Think beyond

the person Teamwork

Civility Human factors

SHOT is affiliated to the Royal College of Pathologists

This report is produced by SHOT working with MHRA

Coordinate

Effective
Safety investigations

Just culture

Proactive Collaborate

Communicate System thinking

ANNUAL SHOT REPORT 2023

Serious Hazards of Transfusion (SHOT)

Steering Group Chair Professor Mark Bellamy
SHOT Medical Director Dr Shruthi Narayan
SHOT Operations Manager Mrs Caryn Hughes
SHOT Haemovigilance Data Manager Ms Debbi Poles
SHOT Haemovigilance /
Patient Blood Management Specialist Ms Emma Milser
SHOT Clinical Incidents Specialist Mr Simon Carter-Graham
SHOT Laboratory Incidents Specialists Mrs Victoria Tuckley
Mrs Nicola Swarbrick
SHOT Incidents Specialist Mrs Vera Rosa
SHOT Data Specialist Mr Darren Hall
SHOT Administrator Ms Raquel Planus Lopez
National Coordinator for Mrs Tali Yawitch
Transfusion-Transmitted Infections
(UK Health Security Agency)

Working Expert Group (WEG) & Writing Group, on behalf of the SHOT Steering Group
Chair: Dr Shruthi Narayan
Dr Peter Baker, Professor Mark Bellamy, Dr Andrew Bentley, Dr Paula Bolton-Maggs, Dr Catherine Booth,
Dr Su Brailsford, Mr Simon Carter-Graham, Mrs Heather Clarke, Dr Anicee Danaee, Dr Jennifer Davies, Miss Chloe
Davison, Dr Sharran Grey, Dr Heli Harvala, Dr Sarah Haynes, Mrs Caryn Hughes, Dr Anne Kelly, Dr Tom Latham,
Dr Puneet Malhotra, Ms Josephine McCullagh, Ms Emma Milser, Mrs April Molloy, Dr Helen New, Mrs Terrie Perry,
Dr Jayne Peters, Ms Debbi Poles, Dr Fiona Regan, Mr Chris Robbie, Dr Susan Robinson, Mrs Vera Rosa, Dr Megan
Rowley, Dr Joseph Sharif, Mrs Charlotte Silver, Mrs Nicola Swarbrick, Ms Tracey Tomlinson, Mrs Victoria Tuckley,
Dr Alison Watt, Mrs Tali Yawitch
Steering Group (SG) during 2023
Chair: Professor Mark Bellamy
Dr Shubha Allard National Blood Transfusion Committee
Royal College of Pathologists
Dr Lynne Anderson Scottish Clinical Transfusion Advisory Committee
Lt Col Lucinda Blake Defence Medical Services
Dr Su Brailsford UK Health Security Agency
Mr Suman Shrestha Royal College of Nursing
Mr Graham Donald Lay member
Prof David Roberts British Blood Transfusion Society
Ms Kerry Dowling UK Transfusion Laboratory Collaborative
Dr Ruth Gottstein Royal College of Paediatrics and Child Health
Ms Mervi Jokinen Royal College of Midwives
Mrs Anne Lockhart Institute of Biomedical Science
Prof Andrea Piccin Northern Ireland Blood Transfusion Service
Dr Stephen Thomas Joint Professional Advisory Committee
Dr Gail Miflin UK Forum
Dr Erum Khan Royal College of Obstetricians and Gynaecologists
Dr Caroline Evans Royal College of Anaesthetists
Dr James Reid Royal College of Physicians
Dr Pete Hersey Faculty of Intensive Care Medicine
Mr Chris Robbie Medicines and Healthcare Products Regulatory Agency
Dr Susan Robinson British Society for Haematology
Ms Katy Veale UK National External Quality Assessment Service (UK NEQAS)
Ms Nina Vinall Expertise in Patient Safety
Honorary Steering Group Members
Dr Hannah Cohen Founder Member and former Steering Group Chair
Dr Dafydd Thomas Former Steering Group Chair
Dr Lorna Williamson Founder Member
Dr John Barbara Founder Member
Prof John Lumley Founder Member
Dr Brian McClelland Founder Member
Dr Derek Norfolk Founder Member
Dr Clare Taylor Former SHOT Medical Director
Dr Sue Knowles Former Interim Medical Director of SHOT
Dr Dorothy Stainsby Former National Medical Coordinator of SHOT
Dr Elizabeth Love Former National Medical Coordinator of SHOT

NB. All members of the WEG are members of the Steering Group in their own right.
Note: Those who have contributed to various chapters in this Annual SHOT Report but are not members of the SHOT WEG have been
included as authors in the respective chapters. We are grateful for their valuable contributions.
 ANNUAL SHOT REPORT 2023

Requests for further information should be addressed to:

Non-infectious hazards Infectious hazards
SHOT Office Mrs Tali Yawitch
Manchester Blood Centre Scientist (Epidemiology)
Plymouth Grove Joint NHSBT/UKHSA Epidemiology Unit
Manchester 61 Colindale Avenue
M13 9LL London NW9 5EQ
Tel +44 (0) 161 423 4208 Email [email protected]
Website www.shotuk.org
X/Twitter @shothv1
Enquiries [email protected]

Disclaimers:
Case studies: the information in Annual SHOT Report case studies is provided to SHOT by reporters. All reports
are anonymised and SHOT relies on reporters submitting correct and accurate information. SHOT does not
accept responsibility for any inaccuracies which may arise from incorrect information being submitted.

Data interpretation: There are many factors that can influence the number of reports submitted to SHOT,
including awareness of what to report, and staffing levels within organisations. Combined with a lack of accurate
real time denominator data about transfusions across the UK, this makes interpretation of the fluctuations in
number of reports very difficult. The comparisons made to reporting numbers from previous years are based on
actual numbers submitted only and should be interpreted with caution.

Copyright notice
Please cite this work as:
Narayan, S. et al., 2024. The 2023 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. https://doi.org/10.57911/605r-em59
This work was undertaken by SHOT. The work was funded by NHS Blood and Transplant, Northern Ireland Blood
Transfusion Service, Scottish National Blood Transfusion Service, and the Welsh Blood Service through the UK Forum.
This report and the individual contributions within it are protected by copyright. The report may be circulated and used
for internal, non-commercial purposes within an organisation or institution.
Derivative works:
Permission from SHOT is required for all derivative works including adaptations and translations.
All rights reserved. No part of this publication may be reproduced, stored, or transmitted in any form or by any means,
without the prior written permission of SHOT, or, in the case of reprographic reproduction, in accordance with the terms
of licences issued by the Copyright Licensing Agency in the UK (www.cla.co.uk). Enquiries concerning reproduction
outside the terms stated here should be sent to SHOT at the address printed on this page.
Making duplicate copies of this Report, or use of the data within, for legitimate clinical, scientific, educational, or other
non-commercial purposes (not including derivative data) is permitted provided that SHOT is identified as the originator
of the information.

Electronic storage or usage:

Permission from SHOT is required to store or use electronically any material contained in this publication, including any
part of a chapter.
Making alterations to any of the information contained within or using the information in any other work or publication
without prior permission, will be a direct breach of copyright. The use of registered names, trademarks etc. in this
publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant
laws and regulation and therefore free for general use.

Copyright © Serious Hazards of Transfusion (SHOT) 2024

Published July 2024

ISBN 978-1-9995968-6-6
Illustrations by Jenny Leonard https://jennyleonardart.com/
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 Contents

Page Chapter
5 1 Foreword ....................................................................................................................................Mark Bellamy
7 2 Participation in United Kingdom (UK) Haemovigilance .................................. Debbi Poles and Shruthi Narayan
15 3 Headline Data: Deaths, Major Morbidity and ABO-Incompatible Transfusions..................................................
. Shruthi Narayan and Debbi Poles
26 4 Key Messages and Recommendations............................ Caryn Hughes, Jennifer Davies and Shruthi Narayan
38 5 The Infected Blood Inquiry and Haemovigilance ................. Shruthi Narayan, Caryn Hughes and Emma Milser
42 6 Acknowledging Continuing Excellence in Transfusion (ACE)........................................... Simon Carter-Graham
49 7 Donor Haemovigilance ................................................................ Jayne Hughes and Champa Manchanayake

ERROR REPORTS
58 8 Human Factors and Ergonomics in SHOT Error Incidents ................................. Emma Milser and Alison Watt
65 9 Adverse Events Related to Anti-D Immunoglobulin (Ig). Jennifer Davies, Simon Carter-Graham and Vera Rosa
71 10 Incorrect Blood Component Transfused (IBCT)... Simon Carter-Graham, Nicola Swarbrick and Victoria Tuckley
86 11 Handling and Storage Errors (HSE)................................ Heather Clarke, Nicola Swarbrick and Victoria Tuckley
91 12 Avoidable, Delayed or Under or Overtransfusion (ADU), and Incidents Related to Prothrombin Complex
Concentrates (PCC) ................................................................... Paula Bolton-Maggs, Simon Carter-Graham,
Catherine Booth, and Josephine McCullagh
94 a. Delayed Transfusions
100 b. Avoidable Transfusions
105 c. Under or Overtransfusion
109 d. Incidents Related to Prothrombin Complex Concentrates

ERROR REPORTS WITH NO HARM

112 13 Near Miss (NM) Reporting ............................................................................................................... Vera Rosa
116 a. Wrong Blood in Tube (WBIT) .........Paula Bolton-Maggs, April Molloy, Vera Rosa and Simon Carter-Graham
123 14 Right Blood Right Patient (RBRP) ..................................Caryn Hughes, Nicola Swarbrick and Victoria Tuckley

ERROR REPORTS COMPOSITE CHAPTERS

130 15 Laboratory Errors ..................................... Victoria Tuckley, Nicola Swarbrick, Peter Baker and Heather Clarke
143 16 Errors Related to Information Technology (IT)............................................ Jennifer Davies and Megan Rowley

REACTIONS IN PATIENTS
150 17 Febrile, Allergic and Hypotensive Reactions (FAHR) .................................. Catherine Booth and Jayne Peters
158 18 Pulmonary Complications....................................................................................Oliver Firth and Sharran Grey
164 a. Transfusion-Associated Circulatory Overload (TACO)............................................................... Sharran Grey
173 b. Pulmonary Complications of Transfusion: Non-TACO........................................ Tom Latham and Oliver Firth
180 19 Haemolytic Transfusion Reactions (HTR).................................................Tracey Tomlinson and Anicee Danaee
188 20 Uncommon Complications of Transfusion (UCT)....................................... Caryn Hughes and Shruthi Narayan
192 21 Transfusion-Transmitted Infections (TTI) .................. Tali Yawitch, Katy Davison, Heli Harvala and Su Brailsford
205 22 Post-Transfusion Purpura (PTP) ................................................................................................... Tom Latham

SPECIAL CLINICAL GROUPS

208 23 Cell Salvage (CS)........................................................................................................................Sarah Haynes
214 24 Paediatric Cases .....................................................................................................Anne Kelly and Helen New
228 25 Haemoglobin Disorders............................................................................... Asha Aggarwal and Joseph Sharif
236 26 Transfusion Errors in Transplant Cases................................... Jennifer Davies, Vera Rosa and Shruthi Narayan
243 27 Immune Anti-D in Pregnancy ......................................................................... Vera Rosa and Susan Robinson
250 Acknowledgements

WEBSITE ONLY
251 28 Medicines and Healthcare products Regulatory Agency (MHRA) Report .................. Chris Robbie, Mike Dawe
. and Shirley Stagg

Please see the beginning of each chapter for a glossary of abbreviations used
 ANNUAL SHOT REPORT 2023

Foreword 1
I am writing this foreword on the day the final report of the Infected Blood Inquiry (IBI) has been released.
I have listened to the live stream presentation, of around an hour, by the chair of the Inquiry, Sir Brian
Langstaff. His presentation was both eloquent and concise. Every moment of it was compelling, yet it
barely scratched the surface of the report the Inquiry produced, which runs to seven volumes. I have had
the opportunity to read the summary pages, and skim through volume one. The report is comprehensive,
but even so cannot hope to be exhaustive. It is wide ranging and detailed; acknowledging the depth of
tragedy and human suffering which necessitated the Inquiry. For those of you who do not have time to
read the report, I highly recommend Sir Brian’s live stream, which is available through the IBI website.

Several important themes come through. There were major failings illustrated in the report around
consent, around patient autonomy, and around medical paternalism. Medical record keeping and
audit were likewise found to have been seriously inadequate. The IBI report describes in detail what
happened, the nature of the response at the time, and what should happen going forward (IBI, 2024). In
part, the report’s recommendations address political remedies, and recommend how processes should
be changed and improved. The future role of SHOT and haemovigilance processes more widely are
outlined in volume one of the report (pages 261 through 267). These conclude with the recommendation:

‘That all NHS organisations across the UK have a mechanism in place for implementing
recommendations of SHOT reports, which should be professionally mandated, and for
monitoring such implementation.’

The IBI report goes on to underline the desirability of establishing the outcomes of every transfusion of
blood components. Had this been achieved at the time of the principal events described in the report,
Sir Brian writes, it is likely that alarm bells would have rung sooner. The Scottish ‘Account for blood’
scheme is described, and most importantly, current major threats, including transfusion-associated
circulatory overload (TACO) are cited. The desperate and urgent need for effective IT solutions is also
mentioned. Sir Brian recommends:

Establishing the outcome of every transfusion

(i) That a framework be established for recording outcomes for recipients of blood components.
That those records be used by NHS bodies to improve transfusion practice (including by
providing such information to haemovigilance bodies)

Success in achieving this will be measured by the extent to which the SHOT reports for the previous
three years show a progressive reduction in incidents of incorrect blood component transfusions
measured as a proportion of the number of transfusions given.

(ii) To the extent that the funding for digital transformation does not already cover the setting
up and operation of this framework, bespoke funding should be provided

(iii) That funding for the provision of enhanced electronic clinical systems in relation to blood
transfusion be regarded as a priority across the UK

These goals align closely with the current philosophy of SHOT, and the priorities we have identified
over recent years. This year‘s Annual SHOT Report, including data until the end of December 2023,
emphasises that errors continue to account for most reports. Near miss events make up a large
proportion of the total incidents. As laid out in the report of the IBI, reporting of all new incidents is
crucial. This year’s Annual SHOT Report relates that transfusion delays and pulmonary complications

1. Foreword 5
 ANNUAL SHOT REPORT 2023

(both TACO and non-TACO) remain leading causes of transfusion-related deaths in the UK, accounting
together for over 76% of the deaths reported.

Notwithstanding that, the absolute risk of death remains relatively low, at 1 in 58,000 components issued.
Harms are at least five times more common. It is unlikely that this situation can be improved upon with
current low levels of resourcing, with under-reporting, and while SHOT collates data and produces
reports, but lacks an effector arm.

In conclusion, I would like to quote two sentences from Sir Brian’s comments at the report launch which,
for me, are the absolute essence of the culture we should nurture.

‘Most, if not all, infections would have been prevented if patient safety had been paramount
throughout’.

‘The public should be trusted with the truth’.

It is timely for Trusts and Health Boards in the UK to take full account of Sir Brian’s findings in the IBI,
and ensure that SHOT recommendations are effectively implemented. I commend this year’s Annual
SHOT Report to you.

Professor Mark Bellamy, Past President, Intensive Care Society; Professor of Critical Care, The Leeds Teaching
Hospitals NHS Trust, and Outgoing Chair of the SHOT Steering Group

Reference
Infected Blood Inquiry (IBI), 2024. The Report HC 569-I, London: Crown. Available at: https://www.infectedbloodinquiry.
org.uk/reports/inquiry-report (Accessed 20 May 2024).

6 1. Foreword
 ANNUAL SHOT REPORT 2023

Participation in
United Kingdom (UK) Haemovigilance 2
Authors: Debbi Poles and Shruthi Narayan

Abbreviations used in this chapter

ACE Acknowledging continuing excellence SABRE Serious adverse blood reactions and events
in transfusion SaBTO Advisory Committee on the Safety of Blood,
FFP Fresh frozen plasma Tissues and Organs
MB-FFP Methylene-blue treated FFP SD-FFP Solvent-detergent FFP
MHRA Medicines and Healthcare products UK United Kingdom
Regulatory Agency
NHS National Health Service

Key SHOT messages

• High levels of participation in haemovigilance reporting to SHOT continues despite challenges
faced by staff

• Variations exist in the patterns and frequency of reports received across the UK

Recommendation
• Participation benchmarking data should be reviewed to inform local improvements. These
discussions should be included in local and regional transfusion meetings

Action: Haemovigilance reporters and local governance teams

Introduction
Haemovigilance reporting and benchmarking play a vital role in promoting transparency, accountability,
and continuous improvement in blood transfusion practices. This ultimately benefits patients, donors
and staff with improved experiences and outcomes. Participating healthcare organisations contribute
valuable data that can be analysed to identify trends, patterns, and areas for improvements in transfusion
practices.

Participation in UK haemovigilance reporting has risen in 2023. There were 4972 reports submitted via
the SABRE online reporting system in 2023, which is an increase of 601 (13.7%) compared to 4371 in
2022. This is the largest annual increase since 2017, however, given the relative dip in reporting seen
in 2020 and 2021, this is more likely to reflect a restoration of the previous upward trajectory that was
suppressed during the pressures of the COVID-19 pandemic.

2. Participation in United Kingdom (UK) Haemovigilance 7

 ANNUAL SHOT REPORT 2023

Figure 2.1:
Haemovigilance 4972
reports submitted 4371
4248 4063 4088
by year 2010-2023 3965 3959 4037
3634
3545 3568 3668
3435
Number of reports 3200

2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Year report submitted

Of these 4972 reports, 3491 (70.2%) were completed by the reporter and have been analysed and
included in this 2023 Annual SHOT Report. Additionally, there were 37 completed anti-D immunisation
reports, and 15 completed ACE reports. The remaining 1429 reports were either withdrawn (875) or
incomplete at the cut-off date for inclusion (554). Common reasons for withdrawal of reports from the
SHOT analysis are reactions that were assessed to be mild or more likely related to underlying condition,
or errors that were MHRA-reportable only (Ryan, et al., 2022).

Figure 2.2: The

status of reports 37 15
submitted to
SHOT during 2023 3491 554 875
(n=4972)

0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000

Completed SHOT reports Anti-D immunisation reports

ACE reports Incomplete Withdrawn

ACE=acknowledging continuing excellence

8 2. Participation in United Kingdom (UK) Haemovigilance

 ANNUAL SHOT REPORT 2023

Reporting to SHOT and the MHRA

There are differences in reporting criteria for both organisations, and the 4972 reports submitted via the
SABRE reporting portal are not always at the same stage of completion or included in the same way by
both SHOT and the MHRA. Figure 2.3 highlights the main differences and commonalities in reporting
criteria between the two organisations.

Further information regarding the numbers of reports accepted by SHOT and the MHRA can be found
in the supplementary information on the SHOT website (https://www.shotuk.org/shot-reports/report-
summary-and-supplement-2023/).

Figure 2.3: SHOT

SHOT only SHOT and MHRA MHRA only and the MHRA
reporting criteria
Serious adverse reactions (SAR)

SAR related to some All SAR related to blood SAR related to blood products,
specific blood products components including anti-D Ig and PCC
e.g., SD-FFP should be reported to the
(FAHR, TACO, HTR, MHRA Yellow Card Scheme
non-TACO pulmonary NOT via SABRE
complications, PTP, TTI, UCT)

Serious adverse events (SAE) where a component WAS transfused

Clinical practice errors (IBCT-WCT, Laboratory errors related to Blood Establishment

IBCT-SRNM, ADU*, HSE, RBRP) blood components where a donation and
Cell salvage errors component was transfused processing errors
PCC and Anti-D Ig administration
(including omission) errors (IBCT-WCT, IBCT-SRNM,
Anti-D immunisation in pregnancy ADU, HSE, RBRP)

SAE where a component WAS NOT transfused (near miss events)

Clinical practice errors Laboratory errors related Blood Establishment (as above),
to blood components that or laboratory errors not involving
WBIT errors were prescribed for a named a named patient, or where the
PCC and Anti-D Ig where an patient, and the component component did not leave
error was identified before left the laboratory cold the laboratory (see MHRA
administration storage control** definitions for examples)

This infographic is for guidance purposes only. It may not cover all reportable events and does not represent
a change to existing reporting requirements.

Full reporting definitions for SHOT and MHRA (Joint UK Haemovigilance User Guide) are available at:
https://www.shotuk.org/reporting/ and for BSQR definitions of blood components/products see
https://www.legislation.gov.uk/uksi/2005/50/made. A ‘blood component’ means a therapeutic constituent of human
blood (red cells, white cells, platelets, and plasma) that can be prepared by various methods; while a ‘blood product’
means any therapeutic product derived from human blood or plasma.

* Includes cases where a component should have been transfused but was not due to a significant delay.
** Clinical errors relating to collection, storage and distribution, or where the primary error was in the laboratory, but
detected later in the clinical area are MHRA-reportable.

ADU=avoidable, delayed and under/overtransfusion; FAHR=febrile, allergic and hypotensive reactions; HSE=handling and storage errors;
HTR=haemolytic transfusion reactions; IBCT-SRNM=incorrect blood component transfused-specific requirements not met; IBCT-WCT=IBCT-
wrong component transfused; Ig=immunoglobulin; MHRA=Medicines and Healthcare products Regulatory Agency; PCC=prothrombin
complex concentrates; PTP=post-transfusion purpura; RBRP=right blood right patient; SABRE=Serious Adverse Blood Reactions and
Events; SD-FFP=solvent-detergent fresh frozen plasma; TACO=transfusion-associated circulatory overload; TTI=transfusion transmitted
infections; UCT=uncommon complications of transfusion; WBIT=wrong blood in tube

2. Participation in United Kingdom (UK) Haemovigilance 9

 ANNUAL SHOT REPORT 2023

Blood component issue data 2023

Table 2.1 lists the total number of blood components issued from the UK Blood Services in 2023, and
the number of SD-FFP (Octaplas®) units issued in each country.
Table 2.1: Blood
Red cells Platelets FFP SD-FFP Cryoprecipitate Totals
components and
NHS Blood and 1,351,959 250,530 169,875 53,710 40,739 1,866,813
SD-FFP issue data Transplant
for the calendar Northern Ireland Blood 42,238 8,886 4,523 772 934 57,353
year 2023 in the Transfusion Service
UK Scottish National Blood 138,372 23,890 14,588 3,490 3,208 183,548
Transfusion Service
Welsh Blood Service 72,932 8,248 7,628 1,490 258 90,556
Totals 1,605,501 291,554 196,614 59,462 45,139 2,198,270
SD=solvent-detergent; FFP=fresh frozen plasma
Cryoprecipitate numbers are expressed as pools and single donations as issued; all other components are adult equivalent doses
SD-FFP data is supplied by Octapharma for England and Scotland; in England, hospitals order directly from Octapharma and in other
countries, the process is via the Blood Services

There were no MB-FFP units issued in any of the UK Blood Services in 2023. This follows the SaBTO
report where the requirement for MB-FFP was withdrawn in 2019 (Thomas, et al., 2022), so this has
been removed from Table 2.1.
Figure 2.4a: Blood
component issue
3000 Red cells Other component types
data in the UK
2012-2023
2500
Number of units issued

2000
Thousands

1500

1000

500

0
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Includes solvent-detergent fresh frozen plasma

While this provides the issue data for the various blood components, it is important to note that there
continues to be a differential demand for some of the blood components. For example, the demand
for O D-negative red cells as a percentage (of the overall demand) continues to rise and demand may
exceed supply, thus putting additional pressure on Blood Services.

10 2. Participation in United Kingdom (UK) Haemovigilance

 ANNUAL SHOT REPORT 2023

Figure 2.4b: Non-

cellular component
Cryoprecipitate
issue data in the
450 MB-FFP
UK 2012-2023
SD-FFP
400 FFP

350
Number of units issued

300
Thousands

250

200

150

100

50

0
2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

FFP=fresh frozen plasma; SD=solvent-detergent; MB=methylene blue

SHOT reporting by UK country

Full tables containing the breakdown of data from 2023 by UK country and previous years can be found
in the supplementary information on the SHOT website (https://www.shotuk.org/shot-reports/report-
summary-and-supplement-2023/).

Cases included in the 2023 Annual SHOT Report n=3833

The total number of reports analysed and included in the 2023 Annual SHOT Report is 3833. This is
an increase of 334 from the 3499 reports analysed in the 2022 Annual SHOT Report (Narayan, et al.,
2023). In addition to these 3833 reports, there were 42 reports of immunisation against the D-antigen
during pregnancy. These are counted separately as part of a stand-alone study.

The number of reports with potential for patient harm (excluding ‘near miss’ and ‘right blood right patient’)
is 2154, an increase of 285 from 2022 (n=1869).

Analysis has been carried out on the reports included in the 2023 Annual SHOT Report to look at
the number of reports per region/country in each main reporting category, plus cell salvage. Figure
2.5 demonstrates that there is some variability between regions in the percentage of reports across
different report types, with near miss reports accounting for between 29.0% and 47.4% of reports in
each geographical area.

2. Participation in United Kingdom (UK) Haemovigilance 11

 ANNUAL SHOT REPORT 2023

Figure 2.5: Number

and percentage
SAE SAR ANTID CS NM NM-WBIT
of reports in each
region/country by
category in 2023
London RTC 162 126 44 45 220

Midlands RTC 243 65 67 69 120

North West RTC 176 106 62 30 112

North East & Yorkshire RTC 166 83 54 65 117

South East RTC 116 72 60 49 107

East of England RTC 138 48 43 45 94

South West RTC 113 48 48 9 38 68

Scotland 105 41 27 44 78

Wales 63 13 12 34 38

Northern Ireland 41 18 5 12 17

Non-NHS Organisations 16 1 3 3 15

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

ANTID=anti-D immunoglobulin errors; CS=cell salvage; NM=near miss; RTC=regional transfusion committee; SAE=serious adverse event;
SAR=serious adverse reaction; WBIT=wrong blood in tube
Note: numbers for CS are too small to be displayed on the figure for most RTC areas

Understanding the contributory factors associated with variations can help identify best practices, areas
for improvement, and potential risks, leading to enhanced patient safety and quality of care. Additionally,
benchmarking fosters collaboration and knowledge sharing among healthcare professionals resulting
in advancements in transfusion medicine.

Reporting organisations in 2023

To calculate participation data by reporting organisations, SHOT combines data from individual hospitals
into their parent NHS Trust or Health Board. This is because there are varying reporting arrangements
between different organisations. Some NHS Trusts/Health Boards submit from only one reporting
account, whereas others may have one reporting account per hospital.

In 2023 there were two NHS Trusts/Health Boards that did not submit any reports. One of these
organisations was a medium level blood user (issued with less than 7,000 components in 2022), and
the other was a low blood user (issued with less than 1,500 components in 2022).

There were 26 non-NHS organisations that submitted 65 reports in 2023 which is an increase from
2022 (48 reports from 19 non-NHS organisations). This includes healthcare organisations situated in
the Channel Islands who are not considered to be a part of the UK and therefore are not regulated
by the MHRA. However, they still report to SHOT and incidents submitted are included in this Annual
SHOT Report.

SHOT participation benchmarking data

SHOT first began publishing participation benchmarking data in 2011, with the aim of promoting
awareness of reporting levels and breadth of reporting (i.e., reporting across a wide range of different
categories). Reporters are encouraged to review their individual reports to understand how many reports
they submit in each of the 4 main categories of reporting (SAE, SAR, NM, and anti-D), and to benchmark
their overall reporting levels against other similar sized organisations.

In 2011 there were 21/188 (11.2%) organisations that submitted reports in less than 2 of the 4 main
categories and only 60/188 (31.9%) reported across all 4 categories. This suggested that some

12 2. Participation in United Kingdom (UK) Haemovigilance

 ANNUAL SHOT REPORT 2023

organisations were not fully participating across all areas of haemovigilance. In 2022, there was a
reduction in organisations submitting in fewer than 2 reporting categories, 6/173 (3.5%) and a move
towards more comprehensive participation, with 83/173 (48.0%) reporting in all 4 main categories (Poles
& Narayan, 2024).

Figure 2.6:
90 Number of NHS
83
organisations
80
Number of NHS reporting organisations

submitting
70
70 2011 2022 64 in reporting
60 categories 2011
60
versus 2022
50

40 37

30
20
20
12
9
10
3 3
0
0 1 2 3 4

Number of main reporting categories

The full 2023 participation benchmarking data for individual organisations will be available to view on the
SHOT website in the autumn of 2024. Benchmarking haemovigilance participation data is important for
assessing compliance and engagement with haemovigilance reporting, identifying disparities, monitoring
progress, potentially informing policy decisions, and promoting accountability. It helps drive quality
improvement and ultimately enhances patient safety in blood transfusion practices.

