were 33 (7%) eventsinvolving errors made during Prescription or Request.In addition, there were 70 (15%) events where thefirst site of error occurred at some point outsiderecognised steps in the work process, these eventswere classified as first occurring at ‘Miscellaneous’steps.
Fig 10: Who was involved
Errors most frequently involved medical & nursingstaff, 261 (56%) events involved doctors and 138(29%) involved nurses. Laboratory staff were alsoinvolved in a significant number of events 50 (10%).A further 50 (10%) events involved ‘other’ grades ofstaff including portering and phlebotomy staff. Mostevents involved more than one grade of staff.
Fig 11: Where Events are Occuring
The high risk clinical areas identified were the generalward areas where 274 (59%) events occurred andA&E where 66 (14%) events occurred. A significantnumber of events, 47 (10%) occurred in thetransfusion laboratory which has been traditionallyviewed as an area where risk of error is low.
111Annual Report
Sample Collection300 (64%)
Manipulation1 (0.5%)Order Entry
1 (0.5%)
Storage1 (0.5%)
Miscellaneous70 (15%)
Unit Transfusion23 (5%)
Pres Req.33 (7%)
Issue10 (2%)
Selection8 (2%)
Sample Handling6 (1%)
Check In4 (0.5%)
Testing10 (2)
Medical Staff261 (56%)
Nursing Staff138 (29%)
Laboratory Staff50 (10%)
Others including Portering & Phlebotomy staff
50 (10%)
Clerical Staff10 (2%)
A&E66 (14%)
Wards274 (59%)
Clinics7 (1%)
Others including Portering & Phlebotomy staff
50 (10%)
ICU15 (3%)
Labour & Delivery26 (6%)
Theatres6 (1%)
Laboratory47 (10%)
Fig 12: Time Events Occured
263 (56%) events occurred during routine workinghours, the remaining 204 (44%) events occurred outof hours or at weekends
Fig 13: Planned versus Unplanned Recovery
The majority of events 383 (82%) were caught andharm to the patient prevented by planned checkingsteps in the work process. The remaining 84 (18%)events were caught by chance.
Fig 14: Human Failures
Fig 15: System Failures
National Haemovigilance Office112
8am - 4pmMon - Fri263 (56%)
Out of HoursWeekends204 (44%)
0
50
100
150
200
250
300
350
400
Planned Recovery
383
Unplanned Recovery
84
0
50
100
150
200
250
300
KnowledgeBased Errors
Verification Errors
InterventionErrors
HumanSlips
0
50
100
150
200
TechnicalDesign
Policies/Procedures
OrganisationalKnowledge
Management Priorities
Root Causes – FindingsTo date, there appears to be several significant trendsemerging from the data in relation to the root causesof error. Most events involved more than one rootcause and single events often contained acombination of both system and human failures.
Human FailuresHuman slips are the most frequently occurring causeof human error. Most of the human slips involved staffforgetting to complete tasks, such as sample labellingor making transcription errors on samples andrequests. These types of errors occur when staff areinattentive while carrying out a task. Reasons sited forthese types of errors were tiredness and distractionscaused by busy workloads and long working hours.
Other root causes relating to human failurehighlighted were staff failing to verify patient orproduct identification at the bedside, failure to carryout cross checks correctly or at all and failure to verifytest results prior to prescribing.
Failure to follow policies/procedures was also shownto be a significant root cause. Practices such as prelabelling of sample tubes, remote labelling andchecking , taking samples from patients with no IDbands and failing to adhere to maximum surgicalblood ordering schedules were all associated witherror.
Finally lack of knowledge was also shown tocontribute to error in a smaller number of events, forexample medical staff prescribing plasma for warfarinreversal inappropriately or being unaware of basicprocedures to follow despite having received training.
System FailuresManagement priorities were the most frequentlyoccurring cause of system failure. For example,decisions made about staffing levels such as notreplacing staff on annual or sick leave were found tocontribute to error. Short staffing in the clinical areaswas frequently cited as a contributory factor when
error occurred.
The absence of systems for gaining access tomedical records out of hours was highlighted as asignificant cause of error in some sites. This led tosituations where patients who were admitted out ofroutine hours could not be assigned a medical recordnumber. The hospitals involved had to use asupplementary numbering system so that eachpatient could have a unique transfusion number. Thissupplementary system was found to be flawed andvery prone to user error and was frequentlyassociated with sample collection errors.
Another significant management failure that emergedfrom the data relates to the limited phlebotomyservices available in some hospital sites. Routinephlebotomy services were found to be minimal orabsent after 1pm in many sites and were frequentlynot available at all in accident and emergencydepartments. This led to situations where medical andnursing staff were expected to take pre transfusionsamples in addition to their already demandingworkload.