SHOT also provides monthly participation data, which includes the number of reports submitted, and
the number of reports completed in each category. However, these numbers are subject to change
following review of the completed cases by the SHOT working expert group.

Please see the links to the annual and monthly participation data on the SHOT website provided in the
‘Recommended resources’ section.

Improvements to the SHOT reporting database

The online SHOT reporting system (supplied by Dendrite Clinical Systems Ltd) was upgraded at the end
of 2023 to modernise the user interface and improve the reporting experience. One of the main changes
was to colour code the questions for status. Unanswered questions are coloured in red, and completed
questions are green. It is hoped that this will encourage more complete reporting and in turn, improve
the quality of the data analysed in the Annual SHOT Report.

2. Participation in United Kingdom (UK) Haemovigilance 13

 ANNUAL SHOT REPORT 2023

A user-satisfaction survey to assess reporters opinions on the new interface will be conducted in the
second half of 2024.

Planned future developments include implementation of dashboards which will provide real-time visibility
of key metrics such as the number of reports submitted by time period, reporting category, location etc.
These will enable stakeholders to make informed decisions and readily identify areas where tangible
actions are needed. These dashboards may help facilitate local improvements with regard to reporting
benchmarking and further actions.

Conclusion
SHOT is grateful for and appreciates the dedication of healthcare staff who contribute towards and
participate in haemovigilance reporting and related activities. This speaks volumes about their commitment
to patient safety and quality care. It demonstrates their recognition of the importance of monitoring and
improving blood transfusion practices amidst challenging circumstances. Their efforts contribute to a
culture of vigilance, continuous learning, and improvement in transfusion practice, ultimately benefiting
patient outcomes.

Recommended resources
Definitions of current SHOT reporting categories & what to report
https://www.shotuk.org/reporting/

SHOT Participation Benchmarking Data

https://www.shotuk.org/reporting/shot-participation-benchmarking/

SHOT Monthly Participation Data

https://www.shotuk.org/reporting/monthly-participation-data/

References
Narayan, S. et al., 2023. The 2022 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. doi: https://doi.org/10.57911/605r-em59.

Poles, D. & Narayan, S., 2024. Looking back to plan ahead: Reflections on over a decade of SHOT UK haemovigilance
participation benchmarking data. Athens, International Haemovigilance Network (IHN). Available at: https://ihn-org.com/
ihn-symposium/posters/ (Accessed 01 July 2024).

Ryan, J., Poles, D., Davies, J. & Narayan, S., 2022. Why has my SHOT report been withdrawn?. Glasgow, British
Blood Transfusion Society (BBTS). Available at: https://www.shotuk.org/shot-publications-2/shot-publications-posters
(Accessed 11 April 2024).

Thomas, S. et al., 2022. Importation of plasma and use of apheresis platelets as risk reduction measures for variant
Creutzfeldt-Jakob disease: The SaBTO review. Transfusion Medicine, 32(1), pp. 24-31. doi: https://doi.org/10.1111/
tme.12840.

14 2. Participation in United Kingdom (UK) Haemovigilance

 ANNUAL SHOT REPORT 2023

Headline Data: Deaths, Major Morbidity

and ABO-Incompatible Transfusions 3
Authors: Shruthi Narayan and Debbi Poles

Abbreviations used in this chapter

ABOi ABO-incompatible SD-FFP Solvent-detergent treated fresh frozen plasma
CAS Central alerting system SRNM Specific requirements not met
IBCT Incorrect blood component transfused TACO Transfusion-associated circulatory overload
NHS National Health Service UK United Kingdom
NM Near miss WBIT Wrong blood in tube
RBRP Right blood right patient WCT Wrong component transfused

Key SHOT messages

• Errors (including near miss) continue to account for the vast majority of reports. In 2023, 3184/3833
(83.1%) of all reports were due to errors with a substantial increase (24.1%) in laboratory errors
where the error was not detected prior to transfusion (transfused errors)

• A steep increase in the transfused laboratory errors in the IBCT-WCT (65.1%) and IBCT-SRNM
(43.1%) categories in comparison to 2022 is concerning and warrants urgent action. Staffing
issues, gaps in staff knowledge, poor skill mix, lone working, ineffective IT, communication issues
and poor safety culture have been reported as contributory factors in these incidents

• Near miss events continue to account for a large proportion, 1420/3833 (37.0%) of the incidents
reported to SHOT

• An increase in the febrile, allergic and hypotensive reactions was noted as compared to previous
years. No changes were evident in the number of haemolytic reactions reported to SHOT. All
staff involved in transfusions must be competent and confident in recognising and appropriately
managing transfusion reactions in recipients

• Transfusion delays and pulmonary complications (TACO and non-TACO) continue to be the
leading causes of transfusion-related deaths in the UK. These two categories together accounted
for 29/38 deaths reported (76.3%)

• The risk of death related to transfusion in the UK is approximately 1 in 58,000 components issued
and the risk of serious harm is approximately 1 in 11,000 components issued. This includes
SD-FFP data

• ABO-incompatible red cell transfusions continue to occur as a result of suboptimal safety checks
throughout the process. Using a patient side pre-administration checklist correctly can prevent
incorrect transfusions in most cases

Given the continuing increasing trend in safety incidents reported, the recommendations from last year
remain pertinent.

3. Headline Data: Deaths, Major Morbidity and ABO-Incompatible Transfusions 15

 ANNUAL SHOT REPORT 2023

Recommendations
• As in previous Annual SHOT Reports, NHS Trusts/Health Boards must use intelligence from all
patient safety data including national haemovigilance data to inform changes in healthcare systems,
policies, and practices to embed the lessons learnt and truly improve patient safety

Action: Hospital chief executives and medical directors, National Blood Transfusion
Committee (or the equivalent for the devolved nations), hospital transfusion teams

• The recommendations from the UK-wide national patient safety alerts on preventing transfusion
delays (SHOT, 2022) and TACO (MHRA and SHOT, 2024) must be implemented effectively to
improve patient safety and address avoidable patient harm from these causes

Action: Hospital chief executives and medical directors, hospital transfusion teams

Introduction
The SHOT haemovigilance data from 2023 show worrying trends which reflect the increasing pressures
healthcare staff continue to face in the UK. These are elaborated on further in this chapter and throughout
the 2023 Annual SHOT Report. The risk of death related to transfusion in the UK is approximately 1
in 58,000 components issued, and the risk of serious harm is approximately 1 in 11,000 components
issued.

Avoidable errors continue to account for most of the reports 3184/3833 (83.1%) (Figure 3.1). This figure
includes errors with no harm to patients but had the potential to do so such as near misses and right
blood right patient errors.

Figure 3.1: Errors

account for most
reports in 2023
(n=3184/3833) 6.7% 10.2%

Errors 3184
391
Errors (all preventable)
Not preventable
83.1% 258 Possibly preventable

83.1%

Figure 3.2 shows the percentage of no harm incidents in the errors reported to SHOT in recent years.
It is concerning to note a dip in the percentage of no-harm incidents in 2023 which conversely means
an increase in potential patient-harm incidents reported. This highlights the urgent need for actions to
improve transfusion safety.

16 3. Headline Data: Deaths, Major Morbidity and ABO-Incompatible Transfusions

 ANNUAL SHOT REPORT 2023

Figure 3.2: No
3500 patient-harm and
52.7% potential patient-
3000 57.4% 53.6% 56.1% harm incidents
56.2% 56.5% 51.0% 53.4% 2010-2023
56.0%
2500 56.9%
56.1% 52.2% 55.3% 1679

1667 1530 1630

2000 1559 1337
55.9% 1510 1371
1430
1336
1239 1122 1180
1500
1000

1000
1505
1238 1327 1286 1278
1125 1178 1201 1198
500 970 1026 955 1010
790

0
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Potential harm errors Non-harm errors (NM & RBRP) % non-harm error reports

Potential harm incidents include incorrect blood component transfused (IBCT) errors, avoidable, delayed and under/overtransfusion (ADU)
errors, handling and storage errors (HSE) and errors related to anti-D immunoglobulin administration
Non-harm incidents include near miss (NM) and right blood right patient (RBRP) errors

Deaths related to transfusion n=38

All serious reactions reported to SHOT are assessed for imputability i.e., the relationship of the blood
transfusion to the reaction. The imputability criteria can be found in the SHOT definitions document (see
‘Recommended resources’).

Pulmonary complications and transfusion delays were the most common causes of transfusion-related
deaths reported to SHOT in 2023, accounting for 29/38 (76.3%) of total deaths. In 2023, TACO (n=15)
was responsible for the highest number of deaths in a single category reported to SHOT, followed by
delays (n=9). A UK-wide national patient safety alert has recently been issued to address rising deaths
from TACO (MHRA and SHOT, 2024). There has been a slight reduction in the number of deaths due to
delays in 2023. It is too early to tell if the impact of the recommendations in the SHOT CAS alert (SHOT,
2022) have helped to reduce these, but it is hoped that this downward trend will continue. Non-TACO
pulmonary cases accounted for 5 patient deaths. Key factors identified in the transfusion-related deaths
are discussed in the relevant chapters of this Annual SHOT Report. Figure 3.3 shows the distribution
of deaths related to transfusion reported in 2023 with imputability.

3. Headline Data: Deaths, Major Morbidity and ABO-Incompatible Transfusions 17

 ANNUAL SHOT REPORT 2023

Figure 3.3:
Deaths related
3 - Definite/certain 2 - Likely/probable 1 - Possible
to transfusion
with imputability
reported in 2023
(n=38)
TACO 2 13

Delays 3 6

Pulmonary non-TACO 2 3

PCC 1 3

HTR 2

UCT 2

Overtransfusion 1

0 2 4 6 8 10 12 14 16

HTR=haemolytic transfusion reactions; UCT=uncommon complications of transfusion; TACO=transfusion-associated circulatory overload;

PCC=prothrombin complex concentrates

A detailed review of the preventable factors in the transfusion-related deaths reported in 2023 can be
found in the supplementary information on the SHOT website (https://www.shotuk.org/shot-reports/
report-summary-and-supplement-2023/).

Figure 3.4 shows the trend in the transfusion-related deaths reported to SHOT since 2010. It is concerning
to note an increasing trend in the deaths reported especially related to transfusion delays and pulmonary
complications. While this could be attributed to improved reporting, the increase in the deaths post
pandemic possibly reflects the worsening challenges faced in healthcare. Delayed healthcare access with
sicker patients, worsening staffing issues with difficulties in staff recruitment and retention resulting in a
mismatch between staff availability and workload; accelerated and abbreviated staff training; poor IT and
other supporting resources could all be contributory. UK-wide national patient safety alerts addressing
preventable transfusion delays and TACO have been issued. These provide system-level improvement
actions to help improve patient safety.

It is important to note that having the right infrastructure is vital in promoting improved standards of
care and well-being for all patients. This is a key pillar in ensuring safety and improving outcomes. Any
health system needs adequate staff, funds, equipment (including IT), information, supplies, transport,
communications and overall guidance and direction to function. Strengthening and building safer health
systems means addressing key constraints in each of these areas. Transfusion incidents reported to
SHOT are commonly errors caused by faulty systems, processes, and conditions. The key to advancing
patient safety is to create systems for reliable healthcare delivery. Improvements in safety do not occur
unless there is commitment and support from senior executive managers. These safety messages
and recommendations have been reinforced repeatedly in recent Annual SHOT Reports (Narayan, et
al., 2021; Narayan, et al., 2022; Narayan, et al., 2023) and remain pertinent as they have not been
addressed meaningfully.

18 3. Headline Data: Deaths, Major Morbidity and ABO-Incompatible Transfusions

 ANNUAL SHOT REPORT 2023

Figure 3.4:
Transfusion-related
COVID-19 pandemic
45 deaths 2010 to
2023 (n=320)
40 Delays HTR
IBCT-WCT FAHR
35 TACO Other
12
Non-TACO 13
30 9

15
25

6 9
20 5 11
1 2
6 18 15
1
15 8 3
7
8
3
1 7 7
10 12 3 14 5 9
6 6 1 5
1 6 3 5 7
5 2 5 3
1 1 2
2 1 4 2 7
3 1 1 5 1 1 4 4 1
2 2 2 2 2 2 1 3
0 1 1 1
2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

IBCT-WCT=incorrect blood component transfused-wrong component transfused; TACO=transfusion-associated circulatory overload;

HTR=haemolytic transfusion reaction; FAHR=febrile, allergic and hypotensive reactions
Delays include 1 delay related to PCC in 2019, 2 in 2022 and 4 in 2023; ‘Other’ includes 1 each for post-transfusion purpura, transfusion-
associated graft-versus-host disease (2012) and anti-D Ig related; there were 9 in the avoidable, over or undertransfusion category, 3
transfusion-transmitted infections, and 22 deaths related to other unclassified reactions

Major morbidity n=197

Febrile, allergic, or hypotensive transfusion reactions continue to account for most of the cases with
major morbidity, 119/197 (60.4%) followed by TACO, 20/197 (10.2%). These are detailed further in the
respective chapters in this Annual SHOT Report. Major morbidity is defined in the SHOT definitions
document which is reviewed and updated annually (see ‘Recommended resources’).

Figure 3.5: Ranking

FAHR 119 of categories to
TACO 20 show number of
serious reactions in
HTR 18
2023 (n=197)
Delays 12

Pulmonary non-TACO 10

IBCT-SRNM 4

TTI 4

CS 3

Under or overtransfusion 2

IBCT-WCT 2

ANTI-D Ig 1

PTP 1

UCT 1

FAHR=febrile, allergic and hypotensive reactions; TACO=transfusion-associated circulatory overload; HTR=haemolytic transfusion reactions;
IBCT-SRNM=incorrect blood component transfused-specific requirements not met; IBCT-WCT=IBCT-wrong component transfused; CS=cell
salvage; PTP=post-transfusion purpura; TTI=transfusion transmitted infections; UCT=uncommon complications of transfusion

3. Headline Data: Deaths, Major Morbidity and ABO-Incompatible Transfusions 19

 ANNUAL SHOT REPORT 2023

Costs of SHOT-reported events resulting in major morbidity and

death (where it is likely or definite that the reaction was caused by
the blood component)

Acknowledgements: Dr Elizabeth A Stokes, Health Economics Research Centre,

Nuffield Department of Population Health, University of Oxford and Prof Lise J Estcourt,
Medical Director for Transfusion, NHS Blood and Transplant
This study’s aim is to estimate the costs of acute management of SHOT-reported events resulting in
major morbidity or death from the hospital perspective. All transfusion-related deaths reported to SHOT
in 2018-2022 where it was likely or definite that the reaction was caused by the blood (imputability 2 or
3) have been reviewed; and all cases with major morbidity reported to SHOT in 2021- 2022, where the
adverse reaction was definitely attributable to the blood.

Preliminary findings: from 9 deaths and 19 cases of major morbidity reported in 2022, the average costs
(range) per case were £5,319 (£0 - £36,899). The key cost drivers were intensive care bed days and
medications. The findings will be written up for publication.

Summary data and risks associated with transfusion

Data collected in 2023 are shown in Figure 3.6. Near miss reports continue to be the largest category
of reports, 1420/3833 (37.0%), however, this is a slight reduction on the overall percentage of reports
in 2022 (39.0%). Reporting and investigating near misses helps identify and control risks before actual
harm results, providing valuable opportunities to improve transfusion safety. Cumulative haemovigilance
data from SHOT between 1996-2023 are shown in Figure 3.7.

Figure 3.6:
Summary data for NM: Near miss 1420
2023, all categories Anti-D: Anti-D immunoglobulin errors 425
(includes RBRP IBCT: Incorrect blood component transfused 356
and NM) (n=3833)
HSE: Handling and storage errors 342
FAHR: Febrile, allergic and hypotensive reactions 336
RBRP: Right blood right patient 259
ADU: Delayed transfusion 212
TACO: Transfusion-associated circulatory overload 172
ADU: Avoidable transfusion 127
HTR: Haemolytic transfusion reactions 53
Non-TACO: Pulmonary complications of transfusion 33
CS: Cell salvage 26
UCT: Uncommon complications of transfusion 24
ADU: Prothrombin complex concentrates (PCC) 23
Error
ADU: Under or overtransfusion 20
Not preventable
TTI: Transfusion-transmitted infection 4
Possibly preventable
PTP: Post-transfusion purpura 1
TAGvHD: Transfusion-associated graft-vs-host disease 0

20 3. Headline Data: Deaths, Major Morbidity and ABO-Incompatible Transfusions

 ANNUAL SHOT REPORT 2023

Figure 3.7:
Cumulative data for
UCT: Uncommon complications of transfusion Cumulative to 2022
SHOT categories
PTP: Post-transfusion purpura 2023
1996-2023
TTI: Transfusion-transmitted infection (n=31025)
Transfusion reactions which
CS: Cell salvage may not be preventable

FAHR: Febrile, allergic and hypotensive reactions

Non-TACO: Pulmonary complications of transfusion

TACO: Transfusion-associated circulatory overload Possibly or probably

preventable by improved
TAGvHD: Transfusion-associated graft-vs-host disease practice and monitoring

Allo: Alloimmunisation

HTR: Haemolytic transfusion reactions

ADU: Under or overtransfusion and PCC

ADU: Delayed transfusion Adverse incidents

ADU: Avoidable transfusion due to errors

HSE: Handling and storage errors

Anti-D: Anti-D immunoglobulin errors

IBCT: Incorrect blood component transfused

0 1000 2000 3000 4000 5000 6000 7000

*Data on alloimmunisation is no longer collected by SHOT since 2015

ABO-incompatible (ABOi) transfusions n=10

In 2023, there were 7 ABOi red cell transfusions reported and 3 ABOi plasma transfusions, with 2 major
morbidities following ABOi red cell transfusion. There was no clinical reaction in the remaining cases.
Figure 3.8 shows the number of ABOi red cell transfusions reported to SHOT in the last decade and
Figure 3.9 shows the number of ABOi plasma transfusions reported. Figure 3.10 shows the outcome
of ABOi red cell transfusions reported to SHOT since reporting began in 1996.

All 7 ABOi red cell cases reported in 2023 were in adult transfusion recipients and all following
primarily clinical errors. Four were related to blood collection errors, and 3 to administration errors.
The 3 administration errors resulted from a lack of pre-transfusion safety checks which provide a final
opportunity to detect mistakes prior to administration.

Of the ABOi plasma transfusions, 2 were due to component selection errors in the transfusion laboratory,
with group O plasma components being transfused to a group A and a group B recipient respectively.
The 3rd case occurred in 2011 following a historical WBIT and was identified in 2023.

These cases are explored in more detail in Chapter 10, Incorrect Blood Component Transfused (IBCT)
and Chapter 15, Laboratory Errors.

3. Headline Data: Deaths, Major Morbidity and ABO-Incompatible Transfusions 21

 ANNUAL SHOT REPORT 2023

Figure 3.8:
Number of ABO-
10
incompatible red
cell transfusions
2014-2023

7 7 7

4 4

1
0

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Figure 3.9:
Number of ABO-
4 4
incompatible
plasma
transfusions 2014-
2023 3 3 3
3

2 2 2

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Figure 3.10:
40
Outcome of ABO- 15 deaths to 2005 7 deaths 2006 - 2023
incompatible red 35
cell transfusions in
30 No or minor adverse reaction
26 years of SHOT BSQR
Major morbidities
reporting 19
25 Deaths (imputability 1-3)
24 NPSA SPN 14
20 Competency-assessments

17
19
15
16
13

10 13 7
8 15
8 5 8
8 8 8 5
5 4 8 6 4 9
4 4 5 6 2 5
4 3 5 3 3 1 2 1
3 1 4 3 4 1 4
1 2 2 1 2 1 2 1 2 1 2 1 1 1 2 1 2 1 2 2
0
2
20 1
19 9

20 0
19 7

06

08

09
19 8

03

04

05

07

22
20

23
21
10

13

16
12

15

18

19
14

17
11
/0
/0
9

/9

/0
/9
6/

20

20
20

20
20

20

20

20

20

20

20
20

20

20

20
20

20

20

20
20

20
01
00
97

99
98
9
19

BSQR=Blood Safety and Quality Regulations; NPSA=National Patient Safety Agency; SPN=safer practice notice

22 3. Headline Data: Deaths, Major Morbidity and ABO-Incompatible Transfusions

 ANNUAL SHOT REPORT 2023

Transfusion of group A red cells to group O patients was associated with the greatest risk of major
morbidity, 15/46 (32.6%), but deaths have occurred in group O patients receiving group AB red cells (2
deaths), B red cells (1 death) and A red cells (1 death). These are shown in Figure 3.11 below.

Figure 3.11:
100% 1 ABO-incompatible
1
90% 1 transfusions and
2
2 2 outcome by groups
15
80% 2010-2023 (n=81)
70%

60%

50% 3

40% 4 7
9
4 30
30%

20%

10%

0%
B to A AB to A AB to O B to O A to B A to O

No serious outcome Major morbidity Death

NHS England is in the process of reviewing the Never Events list and framework. This aims to clarify
whether the current framework is an effective mechanism to drive patient safety improvement. Further
details can be found at this link: https://www.england.nhs.uk/long-read/never-events-framework-
consultation/. SHOT has provided input into this consultation, supporting review of the framework with
continued inclusion of ABOi events, and facilitating appropriate system-level improvements to help
prevent these.

Data from 2016-2023 show that although there were 31 ABOi red cell transfusions, there were 2390
near misses where an ABOi transfusion could have resulted. The majority of these were WBIT incidents
which constitute the largest subset of near miss cases reported to SHOT in 2023, 986/1420 (69.4%),
and these are discussed in Chapter 13a, Near Miss – Wrong Blood in Tube (WBIT). These may not
be detected routinely unless there is a historical record in the transfusion laboratory and demonstrate
the importance of the group-check policy (Milkins, et al., 2013). These errors, which could have lethal
outcomes, highlight the risk of not undertaking positive patient identification at the time of collecting
and labelling pre-transfusion samples. As is evident from the iceberg representation (Figure 3.12), these
occur much more frequently and afford more opportunities to learn than the rarer serious adverse events.
When WBIT are not identified or investigated, they represent missed opportunities that can contribute
to future risks of potentially lethal ABOi.

3. Headline Data: Deaths, Major Morbidity and ABO-Incompatible Transfusions 23

 ANNUAL SHOT REPORT 2023

Figure 3.12:
ABO-incompatible
red cell
transfusions
31 ABO-incompatible
red cell transfusions
2016-2023: few
events (n=31) but
many near misses
(n=2390)

2390 ABO-incompatible
near miss events

Recognising WBIT as potential harm events, identifying and addressing causal and contributory factors
is crucial to improve patient safety and prevent future ABOi transfusions that could result in patient death.

Conclusion
Worrying signals are emerging from the haemovigilance data with increasing numbers of preventable
errors and potential harm incidents. While it is encouraging to see improved haemovigilance reporting,
it is evident that staff have absolutely no spare capacity and are stretched beyond breaking point with
an increasing number at risk of burn out. A shortage of skilled workers, demoralised healthcare staff
and poorly-resourced healthcare organisations with unreliable or ineffective IT systems reflect an NHS in
crisis and an urgent need for reset. A coordinated approach to improve safety should focus on increasing
and supporting the clinical and laboratory workforce, fostering an environment where existing staff
can flourish and collaborate, and ensuring reliable IT systems. The NHS must be staffed and funded
appropriately to deliver optimal care for patients. It is imperative that the gap between ‘work as done’
and ‘work as imagined’ is bridged. Application of human factors and ergonomics principles to design
user-friendly systems, investigate and learn from incidents and promoting a holistic approach to safety
is vital in helping bridge this gap.

Further information and data can be found in the supplementary information on the SHOT website
(https://www.shotuk.org/shot-reports/report-summary-and-supplement-2023/).

24 3. Headline Data: Deaths, Major Morbidity and ABO-Incompatible Transfusions

 ANNUAL SHOT REPORT 2023

Recommended resources
SHOT Bite No. 1a and 1b: Incident Investigation
SHOT Bite No. 17: Near Miss
SHOT Bite No. 20: IBCT-SRNM
https://www.shotuk.org/resources/current-resources/shot-bites/

Safety Notice relating to SRNM and gap analysis

https://www.shotuk.org/resources/current-resources/safety-notices/

SHOT Definitions
https://www.shotuk.org/reporting/

References
Medicines & Healthcare products Regulatory Agency (MHRA) and Serious Hazards of Transfusion (SHOT), 2024. Central
Alerting System: Reducing risks for transfusion-associated circulatory overload. [Online] Available at: https://www.cas.
mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103249 (Accessed 08 April 2024).

Milkins, C. et al., 2013. Guidelines for pre-transfusion compatibility procedures in blood transfusion laboratories.
Transfusion Medicine, 23(1), pp. 3-35. doi: https://doi.org/10.1111/j.1365-3148.2012.01199.x.

Narayan, S. et al., 2021. The 2020 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. doi: https://doi.org/10.57911/FN15-ME02.

Narayan, S. et al., 2022. The 2021 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. doi: https://doi.org/10.57911/QZF9-XE84.

Narayan, S. et al., 2023. The 2022 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
group. doi: https://doi.org/10.57911/WZ85-3885.

Serious Hazards of Transfusion (SHOT), 2022. Central Alerting System: Preventing transfusion delays in bleeding
and critically anaemic. [Online] Available at: https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.
aspx?AlertID=103190 (Accessed 08 April 2024).

3. Headline Data: Deaths, Major Morbidity and ABO-Incompatible Transfusions 25

 ANNUAL SHOT REPORT 2023

4 Key Messages
and Recommendation

Authors: Caryn Hughes, Jennifer Davies and Shruthi Narayan

Abbreviations used in this chapter

ABOi ABO-incompatible NICE National Institute for Health and Care
CIEHF Chartered Institute of Ergonomics Excellence
& Human Factors NMC Nursing and Midwifery Council
GMC General Medical Council PID Patient identification
HCPC The Health and Care Professions Council RCP Royal College of Physicians
HSSIB Health Service Safety Investigations Body SaBTO Advisory Committee on the Safety of Blood,
ID Identification Tissues and Organs
IT Information technology SOP Standard operating procedure
JPAC Joint United Kingdom (UK) Blood Transfusion TACO Transfusion-associated circulatory overload
and Tissue Transplantation Services UK United Kingdom
LIMS Laboratory information management system UKTLC UK Transfusion Laboratory Collaborative
NHS National Health Service WBIT Wrong blood in tube

Key SHOT messages

• Making safe transfusion decisions and ensuring patients are well informed: Transfusions
are very safe and effective when used appropriately. All staff involved in the transfusion pathway
need to have relevant knowledge, appropriate to their role, of blood components, indications for
use, alternate options available, risks and benefits, possible reactions and their management.
Unnecessary transfusions must be avoided. Patients or their carers must be informed about the
risks, benefits and alternatives to transfusions

• Addressing transfusion errors: Errors continue to be the source of most SHOT reports
(83.1%). While transfusions are largely safe, errors can result in patient harm. Communication
issues, assumptions and distraction compounded by staffing issues, ineffective and misuse of
IT and poor safety culture contribute to errors. Errors must be investigated using human factors
principles-based incident investigations and appropriate improvement measures implemented

• Ensuring clinical and laboratory transfusion teams are well resourced: Adequate numbers
of appropriately trained staff must be available to ensure safe transfusions; there should be
contingency planning for staffing levels below a minimum level and for times of high workload.
Safe staffing levels matched to the workload with well-resourced systems are vital for ensuring
high quality care for patients and safety. Together they form the foundation for an effective
healthcare system that prioritises patient safety above all else

• Addressing knowledge gaps, cognitive biases, and holistic training: Transfusion training
with a thorough and relevant transfusion knowledge base should be available to all clinical and
laboratory staff. They should also receive training in patient safety principles, application of human
factors principles and quality improvement approaches. It is important that staff understand
how cognitive biases and assumptions contribute to poor decision making so that they can be
mitigated appropriately

26 4. Key Messages and Recommendations

 ANNUAL SHOT REPORT 2023

• Policies and processes: Policies, guidelines/decision making aids and SOP need to be
simple, clear, easy to follow and explain the rationale for each step. These should be up to date,
accessible and reflect current national guidelines and recommendations. This will ensure staff
are engaged and more likely to follow process, thereby avoiding any workarounds or deviations

• Safety culture: Fostering a strong and effective safety culture that is ‘just, restorative and learning’
is vital to reduce transfusion incidents and errors, enhancing patient safety. Staff should be able
to confidently raise concerns, discuss issues and promote innovative ideas for improvement.
Regular monitoring of the safety culture and its impact on patient safety; and staff wellbeing
should be in place to ensure timely improvement actions are implemented

• Learning from near misses: Reporting and investigating near misses helps identify and control
risks before actual harm results, providing valuable opportunities to improve transfusion safety.
The appropriate response to a near-miss with potential for high-risk transfusion event includes:
(1) reporting to haemovigilance agencies as required, (2) investigating near misses, (3)developing
and implementing a corrective and preventative action plan and (4) monitoring the effectiveness
of interventions

• Shared care: Clear, timely and comprehensive communication between all teams and hospitals
involved in the patient-care pathway is vital in ensuring patient safety. Robust and transparent
processes must be in place for safe and effective transfer of information at all points in the
patient care pathway

• Investigating incidents and focussing on improvements: Investigations must be systematic

and thorough, using human factors principles and systems thinking in order to identify systems-
based corrective and preventative actions. Systemic and organisational problems should be fully
investigated, as staff-related actions are unlikely to resolve underlying systemic issues. Learning
from the incidents should be shared widely

• Safety checks before transfusions: The pre-transfusion patient-side safety check provides a
final opportunity for staff to identify errors ensuring the right component with the right specification
is transfused to the right patient; the TACO risk assessment facilitates appropriate mitigating
measures in vulnerable patients at high risk of TACO. These checks serve as safety pauses to
ensure staff safeguard patient well-being and prevent potentially life-threatening complications.
These are not tick-box exercises

• Patients as safety-partners: Staff must ensure that they involve, engage, and listen to patients as
‘partners’ in their own care and decision-making to support safe transfusions. Engaging patients,
their families, and carers as ‘safety partners’ helps co-create safer systems, identify, and rectify
preventable adverse events

The 2023 Annual SHOT Report highlights continuing error trends with 83.1% reports in 2023 related
to avoidable errors. Continuing reports of preventable ABOi transfusions, transfusion delays, avoidable
transfusions and TACO are sobering to read. A steep increase in the laboratory transfused errors
reported and the worrying signals evident from the recent SHOT-UKTLC survey on safety culture in the
transfusion laboratories cannot be ignored and call for urgent action (see 'Recommended resources').

All staff involved in blood transfusions should have a basic knowledge of blood components, indications
for use, alternative options available, risks and benefits, possible reactions, and their management. This

4. Key Messages and Recommendations 27

 ANNUAL SHOT REPORT 2023

will help staff to have meaningful discussions with patients, carers and families; support shared decision-
making and consent in accordance with the SaBTO recommendations (SaBTO, 2020). Anecdotal reports
of suboptimal consent practices are evident in this report where patients were not adequately informed
about the risks, alternatives, or potential consequences of transfusions. Consent in transfusion is crucial
to facilitate shared decision-making with patients being able to make informed choices about their care.
A recent national comparative audit of the NICE Quality Standard QS138 revealed that only 475/1356
(35%) of transfused patients had evidence of receiving both written and verbal information about the
risks, benefits, and alternatives to transfusion (compared to 26% in the 2021 audit). All hospitals should
urgently review local consent practices, initiate improvements, and ensure optimal consent and shared
decision making for safe patient care. Table 4.1 highlights the key aspects that need to be covered
when consenting patients for transfusions. See 'Recommended resources' at the end of this chapter for
links to the national comparative audit and patient information pages on the SHOT and JPAC websites.
Table 4.1: Key Key aspects to be covered when consenting patients for transfusion
aspects to be 1 Patient and/or family/carer have been provided with relevant information about blood transfusions that would
covered when help in their decision-making process
consenting patients 2 The reason for the transfusion has been discussed
for transfusion 3 The benefits of the transfusion have been explained
4 Transfusion risks, both short and long-term risks have been discussed with the patient and/or family/carer
(including any additional risks pertinent to long term multi-transfused patients)
5 The risks, benefits, and consequences of NOT accepting blood transfusion have been elaborated
6 Transfusion issues specific to the patient have been highlighted
7 Relevant alternative options have been discussed including how they might reduce the need for a transfusion
8 The transfusion process has been explained
9 The need for any specific requirements for blood components and rationale, including need for anti-D Ig post
transfusion as appropriate has been elaborated and relevant patient information leaflet has been provided
10 Patient and/or family/carer has also been informed that once transfused, they are no longer eligible to donate
blood
11 Patients and carers/family have been given the opportunity and been encouraged to ask questions
12 Patient and/or family/carer is aware that if they change their mind at any point before the transfusion, they are
entitled to withdraw their consent, and this should be documented and managed appropriately
13 Synopsis of discussions and decisions taken documented in patient's clinical notes

The Safe Transfusion Checklist that is available to download from the SHOT website covers key aspects
of the transfusion process at the patient side and the ABCDE approach to transfusions support safe
decisions and helps avoid unnecessary transfusions (https://www.shotuk.org/resources/current-
resources/).

Errors in transfusion persist due to a combination of factors including complex processes, communication
issues, lack of standardisation, inadequate training, or resources including suboptimal implementation
or use of transfusion IT. Failing to identify and implement system-focussed interventions reflects missed
opportunities for enhancing safety and failure to optimally learn from incidents. It is also important to
recognise that alongside examples of the failures of care, there are also eminent examples of innovation,
staff working above and beyond while striving to deliver safe care amidst all the challenges. These have
also been highlighted throughout the report. It is encouraging to see a wider recognition of the importance
of human factors and ergonomics principles but more needs to be done to embed these in practice.
An agenda for change with recommendations to enhance safety is covered in all the chapters. Without

28 4. Key Messages and Recommendations

 ANNUAL SHOT REPORT 2023

urgent interventions, the situation is only going to get worse. We must all act now and work together
to improve systems and avoid normalising the unacceptable.

Key SHOT recommendations for 2023

The following main recommendations have been drafted to address the recurring themes identified in
the analysed SHOT reports that impact transfusion safety. Previous SHOT recommendations remain
pertinent, and organisations must endeavour to progress implementation of the same if gaps are
identified.

Addressing patient identification errors to enhance transfusion

safety
Patient misidentification poses a risk to patient safety and has the potential to result in significant harm.
Errors are often the result of multiple factors and patients are at greater risk of misidentification in certain
settings or situations for e.g., handovers, shared care between hospital and clinical settings and in
emergencies. All staff involved in patient care should be aware of the key patient identification criteria
as per local policies and national guidelines (Robinson, et al., 2018).

PID errors occur at all stages of the transfusion process. Examples include clinical staff incorrectly
transcribing or missing vital patient demographics when completing request forms and sample labelling,
maternal and cord blood samples being incorrectly labelled and laboratory staff not transcribing and
inputting data accurately into the LIMS during the booking-in of samples. Many PID errors are the result
of inadequate systems suggesting that investigations into PID errors must be designed to highlight and
resolve these system failures, i.e., identifying and addressing the human factors and ergonomics aspects.

Inaccurate and incorrect patient identification is commonly identified in near miss WBIT cases. These
frequently go undetected and can potentially have fatal consequences making accurate PID and sample
labelling in the preanalytical stage of the transfusion process imperative. Incomplete PID processes were
recognised as a contributory factor in 2 ABOi cases reported in 2022, both of which resulted in patient
fatalities (Narayan, et al., 2023). The use of a pre-transfusion checklist prior to administration has been
recommended in previous Annual SHOT Reports and is the final opportunity to identify a PID error before
the transfusion begins. This is especially important during emergency situations when additional pressure
and distractions are likely. It is vital that staff perform PID steps accurately and completely during all
stages of the transfusion process and wherever possible, involve the patient.

While electronic blood-tracking systems are increasingly being implemented and used in healthcare
to support safe transfusion practices, it is doubtful that technology alone will reduce the risk of patient
misidentification (HSSIB, 2024). Patient identification processes, including related technology can improve
patient safety only by ensuring that systems incorporate the needs of patient groups that are at greater
risk of misidentification. Additionally, IT systems must be correctly implemented, configured, and used by
trained and competent staff. To be effective, they must interface with electronic patient record systems.

Analysis of both clinical and laboratory cases demonstrate gaps in knowledge relating to the importance
of performing accurate and complete patient identification. Staff should recognise the risk of patient
misidentification and its subsequent impact on all aspects of patient care including transfusion support.
It is necessary for NHS Trusts/Health Boards to promote a reliable, just, learning safety culture to ensure
PID policies are implemented, followed, and monitored (Tase, et al., 2013).

4. Key Messages and Recommendations 29

 ANNUAL SHOT REPORT 2023

Main recommendation 1: Addressing patient identification errors

to enhance transfusion safety
Transfusion is a complex multi-step process involving healthcare staff from varied clinical settings
with differing levels of knowledge and skills. Ensuring that patients are accurately and correctly
identified and communicating this information throughout the transfusion process is challenging.
SHOT emphasises that all staff involved in the transfusion process should adhere to correct PID
procedures in accordance with local transfusion policies. Accurate and complete identification of
patients receiving transfusions is essential for patient safety and should be reflected in clinical and
laboratory settings and embedded in transfusion practice.

Actions required:

Hospital senior management should:

• Ensure PID procedures and policies are regularly reviewed and updated and include high-risk
settings, situations, and patient groups where the risk of patient misidentification is greater

• Ensure adequate funding and resources are available for the implementation and maintenance
of effective fully functional IT systems used in PID processes in clinical and laboratory settings

• Foster a safety culture between multidisciplinary teams and ensure adequate support for clinical
and laboratory teams with well-resourced services

• Ensure that electronic patient record systems are compliant with relevant risk management
standards (such as DCB0129, DCB0160 and DCB1077)

• Regularly evaluate the effectiveness of PID processes by consistently auditing practice in clinical
and laboratory settings

Hospital transfusion teams should:

• Review all transfusion-related patient identification errors and establish the causes of patient
misidentification

• Recognise what changes are required to support staff when PID errors happen

• Ensure that knowledge of PID processes is included and emphasised in training and competency
assessments to all staff involved in transfusion and are embedded in practice

Clinical staff should:

• Be supported by training which includes the knowledge and importance of undertaking accurate
and correct PID processes during each step of the transfusion process

• Wherever possible undertake positive patient identification by proactively involving patients in their care

• Perform PID checks at critical steps in the transfusion pathway i.e., sample taking and labelling,
collection of components and pre-administration checks

• Undertake all appropriate PID checks by using a pre-transfusion checklist prior to administering a
transfusion at the patient side. This should include accurately checking the patient’s identity against
the prescription and the blood component compatibility label

30 4. Key Messages and Recommendations

 ANNUAL SHOT REPORT 2023

Pathology laboratory management should:

• Ensure that procedures are in place and SOP reflect PID processes in the transfusion laboratory at
safety critical steps in the transfusion pathway. These include pre-analytical processes, component
selection and labelling, and at point of issue

• Embed the use of a laboratory exit check such as PAUSE (Narayan, et al., 2022), or equivalent to
ensure that that all previous steps have been completed correctly and that unit is safe for issue
to the clinical area

• Ensure that the LIMS incorporates PID processes and is used to its full potential to support
transfusion safety

Safe staffing to support safe transfusions

Appropriate staffing is a key element in provision of a safe transfusion service, from the donor to the
patient, involving medical, nursing, scientific and support staff. Appropriate staffing is not just about
numbers of staff, but also requires the right skill mix and forward planning. The importance of appropriate
staffing was reinforced by the Francis Report into failings at Mid Staffordshire NHS Foundation Trust
in England (Francis, 2013). Capacity planning is critical to understanding safe staffing levels for a
transfusion laboratory (Dowling, et al., 2024). In England, the National Quality Board (2016) set out
expectations relating to getting nursing, midwifery, and care staffing right. This provided a governance
and oversight framework alongside recommended evidence-based tools, resources, and examples of
good practice, to support NHS providers in delivering safe patient care and the best possible outcomes
for their patients. The Health and Care (Staffing) (Scotland) Act 2019 came into force on 1 April 2024
(Scottish Government, 2019). This groundbreaking legislation sets out requirements for safe staffing
across all health and care services in Scotland. The Act places a legal duty on NHS and care providers
to make sure there are always suitably qualified staff working in the right numbers for safe and effective
care. It also imposes a duty on the Scottish government to ensure there are enough registered nurses,
midwives, and medical professionals available to enable employers to ensure safe staffing. The Nurse
Staffing Levels (Wales) Act 2016 protects nurse staffing levels in Wales and was the first law of its kind
in the UK making Health Boards and NHS Trusts legally responsible for providing enough nursing staff
in their nursing services and those they commission (NHS Wales, 2017). Similar campaigns are ongoing
in Northern Ireland to secure staffing in healthcare.

The Royal College of Physicians published Guidance on Safe Medical Staffing in 2018, following concerns
that levels of medical staffing had fallen dangerously low (RCP, 2018). There is no set minimum staffing
level for any of the professions, this is dependent on many factors including workload, levels of information
technology, and the complexity of the service provision within the organisation. Appropriate staffing
is critical to supporting a positive safety culture within an organisation, where excellence in patient
care is supported by a listening culture, good leadership and a workforce that feels empowered to
raise concerns. A positive safety culture will struggle to flourish where the workforce is stretched and
overburdened.

In a survey of healthcare staff in 2022 (Ibbetson, 2022), 966 out of 1016 (95%) staff stated that their
workplace had been affected by staff shortages due to COVID-19. Of the NHS staff whose workplace
had been affected by staff shortages, 71% said that current staff were working overtime or doing extra
shifts, 38% said that their workplace was bringing in agency staff to cope with shortages, and 36% said

4. Key Messages and Recommendations 31

 ANNUAL SHOT REPORT 2023

that staff were being redeployed from nearby locations to assist. Although the number in the survey was
relatively small, similar signals are seen in a survey performed by the UKTLC in 2022 (SHOT, 2022). The
NHS is facing an unprecedented staffing crisis. In its inquiry on the health and social care workforce in
July 2022 (section 3.2), the House of Commons Health and Social Care Committee reported that the
NHS had lost two million full-time equivalent days to sickness in August 2021 (Health and Social Care
Committee, 2022). These included more than 560,000 days to anxiety, stress, depression, or another
psychiatric illness. Workforce challenges are not only related to sickness absence, but high numbers
of staff also continue to leave their profession, disillusioned with pay, conditions and training to support
them in their roles. In the NHS England staff survey 2023 only 31.23% of respondents stated they were
satisfied with their level of pay, 32.40% stated that there were enough staff at their organisation for them
to do their job properly and 57.41% felt supported to develop their potential (NHSE, 2024). Plans to turn
the tide and address workforces shortages have been published for the devolved nations (NHS Long
Term Workforce, 2023; National Workforce Strategy for Health and Social Care in Scotland, 2022; NHS
Wales Workforce, 2023; Workforce Strategy, 2018), however, these long term plans have made little
difference in the short term, and patient waiting lists continue to rise (The King's Fund, 2023).

Innovative solutions to address deficiencies in staffing levels have included accelerated training, using
unregulated staff to make decisions about patient treatment (GMC, 2024) and virtual clinics. These are
well-intentioned but can have unintended consequences that put patient care at risk. Other innovative
solutions include automation and information technology that can be used to support practice and
optimise staff efficiencies. Although innovative solutions may be effective, where they are employed,
implementation processes must consider potential risks and accountability.

A mismatch between workload and staffing levels is implicated in many cases described throughout
the 2023 Annual SHOT Report. It is evident that an appropriate workforce, supported by a good safety
culture and a listening leadership, is the keystone to a safe service. A systems-thinking approach that
builds an environment that makes it easier for staff to do the right thing and harder to do the wrong
thing (see Chapter 8, Human Factors and Ergonomics in SHOT Error Incidents), incorporation of
effective information technology systems (see Chapter 16, Errors Related to Information Technology)
and optimisation of automation in the laboratory (see Chapter 15, Laboratory Errors) are also key to
supporting a safe service.

A recent white paper on ‘Fatigue risk management for health and social care’ from the Chartered
Institute of Ergonomics and Human Factors highlights a chronically fatigued workforce due to several
factors including staffing issues and high workload. It provides a foundation for national health and social
care bodies to recognise the risk that staff fatigue poses to safe and efficient healthcare services and
advocates a systemic approach to managing these risks (CIEHF, 2024).

32 4. Key Messages and Recommendations

 ANNUAL SHOT REPORT 2023

Main recommendation 2: Safe staffing to support safe transfusions

Healthcare leaders should review their organisations workforce needs to ensure that appropriate
staffing is in place with future planning, including digital transformation to support a safe transfusion
service. The review should consider the needs of the organisation, using tools relevant to the
individual professions and must include clear time-bound actions plans where gaps are identified.

Actions required:

Hospital senior management should:

• Have a process in place that measures and monitors appropriate staffing levels across the
organisation to support safe transfusion practice

• Identify and address challenges relating to recruitment and retention of clinical and laboratory staff

• Spearhead a good safety culture and have processes in place to monitor and measure the
effectiveness of the culture and staff engagement

• Support implementation of effective and validated innovative solutions to address the mismatches
between workload and staffing levels, including IT and automation

Clinical and laboratory management should:

• Have processes in place to identify where there are staffing issues that impact on service provision
and escalate risks to the senior management team

• Have capacity plans in place that identify minimum staffing levels for a safe service, including
time required for any quality, training and supervisory related activities

• Have documented forward and succession plans that include agreed timelines and are regularly
reviewed for compliance and any changes within the workforce

• Ensure protected time is provided for staff training and competency assessment within the
working hours

• Support a good safety culture, a listening management team and provide feedback on staff
suggestions

Clinical and laboratory staff should:

• Raise concerns to relevant management personnel when safety risks relating to staffing levels
are identified

• Engage in regular meetings with relevant management personnel, including 1:1 meetings and
appraisals

Effective timely communications to ensure safe transfusions

Effective communication is critical for safe patient care. Patients need to feel secure and empowered
enough to communicate honestly and openly with their care providers to receive effective treatments.
Clinical staff need to convey treatment plans and health education clearly, accessibly, and empathetically
so that patients can receive optimal care. Staff should share information ethically and responsibly to
protect patient confidentiality. This includes accurate documentation of patient information and effective
handovers during shift changes. Healthcare organisations need to apply culturally responsive measures to
bridge communication gaps between stakeholders. Additionally, patient involvement in decision-making
and understanding their care plan is crucial for their safety and well-being.

All healthcare staff must have the knowledge, skills, understanding and confidence they need to be
able to share and use health and care information. The professional standards from the GMC, the NMC
Code and HCPC standards for conduct, performance, and ethics mandate specific communication
standards in healthcare to uphold patient safety (GMC, 2024; NMC, 2015; HCPC, 2023). These ensure

4. Key Messages and Recommendations 33

 ANNUAL SHOT REPORT 2023

that healthcare staff adhere to established guidelines for effective communication, documentation, and
patient engagement throughout the care process. Compliance with these mandates helps minimise
errors, enhance care coordination, and ultimately improve patient outcomes. However, communication
issues (between clinical staff and patients; different teams/care providers and between clinical and
laboratory staff) are repeatedly highlighted in Annual SHOT Reports as contributory to errors and incidents
and must be addressed.

Main recommendation 3: Effective, timely communications to

ensure safe transfusions
Effective communication is crucial for safe patient care. Timely, clear, and concise communication
can help prevent avoidable transfusion errors, foster collaboration, facilitate shared decision-making
and enhances the overall quality of care provided to patients. Clear and succinct messaging
with active listening, structured handovers, team huddles and safety briefings with optimal use
of technology to support safe communications is vital for patient safety. Staff should receive
appropriate training on effective communication skills including cultural sensitivity and feedback
mechanisms must be in place to ensure continuing improvement in processes.

Actions required:

Hospital senior management should:

• Have an oversight of the communication policies, processes and practices in place to support
patient care within their teams

• Ensure they review the effectiveness of communications at least annually

• Ensure that staff are appropriately trained and competent to communicate effectively with
colleagues, patients and families

• Promote a just, learning safety culture and promote sharing of good practices with a collective,
inclusive, and compassionate leadership

• Encourage patients and staff to raise concerns as well as provide constructive feedback

Staff learning and development teams should:

• Provide support and training for all staff in effective communication skills

• Ensure procedures and templates are available to facilitate structured communication

• Provide a platform to share learning and best practices across the whole organisation

Clinical and pathology laboratory management should:

• Ensure staff are trained in effective communication skills and have regular update training as
appropriate

• Ensure structured handovers are in place to facilitate safe communication of relevant patient
information between teams (between clinical teams within a hospital, between clinical and
laboratory teams, when patient is transferred between hospitals)

34 4. Key Messages and Recommendations

 ANNUAL SHOT REPORT 2023

• Ensure regular feedback is sought from patients and staff about effectiveness of communication.
This should be part of regular reviews of the processes in place to ensure safe communication
at all points of the patient pathway with timely improvement actions to address gaps identified

Clinical and laboratory transfusion staff should:

• Follow a structured handover when passing on information related to patient care at all points
(between shifts, between teams and during interhospital transfers). All communications must
be specific, concise, relevant and timely

• Identify solutions with effective and appropriate use of IT to improve communications for safer
patient care

• Undertake regular audits of communication practices for example: consent practices, discharge
communications, management of patients in shared care, quality of handovers in both clinical
and laboratory areas

Conclusions
We need to rethink strategy, consider the people involved and support them, promote a just and
learning safety culture; ensure resources are in place, including adequate financial support with a well-
trained, well-informed, resilient, and competent workforce. Using technology to automate processes
and reduce human intervention is vital. Clinical and laboratory practices need to be evidence-based
with robust governance processes and have a safety culture that promotes learning from experience
including instances of unsafe, suboptimal and excellent care. The long term aims of a haemovigilance
system, such as SHOT, are to help reduce incidents that result in harm while moving towards increased
reporting of near miss events for future learning. Making system-wide changes is absolutely essential.

Recommended resources
A-E decision tree to facilitate decision making in transfusion
Safe Transfusion Checklist
https://www.shotuk.org/resources/current-resources/

Patient information page with relevant resources from the SHOT website
https://www.shotuk.org/patients/
Transfusion information for patients on the JPAC website
https://www.transfusionguidelines.org/transfusion-practice/consent-for-blood-transfusion/consent-
information-for-patients

Royal College of Pathologists - Choosing Wisely

https://www.rcpath.org/profession/patient-safety-and-quality-improvement/patient-safety-
resources/choosing-wisely/recommendations-for-transfusion-medicine.html

Patient Blood Management - Blood assist app

Apple (https://apps.apple.com/gb/app/blood-assist/id1550911130)
Google play (https://play.google.com/store/apps/details?id=uk.nhsbt.bloodassist)
Web based (https://www.bloodassist.co.uk/)

4. Key Messages and Recommendations 35

 ANNUAL SHOT REPORT 2023

SHOT, UKTLC safety culture survey in transfusion laboratories in the UK

https://www.shotuk.org/resources/current-resources/shot-surveys/

National Comparative Audit: 2023 Audit of NICE Quality Standard QS138 and Vein to vein
audit contact details
https://hospital.blood.co.uk/audits/national-comparative-audit/

References
Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO), 2020. Guidelines from the expert advisory
committee on the Safety of Blood, Tissues and Organs (SaBTO) on patient consent for blood transfusion. [Online]
Available at: https://www.gov.uk/government/publications/blood-transfusion-patient-consent/guidelines-from-the-
expert-advisory-committee-on-the-safety-of-blood-tissues-and-organs-sabto-on-patient-consent-for-blood-transfusion
(Accessed 07 May 2024).

Chartered Institute of Ergonomics & Human Factors (CIEHF), 2024. Fatigue risk management for health and social
care. [Online] Available at: https://ergonomics.org.uk/resource/fatigue-risk-management-for-health-and-social-care.html
(Accessed 02 May 2024).

Dowling, K. et al., 2024. UK Transfusion Laboratory Collaborative: Minimum standards for staff qualifications, training,
competency and the use of information technology in hospital transfusion laboratories 2023. Transfusion Medicine,
34(1), pp. 3-10. doi: https://doi.org/10.1111/tme.13029.

Francis, R., 2013. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry. Executive summary, London:
The Stationery Office. Available at: https://assets.publishing.service.gov.uk/media/5a7ba0faed915d13110607c8/0947.
pdf (Accessed 02 May 2024).

General Medical Council (GMC), 2024. Delegation and referral. [Online] Available at: https://www.gmc-uk.org/
professional-standards/professional-standards-for-doctors/delegation-and-referral/delegation-and-referral (Accessed 02
May 2024).

General Medical Council (GMC), 2024. Professional standards. [Online] Available at: https://www.gmc-uk.org/
professional-standards (Accessed 07 May 2024).

Health & Care Professions Council (HCPC), 2023. Communication. [Online] Available at: https://www.hcpc-uk.org/
standards/standards-of-conduct-performance-and-ethics/revised-standards/communication/ (Accessed 07 May 2024).

Health and Social Care Committee, 2022. Workforce: recruitment, training and retention in health and social
care, London: Order of the House. Available at: https://committees.parliament.uk/publications/23246/
documents/171671/default/ (Accessed 07 May 2023).

Health Services Safety Investigations Body (HSSIB), 2024. National learning report: Positive patient identification. [Online]
Available at: https://www.hssib.org.uk/patient-safety-investigations/positive-patient-identification/national-learning-
report/ (Accessed 08 April 2024).

Ibbetson, C., 2022. Nine in ten NHS workers say their workplace has seen staff shortages due to COVID-19. [Online]
Available at: https://yougov.co.uk/health/articles/40783-nine-ten-nhs-workers-say-their-workplace-has-seen-?redirect_fr
om=%2Ftopics%2Fhealth%2Farticles-reports%2F2022%2F02%2F02%2Fnine-ten-nhs-workers-say-their-workplace-
has-seen- (Accessed 02 May 2024).

Narayan, S. et al., 2022. The 2021 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. doi: https://doi.org/10.57911/QZF9-XE84.

Narayan, S. et al., 2023. The 2022 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
group. doi: https://doi.org/10.57911/WZ85-3885.

National Quality Board (NQB), 2016. Supporting NHS providers to deliver the right staff, with the right skills, in the right
place at the right time, England: NHS England. Available at: https://www.england.nhs.uk/wp-content/uploads/2013/04/
nqb-guidance.pdf (Accessed 02 May 2024).

National Workforce Strategy for Health and Social Care in Scotland, 2022. National Workforce Strategy for Health and
Social Care in Scotland, Scotland: The Scottish Government. Available at: https://www.gov.scot/binaries/content/
documents/govscot/publications/strategy-plan/2022/03/national-workforce-strategy-health-social-care/documents/
national-workforce-strategy-health-social-care-scotland/national-workforce-strategy-health-social-care-scotland/
govscot%3Adocument/national-workforce-strategy-health-social-care-scotland.pdf (Accessed 02 May 2024).

36 4. Key Messages and Recommendations

 ANNUAL SHOT REPORT 2023

NHS England (NHSE), 2024. 2023 NHS National Staff Survey. [Online] Available at: https://www.gov.uk/government/
statistics/2023-nhs-national-staff-survey (Accessed 07 May 2024).

NHS Long Term Workforce, 2023. NHS Long Term Workforce Plan. [Online] Available at: https://www.england.nhs.uk/
publication/nhs-long-term-workforce-plan/ (Accessed 02 May 2024).

NHS Wales, 2017. Nurse Staffing Levels (Wales) Act 2016. Statutory Guidance, Wales: Wales Government. Available at:
https://www.legislation.gov.uk/anaw/2016/5/enacted (Accessed 07 May 2024).

Nursing & Midwifery Council (NMC), 2015. The Code. Professional standards of practice and behaviour for nurses,
midwives and nursing associates, London: Nursing & Midwifery Council. Available at: https://www.nmc.org.uk/
globalassets/sitedocuments/nmc-publications/nmc-code.pdf (Accessed 07 May 2024).

Robinson, S. et al., 2018. The administration of blood components: a British Society for Haematology Guideline.
Transfusion Medicine, 28(1), pp. 3-21. doi: https://doi.org/10.1111/tme.12481.

Royal College of Physicians (RCP), 2018. Guidance on safe medical staffing. Report of a working party, London: Royal
College of Physicians. Available at: https://www.bgs.org.uk/sites/default/files/content/resources/files/2018-07-13/2018_
safe-medical-staffing_report.pdf (Accessed 07 May 2024).

Scottish Government, 2019. Health and Care (Staffing) (Scotland) Act 2019. [Online] Available at: https://www.
legislation.gov.uk/asp/2019/6/section/2/enacted (Accessed 07 May 2024).

Serious Hazards of Transfusion (SHOT), 2024. UKTLC. [Online] Available at: https://www.shotuk.org/resources/current-
resources/uktlc/ (Accessed 02 May 2024).

Tase, T. H., Lourenção, D. C. d. A., Bianchini, S. M. & Tronchin, D. M. R., 2013. Patient identification in healthcare
organizations: an emerging infection. Revista Gaucha de Enfermagem, 34(3), pp. 196-200. doi: https://doi.org/10.1590/
S1983-14472013000300025.

The King’s Fund, 2023. Waiting times for elective (non-urgent) treatment: referral to treatment (RTT). [Online] Available at:
https://www.kingsfund.org.uk/insight-and-analysis/data-and-charts/waiting-times-non-urgent-treatment (Accessed 02
May 2024).