Failures on behalf of management to ensure thatsystems are in place for ensuring all staff involved intransfusion are given appropriate training for the tasksthey are expected to carry out was also found to be aroot cause of error. Absence of mandatory trainingprogrammes for certain groups of staff such asagency, locum and medical staff was highlighted.Despite most sites having an establishedHaemovigilance training programme, lack of systemsfor ensuring all staff attended these trainingprogrammes was found to be a particular problem.Lack of appropriate training for staff doing cross callcover in the transfusion laboratory was also found tocontribute to laboratory errors.
Technical failures such as computer systems in thehospital not being fully linked with computer systemsin the transfusion laboratory were also highlighted.This led to situations where updated information on
113Annual Report
hospital patient information systems (PAS) were notcarried across to the laboratory system (LIS). As aresult, vital information relating to patient details weremissed.
Finally, failure to ensure that current policies andprocedures relating to the transfusion process wereavailable in all clinical areas and are reviewed andupdated at regular intervals was also found tocontribute to error in some sites.
Although these findings are only taken from one fullyear of reporting, significant trends in error areemerging and it is hoped that through continuedreporting into the project a much betterunderstanding of transfusion error will be gained atthe end of the three year period.
The data provided in this report would not existwithout the ongoing contribution of all staff involved inthe transfusion chain at hospital level. In particular, theHaemovigilance Officers and laboratory staff whohave coordinated this project in their individual sitesin addition to their existing workload. It is hoped thatreporting rates will continue to grow in the final yearof the project and that the data produced will be usedto target resources where they are needed most inorder to reduce error and improve transfusion safety.
National Haemovigilance Office114
The NHO would like to thank a number of people fortheir invaluable contribution to the compilation of thisreport and gratefully acknowledge the assistancethey provided.
Mr Geoff Lucas and Staff at the International BloodGroup Reference Laboratory, National Blood GroupReference Laboratory, National Blood Service,Bristol.
Dr Joan Gilvarry, Ms Niamh Arthur, Mr John Lynch andMr. Patrick Costello at the Irish Medicines Board,Dublin
Dr. Beatrice Nolan for her contribution towards theTransfusion Associated Circulatory Overload chapter.
Mr Geoff Connell and staff in the Virus ReferenceLaboratory, University College Dublin for their help insuspected transfusion transmitted donorinvestigations.
For those from within the IBTS, thanks are extendedto:
Ms Bernie Quirke and the staff of the VirologyLaboratory, Carmel Sheridan, Recipent Tracing Unitand Pauline Coakley QA Manager IBTS.
Dr Joan O’Riordan for her contribution towards thegeneral content of this report, to Dr Joan Fitzgerald forher input into the Anti-D section and also to Mr DonMullahy for his advice on laboratory matters.
Dr Joan Power, Dr Nuala Moore, Dr Michael Thomas, Communications Officer, Ms Mirenda O’Donovan,Training Officer, Mr Peter McDonnell, and staff of theLibrary Services, Ms Niamh O’Sullivan, Ms LucyO’Doherty and Ms. Janet Kelleher.
115
Acknowledgements
NHO DirectorDr. Emer Lawlor FRCPath, FRCPIConsultant HaematologistDirector NHO
Haemovigilance OfficersMs. Donna Harkin RGN RM DSMHaemovigilance Officer e-mail [email protected]: (01) 432 2890
Ms. Marcia Kirwan RGN RM MScEd Haemovigilance Officer,e-mail [email protected]
Ms Mairead Sheahan RGN DSMHaemovigilance Officere-mail [email protected]: (01) 4322891
Ms. Jackie Sweeney, RGN RM CHN BscNursing(Ord)Haemovigilance Officer, e-mail: [email protected]: (01) 4322891
Near Miss ProjectMs. Derval Lundy RGNHaemovigilance Officer e-mail [email protected]: (01) 432 2825
NHO AdministrationMs. Cathy Scuffil Nat Dip Man & Bus, CISMNHO Programme Administrator e-mail [email protected]: (01) 432 2894
Ms. Marie CarolanAssistant Administratore-mail [email protected]: (01) 432 2854
116
Contacts
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Blood 2004.www.dh.gov./uk/PolicyAndGuidance
Andrzejewski, C. and Popovsky, M.A. (2005) Transfusion-
associated adverse pulmonary sequelae: widening our
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Anand, I.S, Kuskowski, M. A, Rector, T.S, et al. (2005)
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Failure: Results from Val-HeFT. Circulation. 112: 1121-
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Bailie, G.R., Clark J.A., Lane C.E., Lane et al. (2005)
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(TRALI): A serious adverse event of blood transfusion. Vox
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Boehlen, F., Clemeston, K.J., (2001) Platelet chemokines
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119Annual Report
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Appendix 1Management of an Acute Transfusion reaction