Workforce Strategy, 2018. Workforce Strategy - Workforce Information. [Online] Available at: https://www.health-ni.gov.
uk/publications/workforce-strategy-workforce-information (Accessed 02 May 2024).

4. Key Messages and Recommendations 37

 ANNUAL SHOT REPORT 2023

5 The Infected Blood Inquiry

and Haemovigilance

Authors: Shruthi Narayan, Caryn Hughes and Emma Milser

With contributions from SHOT Steering Group and Working Expert Group members

Abbreviations used in this chapter

AOMRC Academy of Medical Royal Colleges NHSBT NHS Blood and Transplant
IBI Infected Blood Inquiry NICE National Institute for Health and Care
MHRA Medicines and Healthcare products Excellence
Regulatory Agency TTI Transfusion-transmitted infection
NHS National Health Service UK United Kingdom

Recommendation
• Complete implementation of the IBI report recommendations to improve healthcare systems and
optimise safety. The effectiveness of the implementation should be monitored regularly

Action: All professional organisations related to healthcare in the UK and all relevant
bodies responsible for various recommendations as detailed in the report

Introduction
The IBI was an independent, public, statutory inquiry established to examine the circumstances in which
men, women and children treated in the NHS were given infected blood and infected blood products,
particularly in the 1970s and 1980s. Sir Brian Langstaff chaired the Inquiry, and the final report was
published on 20 May 2024 (IBI, 2024). SHOT released a statement following the release of the IBI Report
(See ‘Recommended resources’).

It has been humbling, upsetting, and moving to hear and read the report’s findings, evidence and lived
experiences of the Infected and Affected. The SHOT Steering Group and Working Expert Group members
would like to acknowledge the scale of the tragedy and extend their heartfelt compassion. We are
considering the findings and recommendations from this comprehensive report. We are committed to
working with the MHRA as the regulator and other key stakeholders, including patients, and pledge to
assist and support effective implementation of all recommendations related to haemovigilance.

Recommendations relating to haemovigilance and transfusion

safety
It is encouraging to see several recommendations in the IBI Report supporting haemovigilance, patient blood
management, transfusion education, laboratory support and digital transformation within transfusion. Many
of these recommendations align closely with the philosophy of SHOT, and priorities we have identified over
recent years. There were several themes that emerged from the final report of the IBI. Sir Brian Langstaff
identified the first theme as the failure to make patient safety the paramount focus of decision making and
action. The report contains several wide-ranging recommendations that addresses the wider healthcare
system and practices, not just transfusion medicine (IBI, 2024). The following infographic summarises
the main themes from the safety messages and recommendations from the report. Recommendation 7
focusses on ‘Patient Safety: Blood Transfusions’.

38 5. The Infected Blood Inquiry and Haemovigilance

 ANNUAL SHOT REPORT 2023

Figure 5.1:
Key themes from the Infected Blood Inquiry Report Key themes
haemovigilance and transfusion safety from the IBI
Report related to
Adequate resources/funding support, safe staffing with
haemovigilance
appropriate training and knowledge
Digitisation, traceability and transfusion
Safe transfusion decision-making, safety (IBI, 2024)
PBM practices, avoiding unnecessary
Clinical audit should include transfusions, recording outcome of
patient satisfaction and concern transfusions

Safety as the Consent, shared decision-making,

Meeting needs for patients main guiding empowering the patient voice,
with sickle cell disease and getting answers when things go
thalassaemia principle wrong; feedback loops in place

Transparency, duty of candour,

Laboratory safety
leadership accountability, breaking silos

Safety culture, raising concerns, owning Reporting to SHOT and the MHRA; implementing safety
up when things go wrong recommendations, report and act on NM, effective
incident investigations which are fit for purpose

MHRA=Medicines and Healthcare products Regulatory Agency; NM=near miss; PBM=patient blood management

The Inquiry report has put the spotlight on haemovigilance, acknowledging the importance and value of
reporting and learning from incidents and implementing SHOT recommendations to improve transfusion
safety. Recommendation 7e states:

7 (e) That all NHS organisations across the UK have a mechanism in place for implementing
recommendations of SHOT reports, which should be professionally mandated, and for monitoring
such implementation.

Partnering with patients to enhance safety

Giving patients a voice is one of the main messages from the IBI Report (IBI, 2024). Recommendation 10
focuses this and lists several measures for action.

Engaging patients, their families, and carers as ‘safety partners’ to co-create safer systems, identify, and
rectify preventable adverse events was one of the main recommendations in the 2021 Annual SHOT Report
(Narayan, et al., 2022). It is time to transform healthcare by elevating the patient’s voice to its rightful place
of importance – their voices hold the key to creating a healthcare system that is not only effective but also
compassionate and truly patient-centred. Shared decision-making should become the norm and patients
must be active partners in their care and in improving organisational safety. This begins with a commitment
to listen and to learn from those who experience care firsthand. Transparent and open communication is
the foundation of trust. Healthcare providers must embrace this recommendation, enhance communication
skills, understand the diverse backgrounds of their patients, and build stronger, meaningful relationships
with patients, carers and families with appropriate use of technology. Feedback mechanisms must be in
place to ensure the healthcare system evolves with the needs and insights of those it serves. By giving
patients a voice, we honour their experiences and insights, creating a healthcare system that is safer, more
effective, and profoundly more compassionate.

Several resources have been developed to support consent and shared decision-making for transfusion
(See ‘Recommended resources’). However, a recent 2023 national comparative audit of NICE Quality
Standard QS138 showed that only 475/1356 (35.0%) transfused patients had evidence of receiving both
written and verbal information about the risks, benefits, and alternatives to transfusion (compared to 26%
in the 2021 audit) (NHSBT, 2024; NICE, 2016). This highlights the need to urgently improve and implement
systems to ensure appropriate informed consent for transfusions and promote shared decision-making.

5. The Infected Blood Inquiry and Haemovigilance 39

 ANNUAL SHOT REPORT 2023

A new mobile application called ‘MyTransfusion’ is in development. This has been co-created with input
from patient representatives and transfusion experts and is expected to be released later this year and
aims to support the shared decision-making process.

TTI risk-reduction measures

The UK Blood Services are among the safest in in the world and several measures have been implemented
to minimise the risk of TTI. Improvements in the transfusion pathway including stringent donor selection,
arm cleaning, diversion of initial part of the donation, microbiological screening tests, optimal storage and
transport, quality-control processes and safe management of any suspected TTI cases have helped minimise
the risk of TTI in the UK blood supply. Several resources have been released recently capturing the safety
measures to ensure microbiological safety and trends in infections reported (See ‘Recommended resources’).

Conclusion
The recommendations from the IBI report are crucial for addressing the failures of the past and significantly
enhancing the safety and trustworthiness of healthcare systems. We must ensure effective implementation of
the recommendations to prevent similar incidents in the future. This begins with meaningful engagement and
partnering with patients, and ensuring that the healthcare system is transparent, accountable, and provides
high-quality care. The Report is not just a document but a call to action, urging all of us to reinforce our
commitment to safety which should be the main guiding principle for decision-making in healthcare. It provides
us with a clear roadmap for achieving excellence in transfusion safety and we should use the insights from
this report to drive impactful changes, promote innovation and foster a culture where safety is paramount.

Several safety initiatives across the UK in the last couple of decades have helped improve transfusion
safety (See ‘Recommended resources’). There, however, cannot be any complacency and the real work
lies ahead to address the increasing challenges we are facing in an NHS that is in crisis. A recent AOMRC
report states, ‘If we do not act with urgency, we risk permanently normalising the unacceptable standards
we now witness daily, to the detriment of us all’ (AOMRC, 2022). We must take action to prevent further
avoidable harm and make meaningful strides towards building a system that protects and promotes health
for everyone with engagement, collaboration with patients and rebuilding trust with continued vigilance.

Based on the emerging themes from serial Annual SHOT Reports and aligned with the IBI Report, tangible
actions are needed in all areas captured in the illustration below to truly improve transfusion safety in the UK.

Figure 5.2:
Fundamental
pillars enhance
transfusion safety Fundamental pillars for enhancing transfusion safety
in the UK
Public health messaging and addressing anaemia in the community

Staffing – Adequate Partnering with Safety culture - IT - supporting Strengthening

adequate knowledge and patients – just, learning, safe the blood donor
numbers of training of staff - improving restorative; implementation base and
appropriately technical and consent, making every and effective improving
skilled staff, non-technical shared experience count, use of reliable, ethnicity mix=
access to SME (HFE) to make decision-making holistic approach safe IT resilient, reliable
safe transfusion and giving with Safety-I and vein-to-vein, supply chain
decisions and patients a Safety-II, learning access to SME,
effective PBM voice from NM consideration of
practices HFE factors

Allocation of appropriate funding support for transfusion teams backed by

commitment from healthcare leaders to support adequately-resourced systems
Applicable to both clinical and laboratory transfusion teams
HFE=Human factors and ergonomics; IT=information technology; NM=near miss; PBM=patient blood management; SME=subject matter expert

40 5. The Infected Blood Inquiry and Haemovigilance

 ANNUAL SHOT REPORT 2023

The Thirlwall inquiry recently published a damning summary of progress made by the NHS and
government across 30 inquiries, including Mid-Staffordshire NHS Foundation Trust – dating back to
1967 (Thirlwall Inquiry, 2024). The analysis found that just 302 of more than 1,400 recommendations
had been adopted. We stand at a critical juncture, one where words must transform into actions and
promises must become reality. It is our collective responsibility to ensure the recommendations from
the Inquiry do not gather dust but are actively pursued and implemented. Let us honour the voice of all
the Infected and the Affected, their experiences should be catalysts for change.

Recommended resources
Statement from SHOT in response to the Infected Blood Inquiry Report
Statement from SHOT in response to the IBI report - Serious Hazards of Transfusion (shotuk.org)

Transfusion safety initiatives across the UK

Current Resources - Serious Hazards of Transfusion (shotuk.org)

Patient information page on the SHOT website

https://www.shotuk.org/patients/

Consent for transfusion – information for patients

Transfusion Information for Patients (transfusionguidelines.org)

Support available through the Inquiry from the British Red Cross
Psychological support provided by the Inquiry | Infected Blood Inquiry.

Managing the safety of the blood supply video

SHOT Videos - Serious Hazards of Transfusion (shotuk.org)

Infected Blood Inquiry website

Homepage | Infected Blood Inquiry

Transfusion-Transmitted Infections (TTI) Cumulative Data

Cumulative SHOT Data by Category - Serious Hazards of Transfusion (shotuk.org)

References
Academy of Medical Royal Colleges (AOMRC), 2022. Fixing the NHS - Why we must stop normalising the unacceptable,
London: Academy of Medical Royal Colleges. Available at: https://www.aomrc.org.uk/wp-content/uploads/2022/09/
Fixing_the_NHS_210922.pdf (Accessed 20 June 2024).

Infected Blood Inquiry (IBI), 2024. The Report HC 569-I , London: Crown. Available at: https://www.infectedbloodinquiry.
org.uk/reports/inquiry-report (Accessed 20 June 2024).

Narayan, S. et al., 2022. The 2021 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. doi: https://doi.org/10.57911/QZF9-XE84.

National Institute for Health and Care Excellence (NICE), 2016. Blood transfusion – Quality standard [QS138]. [Online]
Available at: https://www.nice.org.uk/guidance/qs138 (Accessed 20 June 2024).

National Health Service Blood and Transplant (NHSBT), 2024. 2023 National Comparative Audit of NICE Quality
Standard QS138. [Online] Available at: https://hospital.blood.co.uk/audits/national-comparative-audit/reports-grouped-
by-year/2023-national-comparative-audit-of-nice-quality-standard-qs138/ (Accessed 20 June 2024).

Thirlwall Inquiry, 2024. The Thirlwall Inquiry - Review of Implementation of Recommendations from Previous Inquiries into
Healthcare Issues prepared by the Thirlwall Inquiry Legal Team, UK: Crown. Available at: Table-of-Inquiries-Reviews-and-
Recommendations-made-and-whether-they-were-implemented.pdf (thirlwall.public-inquiry.uk) (Accessed 20 June 2024).

5. The Infected Blood Inquiry and Haemovigilance 41

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6 Acknowledging Continuing Excellence

in Transfusion (ACE) n=15

Author: Simon Carter-Graham

With contributions from: Members of the SHOT team and ACE WEG

Definition:
Exceptional transfusion practice by a team or department, that was above and beyond routine
practice and has widespread learning opportunities.

Abbreviations used in this chapter

ACE Acknowledging continuing HCA Healthcare assistant
excellence in transfusion Ig Immunoglobulin
BMS Biomedical scientist MDT Multi-disciplinary team
CT Computed tomography MH Major haemorrhage
DAT Direct antiglobulin test MOH Major obstetric haemorrhage
ED Emergency department OSHA Occupational Safety and Health Administration
GI Gastrointestinal PCC Prothrombin complex concentrates
GP General practitioner TACO Transfusion-associated circulatory overload
G&S Group and screen WBIT Wrong blood in tube
Hb Haemoglobin

Key SHOT messages

• It is encouraging to see an increase in the number of reports where organisations have shared
excellent practice and learning

• Key themes include positive process change, collaboration, and excellent communication
between teams

42 6. Acknowledging Continuing Excellence in Transfusion (ACE)

 ANNUAL SHOT REPORT 2023

Recommendations
• All healthcare organisations should embrace a Safety-II approach (learning from excellence and
day-to-day events) as a complement to Safety-I. It is necessary to analyse where and when
things go wrong, whilst proactively seeking to promote good practice by celebrating when things
go right and developing ways to support, augment and encourage this

• All healthcare organisations should regularly measure safety culture in clinical and laboratory
teams with appropriate improvement actions, provide education and resources to support an
effective safety culture based on a proactive approach to patient safety

Action: Senior management and leadership teams in all healthcare organisations

Introduction
SHOT ACE is an example of learning from excellence, emphasising studying successful outcomes or
practices to improve safety. It is about shifting the focus from solely analysing failures to understanding
what works well and replicating those strengths and behaviours. This approach promotes a more
positive and proactive learning culture. It is encouraging to see a steady increase in the number of
reports submitted to SHOT in this category.

In 2023 there were 15 reports accepted under a wide range of ACE sub-categories. As with previous
years, the cases reported reflect the continued commitment of healthcare staff who work tirelessly to
deliver safe and appropriate transfusions despite the challenges faced within healthcare settings.

This year’s ACE chapter captures the importance of acknowledging and celebrating excellence, with the
aim to encourage organisations to focus on the things that are going well rather than when things go
wrong. This approach offers an opportunity to learn from good transfusion practice and ultimately improve
patient care. Furthermore, it aims to highlight the importance of incorporating civility and safety indicators
in workplace processes as well as fostering and embedding a safety culture in everyday practice.

ACE cases 2023

Table 6.1 shows a summary of cases accepted under ACE in 2023 and the themes identified which
make the events noteworthy. Full case descriptions can be found in the supplementary information on
the SHOT website (https://www.shotuk.org/shot-reports/report-summary-and-supplement-2023/).

While the name of the category SHOT ACE suggests that it tends to identify extremely good (i.e.,
excellent) examples of work/practices, submitted reports are actually capturing everyday excellence;
examples of good communication, collaboration, and innovation to address patient-care issues or a
human approach resulting in a positive outcome, occurring in often difficult circumstances amidst staff
shortages, high workload and poor IT. The SHOT team would like to acknowledge the hard work,
dedication, and teamwork that transfusion staff in both clinical and laboratory areas demonstrate whilst
caring for patients despite all the challenges. This chapter is a celebration of these efforts.

6. Acknowledging Continuing Excellence in Transfusion (ACE) 43

 ANNUAL SHOT REPORT 2023

Table 6.1: Case

Summary ACE themes
Acknowledging number
continuing Transfusion practice - clinical
excellence (ACE) Collaboration
Major haemorrhage in ED. Excellent multidisciplinary communication.
case summaries 1* Communication
Rapid issue of PCC.
2023 (n=15) Patient focus
Collaboration
Major haemorrhage in theatres. Excellent multidisciplinary communication.
2 Communication
Porter supervisor and recovery nurse went above and beyond duty.
Patient focus
Nurse and HCA challenged a doctor who had not correctly identified a patient
Patient focus
3 when taking a pre-transfusion blood sample and had left the patient’s side with
Relatable education
the unlabelled sample.
Major haemorrhage patient dealt with by a team unfamiliar with this situation. Collaboration
4 Rapid action was taken on the low Hb result (41g/L). Whole team including porters Communication
and transfusion laboratory staff acted coherently and efficiently. Patient focus
Doctor completed a prompt review of a patient with TACO. Always provides very Collaboration
5 detailed clinical reviews and has an excellent awareness of transfusion adverse Communication
events thus ensuring prompt reporting to SHOT. Patient focus
Transfusion practice - laboratory
Excellent communication and collaboration during two extremely challenging major Communication
6* trauma cases. Anaesthetists and surgeons made sure all involved staff were thanked Collaboration
for the fantastic job they did. Patient focus
The clinical team stated the biomedical staff did exceptionally well and assisted Communication
7 with great communication throughout a MOH and issued blood products in a timely Collaboration
manner under difficult circumstances. Patient focus
Fetal bleed detected in patient's G&S sample as part of a pre-delivery screen. BMS Communication
8 showed superior knowledge in advising clinicians. Mother was given the appropriate Collaboration
dose of anti-D Ig. Patient focus
BMS identified WBIT based on the patient's haematocrit for a patient who had not Communication
9 previously had a G&S sample sent. This prevented the incorrect samples from being Collaboration
processed and an incorrect blood group being recorded in the patient's file. Patient focus
Teamwork and collaboration
Innovation
New process in place to ensure patients have their transfusion specific requirements
Collaboration
10* assessed and managed with any requirements being communicated to the MDT, the
Positive change
patient, and their GP being informed and involved in the process.
Patient focus
BMS staff suggested and designed a form to aid carrying out the process of
Innovation
phenotyping for multiple red cell antigens involving the use of multiple anti-sera
Collaboration
11 reagents with different techniques and incubation requirements. Previously only
Positive change
detailed individually by referral to the manufacturer's product information sheet for
Patient focus
each anti-sera.

MDT work within the hospital and Blood Service to crossmatch for a patient
Collaboration
experiencing a haemorrhage. The antibody screen had proved positive and the group
12 Patient focus
was inconclusive and DAT positive. Due to the complex result a total of 28 units were
Communication
crossmatched in order to obtain compatible units.

Two MH occurred around 19:30. On top of these two further code reds were
called in shortly afterwards. The laboratory team worked extremely well together Collaboration
13 demonstrating exceptional practice and excellent communication skills. Two Patient focus
members of staff went above and beyond by staying an extra 2 hours after a 12-hour Communication
shift to help their colleagues.

Pregnant patient with pancytopenia (36+4/40). The patient had markedly low B12 and
Collaboration
folate levels and required an emergency caesarean section overnight and multiple
14 Patient focus
blood components. The BMS was lone working at the time of delivery. It was an
Communication
exceptional example of truly multidisciplinary teamwork.

A specific protocol was developed for authorisation of PCC where intracranial

Innovation
haemorrhage has been confirmed on CT or life-threatening GI bleed has been
Collaboration
identified and 1000IU of PCC can be administered immediately allowing time to
15* Positive change
discuss further PCC requirement with the consultant haematologist. Audit results
Patient focus
identified that 67% patients now receive PCC within 1 hour of the decision being
Relatable education
made.
*Please see the supplementary information on the SHOT website for a detailed discussion of these cases (https://www.shotuk.org/shot-
reports/report-summary-and-supplement-2023/)

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 ANNUAL SHOT REPORT 2023

Communication and civility

Excellent communication was noted between the clinical area and the transfusion laboratory in several of
the ACE cases, especially in MH situations where effective communication is vital to ensure co-ordinated
care for transfusion safety. In several incidents the staff involved were commended for their skills and
commitment to patient safety. In these incidents it is clear that civility played a part. In very stressful
situations, the language and tone of what is said between colleagues is very important as incivility can
adversely impact patient care and safety. Civility is often regarded as kindness and a sense of security.
When this is lacking, safety may be compromised resulting in a negative clinical impact for patients (Porath
& Pearson, 2013). In 1 case, a healthcare professional challenged the unsafe practice of a colleague,
preventing a potential error. This shows that difficult conversations can be had with positive outcomes.

Figure 6.1: What

is psychological
safety at work?
How leaders
can build
psychologically
safe workplaces

Reproduced with permission from by the Center for Creative Leadership, Originally published in ‘What Is Psychological Safety at Work? How
Leaders Can Build Psychologically Safe Workplaces’

To ensure psychological safety for all staff, leaders need to show compassionate leadership and
understand the experiences and needs of their workforce. There is clear evidence that compassionate
leadership results in more engaged and motivated staff with high levels of wellbeing, which in turn results
in high quality care (West, 2021). Civility in the workplace and psychological safety is discussed in more
detail in the ACE chapter of the 2021 Annual SHOT Report (Narayan, et al., 2022).

Positive procedural changes

In 3 cases, changes were made to recognised protocols such as the way PCC use was standardised
and made more efficient.

In 1 case, the process for ensuring patient’s specific transfusion requirements were met was improved.
Updates were made to ensure the appropriate training was given to the relevant staff.

Safety indicators in healthcare: leading/lagging indicators

Safety indicators in healthcare encompass a wide range of measures that assess various aspects of
patient care, organisation processes and factors impacting safety. Leading indicators are proactive,

6. Acknowledging Continuing Excellence in Transfusion (ACE) 45

 ANNUAL SHOT REPORT 2023

preventative, and predictive measures that provide clues to future incidents. They also offer evidence
on the effectiveness of a safety management system. Preventative actions can then be undertaken
before an error or incident occurs. According to OSHA (2019) ‘Whilst lagging indicators can alert you
to an error or to the existence of a hazard, leading indicators are important because they can tell you
whether activities are effective at preventing incidents’. Some examples of leading indicators include
near miss reporting rates, safety culture surveys, equipment maintenance schedules, while incident rates
and patient outcomes are lagging indicators. By utilising both leading and lagging indicators, healthcare
organisations can implement a balanced approach to safety management focusing on both proactive
prevention and reactive response to optimise patient care and staff wellbeing. Figures 6.2 and 6.3 show
the key differences between the lagging and leading indicators for safety.

Figure 6.2: Lagging

versus leading
indicators
Lagging indicators: Leading indicators
• Are typically outcome oriented Influences future performance
• Easy to measure, but difficult to Includes: Staff turnover rate, safety
improve or influence training, inspections, audits, staff
• Measure failure perception and safety culture surveys,
equipment maintenance schedules, real
time patient feedback, HFE improvement
opportunities identified and corrected

Incident

Lagging indicators
Analyses past performance Leading indicators:
Includes: Incident rates, patient • Are proactive and predictive
outcomes, patient surveys, near • Typically, future input oriented
miss incidents, injuries recorded, • More difficult to measure but
lost workdays easier to influence
• Leading indicators help plan and
implement improvements actions

Figure 6.3: Safety

performance
indicators and
the Swiss cheese Lagging indicators
model Respond to detection
of holes

Leading indicators
Test the integrity of controls

HARM

Source: https://risktec.tuv.com/knowledge-bank/measuring-safety-safety-related-key-performance-indicators/, The ‘Swiss cheese model’

of accident causation was originally proposed by James Reason focussing on the systemic failures of safeguard and barriers that can result
in patient harm

Further information on this can be found in the supplementary information on the SHOT website
(https://www.shotuk.org/shot-reports/report-summary-and-supplement-2023/).

46 6. Acknowledging Continuing Excellence in Transfusion (ACE)

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Safety culture
Building a strong safety culture is essential in reducing transfusion errors, improving patient outcomes,
and promoting a positive work environment for healthcare professionals. Regular measurement of safety
culture in healthcare is essential for fostering a culture of continuous improvement, enhancing patient
safety, and maintaining organisational effectiveness. Any concerning signals from safety culture surveys
(SHOT, 2024) require prompt urgent, proactive action to address identified issues, prevent harm, engage
stakeholders, and enhance safety for all patients, blood donors and staff.

A strong, just, no-blame, learning safety culture promotes open communication, teamwork, continuous
improvement, and a focus on learning from experiences to enhance patient care and outcomes (See
'Recommended resources' at the end of the chapter). Figure 6.4 outlines tangible ideas to improve
safety culture.

Figure 6.4: How

Changing culture in the workplace is neither quick nor easy. It takes effort, commitment changing safety
and time. Start with small steps and grow at the right pace for the team culture in the
workplace can
Compassion leadership training; improve transfusion
Small group sessions to increase
open discussion about assumptions
awareness on civility saves lives safety
and bias

Promotion of resources from civility

Team building events and work
saves lives (eg. videos, podcasts,
social events
books)

Regular ‘informal coffee mornings’

or ‘lunch and learn’ sessions on Instigating 1:1 meetings between
civility, workforce policies and line managers and staff members
related topics

Include ‘360’ element in

performance reviews for managers Include regular ‘thanks and gratitude
(e.g. feedback from those managed circles’ within team huddles
as well as line manager)

For information about the 2023 UK-wide transfusion laboratories safety culture survey please see
'Recommended resources'.

Conclusion
Widespread learning from excellence is important for all organisations as it allows individuals and teams
to understand what works well and replicate those successes. By analysing and recognising excellence,
we can identify best practices, develop strategies for improvement and foster a culture of continuous
learning and growth. This approach helps to reinforce positive behaviours and achievements, leading to
greater staff engagement, efficiency, innovation, and overall success. Additionally, celebrating excellence
can boost morale and motivation within teams, creating a supportive and positive work environment.
Promoting a learning culture where staff learn from day-to-day events enhances resilience, provides
valuable insights, allows adaptation, and supports a growth mindset. Staff should receive training to be
able to use tools to support learning from day-to-day events and excellence, thereby paving the way
for a holistic approach to safety.

While more teams and organisations are adopting learning from excellence, it is important to recognise
the impact of system changes on patients and staff involved. Feedback loops must be in place to ensure
the impact of these changes are captured and acted upon promptly.

6. Acknowledging Continuing Excellence in Transfusion (ACE) 47

 ANNUAL SHOT REPORT 2023

Recommended resources
ACE reporting – SHOT Definitions and ACE Examples
https://www.shotuk.org/reporting/ace-reporting/

SHOT Bite No. 23: Civility in Healthcare (2023)

SHOT Bite No. 24: Speaking up for safety (2023)
SHOT Bite No. 26: Acknowledging Continuing Excellence (ACE) (2023)
https://www.shotuk.org/resources/current-resources/shot-bites/

Learning from Excellence

https://learningfromexcellence.com/

NHS Innovation Service

https://innovation.nhs.uk/innovation-guides/

Life Sciences Hub, Wales

https://lshubwales.com/

InnoScot health
https://innoscot.com/

Civility in the workplace

https://www.civilitysaveslives.com/

References
Narayan, S. et al., 2022. The 2021 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. doi: https://doi.org/10.57911/QZF9-XE84.

Occupational Safety and Health Administration (OSHA), 2019. Using Leading Indicators to Improve Safety and Health
Outcomes [Online], s.l.: OSHA. Available at: https://www.osha.gov/sites/default/files/publications/OSHA_Leading_
Indicators.pdf (Accessed 11 April 2024).

Porath, C. & Pearson, C., 2013. The price of incivility. Harvard Business Review, 91(1-2), pp. 114-121. Available at:
https://hbr.org/2013/01/the-price-of-incivility (Accessed 16 May 2024).

Serious Hazards of Transfusion (SHOT), 2024. UKTLC. [Online] Available at: https://www.shotuk.org/resources/current-
resources/uktlc/ (Accessed 02 May 2024).

West, M., 2021. Compassionate Leadership: Sustaining Wisdom, Humanity and Presence in Health and Social Care.
s.l.:The Swirling Leaf Press. Available at: https://swirlingleafpress.com/compassionate-leadership/ (Accessed 08 May
2024).

48 6. Acknowledging Continuing Excellence in Transfusion (ACE)

 ANNUAL SHOT REPORT 2023

Donor Haemovigilance 7
Main authors: Dr Jayne Hughes, Specialty Doctor, SNBTS and Dr Champa
Manchanayake, Specialty Doctor, SNBTS
With contributions from the Donor haemovigilance chapter writing group comprising:
Dr Shruthi Narayan, SHOT Medical Director and Consultant Donor Medicine, NHSBT
Dr Liezl Gaum, Specialty Doctor, NHSBT
Jessica Ryan, Senior Nurse Practitioner, Clinical Support Team, NHSBT
Julie Curry, Training Advanced Practitioner in Donor Care, WBS
Dr Hasarika Dodampegamage, Specialty Doctor, WBS
Dr Kathryn Maguire, Consultant in Transfusion Medicine, NIBTS
Dr Asma Sadiq, Specialty Doctor, NIBTS

Definition:
Donor haemovigilance: the systematic monitoring of adverse reactions and incidents in the
whole chain of blood donor care, with a view to improving quality and safety for blood donors.

Serious adverse reaction: An unintended response in a donor or in a patient associated with the
collection or transfusion of blood or blood components that is fatal, life threatening, disabling,
incapacitating, or which results in, or prolongs, hospitalisation or morbidity (according to Article
3 (h) of Directive 2002/98/EC).

Abbreviations used in this chapter

AABB Association for the Advancement of NHSBT National Health Service Blood and Transplant
Blood & Biotherapies NIBTS Northern Ireland Blood Transfusion Service
DV Delayed vasovagal reaction PfM Plasma for Medicine
EBA European Blood Alliance PLT Platelets
GP General practitioner SAED Serious adverse event of donation
ISBT International Society of Blood Transfusion SDC Serious donor complication
IHN International Haemovigilance Network SNBTS Scottish National Blood Transfusion Service
JPAC Joint United Kingdom (UK) Blood Transfusion UK United Kingdom
and Tissue Transplantation Services WBS Welsh Blood Service
Professional Advisory Committee
MHRA Medicines and Healthcare products
Regulatory Agency

Recommendations
• All UK Blood Services should work collaboratively to ensure best practice in the prevention
and management of donor adverse events is developed and shared. Measures such as the
implementation of the severity grading tool and the development of standard questions for donor
adverse event follow up will facilitate this aim

• Effective donor education has a key role in reducing the frequency and severity of adverse events.
All donors should be educated to speak up if they feel unwell or experience arm symptoms
during and after donation

7. Donor Haemovigilance 49
 ANNUAL SHOT REPORT 2023

• Staff dealing with blood donors should have adequate knowledge about potential complications
and be able to identify and manage them promptly on session

Action: All staff involved in care and management of blood donors

Introduction
Blood donation in the UK is a voluntary non-remunerated act that is essential to support patient care
across all disciplines. Although generally safe, complications do sometimes occur. Appropriate donor care
includes giving donors information about the material risks of blood donation, implementing measures
to minimise those risks, and providing appropriate clinical management for any adverse reactions which
occur.

Serious adverse events of donation

SAED are complications or events where a donor experiences serious harm, or very rarely, result in
donor death. The ten SAED categories are listed in Table 7.2. SAED are also given an imputability score,
as follows:

3. Definite or certain link to donation

2. Probable or likely link to donation

1. Possible link to donation

0a. Link to donation unlikely

0b. Link to donation excluded

Data from 2023

UK donations
A total of 1,808,690 donations were collected by the four UK Blood Services in 2023 (Table 7.1). As
well as whole blood and component donations, this includes 24,104 plasma donations collected by
NHSBT for the manufacture of medicinal products.

50 7. Donor Haemovigilance
 ANNUAL SHOT REPORT 2023

Table 7.1:
Donations from 2023 NHSBT SNBTS WBS NIBTS UK
Cumulative
Donations from
738,706 69,392 38,193 21,638 867,929 donation data from
male donors
Donations from the four UK Blood
698,272 78,797 40,606 21,004 838,679
female donors Services in 2023
Donations from (n=1,808,690)
Whole blood 171,635 7,892 6,020 3,207 188,754
new donors
Donations from
1,265,343 140,297 72,779 39,435 1,517,854
repeat donors
Total whole
1,436,978 148,189 78,799 42,642 1,706,608
blood donations
Donations from PLT 58,541 6,293 2,061 3,189
86,470
male donors PfM 16,386
Donations from PLT 6,805 328 384 377
15,612
female donors PfM 7,718
Donations from PLT 8,807 0 85 0
Apheresis 18,766
new donors PfM 9,874
Donations from PLT 56,539 6,621 2,360 3,566
83,316
repeat donors PfM 14,230

Total apheresis PLT 65,346 6,621 2,445 3,566

102,082
donations PfM 24,104

Total number of donations in 2023 1,526,428 154,810 81,244 46,208 1,808,690

NHSBT=National Health Service Blood and Transplant; SNBTS=Scottish National Blood Transfusion Service; WBS=Welsh Blood Service;
NIBTS=Northern Ireland Blood Transfusion Service; UK=United Kingdom; PfM=Plasma for Medicine; PLT=platelets

Table 7.2 summarises the number of SAED by category for all four UK Blood Services combined for the
period January 2023 to December 2023.

2023 2022 Table 7.2:

SAED category SAED by category
NHSBT 1
SNBTS WBS NIBTS UK UK
in 2023 (All SAED
01 Death within seven days of donation 0 0 0 0 0 2
included here
02 Hospital admission within 24 hours of donation 2 0 1 0 3 11 irrespective of
03 Injury resulting in a fracture within 24 hours of 2 imputability)
7 (includes (includes 2 0 0 9 8
donation (including fractured teeth) 4 with DV2)
with DV2)

04 Road traffic collision within 24 hours of donations 0 0 0 0 0 4

05a Problems relating to needle insertion persisting for
more than one year (this mainly includes suspected or 23 7 3 1 34 24
confirmed nerve and tendon injuries)
05b Problems relating to needle insertion requiring
hospitalisation/intervention (this mainly includes vascular 0 0 0 0 0 0
complications)
06 Acute coronary syndrome diagnosed
2 0 0 0 2 5
within 24 hours of donation
07 Anaphylaxis (component donation) 1 0 0 0 1 0
08 Haemolysis (component donation) 0 0 0 0 0 0
09 Air embolism (component donation) 1 0 0 0 1 0
10. Other event related to donation resulting in:
• Hospital admission,
• Intervention, or 3 0 0 0 3 1
• Disability or incapacity lasting more than one year and
not included above
Total reported SAED 39 9 4 1 53 55
1 Data includes 3 imputability 0a SAED (1x category 02 Hospital admission; 2x category 06 Acute coronary syndrome), all reported by NHSBT
2 DV: delayed vasovagal reaction – i.e., a vasovagal reaction occurring after the donor has left the donation session
NHSBT=National Health Service Blood and Transplant; SNBTS=Scottish National Blood Transfusion Service; WBS=Welsh Blood Service;
NIBTS=Northern Ireland Blood Transfusion Service; UK=United Kingdom; SAED=serious adverse events of donation

7. Donor Haemovigilance 51
 ANNUAL SHOT REPORT 2023

As in 2022, problems related to venepuncture lasting more than one year (category 05a) account
for the majority of SAED and are typically due to nerve injury, although 2 cases from NHSBT were
suspected to be tendon injuries. Arm pain events have increased in 2023, but the reasons behind this
are not clear. Improved awareness and reporting may be a factor. It should be noted, that of the 34
cases reported, 25 donors developed symptoms (pain or paraesthesia) immediately at venepuncture
but only 13 informed session staff at the time. In 10 of these cases, the needle was withdrawn, but in
3 cases donation continued. Further details about the category 05a SAED are given in the data tables
in the supplementary information on the SHOT website (https://www.shotuk.org/shot-reports/report-
summary-and-supplement-2023/).

Learning point
• Donors must be encouraged to speak up if they experience pain or paraesthesia at the time of
venepuncture. Donation should be stopped, and the needle carefully withdrawn if the donor has
immediate symptoms suggestive of nerve or tendon injury

Table 7.3 summarises the total number of donations and SAED reported for each of the four UK Blood
Services in 2023. The rate of SAED was 0.29 per 10,000 donations, irrespective of imputability, or 0.28
per 10,000 donations excluding imputability scores of 0a or 0b.
Table 7.3: Summary NHSBT SNBTS WBS NIBTS
of total donations
Total donations (whole blood and apheresis) 1,526,428 154,810 81,244 46,208
for the four UK
Total number of SAED in the calendar year
Blood Services and 39 9 4 1
2023
total numbers of
Total number of SAED excluding those
SAED for 2023 scored with an imputability of ‘unlikely’ or 36 9 4 1
‘not related to blood donation’
Rate of total SAED per 10,000 donations
in UK for 2023 (all submitted reports 0.29
irrespective of imputability)
Rate of SAED per 10,000 donations
in UK for 2023 excluding those with
0.28
imputability of ‘unlikely’ or ‘not related
to donation

Comparison of trends with previous years

The four UK Blood Services have produced an annual summary report to SHOT of SAED recorded
since 2015.

52 7. Donor Haemovigilance
 ANNUAL SHOT REPORT 2023

Figure 7.1: Rate of

Total donations SAED reported per

10,000 donations in
Rate of SAED reported per 10,000 donations
the UK 2015-2023
Rate of SAED reported per 10,000 donations excluding imputability of 'unlikely' or 'not' related to donation

2,200,000 0.35
2,126,808
0.30
2,100,000 0.29 0.30
0.28
0.26 0.26 0.28
2,004,650
2,000,000 0.23 0.23 0.23 0.25
0.24
1,913,650 0.21
1,900,000 1,883,153 0.19 0.20
0.21
0.20 1,841,660 1,822,689 1,816,191
1,808,690
1,800,000 0.15
1,742,217

1,700,000 0.10

1,600,000 0.05

1,500,000 0.00
2015 2016 2017 2018 2019 2020 2021 2022 2023

SAED=serious adverse event of donation; UK=United Kingdom

Overall SAED rates are unchanged from 2022, but this masks a rise in rates for SAED with imputability
1-3 to 0.28 per 10,000 donations (from 0.24 per 10,000 donations in 2022). This rise may reflect
better reporting, but other factors should be considered, and appropriate actions taken to reduce the
frequency and severity of donor adverse events. Areas to address include donor education, staff training,
monitoring of donor adverse events, regular audits with improvements to the session environment and
procedures. Shared learning across the four UK Blood Services promotes adoption of best practices
and facilitates improvements.

Implementation of donor adverse event severity grading

The UK Blood Services have agreed to implement the validated donor severity grading criteria developed
by the AABB Donor Haemovigilance Working Group and endorsed by ISBT, IHN and EBA (Townsend,
et al., 2020). Donor adverse events will be recorded according to the new grading criteria which rate
severity of donor adverse events by grades 1-5, with 1 through 5 being associated with mild, moderate,
severe, life-threatening and death. Any event of grade 3 or above will be reported as a SDC. Once
implemented by all the Blood Services, the reporting of SDC will replace the previous SAED categories.
It is anticipated that the new grading system will result in more SDC being reported and recorded than
in previous years.

Individual UK Blood Services are implementing severity grading over different timescales. During this
transition period, services may record either SDC or SAED. It is hoped that by 2025, the new system
will be fully implemented across the UK.

Plasma for Medicine project

Since April 2021, NHSBT has been collecting both sourced and recovered plasma for the purpose of
manufacturing PfM. In October 2020, a comprehensive review of the evidence to reassess the safety
of UK plasma to manufacture plasma-derived medicinal products was undertaken, and the results
presented to the Commission on Human Medicines (MHRA, 2021). In April 2021, under the advisement
of the MHRA, the Government directed NHSBT to recommence the collection of plasma, to produce
lifesaving medicines, for the benefit of UK patients. Based on the scientific review, blood regulators
and operators have been urged to take account of the safety profile when considering fractionation

7. Donor Haemovigilance 53
 ANNUAL SHOT REPORT 2023

of UK plasma, and to revise their guidelines on the deferral of donors who have lived in, or received a
transfusion in, the United Kingdom (Thomas, et al., 2023).

As with whole blood donations, PfM is an invasive procedure that can result in donor adverse events, and
therefore, as for other blood donations, requires careful monitoring and management of donors during
their donation. Adverse events related to donors feeling faint or losing consciousness are consistently
reported at 1.4%. This is similar to rates seen in whole blood donors. Bruising is the most common
adverse event in plasma donors and rates are higher than in either whole blood or apheresis platelet
donors (5.0% in PfM donors vs 0.9% whole blood and 2.5% platelet). Further details and relevant
graphs can be accessed in the supplementary information on the SHOT website (https://www.shotuk.
org/shot-reports/report-summary-and-supplement-2023/).

Illustrative case
Case 7.1: Venepuncture-related pain and paraesthesia but no abnormalities on
electromyography or nerve conduction studies

A regular male whole blood donor, who had donated fifteen times previously, reported persistent
problems with his donation arm when he returned to donate five months later. The donor remembered
experiencing a sharp pain at the time of needle insertion but this improved during the donation
process and this was not reported to staff. A full donation was taken. Post donation, minor bruising in
the right antecubital fossa and the medial aspect of right forearm was experienced. Since donation,
the donor described having a painful cramp and tingling sensation when holding a phone to his ear
for long periods or when lifting weights. The donation arm was painful with elbow flexion but not
at rest. He occasionally woke in the mornings with discomfort in his arm if his hand or elbow came
under his weight. There was no loss of power or coordination, no swelling, or lump.

The donor was subsequently assessed by his GP for numbness in his right thumb/thenar eminence
and pain on elbow flexion against resistance. He was seen by a consultant neurologist and a clinical
neurophysiologist, 10 months after donation. Neurological examination, electromyography and nerve
conduction studies were all normal. He also had a normal magnetic resonance imaging scan of his
right forearm. The donor has been withdrawn from future blood donations.

Venepuncture-related arm problems do occur and can have debilitating long-term effects due to ongoing
pain and restricted function. Needle-related complications include haematoma, arterial puncture, and
painful arm, which may result from nerve irritation through a haematoma or from direct injury to a nerve
or other structure (Working Group on Donor Vigilance of the ISBT Working Party on Haemovigilance,
2014). Peripheral nerve injuries are defined by a persistent burning, shooting, electrical-type pain or
paraesthesia in a specific nerve distribution, which begins immediately while the needle is in situ, or can
be delayed for several hours thereafter. Published evidence suggests that 30–70 donors per 100,000
donations will develop a nerve injury (Newman, 2013; Sorensen, et al., 2008). Of these around 5 per
100,000 may develop long-term symptoms.

Donation staff must be aware of these possible complications and advise donors accordingly during
acquisition of informed consent. Some donors may be reluctant to report any venepuncture-related
pain or discomfort. It is therefore important that staff check with the donor if they have any of these
symptoms, as the needle should be removed immediately to minimise the risks of any long-term injury.
Guidance for the management of donors who do sustain a possible nerve injury is available on the JPAC
website (See 'Recommended resources' at the end of this chapter).

This donor had several investigations, all of which were normal. There is some evidence that nerve
injury can still be present despite normal nerve conduction studies. A recent study by Kang et al. (2023)
focused on the limitations of electrophysiological tests as diagnostic tools. Individuals for whom normal
data were obtained in the nerve conduction studies were eventually diagnosed with nerve swelling on
ultrasonography. These false-negative results imply that electrophysiological tests cannot be used as
an independent method for diagnosing or determining the clinical severity of venepuncture-related
nerve injuries. Assessment of clinical symptoms alongside knowledge of cutaneous nerve distribution

54 7. Donor Haemovigilance
 ANNUAL SHOT REPORT 2023

provides significant indicators for inferring nerve damage. In cases where electrophysiological tests are
normal, ultrasonography may reveal morphological damage to the corresponding nerves and should
be considered.

Conclusion
While blood donation is generally very safe, donor complications sometimes occur either during or
after blood donation. Most of these are non-severe and resolve promptly but are still unpleasant for
the donor. SAED occur infrequently and may result in long-term or permanent disability or injury to the
donor. Preventing these adverse events must be a priority and when donor complications do occur,
they should be managed promptly and appropriately. Continuing donor haemovigilance and embedding
lessons learnt from surveillance helps improve quality and safety for all blood donors.

Blood Services should encourage donors to make early contact with the clinical team if they experience
any complications so that they can be appropriately investigated and managed. Post-donation information
must be provided to all donors. This should include the risk of delayed reactions, when to seek medical
advice and guidance on prevention. Understanding these complications and predisposing risk factors
will help lead to the development of appropriate interventions to reduce their likelihood, as well as better
donor selection criteria to ensure donor safety.

Recommended resource
Post donation management of blood donors with nerve injury related to donation
Post-donation management of blood donors with nerve injury related to donation V2.pdf
(transfusionguidelines.org)

References
Kang, M. S. et al., 2023. Clinical, Electrophysiological, and Sonographic Findings in Patients With Nerve Injury After
Vessel Puncture. Journal of Clinical Neurology, 19(4), pp. 371-375. doi: 10.3988/jcn.2022.0285.

Medicines and Healthcare products Regulatory Agency (MHRA), 2021. Critical risk assessment report: use of UK
plasma for the manufacture of immunoglobulins and vCJD risk. [Online] Available at: https://www.gov.uk/government/
publications/critical-risk-assessment-report-use-of-uk-plasma-for-the-manufacture-of-immunoglobulins-and-vcjd-risk/
critical-risk-assessment-report-use-of-uk-plasma-for-the-manufacture-of-immunoglobulins-and-vcjd-risk (Accessed 25
April 2024).

Newman, B., 2013. Arm Complications After Manual Whole Blood Donation and Their Impact. Transfusion Medicine
Reviews, 27(1), pp. 44-49. doi: https://doi.org/10.1016/j.tmrv.2012.05.002.

Sorensen, B. S., Johnsen, S. P. & Jorgensen, J., 2008. Complications related to blood donation: a population-based
study. Vox Sanguinis, 94(2), pp. 132-137. https://doi.org/10.1111/j.1423-0410.2007.01000.x.

Thomas, S. et al., 2023. Safety profile of plasma for fractionation donated in the United Kingdom, with respect to variant
Creutzfeldt–Jakob disease. Vox Sanguinis, 118(5), pp. 341-413. doi: https://doi.org/10.1111/vox.13416.

Townsend, M. et al., 2020. Development and validation of donor adverse reaction severity grading tool: enhancing
objective grade assignment to donor adverse events. Transfusion, 60(6), pp. 1231-1242. https://doi.org/10.1111/
trf.15830.

Working Group on Donor Vigilance of the International Society of Blood Transfusion (ISBT) Working Party on
Haemovigilance, 2014. Standards for Standard for Surveillance of Complications Related to Blood Donation, s.l.:
Association for the Advancement of Blood & Biotherapies (aabb).

7. Donor Haemovigilance 55
 Serious adverse events following blood donation reported to the
Serious Adverse Events following Blood Donation reported
UK Blood Services in 2023
to the UK Blood Services in 2023
In 2023 the UK Blood Services collected approximately 1.8 million donations
(whole blood and apheresis); this includes plasma collected for fractionation at
NHSBT. Fifty-three serious adverse events of donation (SAED) have been
reported last year and includes all categories of imputability; this equates to a
rate of 0.29 per 10,000 donations, or 1 in 34,126 donations. Of the 53 cases
reported, 3 were not related to blood donation. The remaining 50 cases are
described below. Serious adverse events are very rare but do occur and can
have a significant impact on donor health and donor retention. UKBTS are
planning implementation of the internationally validated donor adverse
events severity grading criteria over the next year.

Breakdown of serious adverse events in 2023

SAED categories

12%
Excluding SAED with an imputability of 0a and 0b 6/50 SAED were as a direct
result of a delayed vasovagal
Other, reaction.
3 Hospital admission, 2
Anaphylaxis, 1
Fracture, 9
34/50 SAED reported were
Air

68%
embolism, related to persistent arm
Arm 1 problems more than one year
problems post donation.
>12/12 All were whole blood donors.
post
donation,
34
47/50 donors were withdrawn from future donations.
3 donors were not withdrawn. This includes 2 donors
with arm pain who were allowed to return if donating
SAED were seen in both female from their other arm.
(30/50, 60%) and male donors
(20/50, 40%). 3/50 SAED were in component donors (1 platelets, 2
3 SAED were reported in first time plasma for medicine). The rate of apheresis SAED is 1 in
donors, all of these being whole 34,027 donations, similar to the overall SAED rate.
blood donors.

6/9 fractures were

related to delayed Key messages
vasovagal
reactions. Female Blood Services must ensure
donors accounted that blood donors are
for all of these aware of any ‘material Effective donor education
cases. None were risks’ involved in donating has a key role in reducing
first time donors. blood and the measures the frequency and severity
that need to be taken to of adverse events.
reduce risk of these
There were no complications.
reports of any
deaths or road Whole blood and component donation is safe but
traffic collisions, or complications do sometimes occur. The overall incidence of
haemolysis due to SAED remains low. The rate of SAED in UK for 2023 is 0.28 per
component 10,000 donations taking into account the SAED where blood
donation, reported donation was deemed to have potentially contributed to the
in 2023. donor adverse event.

56 7. Donor Haemovigilance
 ANNUAL SHOT REPORT 2023

ERROR
REPORTS:
Human Factors

Chapter Page
ERROR REPORTS
8 Human Factors and Ergonomics in SHOT Error Incidents............................... Alison Watt and Emma Milser 58
9 Adverse Events Related to Anti-D Immunoglobulin (Ig)............... Jennifer Davies, Simon Carter-Graham and 65
Vera Rosa
10 Incorrect Blood Component Transfused (IBCT)... Simon Carter-Graham, Nicola Swarbrick and Victoria Tuckley 71
11 Handling and Storage Errors (HSE).......................... Heather Clarke, Nicola Swarbrick and Victoria Tuckley 86
12 Avoidable, Delayed or Under or Overtransfusion (ADU) and Incidents Related to Prothrombin Complex 91
Concentrates (PCC) ................................... Paula Bolton-Maggs, Simon Carter-Graham, Catherine Booth
and Josephine McCullagh
a. Delayed Transfusions 94
b. Avoidable Transfusions 100
c. Under or Overtransfusion 105
d. Incidents Related to Prothrombin Complex Concentrates 109
ERROR REPORTS WITH NO HARM
13 Near Miss (NM) Reporting ............................................................................................................... Vera Rosa 112
a. Wrong Blood in Tube (WBIT) .........Paula Bolton-Maggs, April Molloy, Vera Rosa and Simon Carter-Graham 116
14 Right Blood Right Patient (RBRP) ............................. Caryn Hughes, Nicola Swarbrick and Victoria Tuckley 123
ERROR REPORTS COMPOSITE CHAPTERS
15 Laboratory Errors ................................ Victoria Tuckley, Nicola Swarbrick, Peter Baker and Heather Clarke 130
16 Errors Related to Information Technology (IT).......................................... Jennifer Davies and Megan Rowley 143

57
 ANNUAL SHOT REPORT 2023 ERROR REPORTS

8 Human Factors and Ergonomics in

SHOT Error Incidents n=3184

Authors: Emma Milser and Alison Watt

Definition:
Human factors and ergonomics is the scientific discipline concerned with the understanding of
interactions among humans and other elements of a system.

Abbreviations used in this chapter

CAPA Corrective and preventative actions NHSE NHS England
HFE Human factors and ergonomics PSIRF Patient Safety Incident Response Framework
HFIT Human factors investigation tool RCA Root cause analysis
HR Human resources UKTLC United Kingdom Transfusion Laboratory
IT Information technology Collaborative
MHRA Medicines and Healthcare products WBIT Wrong blood in tube
Regulatory Agency YCFF Yorkshire Contributory Factors Framework
NHS National Health Service

Key SHOT messages

• It is encouraging to see a continued rise in the use of HFE frameworks for incident investigations
and consideration of systemic contributory factors

• Within a restorative just culture, staff undertaking reflection as an action from investigations may
limit learning and can be perceived as punitive

• Long-term actions to reduce risk (e.g., IT solutions, improved staffing) should continue to be
considered with improvement plans in place even if they cannot be readily resolved

Recommendation
• Healthcare organisations should introduce and promote a restorative just culture, with buy-in from
leadership at all levels. This shifts the focus from blaming staff to wider organisational learning,
with the objective of repairing trust and relationships damaged after an incident

Action: Hospital senior management

58 8. Human Factors and Ergonomics in SHOT Error Incidents

ERROR REPORTS ANNUAL SHOT REPORT 2023

Introduction
A good, learning, just safety culture in healthcare is vital to ensure patient and staff safety. It values
transparency, encourages reporting of errors or near misses and prioritises staff training and support
to prevent harm to patients. Just culture within many organisations remains retributive, organised
around rules, policies and violations, thus becoming a blunt HR instrument, with no wider learning. In
comparison, a restorative just culture is a learning approach to deal with adverse events, which focuses
not on blame, but on controlling harm done and repairing trust and damaged relationships (Dekker,
et al., 2022). Restorative just culture concentrates on impacts, needs and obligations (Table 8.1).

Table 8.1:
Retributive just culture Restorative just culture
Comparison of
What rule is broken? Who is impacted?
retributive and
How bad is the breach? What do they need?
restorative just
What should be the consequences? Who is going to meet that need?
culture
Employee has to settle/pay account Get employee to tell/share account
Focuses on past and blame Focuses on future
Accountable for compliance Accountable for setting people up to succeed
Tries to stop things going wrong Enhances capacities that make things go right
Meets hurt with more hurt Meets hurt with healing

The table above is a summary taken from the work done by Sidney Dekker (https://sidneydekker.com/) and Mersey Care
(https://www.merseycare.nhs.uk/restorative-just-learning-culture)

Mersey Care NHS Foundation Trust is widely acknowledged for being a centre of excellence and
sharing their journey to create and maintain a restorative ‘just and learning’ culture where colleagues
feel supported and empowered to learn when things do not go as expected, rather than blamed
(Mersey Care NHS Foundation Trust, 2024). This approach has demonstrated some impressive
outcomes, including improvements in staff retention, particularly important when organisations are
faced with continuing workforce shortages. Key to improving culture at the organisation has been
leadership buy-in at all levels, and the newly released NHS leadership competency framework for board
members (NHSE, 2024) includes a competency domain specifically for skills and behaviours required
to create a compassionate, just, and positive culture. In Wales, the National Policy on Patient Safety
Incident Reporting & Management (NHS Wales Executive, 2023) supports a just culture for healthcare
organisations and staff so they may feel encouraged to recognise, report and learn from patient safety
incidents. It recognises that the exploration of incident reporting can facilitate healthcare organisations
to share learning from incidents, help identify emerging risks and act as a mechanism for oversight
and provide reassurance when substantial harm has occurred. Healthcare improvement in Scotland
provides an overarching approach by advocating learning from adverse events through reporting and
review – A national framework for Scotland (Healthcare Improvement Scotland, 2019). The principle of
this overarching framework includes learning from adverse events, promoting good practice, a system
focussed approach, promoting a just and safety culture and supports building on the fundamental values
of care, compassion, respect, transparency, accountability, excellence, and teamwork. Northern Ireland
have not adopted PSiRF but a patient safety incident framework, led by the Department of Health, is
currently being developed.

The NHS England Patient Safety Incident Response Framework (PSIRF) (NHSE, 2023) has included
compassionate engagement and involvement of those affected by patient safety incidents as a
foundational pillar and thus offers promise of increased attention to restorative just culture within England’s
safety work (Lounsbury & Sujan, 2023). A checklist developed from Dekker’s work on restorative just
culture can be found on his website (Dekker, 2022).

Learning point
• Resources are readily available for organisations to use, such as Dekker’s checklist and the
Mersey Care website, to help implement a restorative just culture

8. Human Factors and Ergonomics in SHOT Error Incidents 59

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

Analysis of SHOT error reports in 2023 showed ‘reflective learning’ appears in almost 5% of cases
(155/3184). The recommendation from the 2022 Annual SHOT Report that reflective learning should
not be used as a stand-alone action remains pertinent, especially when developing a restorative just
culture (Narayan, et al., 2023).

Case 8.1: Individual staff member was asked to reflect despite report showing wider staffing
and organisational issues

A sample from a patient in ED grouped as O D-positive, historic group A D-positive. A WBIT incident
was identified because the staff member who performed phlebotomy realised that they had bled
the wrong patient and escalated to a senior clinician who informed laboratory staff. Due to workload
pressures, the samples were labelled remotely from the patient with inadequate patient identification
and patient notes from the neighbouring bed space were used. The ED had an operational escalation
process in place due to extreme pressures. Patients were being seen on the ambulance corridor and
there was only one nurse and one nursing assistant. The member of staff involved had to undergo
retraining, competency-assessment, and completed a reflection tool.

The most important contributory factor in Case 8.1 was recorded in the HFIT as local working. The
question regarding one thing to make this incident less likely to happen again, was answered with the
need for an electronic end-to-end process for identifying patients prior to taking samples or administering
blood. A staff member undergoing retraining and reflection is unlikely to impact the working conditions or
the aspiration to secure an electronic system for sampling and administration. This mismatch continues to
be observed regularly in incident reports and is incongruous with the principles of a restorative just culture.

To ensure a restorative just culture, it is essential to consider and question if the rules that staff are
expected to follow are themselves ‘just’, and if the rule-makers understand ‘work as done’ rather
than ‘work as imagined’. Healthcare professionals face the challenge of navigating a maze of policies,
striving to provide quality care while keeping up with an ever-expanding set of guidelines (Carthey, et
al., 2011) making non-compliance a significant risk. Exploring this further, Johnstone (2017) surmised
that it would take 2000 years for a USA anaesthetist to read all the relevant guidelines, and for these
very reasons, a restorative just culture can fail. A just restorative culture cannot be fully implemented
until staffing issues are addressed.

A joint SHOT and UKTLC Laboratory Safety Culture Survey was undertaken in November 2023 and the
summary report and findings can be viewed on the SHOT website SHOT Surveys - Serious Hazards
of Transfusion (shotuk.org). Concerning signals are evident from this safety culture survey and key
recommendations have been provided to improve this. Organisations must encourage a just culture
and have a clear strategy to listen to staff, support them, and actively work to create safe, positive
work environments. This is not just about staff wellbeing, it is about ensuring the highest quality care
for patients and promoting safe care.

Analysis of the SHOT HFIT

The SHOT HFIT was updated in January 2023 to remove scoring following an analysis shown in the
2022 Supplementary Information, Figure 7.4. https://www.shotuk.org/shot-reports/report-summary-
and-supplement-2022/. This demonstrated that irrespective of scoring, the percentages given for each
factor were almost identical. The updated tool asks reporters to answer yes or no for the contributory
factors involved and provide any relevant information instead of providing a score.

60 8. Human Factors and Ergonomics in SHOT Error Incidents

ERROR REPORTS ANNUAL SHOT REPORT 2023

A total of 3184 error cases were included in 2023, which is an increase in the error cases reported in 2022
(n=2908). Throughout SHOT’s historical analysis of HFE, there has been evidence of an over-emphasis
on individual behaviours, but analyses of both the 2022 and 2023 data showed an improved appreciation
of system and organisational factors. Figure 8.1 shows consideration across the breadth of factors, with
an increase of 14.4% attributed to situational factors and an increase of 5.1% to communication and
culture. The increase in allocation of situational factors and decrease in local working, organisational and
external factors compared to 2022 is slightly concerning as it may indicate that factors are being over-
selected in the first category without full consideration of the other categories. As this has coincided with
scoring being removed for 2023, the trend will be monitored to determine if any changes are required
to the HFIT question set.
Figure 8.1: A
60.0%
comparison of
HFIT categories
50.0% assigned by SHOT
reporters in 2022
40.0% and 2023
Percentage of cases

30.0%

20.0%

10.0%

0.0%
Situational Communication Local working Organisational External
and culture

Percentage 2022 Percentage 2023

A recommendation was made in the 2021 Annual SHOT Report that ‘a tried and tested human factors-
based framework’ should be applied to incident investigations. In 2023 2376/3184 (74.6%) cases
specified that HFE principles or a framework/model was used to investigate incidents and a further
382/3184 (12.0%) indicated they were planning to in the future. Figure 8.2 shows this is a slight increase
compared to 2022 (67.0% used, 14.7% planning) and8.2
figure 2021 (70.0% used, 12.8% planning) but these
figures indicate that many cases are investigated without using a formal framework to consider human
factors.
Figure 8.2:
Yes No but planning to Percentage of
cases investigated
using HFE
80.0% 74.6%
70.0% principles or
70.0% 67.0%
framework
Percentage of cases

60.0%

50.0%

40.0%

30.0%

20.0% 14.7%
12.8% 12.0%
10.0%

0.0%
2021 2022 2023

8. Human Factors and Ergonomics in SHOT Error Incidents 61

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

Of those using a HFE framework, 2227/2376 (93.7%) provided data about the type that was used. The
most common response 957/2227 (43.0%) used the SHOT HFIT questions, which were adapted from
the evidence-based YCFF framework (Improvement Academy, 2022) and 146/2227 (6.6%) used the
YCCF framework, making it the fifth most commonly used. Figure 8.3 shows that apart from using SHOT
questions, the top frameworks used were most commonly in-house HFE and RCA tools. It should be
noted that it is an outdated concept to use RCA tools that encourage searching for a single root cause
(Peerally, et al., 2017).

PSIRF was introduced in England in 2022 to replace the NHSE Serious Incident Framework and
understandably, in that year, PSIRF was selected as the framework in only a handful of investigations,
14/1717 (0.8%). For 2023, this has risen to 102/2227 (4.6%) as organisations in England transition and
implement the framework. A document is available to answer questions regarding the recording, reporting
and investigation of transfusion-related adverse incidents following the introduction of PSIRF (see
‘Recommended resources’). It remains important that8.3
figure SHOT-reportable incidents are fully investigated
and in the case of MHRA-reportable incidents the BSQR requires an investigation of factors leading to
the incident and appropriate CAPA (Department of Health, 2005).
Figure 8.3: Top
six human factors 1200
frameworks
used for incident 1000 957

investigation as
submitted by SHOT 800

reporters in 2023
No. Cases

600

413
400
293
225
200 146
102

0
SHOT In house HF In house RCA Fishbone YCFF PSIRF

Framework or model

HF=human factors; PSIRF= Patient Safety Incident Response Framework; RCA=root cause analysis; YCFF=Yorkshire Contributory Factors
Framework

The SHOT HFIT questions, and the analyses in this chapter, are only included for reports in established
error categories, but it can be demonstrated that some reaction cases may also be error-based. For
the first time this year, a TACO case has been included in the supplementary information using the
HFIT main headings to examine the significance of the HFE involved. This case can be found in the
supplementary information on the SHOT website (https://www.shotuk.org/shot-reports/report-summary-
and-supplement-2023/).

A general observation from the analysis of contributory factors provided in reports was that residual
COVID-19 pressures remain apparent, affecting both workforce and processes. This has been
demonstrated in Chapter 15, Laboratory Errors. A report on wider workforce and patient safety issues,
including the impact of temporary staffing in England was published by the HSSIB in March 2024
(HSSIB, 2024).

62 8. Human Factors and Ergonomics in SHOT Error Incidents

ERROR REPORTS ANNUAL SHOT REPORT 2023

Conclusion
It is vital that senior management in healthcare organisations recognise the importance of an understanding
of HFE and that there is a growing evidence base, and thus business case, for introducing a restorative
just culture. Within a restorative just and learning culture, the continued use of actions targeting individual
staff members is unsuitable. Recognition and implementation of system-level interventions are paramount.
Action plans should be in place to facilitate long-term interventions, such as vein-to-vein IT solutions,
even if these actions cannot be easily closed on quality management systems.

Recommended resources
SHOT Human Factors and Ergonomics (HFE) module
https://learninghub.nhs.uk/catalogue/NHSBT-Learning-Zone

SHOT Videos: Human factors videos

https://www.shotuk.org/resources/current-resources/videos/

SHOT Bite No. 1(a) and 1(b): Incident Investigation

SHOT Bite No. 12: Cognitive Bias
https://www.shotuk.org/resources/current-resources/shot-bites/

SHOTcast: Human Factors

https://www.shotuk.org/resources/current-resources/shot-casts/

SHOT Webinar: Human Factors

https://www.youtube.com/watch?v=ie0UK9R5IbM

Yorkshire Contributory Factors Framework

https://improvementacademy.org/resource/yorkshire-contributory-factors-framework/

Human Factors in Healthcare AI

https://ergonomics.org.uk/resource/human-factors-in-healthcare-ai.html

Patient Safety Incident Response Framework (PSIRF)

https://www.england.nhs.uk/patient-safety/incident-response-framework/

NHS HEE Patient Safety Syllabus

https://www.hee.nhs.uk/our-work/patient-safety

NHS Patient Safety Syllabus training programme

https://www.e-lfh.org.uk/programmes/patient-safety-syllabus-training/

NHSE: A just culture guide

https://www.england.nhs.uk/wp-content/uploads/2021/02/NHS_0932_JC_Poster_A3.pdf

SHOT Human Factors Tuition Package

https://www.shotuk.org/reporting/human-factors-tuition-package/

8. Human Factors and Ergonomics in SHOT Error Incidents 63

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

References
Carthey, J. et al., 2011. Breaking the rules: understanding non-compliance with policies and guidelines. BMJ,
343(d5283). doi: https://doi.org/10.1136/bmj.d5283.

Dekker, S., 2022. Restorative Just Culture Checklist. [Online]

Available at: https://sidneydekker.com/wp-content/uploads/2022/04/RestorativeJustCultureChecklist.pdf
(Accessed 06 March 2024).

Dekker, S., Oates, A. & Rafferty, J., 2022. Restorative Just Culture in Practice Implementation and Evaluation. 1st ed.
New York: Routledge. doi: https://doi.org/10.4324/9781003162582.

Department of Health, 2005. The Blood Safety and Quality Regulations 2005. [Online]
Available at: https://www.legislation.gov.uk/uksi/2005/50/introduction/made
(Accessed 11 April 2024).

Healthcare Improvement Scotland, 2019. Learning from adverse events through reporting and review. A
national framework for Scotland, Scotland: Healthcare Improvement Scotland. Available at: https://www.
healthcareimprovementscotland.scot/wp-content/uploads/2024/03/20191216-AE-framework-4th-Edition.pdf (Accessed
03 May 2024).

Health Services Safety Investigations Body (HSSIB), 2024. Workforce and patient safety. [Online]
Available at: https://www.hssib.org.uk/patient-safety-investigations/workforce-and-patient-safety/
(Accessed 25 May 2024).

Improvement Academy, 2022. Yorkshire Contributory Factors Framework. [Online]

Available at: https://improvementacademy.org/resource/yorkshire-contributory-factors-framework/
(Accessed March 27 2024).

Johnstone, R., 2017. Glut of anesthesia guidelines a disservice, except for lawyers. [Online] Anesthesiology News, 43(1),
pp.1-6. Available at: https://www.researchgate.net/publication/315754396_Glut_of_anesthesia_guidelines_a_disservice_
except_for_lawyers (Accessed 08 April 2024).

Lounsbury, O. & Sujan, M., 2023. Achieving a restorative Just Culture through the patient safety incident
response framework. Journal of Patient Safety and Risk Management, 28(4), pp. 153-155. doi: https://doi.
org/10.1177/25160435231194397.

Mersey Care NHS Foundation Trust, 2024. Restorative Just and Learning Culture. [Online]
Available at: https://www.merseycare.nhs.uk/restorative-just-learning-culture (Accessed 06 March 2024).

Narayan, S. et al., 2023. The 2022 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. doi: https://doi.org/10.57911/WZ85-3885.

NHS Wales Executive, 2023. National Policy on Patient Safety Incident Reporting & Management, Wales: NHS Wales.
Available at: https://du.nhs.wales/files/incidents/national-policy-on-patient-safety-incident-reporting-2-0-pdf/ (Accessed
03 May 2024).

NHS England (NHSE), 2023. Patient Safety Incident Response Framework. [Online]
Available at: https://www.england.nhs.uk/patient-safety/patient-safety-insight/incident-response-framework/ (Accessed
31 January 2024).

NHS England (NHSE), 2024. NHS leadership competency framework for board members. [Online]
Available at: https://www.england.nhs.uk/long-read/nhs-leadership-competency-framework-for-board-members/
(Accessed 03 March 2024).

Peerally, M. F., Carr, S., Waring, J. & Dixon-Woods, M., 2017. The problem with root cause analysis. BMJ Quality &
Safety, Volume 26, pp. 417-422. doi: https://doi.org/10.1136/bmjqs-2016-005511.

64 8. Human Factors and Ergonomics in SHOT Error Incidents

ERROR REPORTS ANNUAL SHOT REPORT 2023

Adverse Events Related to Anti-D

Immunoglobulin (Ig) n=425 9
Authors: Jennifer Davies, Simon Carter-Graham and Vera Rosa

Definition:
Events relating to the requesting and administration of anti-D immunoglobulin (Ig) to women of
childbearing potential and events relating to the administration of anti-D Ig following transfusion
of D-mismatched platelets.

Abbreviations used in this chapter

BSH British Society for Haematology NICE National Institute for Health and Care Excellence
cffDNA Cell-free fetal deoxyribonucleic acid NIPT Non-invasive prenatal testing
FMH Fetomaternal haemorrhage PSE Potentially sensitising event
IBGRL International Blood Group Reference Laboratory RAADP Routine antenatal anti-D Ig prophylaxis
Ig Immunoglobulin SOP Standard operating procedure
IT Information technology SOT Solid organ transplant
LIMS Laboratory information management system

Key SHOT messages

• High numbers of anti-D Ig errors continue to be reported. Delays and omissions in administration
of anti-D Ig (following PSE and RAADP) account for the majority of errors. Previous SHOT
recommendations remain relevant to reduce risk of these errors

• NIPT using cffDNA can predict the D-type of the fetus supporting targeted use of anti-D Ig/
RAADP. Challenges remain with access to results, misinterpretation of results and false-positive/
negative results

Recommendations
• Interoperability between LIMS, including reference laboratory, and maternity systems reduces
risk of transcription errors and should be implemented

• Organisations should review current processes to identify gaps where improvements could be
implemented to support safe practice

• Processes should be in place that support recognition of the need for anti-D Ig in non-gynaecology
and maternity settings

Action: Laboratory management, IT departments, maternity services, reference

laboratories

9. Adverse Events Related to Anti-D Immunoglobulin (Ig) 65

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

Headline data 2023 Anti-D lg reports by year

466
426 413 425
409 400
359 350 345
341
Number of reports n=425
Deaths n=0
Major morbidity n=1

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Demographic data Potential for major morbidity n=284

Late/omitted RAADP n=98

Late/omitted anti-D lg following
Male Female Adults Paediatric a PSE (including delivery) n=186
n=0 n=425 n=412 n=1

Unknown n=12

Introduction
Guidelines for safe and appropriate administration of anti-D Ig post sensitising events and RAADP
have now been in place for many years (Qureshi, et al., 2014; NICE, 2008; NICE, 2019; NICE, 2023).
It is essential that these guidelines are reflected in local policies and systems are in place that support
compliance in all healthcare settings. Anti-D Ig is also important in reducing the risk of developing
immune anti-D in D-negative patients with childbearing potential (including paediatric patients) following
transfusion of D-positive blood components and D-mismatch SOT (Qureshi, et al., 2014). In this chapter,
425 cases have been analysed, mainly related to anti-D Ig management during pregnancy. In addition,
41 near miss cases were reported.

SHOT data continue to demonstrate that errors in anti-D Ig and RAADP management occur in both clinical
and laboratory settings. The management of patients requiring anti-D Ig and RAADP is multifaceted,
errors can occur at all stages of the process.

Deaths related to transfusion n=0

There were no deaths reported in the cases analysed for 2023 related to anti-D Ig errors.

Major morbidity n=1

A mother developed immune anti-D following omission of anti-D Ig during pregnancy, this is detailed
in Chapter 27, Immune Anti-D in Pregnancy. Delays, omissions, under-dosing, and failures to perform
follow up testing after an FMH of more than 4mL have the potential to result in development of immune
anti-D and haemolytic disease of the fetus and newborn in future pregnancies. The impact of anti-D Ig
and RAADP errors should not be underestimated.

66 9. Adverse Events Related to Anti-D Immunoglobulin (Ig)

ERROR REPORTS ANNUAL SHOT REPORT 2023

Overview of cases n=425

Omission or late administration of anti-D Ig/RAADP continue to account for the majority of errors,
284/425 (66.8%) (Table 9.1). These were mainly related to discharge prior to administration, 81/284
(28.5%), failure to order, 60/284 (21.1%), failure to check relevant results, 44/284 (15.5%) and incorrect
decision to omit, 36/284 (12.7%). Where incorrect decisions resulted in omission, the majority were for
PSE (30/36), notably where mothers were seen outside of maternity and gynaecology settings. Formal
investigation following the error had been performed in 282/425 (66.4%) cases. Failures in team function,
poor written or verbal communication, gaps in knowledge and mismatch between workload and staff
provision were the most common contributory factors identified in errors.

Anti-D Ig category Number of reports Table 9.1:

Omission or late administration of anti-D Ig 284 Distribution of

Anti-D Ig given to the mother of a D-negative infant 59 anti-D Ig related

Wrong dose of anti-D Ig given 16 error reports in

2023 (n=425)
Anti-D Ig given to a woman with immune anti-D 15
Anti-D Ig handling and storage errors 14
Anti-D Ig given to a D-positive woman 11
Anti-D Ig given to the wrong woman 10
Right product right patient 8
Miscellaneous 8
Total 425

Case 9.1: Incorrect decision to omit anti-D Ig

During a major haemorrhage protocol activation, an adult therapeutic dose of D-positive platelets
was transfused to a D-negative mother. The baby’s sample tested D-negative at delivery. The clinical
team returned the anti-D Ig because the baby was D-negative, failing to recognise the need for anti-D
Ig following the transfusion of D-positive platelets.

It is important to remember that anti-D Ig may be required where D-positive blood components are
given to D-negative patients of childbearing potential (Qureshi, et al., 2014). This can occur within, or
outside the maternity setting and is unrelated to the infant D-type.

Case 9.2: Incorrect dose of anti-D Ig following cell salvage

A dose of 500IU anti-D Ig was given to a mother post delivery. The laboratory was not informed
that cell salvage products had been re-infused and that a 1500IU dose should have been provided.

Where 500IU anti-D Ig is used for PSE and post delivery, effective communication with the laboratory
where cell salvage has been re-infused helps ensure an appropriate dose (1500IU) is provided in
accordance with BSH guidelines (Qureshi, et al., 2014).

Non-invasive prenatal screening n=53

Since 2016, high-throughput NIPT for fetal RHD (cffDNA) screening has been available across the UK for
non-immunised D-negative pregnant women (NICE, 2016). Prediction of the fetal D-type enables targeted
administration of anti-D Ig. The assay has limitations, with sensitivity of 99.3% (95% CI 0.982-0.997)
and specificity of 98.4% (95% CI 0.964-0.993) (Mackie, et al., 2017) leading to a small risk of false-
positive or false-negative screening results. False-positive and false-negative results must be reported

9. Adverse Events Related to Anti-D Immunoglobulin (Ig) 67

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

to SHOT and to the test provider. A checklist for investigation of discrepant results is available on the
SHOT website and can be used for local investigation (see ‘Recommended resources’). The screening
assay should not be confused with the diagnostic assay for fetal D-typing, provided by IBGRL, which
figureand
provides a higher level of specificity and sensitivity 9.1is performed where the mother has immune
anti-D. SHOT only collect data relating to errors with the screening assay.
Figure 9.1: Number
and breakdown 26
False-positive cffDNA result
of cases related
to non-invasive
False-negative cffDNA result 12
prenatal screening
for RHD (n=53)
cffDNA result available not checked 9

cffDNA result available on Sp-ICE but not to the clinical team 2

cffDNA result checked was from previous pregnancy 1

Sample rejected due to labelling error 1

Clinical decision to administer anti-D Ig when cffDNA predicted

1
D-negative infant

Partial D - apparent false-positive cffDNA result 1

cffDNA=cell free fetal deoxyribonucleic acid; Ig=immunoglobulin; Sp-ICE=Specialist Services Integrated Clinical Environment

In total, 53 reports were analysed by SHOT in 2023. From those 26/53 were false-positive cffDNA results
and 12/53 false-negative (Figure 9.1). Cases where cffDNA results were available to both laboratory
and clinical areas but not checked prior to anti-D Ig issuing or administration accounted for 9/53 cases.

Involvement of information technology n=68

IT was noted as being involved in errors in 68/425 (16.0%) of cases, the majority of these related to
omission or delay, 26/68 (38.2%) and anti-D Ig administered to a mother with a D-negative infant, 20/68
(29.4%).

The involvement of IT was varied but the main themes included:

• IT in place but not used, used incorrectly or not working

• Lack of interoperability between different IT systems (reference laboratory, local laboratory, and
clinical systems)

• Flags in laboratory IT systems not heeded

• HSE cases where anti-D Ig was stored in devices outside laboratory control and without electronic
temperature excursion alerts

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Near miss cases n=41

There were 41 near miss cases analysed in 2023. Omission or late administration (8/41) and wrong
dose (8/41) were the most common categories, followed by anti-D Ig issued but not administered to a
woman carrying/delivering a D-negative infant (7/41) (Table 9.2). Laboratory errors accounted for over
half of the total cases, 28/41 (68.3%) with 12 errors occurring during component selection where baby’s
blood group, mother antibody status or cffDNA results for current pregnancy were not checked prior
to issue of anti-D Ig (8/12).

In most cases, 28/41, (68.3%) the NM occurred due to a failure to follow SOP or policy. This highlights
the importance of ensuring that SOP and policies are clear and comprehensive to allow easy and
unambiguous practice embedded within a system that supports safe practice.

Checks at pre-administration were the point of error detection in 16/41 cases, with a pre-administration
checklist used in 10/16 cases. Other stages of detection included during testing, at authorisation of
results, at collection and during routine equipment checking.

Anti-D Ig category Number of reports Table 9.2:

Omission or late administration of anti-D Ig 8 Distribution of

Wrong dose of anti-D Ig given 8 anti-D Ig related

near miss events in
Anti-D Ig given to the mother of a D-negative infant 7
2023 (n=41)
Anti-D Ig handling and storage errors 4
Right product right patient 4
Anti-D Ig given to a D-positive woman 3
Anti-D Ig given to a woman with immune anti-D 3
Anti-D Ig given to the wrong woman 2
Miscellaneous 2
Total 41

A formal investigation was performed in 30/41 (73.2%) cases. The NM event was reviewed in 32/41
(78.0%) cases and in 6/32 changes were made to transfusion procedures or policy. These changes
included implementation of checklists and additional checking steps. In 1 case, a distraction-free area in
the blood transfusion laboratory was created where critical tasks are performed. Learning from NM events
is acknowledged as a process to improve patient safety where patient harm has occurred (Woodier, et
al., 2023; Jung, et al., 2021). It is important to recognise the valuable learning from NM and apply the
same investigation tools to NM as for actual incidents. SHOT has been promoting the learning from
NM as ‘free lessons’ and organisations should embed the NM investigation as part of their policies.

Learning point
• Management of anti-D Ig requires laboratory and clinical involvement. There are multiple steps
to safe and appropriate administration. Formal investigation of errors and review of systems
enables identification of potential gaps in processes and effective preventive measures that
can be implemented

9. Adverse Events Related to Anti-D Immunoglobulin (Ig) 69

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

Conclusion
Safe and appropriate management of anti-D Ig requires a collaborative approach between the laboratory
and other services, including maternity and gynaecology. Application of a systems-thinking approach,
including consideration of human factors and ergonomics, enables implementation of barriers to error
at each step in the process. It is encouraging to note that more organisations are looking to IT systems
to support safe practice. IT systems, laboratory and clinical, can support safe practice but it is important
to remember that these provide a safety net, they do not replace staff knowledge, and they need to
be configured, maintained, and used correctly to optimise benefit. Staff training is a keystone in safe
practice, induction training is critical as processes may be different across organisations. D-negative
mothers, or their carers, should be provided with clear information about anti-D Ig, including the risks
of missing routine appointments, and considered partners in antenatal care. Errors related to anti-D Ig
consistently account for the highest proportion of errors reported to SHOT. Organisations where effective
processes have been implemented, and where low error rates are seen, are encouraged to share their
excellent practice via SHOT ACE reporting.

Recommended resources
Anti-D Immunoglobulin (Ig) Administration to avoid sensitisation in pregnancy
- an aide memoire SHOT 2023
cffDNA discrepancy investigation form
IT supports anti-D Ig management in pregnancy
https://www.shotuk.org/resources/current-resources/
SHOT Bite No 2: Anti-D Ig Administration
SHOT Bite No 28: cffDNA screening errors
https://www.shotuk.org/resources/current-resources/shot-bites/
SHOT Videos Anti-D Immunoglobulin errors and immunisation in pregnancy: insights
from SHOT (Part 1 and Part 2)
https://www.shotuk.org/resources/current-resources/videos/

References
Jung, O. S. et al., 2021. Resilience vs. Vulnerability: Psychological Safety and Reporting of Near Misses with Varying
Proximity to Harm in Radiation Oncology. The Joint Comission Journal on Quality and Patient Safety, 47(1), pp. 15-22.
doi: 10.1016/j.jcjq.2020.09.005.

Mackie, F. L. et al., 2017. The accuracy of cell-free fetal DNA-based non-invasive prenatal testing in singleton
pregnancies: a systematic review and bivariate meta-analysis. An International Journal of Obstetrics and Gynaecology,
124(1), pp. 32-4. doi: https://doi.org/10.1111/1471-0528.14050.

National Institute for Health and Care Excellence (NICE), 2008. Routine antenatal anti-D prophylaxis for women who are
rhesus D negative TA156. [Online] Available at: https://www.nice.org.uk/guidance/ta156 (Accessed 12 February 2024).

National Institute for Health and Care Excellence (NICE), 2016. High-throughput non-invasive prenatal testing for fetal
RHD genotype [DG25]. [Online] Available at: https://www.nice.org.uk/guidance/dg25 (Accessed 12 February 2024).

National Institute for Health and Care Excellence (NICE), 2019. Abortion care [NG140]. [Online] Available at: https://www.
nice.org.uk/guidance/ng140/chapter/Recommendations#anti-d-prophylaxis (Accessed 12 February 2024).

National Institute for Health and Care Excellence (NICE), 2023. Ectopic pregnancy and miscarriage: diagnosis and initial
management [NG126]. [Online] Available at: https://www.nice.org.uk/guidance/ng126/chapter/Recommendations#anti-
d-rhesus-prophylaxis (Accessed 12 February 2024).

Qureshi, H. et al., 2014. BCSH guideline for the use of anti-D immunoglobulin for the prevention of haemolytic disease of
the fetus and newborn. Transfusion Medicine, 24(1), pp. 1-66. doi: https://doi.org/10.1111/tme.12091.

Woodier, N., Burnett, C., Sampson, P. & Moppett, I., 2023. Patient safety near misses – Still missing opportunities to
learn. Journal of Patient Safety and Risk Management, 0(0), pp. 1-7. doi: 10.1177/25160435231220430.

70 9. Adverse Events Related to Anti-D Immunoglobulin (Ig)

ERROR REPORTS ANNUAL SHOT REPORT 2023

Incorrect Blood Component Transfused

(IBCT) n=356 10
Authors: Nicola Swarbrick, Simon Carter-Graham and Victoria Tuckley with input from
Caryn Hughes and Shruthi Narayan

Definition:
Wrong component transfused (WCT)

Where a patient was transfused with a blood component of an incorrect blood group, or which
was intended for another patient and was incompatible with the recipient, which was intended
for another recipient but happened to be compatible with the recipient, or which was other than
that prescribed e.g., platelets instead of red cells.

Specific requirements not met (SRNM)

Where a patient was transfused with a blood component that did not meet their specific
requirements, for example irradiated components, human leucocyte antigen (HLA)-matched
platelets when indicated, antigen-negative red cell units for a patient with known antibodies,
red cells of extended phenotype for a patient with a specific clinical condition (e.g.,
haemoglobinopathy), or a component with a neonatal specification where indicated. (This does
not include cases where a clinical decision was taken to knowingly transfuse components not
meeting the specification in view of clinical urgency).

Abbreviations used in this chapter

ABOi ABO-incompatible LIMS Laboratory information management system
AIHA Autoimmune haemolytic anaemia MHP Major haemorrhage protocol
BMS Biomedical scientist NM Near miss
CMV Cytomegalovirus PID Patient identification
FFP Fresh frozen plasma PPID Positive patient identification
Hb Haemoglobin SRNM Specific requirements not met
HSCT Haematopoietic stem cell transplant UK United Kingdom
HSSIB Health Service Safety Investigations Body UKTLC UK Transfusion Laboratory Collaborative
IBCT Incorrect blood component transfused WBIT Wrong blood in tube
ID Identification WCT Wrong component transfused
IT Information technology

10. Incorrect Blood Component Transfused (IBCT) 71

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

Key SHOT messages

• Laboratory IBCT errors, both WCT and SRNM, have increased substantially (356 in 2023
compared to 296 in 2022)

• There were 10 ABOi transfusions in 2023, 7 red cell and 3 FFP

• There has been a dramatic rise in the number of component selection errors, particularly to
HSCT patients, resulting in the wrong ABO group being transfused to patients

• Many errors involve patient identification, particularly at sample taking, blood collection and
administration

Recommendations
• Accurate and complete PID is fundamental to transfusion safety. Training in correct PID
procedures must be provided to all staff

Action: All staff in transfusion, ward managers

• Transfusion competency training and assessment should be audited for effectiveness, particularly
following errors. Competency-assessment should not just be a tick-box exercise

• Access to specialist transfusion advice should be available to all transfusion staff at all times
(SHOT, 2024)

Action: Transfusion laboratory managers, ward managers

Headline data 2023 IBCT reports by year

331 356
329 323
307
296
278 280 272 266
Number of reports n=356
Deaths n=0
Major morbidity n=6

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Demographic data Blood component data

Red cells n=304
Platelets n=35
Plasma n=12
Multiple components n=1
Male Female Adults Paediatric Granulocytes n=0
n=160 n=177 n=290 n=45
Cryoprecipitate n=1
Unknown n=19 Unknown n=21 Unknown n=3

Introduction
IBCT events have the potential to lead to patient harm including major morbidity and death, as seen in
serial Annual SHOT Reports. These errors accounted for 356/3833 (9.3%) of reports in 2023, which
is an increase on previous year’s data. A reduction in clinical errors but a striking increase in laboratory
errors was noted. The total number of IBCT-WCT reports has increased in 2023 to 121 from 87 in
2022, and an increase in the number of IBCT-SRNM reports to 235 from 209 in 2022. Figure 10.1
provides an overview of reports submitted to SHOT in 2023 where an incorrect blood component was
transfused. This category includes instances where wrong components were transfused, and/or specific
requirements were not met.

72 10. Incorrect Blood Component Transfused (IBCT)

ERROR REPORTS figure 10.1 ANNUAL SHOT REPORT 2023

Figure 10.1:
Overview of reports
Incorrect blood component transfused (IBCT) n=356 where an incorrect
blood component

129 was transfused in

Clinical
2023 (n=356)

Laboratory 227

Wrong component transfused Specific requirements not met

(WCT) n=121 (SRNM) n=235

Clinical 50 Clinical 79

Laboratory 71 Laboratory 156

figure 10.2
Figure 10.2:
Total IBCT errors
Clinical IBCT-WCT Laboratory IBCT-WCT categorised by
Clinical IBCT-SRNM Laboratory IBCT-SRNM the step in the
transfusion process
Request 12 70 where the error
occurred (n=356)
Sample taking 4 2

Sample receipt and registration 6 10

Testing 10 92

Component selection 52 48

Component labelling 2

Availability 12

Handling and storage 1

Collection 15 4

Prescription 11

Administration 17 2

Miscellaneous 1 3
0 20 40 60 80 100 120

IBCT-SRNM=incorrect blood component transfused-specific requirements not met; IBCT-WCT=IBCT-wrong component transfused

Most clinical errors occurred at the request step of the transfusion process, 82/129 (63.6%), followed
by collection, 19/129 (14.7%) and administration, 19/129 (14.7%) stages. In the laboratory, most errors
occurred at testing, 102/227 (44.9%) and component selection, 100/227 (44.1%) stages.

Deaths related to transfusion n=0

There were no patient deaths in 2023 due to IBCT errors.

10. Incorrect Blood Component Transfused (IBCT) 73

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

Major morbidity n=6

There were 6 cases of major morbidity related to IBCT errors: 4 laboratory and 2 clinical. The 2 clinical
cases are detailed below in Table 10.1. In 1 case, the safety checks were not performed correctly at
the collection stage and in the other, there was a failure to perform PPID at the administration stage.

The 4 laboratory cases of major morbidity resulted in sensitisation to the K antigen in patients of
childbearing potential due to component selection errors. One patient developed an anti-K antibody
with a titre of 1 in 256. In 3 cases there were LIMS alerts to prevent the error, but these were
overridden by BMS staff. These cases are discussed further in Chapter 15, Laboratory Errors.

ABO-incompatible (ABOi) transfusions n=10

There were 7 red cell and 3 FFP ABOi transfusions included in 2023. All the red cell ABOi transfusions
were because of clinical errors (collection and administration errors), with 2 resulting in major morbidity.
Two component selection errors in the laboratory resulted in group O FFP being issued to non-group
O patients. The third FFP case involved a historical WBIT sample which occurred in 2011 and was
reported in 2023. Salient points of these are covered in Table 10.1, and detailed case descriptions can
be found in the supplementary information on the SHOT website (https://www.shotuk.org/shot-reports/
report-summary-and-supplement-2023/).
Table 10.1: Case number Case 1 Case 2 Case 3
ABOi transfusions Component transfused Red cells group A Red cells group B Red cells group A
reported in 2023
(n=10)

A B A

Patient group Group O Group O Group O

Volume transfused >50mL <50mL >50mL
Administration Administration Collection
Ineffective patient ID checks Ineffective patient ID checks Wrong pickup slip used.
Primary error Ineffective patient ID checks

When patient became unwell When 15 minute When patient became

Error detection after 100mL transfused observations were being unwell after whole unit
carried out transfused
Patient impact Major morbidity Minor morbidity Death (unrelated)
Imputability 3 2 0
Urgency Routine Routine Emergency
MHP No No No
Department Ward Ward Ward
Adult/paediatric Adult Adult Adult
Administration checklist Yes (paper) 2-person Yes (paper) 2-person
No 2-person check
used. Patient ID independent check independent check
ID band in place Yes Yes Yes

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ERROR REPORTS ANNUAL SHOT REPORT 2023

Case number Case 4 Case 5 Case 6

Component transfused Red cells group A Red cells group A Red cells group A

A A A

Patient group Group O Group O Group O

Volume transfused >50mL >50mL 1 unit
Collection Collection Collection
Wrong unit collected Wrong unit collected Ineffective patient ID checks
Primary error Ineffective patient ID checks Ineffective pre-transfusion
checks
Within 3 minutes of start of When patient became Six days later when patient
Error detection transfusion unwell after at least 50mL had repeat group and save
transfused
Patient impact Death (unrelated) Major morbidity No clinical reaction
Imputability 0 3 N/A
Urgency Emergency Routine Routine
MHP No No No
Department Intensive care unit Hamatology OPD Ward
Adult/paediatric Adult Adult Adult
Administration checklist No 2-person dependent
No 2-person check Yes (paper) 1-person check
used. Patient ID check
ID band in place Yes Yes Yes

Case number Case 7 Case 8 Case 9 Case 10

Component Red cells group B FFP group O FFP group O FFP group O
transfused

B O O O

Patient group Group O Group B Group B Group B

Volume transfused <50mL 2 units <50mL <50mL
Administration Component Component Sample taking
Incomplete patient ID selection selection Historical (2011) WBIT
checks carried out Group O red cells Issued group O FFP
issued due to limited B when only one previous
stock, which prompted sample. Infant
Primary error
laboratory to issue transfused O red cells
group O FFP in error. at other organisation,
LIMS did not prevent therefore grouping as
issue of group O to group O
non-O patients
Identified by ward staff When laboratory staff Communication from Lookback investigation
Error detection when there was an realised their error transferring hospital following subsequent
issue with IV line sample issue

Patient impact No clinical reaction No clinical reaction Death (unrelated) No clinical reaction
Imputability N/A N/A 0 N/A
Urgency Routine Emergency Urgent Emergency
MHP No Yes No Not known
Department Ward Theatre NICU ED
Adult/paediatric Adult Adult Neonate Adult

10. Incorrect Blood Component Transfused (IBCT) 75

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

Case number Case 7 Case 8 Case 9 Case 10

Yes (paper) 2-person
Administration
Yes (paper) 2-person independent check.
checklist used. Not known Not known
independent check Exit checklist used by
Patient ID
laboratory
ID band in place Yes Yes Yes Not known

It is concerning to note the upward trend in ABOi red cell transfusions (see Chapter 3, Headline Data,
Figure 3.8). Sample taking, collection and administration stages of the transfusion pathway remain
weak points for accurate patient identification leading to IBCT errors. Staffing shortages with steep
increases in workload, resource constraints, administrative burdens, and complexity of healthcare
delivery all contribute to these errors. The recently published HSSIB report, detailing issues relating to
patient misidentification, outlines that these concerns impact on patient safety in all areas of healthcare
including blood transfusion (HSSIB, 2024). Urgent actions are needed to address these issues and
improve patient safety.

Clinical IBCT errors n=129

There were 129/356 (36.2%) cases reported in 2023 which is a decrease from the 144/296 (48.6%) in
the 2022 Annual SHOT Report.

Clinical IBCT-WCT errors n=50

This was a slight increase in cases from 44 in the 2022 Annual SHOT Report.

There was a total of 15/50 (30.0%) transfusions of the wrong component type, 17/50 (34.0%) of the
wrong group and 18/50 (36.0%) to the wrong patient.

More than a third of the IBCT-WCT errors, 17/50 (34.0%) occurred at the point of administration and
resulted in 1 transfusion of the wrong component type, 3 wrong group transfusions and 13 cases where
blood components were transfused to the wrong patient (Figure 10.3). This included 3 ABOi red cell
transfusions.

There were 15/50 (30.0%) errors at collection of the component from the storage area which resulted in
9 wrong component types transfused, 3 wrong blood group transfused and 3 where components were
administered to the wrong patient (Figure 10.3). This included 4 ABOi red cell transfusions.

Case 10.1: Red cells administered in error instead of platelets

A patient was due to undergo spinal surgery. As they had been taking clopidogrel, two adult
therapeutic units of platelets were prescribed to be given pre surgery. The patient’s Hb was 152g/L.
A nurse asked the porter to collect ‘one unit of blood’ from a remote issue refrigerator. The red
cells were issued to the patient for use during surgery if required but had not been prescribed. The
nurse administering the transfusion reported that pre-transfusion safety checks were completed,
but this failed to pick up that the wrong blood component was about to be administered. The unit
of red cells was transfused uneventfully. When another nurse requested platelets to be collected, a
second unit of red cells was brought to the ward. When the nurse realised the wrong component
had been delivered, the previous transfusion was checked, and the earlier error was identified. The

76 10. Incorrect Blood Component Transfused (IBCT)

ERROR REPORTS ANNUAL SHOT REPORT 2023

patient suffered no ill effects from the red cell transfusion and surgery went ahead as planned with
the prescribed platelets being administered during the surgery.

The transfusion laboratory was reported to have been

figure very busy so the platelets had not been issued
10.3
to the patient when the first collection was requested and would not have appeared on the IT system.
Figure 10.3:
Categorisation of
clinical IBCT-WCT
Request 7 1 4
errors by step
where the primary
Sample taking 3 1
error occurred
(n=50)
Collection 3 3 9

Prescription 1

Administration 3 13 1

Miscellaneous 1

0 2 4 6 8 10 12 14 16 18

Wrong group Wrong patient Wrong component type

Of the clinical IBCT-WCT errors, 20/50 (40.0%) were routine transfusions and 10/50 (20.0%) were
emergency. Most transfusions 36/50 (72.0%) occurred between 08:00-20:00.

IT was involved in 20/50 (40.0%) which included lack of functionality of some systems, lack of
interoperability and systems being available but not being used.

Learning points
• Collection and administration of blood components are critical steps in the transfusion process
and effective procedures should be in place to ensure that necessary checks are performed

• It is vital to conduct positive patient identification and complete all the final checks next to the
patient immediately prior to administration of the component

• When completing final administration checks it is important to ensure the correct component
type is being given

Clinical IBCT-SRNM errors n=79

The number of clinical IBCT-SRNM 79/356 (22.2%) has decreased from 100/296 (33.8%) in the 2022
Annual SHOT Report.

There were 54/79 (68.4%) cases where the requirement for irradiated components was not met. In
18/54 (33.3%) of reports the patient had a diagnosis of Hodgkin lymphoma. A further 20/54 (37.0%)
patients had received purine analogues. Reasons for these failures included poor communication through
shared care, clinical electronic systems not being updated and lack of knowledge of the requirement.

Errors mostly occurred at the request stage 70/79 (88.6%), with further errors at the collection stage
4/79 (5.1%), 2/79 (2.5%) each at sample taking and administration and 1/79 (1.3%) at the prescription/
authorisation stage.

10. Incorrect Blood Component Transfused (IBCT) 77

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

Case 10.2: Shared care communication failure leads to transfusion of a non-irradiated blood
component

A patient with a history of Hodgkin lymphoma did not receive an irradiated red cell unit for an elective
transfusion. The laboratory had not been informed of the patient’s diagnosis by the clinician when
the request was made therefore no alert was in place on the LIMS. Neither the request form nor the
prescription/authorisation record stated the specific requirements, and no relevant clinical history
was provided.

The patient was diagnosed several years previously, and their current care was shared by two hospitals,
with no common electronic patient records or LIMS access. Lack of adequate patient information and
access to appropriate records from the other hospital prevented any further questioning of the patients’
specific requirements. At the time of writing, there was work being done to resolve this issue. The patient
had no ill effects from this omission.

Adults and children with Hodgkin lymphoma are to receive irradiated blood components for life (Foukaneli,
et al., 2020), yet data has shown that often the irradiation requirements for these patients is missed (Elliot,
et al., 2021). In 2022 SHOT published a safety notice to highlight the importance of meeting transfusion
specific requirements for all elective transfusions.

As with many reports in this category effective communication is key to preventing such errors. Highlighted
in the ACE chapter is a case where staff made the specific requirements section of the request form
mandatory (Chapter 6, Acknowledging Continuing figure 10.4 in Transfusion (ACE), Case 11).
Excellence

Figure 10.4: Clinical

IBCT-SRNM errors
and transfusion Not irradiated 53 1
step where the
error occurred
(n=79) Not CMV-screened 9

Not phenotyped antigen-negative 6 3

Invalid sample 2 1

Blood warmer not used 11

Sample taking
Request
Inappropriate electronic issue 1
Prescription
Collection
Not HLA-matched 1 Administration

0 10 20 30 40 50 60

CMV=cytomegalovirus; HLA=human leucocyte antigen

Learning points
• It is vital that all healthcare professionals involved with transfusion have an awareness of specific
transfusion requirements, and patient cohorts where these requirements are relevant

• Specific requirements for transfusions must be documented in patient records (manual and/or
electronic) and be easily accessible

• Effective processes for communication of specific requirements between the clinical area and
laboratory increase the likelihood of safe transfusions occurring

78 10. Incorrect Blood Component Transfused (IBCT)

ERROR REPORTS ANNUAL SHOT REPORT 2023

• There are opportunities to identify the correct specific requirements at several steps in the
transfusion process. Staff in both clinical and laboratory areas should remain vigilant and raise
any suspected omission with requesting clinicians

• Where failures to meet specific requirements occur, these incidents should be thoroughly
investigated, and appropriate improvement actions taken

• Healthcare professionals should comply with duty of candour to ensure transparency and
partnership with patients

Laboratory IBCT errors n=227

In 2023 there has been a striking increase in reports of incorrect blood components transfused due to
laboratory errors from 152/296 (51.4%) in 2022 to 227/356 (63.8%) in 2023. There has been an increase
of laboratory errors resulting in IBCT-WCT from last year from 43 to 71, and an increase in IBCT-SRNM
errors from 109 to 156 in 2023.

Laboratory IBCT-WCT errors n=71

Table 10.2:
Error Sample receipt Component Component Component Laboratory IBCT-
Testing
subcategory and registration selection labelling availability
WCT errors in 2023
(n=71)

Number of
6 10 52 2 1
error reports

There were 71 laboratory errors which led to the wrong component being transfused, most of which
were due to component selection errors, 52/71 (73.2%) and testing errors, 10/71 (14.1%) (Figure 10.5).

10. Incorrect Blood Component Transfused (IBCT) 79

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

figure 10.5
Figure 10.5:
Laboratory IBCT- 0 10 20 30 40 50 60
WCT errors by
transfusion step
Sample receipt and registration 5 1
(n=71)

Testing 10

Component selection 47 1 4

Component labelling 2

Component availability 1

Wrong group Wrong patient Wrong component type

There were 28 laboratory errors which led to the wrong ABO/D group being transfused to transplant
patients (Figure 10.6). Errors of incorrect group to transplant patients has more than doubled from
last year’s number of 13. IT was stated as an influencing factor in 27/28 cases and included lack of
functionality in LIMS for transplant patients (16/28), LIMS flags not heeded (6/28), alerts not added or
added incorrectly to LIMS (4/28) and failure to consult the historic record (1/28).

There were 14 laboratory errors which led to D-negative individuals receiving D-positive blood
components, of which 4 were to children and 4 to females of childbearing potential.

Of the 19 laboratory IBCT-WCT errors which resulted in an ABO-compatible transfusion, 7 were due to
figure
group specific components being issued in the 10.6of a confirmatory group result.
absence

Figure 10.6:
Laboratory IBCT- 0 5 10 15 20 25 30
WCT error by Wrong ABO/D to
28
category (n=71) transplant recipient

ABO-compatible 16 3

D-mismatch 14

Adult unit to neonate 4

Wrong component type 2

ABO-incompatible 2

Not high-titre negative 1

Miscellaneous 1

Wrong group Wrong patient Wrong component type

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ERROR REPORTS ANNUAL SHOT REPORT 2023

Case 10.3: Incorrect ABO red cells transfused to a post-HSCT patient due to not heeding IT
alerts

A group A D-positive patient received a group O D-positive HSCT. The patient grouped as O D-positive
and seemed to be fully converted but further investigations were required to see if the patient had
been transfused elsewhere to confirm this. A request for two units of red cells was received, and two
A D-positive red cell units were issued, of which the patient received one unit. The patient’s clinical
notes clearly stated that O D-positive red cells should be given, and a ‘specific group needed’ flag
previously added to the LIMS. The flag appeared when issuing the components but was misread and
cleared using a comment designed for use on a ‘phenotype required’ flag. Secondary LIMS checks
were also bypassed as the group and screen results were not validated before the blood was issued.
Outstanding results were discovered and validated 12 hours later when checking the outstanding
work. Unfortunately, the error was not noticed at this point and the second unit remained available
for collection but was not required. The error was only detected during a subsequent request for
red cell transfusion when BMS staff looked through recent transfusion history.

The BMS involved stated that they had been called in to cover the shift at short notice and were
rushing to clear the workload. The laboratory has plans to install a new LIMS system which has rules
for HSCT patient grouping requirements.

Please see 'Recommended resources' for guidance on safe transfusions in HSCT patients.

Learning points
• Where possible LIMS alerts and algorithms should be used to their full potential for transplant
patients, both solid organ and HSCT

• Laboratory staff require sufficient knowledge of transplant ABO requirements to not rely on IT
alerts alone

• Policies and processes must be in place to ensure specific transfusion requirements are met for
all patients especially those with complex requirements

Laboratory IBCT-SRNM errors n=156

There were 156 laboratory errors which led to patients receiving blood components which did not meet
their specific requirements, with the majority due to testing errors, 92/156 (59.0%) and component
selection errors, 48/156 (30.8%), as illustrated in Table 10.3 and Figure 10.7.

Table 10.3:
Component Laboratory IBCT-
Error Sample receipt Component Component
Testing handling
subcategory and registration selection availability SRNM errors in
and storage
2023 (n=156)

Number of
10 92 48 1 2
error reports

Miscellaneous n=3

10. Incorrect Blood Component Transfused (IBCT) 81

 ANNUAL SHOT REPORT 2023 ERROR REPORTS
figure 10.7

Figure 10.7:
Laboratory IBCT-
Incomplete testing 44
SRNM errors by
transfusion step Incorrect phenotype 2 11 19 1
(n=156)
Inappropriate EI 2 28 1

Not irradiated 5 11 1

Sample not valid 1 9 1 Sample receipt

and registration
Not K-negative 11
Testing
Component selection
Not CMV-screened 3 1 Component availability
Component handling
Not HLA-matched 2 1 and storage
Miscellaneous
Miscellaneous 11

0 5 10 15 20 25 30 35 40 45 50

EI=electronic issue; HLA=human leucocyte antigen; CMV=cytomegalovirus

Testing errors n=92

Laboratory testing errors were due to issuing of components where testing was incomplete (44/92),
inappropriate use of electronic issue (28/92), issue of red cells which were not phenotype/antigen-
matched (11/92), and testing performed on invalid sample (exceeding validity timing) (9/92).

Where testing was incomplete, this was mainly due to:

• Failure to complete antibody identification (21/44) including incorrect antibody identification

• Failure to complete internal quality control prior to transfusion (6/44)

• Failure to validate test results prior to issue (5/44)

In 23/44 of the incomplete testing cases, there were issues related to LIMS, with alerts overridden, LIMS
not used correctly, or LIMS not set up appropriately allowing issue of units prior to completion of tests.

Case 10.4: Red cells transfused to patient not meeting antigen requirements and without
serological crossmatch

Red cell units were electronically issued to a patient with AIHA and detected autoantibodies for an
urgent transfusion. This was based on a report from the reference laboratory using samples that had
exceeded the 72-hour sample expiry rule. The current sample had not been tested in-house and no
further samples had been sent to the reference laboratory for antibody investigations. Furthermore,
the unit selection recommended by previous reference laboratory reports suggested issuing
C-, K- ABO D-compatible units, but C+, K- units were selected instead. The reporter stated this
error occurred out-of-hours and that the BMS involved was not fully competent in this task. They
were asked to cover the shift at short notice due to illness, as no other sufficiently trained staff were
available. The BMS did not seek transfusion advice for this complex patient.

82 10. Incorrect Blood Component Transfused (IBCT)

ERROR REPORTS ANNUAL SHOT REPORT 2023

Learning points
• LIMS rules and algorithms should be used to full advantage to ensure blood components are
not issued prior to completion of laboratory tests and meet all specific requirements

• Electronic issue rules on LIMS should be robust, and consider all national requirements (Staves,
et al., 2024; MHRA, 2010)

• LIMS have the potential to reduce laboratory errors, but lack of functionality impacts on detection
of errors prior to issue of units. LIMS suppliers must review the capability of LIMS rules and
algorithms to ensure they are meeting patient and laboratory requirements

• Laboratory staff should adhere to UKTLC recommendations (Dowling, et al., 2024) in relation
to staff knowledge and skills, particularly where they have a requirement to provide training to
other staff to minimise the potential for compounding knowledge gaps

Contributory factors for IBCT-WCT and IBCT-SRNM

Many similar contributory factors have been found within both clinical and laboratory IBCT reports, and
impact upon patient safety (Figure 10.8).
Figure 10.8:
Contributory
factors for IBCT
errors in 2023
Over 80% of errors occurred when
staff member was deemed In the laboratory over 75% of
competency-assessed for the task errors involved IT. In the clinical
Over 20% occurred when there were area this was over 60%
gaps in staff skills or knowledge

In both the laboratory and

Over 75% of clinical errors occurred
clinical areas over 28% of reports
despite the use of a pre-administration
mention staffing and skill mix issues.
checklist. In the laboratory over 65%
In the laboratory just under 50%
of errors occurred despite the use
of errors occurred when the member
of a component labelling and exit
of staff was lone working
check being used

In nearly 50% of all IBCT-WCT and

IBCT-SRNM reports a breakdown in Over 30% of laboratory errors
communication was implicated involved emergency or urgent
transfusions. This was 57% in
clinical areas

Learning points
• A laboratory exit check, used correctly, should identify most laboratory errors prior to release of
blood components. The implementation and effective use of the PAUSE checklist or equivalent
is recommended for all transfusion laboratories (Narayan, et al., 2022)

• Errors continue to occur when staff are deemed competent. Competency documentation should
be reviewed for effectiveness and potential gaps. Competency assessments should reflect
changing demands and current standards

• Mismatches between staffing levels and workloads continue to impact on transfusion safety.
During incident investigation, potential impact of staffing levels and skill mix, particularly out-of-
hours, should be addressed and issues escalated

10. Incorrect Blood Component Transfused (IBCT) 83

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

Near miss IBCT cases n=152 (87 clinical, 65 laboratory)

In 2023 there were 152 NM IBCT events due to 87 clinical and 65 laboratory errors. Most NM IBCT-WCT
involved potential transfusion to the wrong patient, 75/107 (70.1%) and most NM IBCT-SRNM involved
potential transfusion of non-irradiated components when these were required, 32/45 (71.1%). These
themes match those observed in transfused errors for clinical incidents, but differ to the themes seen
in laboratory transfused errors (the majority being wrong group to transplant patient and incomplete
testing). NM IBCT cases are discussed further in the supplementary chapter which can be found in the
supplementary information on the SHOT website (https://www.shotuk.org/shot-reports/report-summary-
and-supplement-2023/).

Conclusion
Ineffective safety checks at various steps in the transfusion process continue to lead to IBCT errors. This
includes patient misidentification, which remains a safety issue throughout all of healthcare, as outlined in
the HSSIB patient safety report (HSSIB, 2024). For blood transfusion, misidentifying patients may result
in patients receiving blood intended for another patient, or not receiving blood when required, both of
which can result in serious patient harm. Patient identification can be challenging and often repetitive, and
the critical importance of accurate PID can be overlooked. SHOT data indicates that PID weaknesses
lie at sample taking, collection and administration stages of the transfusion pathway. As recommended,
the use of a pre-administration transfusion checklist should now be embedded into healthcare settings
(Davies & Cummings, 2017), but significant numbers of errors continue to be reported. Where these
errors occur within organisations, checklists must be reviewed for their effectiveness and improved.
This point is mirrored in the laboratory IBCT errors reported, where over 65% of reporters stated their
organisation used a laboratory exit check for components.

Safety checks are not merely check boxes to be marked off. They are critical actions designed to ensure
integrity of the process and patient safety. Safety checks require careful attention, thoroughness and
understanding of the underlying principles to be effective. Treating them as mere formalities undermines
their purpose and can lead to serious consequences.

Laboratory IBCT errors, both WCT and SRNM, have increased substantially. There has been a dramatic
rise in the number of component selection errors, particularly to HSCT patients, resulting in the wrong
ABO group being transfused to patients. Errors where blood components were issued before laboratory
testing was completed and errors where blood was issued inappropriately using electronic issue have
also increased significantly. LIMS rules should provide assistance and prompts in these circumstances,
yet these errors continue to increase. LIMS rules and algorithms must identify these errors and alert
staff prior to the release of blood components.

Suboptimal training is still evident as indicated by the large number of staff who are deemed competent
for the task undertaken. Competency assessments are limited in developing the higher-level knowledge
and skills in problem-solving, decision-making and critical thinking. Persistent recruitment and retention
issues impact hugely on the ability to train new staff and maintain competency in existing staff. SHOT
reports suggest gaps in staffing numbers have required some staff to join out-of-hours and lone working
situations before they are trained.

IT continues to be a contributory factor in IBCT errors. Increasing numbers of organisations are

implementing new hospital-wide electronic patient record systems, thus adding an additional burden
to staff. New systems can resolve some existing problems but do introduce new issues. The Judiciary
Preventable Future Deaths have detailed cases which include concerns relating to hospital IT systems,
including poor interoperability between IT systems, and sufficient alerts and flags in line with UK guidance
and recommendations (Courts and Tribunals Judiciary, 2024).

84 10. Incorrect Blood Component Transfused (IBCT)

ERROR REPORTS ANNUAL SHOT REPORT 2023

Recommended resources
Pre-transfusion administration checklist
Laboratory and clinical PAUSE checklists
https://www.shotuk.org/resources/current-resources/
SHOT Safety Notice 02: SRNM 2022
https://www.shotuk.org/resources/current-resources/safety-notices/

Safe transfusions in haemopoietic stem cell transplant recipients

https://www.shotuk.org/resources/current-resources/

Shared care - Blood transfusion shared care form

https://nationalbloodtransfusion.co.uk/rtc/east-england/documents-and-resources/

References
Courts and Tribunals Judiciary, 2024. Prevention of Future Death Reports. [Online] Available at: https://www.judiciary.
uk/?s=&pfd_report_type=&post_type=pfd&order=relevance (Accessed 01 May 2024).

Davies, D. S. & Cummings, J., 2017. Safe transfusion practice: use a bedside checklist, UK: Medicines and Healthcare
products Regulatory Agency (MHRA). Available at: https://www.cas.mhra.gov.uk/Home.aspx (Accessed 08 April 2024).

Dowling, K. et al., 2024. UK Transfusion Laboratory Collaborative: Minimum standards for staff qualifications, training,
competency and the use of information technology in hospital transfusion laboratories 2023. Transfusion Medicine,
34(1), pp. 3-10. doi: https://doi.org/10.1111/tme.13029.

Elliot, J. et al., 2021. Missed irradiation of cellular blood components for vulnerable patients: Insights from 10 years of
SHOT data. Transfusion Medicine, 61(2), pp. 385-392. doi: https://doi.org/10.1111/trf.16189.

Foukaneli, T. et al., 2020. Guidelines on the use of irradiated blood components. British Journal of Haematology, 191(5),
pp. 704-724. doi: https://doi.org/10.1111/bjh.17015.

Health Services Safety Investigations Body (HSSIB), 2024. National learning report: Positive patient identification. [Online]
Available at: https://www.hssib.org.uk/patient-safety-investigations/positive-patient-identification/national-learning-
report/ (Accessed 08 April 2024).

Medicines and Healthcare products Regulatory Agency (MHRA), 2010. Guidance: Electronic issue of blood components.
[Online] Available at: https://www.gov.uk/government/publications/electronic-issue-of-blood-components (Accessed 01
May 2024).

Narayan, S. et al., 2022. The 2021 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. doi: https://doi.org/10.57911/QZF9-XE84.

Serious Hazards of Transfusion (SHOT), 2024. UKTLC. [Online] Available at: https://www.shotuk.org/resources/current-
resources/uktlc/ (Accessed 02 May 2024).

Staves, J. et al., 2024. Guidelines for the specification, implementation and management of IT systems in hospital
transfusion laboratories: A British Society for Haematology Guideline. Transfusion Medicine, 34(2), pp. 81-166. doi:
https://doi.org/10.1111/tme.13027.

10. Incorrect Blood Component Transfused (IBCT) 85

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

Handling and Storage Errors (HSE)

11 n=342

Authors: Heather Clarke, Nicola Swarbrick, and Victoria Tuckley

Definition:
All reported episodes in which a patient was transfused with a blood component or plasma
product intended for the patient, but in which, during the transfusion process, the handling and
storage may have rendered the component less safe for transfusion.

Abbreviations used in this chapter

HSE Handling and storage error NM Near miss

Key SHOT messages

• Clinical errors contribute to 259/342 (75.7%) of HSE errors reported in 2023, with excessive time
to transfuse, pump and giving set errors accounting for most of these errors, 193/259 (74.5%)

• Of the laboratory errors, cold chain errors including inappropriate return to stock and refrigerator
failure accounted for most errors, 54/83 (65.1%)

Recommendations
• Laboratories should have an effective procedure in place to periodically test the functionality
and alarm settings of their temperature-monitoring systems

Action: Transfusion laboratory managers

• A structured handover in clinical areas is needed when patients are receiving a transfusion that
continues into the next shift. This should be audited regularly to inform local improvement actions

• Any gaps in staff knowledge need to be identified and addressed in transfusion training

Action: Education leads, ward managers, audit leads

86 11. Handling and Storage Errors (HSE)

ERROR REPORTS ANNUAL SHOT REPORT 2023

Headline data 2023 HSE reports by year

278 272
264 342
254
243 244
306
278 272
193 254
188 192 264
244
Number of reports n=342
243

188 192
Deaths n=0
Major morbidity n=0

2014
2013 2015
2014 2016
2015 2017
2016 2018
2017 2019
2018 2020
2019 2021
2020 2022
2021 2023
2022

Demographic data Blood component data

Red cells n=289

Platelets n=29
Plasma n=16
Cryoprecipitate n=4
Male Female Adults Paediatric
n=170 n=147 n=282 n=32 Granulocytes n=1
Multiple components n=3
Unknown n=25 Unknown n=28

Introduction
There was an increase of errors reported from 272 in 2022 to 342 in 2023. HSE errors accounted for
342/3833 (8.9%) errors in 2023 compared with 272/3499 (7.8%) in 2022 (Narayan, et al., 2023). Clinical
errors accounted for 259/342 (75.7%), which figure 11.1percentage than 2022, 218/272 (80.1%), and
is a smaller
laboratory errors for 83/342 (24.3%), which is an increase from 2022, 54/272 (19.9%). The variation
between clinical and laboratory errors are illustrated in Figure 11.1.
Figure 11.1:
Breakdown of
Handling and storage errors n=342 2023 handling and
storage error (HSE)
reports (n=342)
Clinical 259

Laboratory 83

Technical Excessive time Cold chain errors Expired unit Reservation Unit damaged or Miscellanous Incorrectly
administration to transfuse n=86 transfused period exceeded tampered with n=2 prepared n=1
errors n=118 errors n=89 n=24 n=18 n=4

118 89 32 14 1 4 1

54 10 17 1 1

Deaths related to transfusion n=0

There were no deaths that were related to errors associated with HSE in 2023.

Major morbidity n=0

There was 1 case of major morbidity related to a HSE error in 2023, but as an uncommon reaction,
this has been included in the numbers for the UCT category. A patient developed chest pains and
desaturation soon after the start of a blood transfusion. The clinical deterioration was due to venous air

11. Handling and Storage Errors (HSE) 87

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

embolism following inappropriate preparation of the line prior to transfusion. This highlights the potential
complications following HSE errors. Proper handling and storage of blood products are crucial for
ensuring patient safety and effectiveness of transfusions. See Chapter 20, Uncommon Complications
of Transfusion (UCT), Case 20.3 for more details.

Clinical HSE errors n=259

The number of clinical errors has increased (from 218 reported in 2022 to 259 in 2023) and a similar
rise in technical administration errors was noted,118/259 (45.6%) in 2023 and 94/218 (43.1%) in 2022.
Technical administration errors have been further categorised in Table 11.1.

Table 11.1: Technical administration error Total

Clinical technical Pump programming error 62
administration Incorrect giving set 39
errors (n=118) Same venous access used 7
Manual drip rate incorrect 4
Miscellaneous 3
Prescribed too fast 2
Recalled but given in error 1
Total 118

Of the 62 administration pump errors, 51 incidents related to the pump being set incorrectly despite a
correct prescription. There were 39 errors related to giving sets, of which 2 also had additional errors
(excessive time to transfuse and incorrect preparation).

Excessive time to transfuse errors occur equally within routine hours and out of routine hours. These
are reported more frequently following routine requests (46/89) than during emergency/urgent requests
(31/89). When asked, 42/89 reporters felt that handover had impacted on the error but only 23/42 had
a structured handover in place between shifts and staff changes. Examples of structured handover
process were initially outlined by the NHS Institute for Innovation and Improvement (2010) Situation,
Background, Assessment and Recommendation (SBAR) implementation and training guide. Laboratory
areas can also benefit from good quality structured handovers (Tuckley, et al., 2022).

Case 11.1: Excessive time to transfuse using the wrong giving set

When receiving a non-urgent transfusion, the patient reported that the transfusion they were receiving
had run for an extended period (approximately 6 hours). It was found to have been administered
through the incorrect giving set. Upon investigation, the documentation was found to be sub-
optimal. No stop time and no end observations were recorded. There were no medical or nursing
notes pertaining to the transfusion. The patient was in the day surgery unit which after hours was
covered by agency staff supervised by a single substantive nurse not familiar with this area.

Non-urgent transfusion should be avoided outside of routine hours, where at all possible and not
detrimental to patient safety. Providing comprehensive orientation and support to agency staff can help
address challenges they face when working in unfamiliar surroundings. It is important that transfusions
are given in settings which support safe practice and have appropriately trained staff.

Laboratory HSE errors n=83

The number of laboratory errors have increased to 83 in 2023 from 54 in 2022, with the majority being
cold chain errors, 54/83 (65.1%), which have been further categorised in Table 11.2.

88 11. Handling and Storage Errors (HSE)

ERROR REPORTS ANNUAL SHOT REPORT 2023

Table 11.2:
Cold chain error Number of cases
Laboratory cold
Inappropriate return to stock 27
chain errors (n=54)
Refrigerator/equipment failure 17
Incomplete cold chain 7
Transport and delivery 2
Inappropriate storage 1
Total 54

Of the 17 refrigerator/equipment failure errors, 9 involved a temperature-monitoring system and of the

27 inappropriate returns to stock errors, 7 involved a blood-tracking system.

Case 11.2: Temperature-monitoring system alarm limits set incorrectly

During a training session the transfusion practitioner noted that the issue refrigerator door was
slightly ajar, and closed the door, but did not inform the laboratory staff at the time of the event.
Later, when laboratory staff reviewed the temperature logs on the temperature-monitoring system
and the paper chart on the refrigerator, it was noted that the temperature had been above 6oC for
approximately 2 hours. The lead biomedical scientist immediately initiated a recall of all red cell
components that had been stored in the refrigerator during the time that it had been outside the
acceptable temperature.

It emerged that one patient had been transfused with a unit of red cells implicated in the temperature
excursion. The consultant haematologist was made aware and there was no obvious adverse
reaction in the patient. Five other red cell units were disposed of. The blood refrigerator temperature-
monitoring system usually triggers an audible and visual alarm in the laboratory, but this did not
occur. The alarm settings were reviewed, and it was noted that the air temperature alarm was set
to trigger at 7.7oC with a 5-minute delay. No justification could be provided for the air alarm setting
and so it was immediately adjusted to meet requirements. The blood refrigerator temperature probes
were connected to a third-party alarm escalation service, but did not trigger an alarm to switchboard
as expected.

The blood refrigerator was also fitted with a door open alarm. The settings for this were checked
and found to be on 3-minute delay, this has since been adjusted to a 1-minute delay. It is not clear
whether the door alarm did sound on the day of the event but, during testing, it was observed that
the alarm was not very loud.

Learning points
• Blood giving sets should be stored in clearly labelled containers and distinguishable from other
giving sets to prevent selection of the wrong type

• Staff should be trained to use pumps appropriately, verify pump settings regularly and minimise
interruptions to focus on critical tasks

• To prevent excessive time to transfuse incidents, clinical areas need to have a system in place
to alert staff and the patient when a transfusion should stop, and the unit be taken down. An
example of an innovative solution can be found in Chapter 10, Handling and Storage Errors
(HSE) of the 2022 Annual SHOT Report (Narayan, et al., 2023)

11. Handling and Storage Errors (HSE) 89

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

Near miss HSE errors n=138

There were 138 handling and storage near miss events in 2023, including 104 clinical errors and 34
laboratory errors. Of the clinical NM-errors, 93 were cold chain errors where blood components were
stored in inappropriate conditions in the clinical area, and in 11 cases expired blood components were
collected. Of the laboratory NM-errors these were mainly due to 23 expired units issued, and 6 cold
chain errors. Insufficient handover impacted upon 37/138 (26.8%) NM-HSE errors, and mostly affected
clinical cold chain errors, 25/93 (26.9%).

Conclusion
The overall findings remain consistent with previous Annual SHOT Reports with an increasing trend in
reported errors especially in the laboratory. There continues to be a mismatch between workload and
staffing in both the clinical and laboratory areas. It also highlights that even though staff are trained and
competency-assessed the same errors keep happening. SHOT reiterates that all staff who participate
in the handling and storage of blood components throughout the transfusion process should be aware
of and adhere to the correct procedures that are outlined in guidelines and their local transfusion policy.
Transfusion policies should be easy to access and contain useful information based on the most current
published guidance available (Robinson, et al., 2018). By embedding these policies in working practice,
safe patient care overall can be achieved.

Recommended resources
Patient Blood Management - Blood assist app

Apple (https://apps.apple.com/gb/app/blood-assist/id1550911130)
Google play (https://play.google.com/store/apps/details?id=uk.nhsbt.bloodassist)
Web based (https://www.bloodassist.co.uk/)

NHS Institute for innovation and improvement Safer care SBAR Situation,
Background, Assessment and Recommendation implementation and training guide:
https://www.england.nhs.uk/improvement-hub/wp-content/uploads/sites/44/2017/11/SBAR-
Implementation-and-Training-Guide.pdf

References
Narayan, S. et al., 2023. The 2022 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. doi: https://doi.org/10.57911/WZ85-3885.

NHS Institute for Innovation and Improvement, 2010. Safer care SBAR, Situation, Background, Assessment and
Recommendation implementation and training guide, UK : NHS England (NHSE). Available at: https://www.england.nhs.
uk/improvement-hub/wp-content/uploads/sites/44/2017/11/SBAR-Implementation-and-Training-Guide.pdf (Accessed
08 April 2024).

Robinson, S. et al., 2018. The administration of blood components: a British Society for Haematology Guideline.
Transfusion Medicine, 28(1), pp. 3-21. doi: https://doi.org/10.1111/tme.12481.

Tuckley, V. et al., 2022. Safe handovers: Safe patients-why good quality structured handovers in the transfusion
laboratory are important. Transfusion Medicine, 32(2), pp. 135-140. doi: https://doi.org/10.1111/tme.12853.

90 11. Handling and Storage Errors (HSE)

ERROR REPORTS ANNUAL SHOT REPORT 2023

Avoidable, Delayed or Under/

Overtransfusion (ADU) and Incidents
Related to Prothrombin Complex
Concentrate (PCC) n=382 12
Authors: Paula Bolton-Maggs, Simon Carter-Graham, Catherine Booth, and Josephine McCullagh

Abbreviations used in this chapter

AAGBI Association of Anaesthetists of ICH Intracranial haemorrhage
Great Britain and Ireland ICU Intensive care unit
ADU Avoidable, delayed or under/overtransfusion INR International normalised ratio
BMS Biomedical scientist IR Interventional radiology
BSH British Society for Haematology IT Information technology
CAS Central alerting system MHP Major haemorrhage protocol
CT Computed tomography NHSE National Health Service England
DOAC Direct acting oral anticoagulant PCC Prothrombin complex concentrate
ED Emergency department 4F-PCC Four factor PCC
FBC Full blood count TACO Transfusion-associated circulatory overload
FFP Fresh frozen plasma TRALI Transfusion-related acute lung injury
GI Gastrointestinal UK United Kingdom
Hb Haemoglobin WBIT Wrong blood in tube

Key SHOT messages

• Delays in blood component transfusion and PCC administration are often multifactorial and
impact on patient safety

• Avoidable and overtransfusions could be reduced by improved management of haematinic

deficiency

• Mistakes continue to be made with paediatric prescribing and administration

• Common contributory factors to reported incidents include suboptimal staffing levels, mismatched
with workload, gaps in staff knowledge, poor staff training, failure to communicate effectively

Specific chapter-related recommendations are covered in the individual chapters. Only those applicable
to all categories are covered here.

Recommendations
• Clear guidelines for patients being transferred between hospital departments, or between
hospitals must be available and followed to ensure patient safety. This should include the need
for adequately trained and skilled staff to supervise the transfer

• Major haemorrhage protocols should be reviewed and practiced end-to-end with drills to ensure
that they are workable, and that staff are familiar with them

Action: Hospital chief executive officers, transfusion laboratory managers, hospital

transfusion committees

12. Avoidable, Delayed or Under/Overtransfusion (ADU),

91
and Incidents Related to Prothrombin Complex Concentrates (PCC)
 ANNUAL SHOT REPORT 2023 ERROR REPORTS

Headline data 2023 ADU reports by year

382
365
347

279 285

Number of reports n=382 245 246

225 236
185
Deaths n=14
Major morbidity n=14

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Demographic data Blood component data

Red cells n=274
Platelets n=33
Plasma n=11
Multiple components n=25
PCC n=23
Male Female Adults Paediatric
Granulocytes n=3
n=162 n=215 n=331 figure Cryoprecipitate
n=40 12.1 n=1
Unknown n=5 Unknown n=11 Unknown n=12

Figure 12.1: ADU

reports by category
2014-2023 Avoidable
400
Delayed
23
350 Under or Overtransfusion 21 20
18 18
PCC
34
300
16 17
250 25
4 10 35 212
31 21 9 205
5 15
24 179
200
2 133
10
94 101 106 129
150 50 95

100
123 116 114 101 106 99 110 116 121 127
50

0
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

PCC=prothrombin complex concentrates

12. Avoidable, Delayed or Under or Overtransfusion (ADU),

92
and Incidents Related to Prothrombin Complex Concentrates (PCC)
ERROR REPORTS ANNUAL SHOT REPORT 2023

Overview of ADU cases

Cases submitted to SHOT in the ADU categories have been increasing steadily in the recent years. The
cases from 2023 are summarised in Table 12.1.

Deaths Table 12.1:

Major Paediatric Near miss
ADU category Total cases related to Overview of ADU
morbidity cases cases
transfusion* cases in 2023
Delayed transfusions 212 9 12 23 0 (n=382)
Avoidable transfusions 127 0 0 8 3
Under or overtransfusion 20 1 2 9 1
Incidents related to PCC 23 4 0 0 0
Total 382 14 14 40 4
*There was 1 death that was definitely related to delayed PCC (imputability 3), and 3 deaths due to delays that were probably related
(imputability 2). The remaining 10 deaths were possibly related to transfusion (imputability 1)

Problems with MHP activations n=65

In 65 cases, errors related to activation of the MHP were reported (28 of these occurred out-of-hours):

• 50 delays (2 deaths possibly related)

• 12 avoidable including 10 instances with use of O D-negative red cells

• 1 undertransfusion

• 2 overtransfusion (1 death possibly related)

For more information, analysis, and case studies on problems with MHP activations, please see the
supplementary information on the SHOT website (https://www.shotuk.org/shot-reports/report-summary-
and-supplement-2023/).

Recommended resources
Avoidable, Delay and Under or Overtransfusion (ADU) Cumulative Data
https://www.shotuk.org/resources/current-resources/data-drawers/avoidable-delay-and-under-or-
overtransfusion-adu-cumulative-data/

12. Avoidable, Delayed or Under/Overtransfusion (ADU),

93
and Incidents Related to Prothrombin Complex Concentrates (PCC)
 ANNUAL SHOT REPORT 2023 ERROR REPORTS

12a Delayed Transfusions n=212

Authors: Paula Bolton-Maggs, Josephine McCullagh, Simon Carter-Graham

Definition:
Where a transfusion of a blood component was clinically indicated but was not undertaken or
non-availability of blood components led to a significant delay (e.g., that caused patient harm,
resulted in admission to ward, or return on another occasion for transfusion).

Key SHOT messages

• Poor communication at multiple points during the patient’s care is common and exacerbates delays

• Delayed recognition of bleeding increases morbidity and mortality. Low blood pressure should
alert clinicians to consider haemorrhage

• MHP are either not activated when indicated or not followed correctly

• Staffing issues contribute to delayed transfusions

• Lack of knowledge and awareness of correct procedures contributes to delays in transfusion

Recommendations
• Activation of MHP should be simple and standardised to avoid issues with hospital-specific
procedures

• Hospitals should review their MHP and test them with drills and simulation to ensure they are fit
for purpose. This should cover all the steps in the process from end-to-end and must include
all staff groups involved

• MHP activations should be followed by a debrief with everyone involved to identify what went
well and what could be improved

• Transfusion professionals should work closely with higher education institutes to ensure that
the courses they are offering are fit for purpose and ensure all staff are equipped with the skills
and knowledge they require to deliver safe transfusions

Action: Hospital transfusion committees, higher education institutes

Introduction
The number of delays in transfusion reported to SHOT has increased (n=212) when compared to the
previous year (n=205) see Figure 12a.1. Incorrect activation of the MHP remains a key issue contributing
to delays in transfusion, and this is consistent over the past 5 years. Increasing reports of delays prompted
the publication of a CAS alert, with actions for hospitals (SHOT, 2022). A recent survey evaluating the
effectiveness of the CAS national alert noted that 42% of responders did not have adequate resources
to action the recommendations, and 71% identified staffing issues as the main barrier to implementing
any actions. Inadequate staffing and poor skills mix in transfusion laboratories has increased over the
last decade. See the ‘Recommended resources’ for a link to the survey report.

94 12a. Delayed Transfusions

 figure 12a.1
ERROR REPORTS ANNUAL SHOT REPORT 2023

Figure 12a.1:
Delayed
212 transfusions by
Total cases 205
Deaths year 2011-2023
179

129 133

106
99 95
94

50
34
21 12 13
12 9 6 8 9 9
1 0 5 3 6 2

2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Deaths related to transfusion n=9

There were 9 deaths reported due to delays. This compares with 13 deaths in 2022 and 9 in 2021.
More than half of all deaths were associated with delays in urgent or emergency transfusions for patients
in the ED. Common themes were delays in decision-making and missing vital steps in the transfusion
process due to lack of knowledge, training, and poor staffing levels. In 4 cases, there were transfusion
delays in patients with acute bleeding. Three deaths were probably related (imputability 2) and 6 were
possibly related (imputability 1) to the transfusion delay.

Case 12a.1: Delay in red cell transfusion in patient with a GI bleed awaiting a hospital
bed contributes to death
An elderly patient with haematemesis, dark stool and shortness of breath was attended at home by
a paramedic crew. The patient had tachycardia and was pale with low blood pressure. The patient
was taken as an emergency to the ED. On arrival there were delays offloading from the ambulance
due to lack of available space. Whilst still in the ambulance, the patient began to deteriorate and
despite escalating care from the paramedics and a haemoglobin of 38g/L, treatment was delayed
by more than 2 hours and the patient passed away from a cardiac arrest.

Case 12a.2: Lack of understanding on how to activate the MHP contributes to patient
death
A patient with a perforated duodenal ulcer was being managed as an outlier in a COVID-19 bay.
The clinical team caring for the patient identified that the patient was bleeding and there was a
requirement for urgent blood components. Due to unfamiliarity with the management of MH, staff
failed to correctly activate the MHP. Instead, a doctor instructed a nurse, not directly involved in
this patient’s care, to ‘get blood’ without conveying the urgency. Lack of vital information caused
confusion between the laboratory staff and the nurse as to what was expected. The communication
difficulties were compounded by lack of understanding among staff about how to activate the MHP.
The patient was in a COVID-19 bay and the rarity of major bleeding in a ward environment caused
delay in blood transfusion which contributed to the death of this patient.

One case resulted in the death of a patient due to incorrect laboratory procedures with delay in recognition
and subsequent treatment. This involved a patient who presented with cytopenia with a delay in the
diagnosis of acute promyelocytic leukaemia and died of bleeding. This case is described in detail in
Chapter 15, Laboratory Errors (Case 15.1).

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Learning points
• Failure to communicate urgency of requests leads to delays in blood component provision.
Ensure that requests for samples and blood components are clear and that the urgency is stated

• Good handover is essential especially when serious bleeding occurs out-of-hours

• Recognition of bleeding is crucial for timely and appropriate treatment

• Laboratory staff working in transfusion must be adequately trained and competency-assessed,

especially in identifying urgent cases when ‘lone working’ out-of-hours

Major morbidity n=12

Seven of 12 reports that resulted in major morbidity were associated with MHP and 10/12 were due to
delays in urgent (2) or emergency (8) transfusion.
figure 12a.2
Delays associated with MHP n=50
There has been a general increase in the number of delays associated with MHP over the last few years
of SHOT reporting, see Figure 12a.2.

Figure 12a.2:
Number of delayed 50
transfusions
associated with 42

MHP 2016-2023

28
25

19 19
16 16

2016 2017 2018 2019 2020 2021 2022 2023

Figure 12a.3 illustrates the key factors contributing to delayed transfusion in major haemorrhage situations
reported to SHOT in 2023.

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Figure 12a.3: Key

factors contributing
Communication 34 to delayed
Laboratory not involved in MHP activation
transfusions in
Request misunderstood by laboratory staff
Incomplete or confusing information given major haemorrhage
Unable to access emergency blood
in 2023 (n=50)

Failure to follow MHP correctly 22

Failure to activate MHP
Incorrect activation method
Lack of knowledge of MHP

Laboratory - grouping,
Components received
Haemorrhage call antibody screen, component
and transfused
selection and issue

Staff skill and knowledge 19 IT/machine issues 16

Delay in decision-making Access to refrigerator
Delayed recognition of bleeding Printer failure
Pager failure

Blood components administered during MH

Red cells = 27 Plasma = 2 Platelets = 1 Red cells and plasma = 13
Red cells, platelets and plasma = 2 Multiple components (unknown) = 5

MHP=major haemorrhage protocol; IT=information technology

Learning points
• Failure to communicate effectively in urgent situations causes unnecessary delays in transfusion

• MHP are either not activated when indicated or not followed correctly. Emergency procedures
such as MHP should be simple and easy to follow

Laboratory errors n=56

Laboratory errors discussed here cover both hospital transfusion laboratories and Blood Services. Key
themes identified in laboratory errors resulting in delays were lack of knowledge and training of staff
(n=17) and failure in effective communication (n=18).

Case 12a.3: A sample that did not meet acceptance criteria was sent to the Blood Service
resulting in unnecessary delay in transfusion
An elderly person requiring transfusion for the treatment of chronic anaemia had a blood sample
taken for group and screen. The sample was accepted by the hospital transfusion laboratory and
referred to the laboratory in the Blood Service for further testing. The Blood Service staff telephoned
the hospital laboratory to inform them that the surname on the sample did not match the surname
on the request form and therefore the sample had been rejected. This required a repeat sample and
caused a delay in the provision of red cells for the patient.

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The labelling error should have been detected earlier in the process which would have avoided the delay.

Case 12a.4: BMS decided not to thaw cryoprecipitate due to previous high levels of
wastage
The MHP was activated for a patient with major bleeding post-surgery. Cryoprecipitate was ordered
as part of the initial ‘Pack 1’. The BMS working in the transfusion laboratory decided not to thaw the
cryoprecipitate because they had encountered wastage of frozen components in a previous shift.
This decision resulted in a 75-minute delay in the issue of cryoprecipitate. The patient recovered
and survived.

Case 12a.5: Printer failure caused delay in transfusion

The MHP was activated for a patient suffering from a GI bleed. There was a delay in the blood
components being issued as the printer failed to print labels. The BMS did not realise that the printer
had run out of labels and tried to reprint. The BMS contacted senior staff at home for advice. The
printer was reloaded with labels, but they were misaligned. The patient was given two units of red
cells after a 15-minute delay.

Laboratory staff failed to use backup label printer/emergency unit labels to allow issue of units in a
timely manner.

Learning points
• Awareness of contingency/back up plans is essential to ensure smooth processes when technical
issues arise

• Worries about component wastage should not result in delays in component provision especially
in emergency situations

• Timely communication can prevent additional delays

Blood Service errors n=8

There were 8 reports due to Blood Service issues that resulted in delay in transfusion, an increase
compared to 1 in the 2022 Annual SHOT Report (Narayan, et al., 2023).

Case 12a.6: Incorrect red cell units sent to the hospital results in delayed transfusion
Samples were sent from a hospital transfusion laboratory to a Blood Service reference laboratory
for further testing and crossmatching of red cell units. The reference laboratory completed the
testing but sent the blood components to the wrong hospital. This error resulted in a 2-hour delay
in treatment.

Learning points
• Clear and adequate communication between Blood Service staff and hospital laboratory staff is
essential to prevent miscommunication and to avoid delays in testing and supply of urgent blood
components

• The risk of blood components being sent to the wrong location can be reduced by ensuring
there are sufficient checks in place before sending blood components to hospitals transfusion
laboratories

Conclusion
Patients should not die or suffer harm from transfusion delays. Poor communication, lack of staff
knowledge and skills contributes to many cases of delay especially during major haemorrhage. The
recommended actions in the SHOT CAS alert will help address preventable transfusion delays and
improve patient safety (SHOT, 2022). Staffing levels and skill mix have been identified as barriers for
effective implementation of the recommendations and must be addressed.

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Recommended resources
SHOT Bite No. 8: Massive Haemorrhage Delays
https://www.shotuk.org/resources/current-resources/shot-bites/

SHOT Video: Delayed Transfusion in Major Haemorrhage

https://www.shotuk.org/resources/current-resources/videos/

SHOT Webinar: Every Minute Counts

https://www.shotuk.org/resources/current-resources/webinars/

2018 National Comparative Audit of Major Haemorrhage

https://hospital.blood.co.uk/audits/national-comparative-audit/reports-grouped-by-year/2018-audit-
of-the-management-of-major-haemorrhage/

Can you PACE yourself? The power of language to flatten hierarchy and empower multi-
disciplinary healthcare teams in simulated critical scenarios
https://www.gloshospitals.nhs.uk/work-for-us/training-staff/gsqia/quality-improvements/Can-you-
PACE-yourself/

15s30m stands for 15 seconds, 30 minutes – taking a few extra seconds at the start of a
process can save someone a lot of time further along, reducing frustration and increasing
joy at work.
https://fabnhsstuff.net/fab-stuff/15-seconds-30-minutes

Transfusion 2024 – A 5-year Plan for Clinical and Laboratory Transfusion

https://www.nationalbloodtransfusion.co.uk/sites/default/files/documents/2023-03/Transfusion%20
2024%20Brochure%20FINAL%20%2811.12.2020%29.pdf

References
Narayan, S. et al., 2023. The 2022 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. doi: https://doi.org/10.57911/WZ85-3885.

Serious Hazards of Transfusion (SHOT), 2022. Central Alerting System: Preventing transfusion delays in bleeding
and critically anaemic. [Online] Available at: https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.
aspx?AlertID=103190 (Accessed 08 April 2024).

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12b Avoidable Transfusions n=127

Authors: Catherine Booth, Paula Bolton-Maggs and Simon Carter-Graham

Definition:
Where the intended transfusion is carried out, and the blood component itself is suitable for
transfusion and compatible with the patient, but where the decision leading to the transfusion is
flawed. Every unit transfused should be an individual decision, so this might include transfusion
of multiple units where not all were appropriate/necessary.

Reporting should include:

• Components that are not required or are inappropriate because of erroneous laboratory
results, transcription errors, miscommunication, or faulty clinical judgement

• Components that are for an inappropriate indication

• Transfusion of an asymptomatic patient with haematinic deficiency

• Avoidable use of emergency group O blood (D-negative or D-positive) where group-specific

or crossmatched blood was readily available for the patient or the laboratory could have
supplied a more suitable component, including use of group O when time would allow a
more appropriate group to be remotely allocated from a remote release refrigerator system

Key SHOT messages

• It is essential to establish the cause of thrombocytopenia before transfusing platelets. A blood
film should be examined to confirm a low platelet result even in patients who might be expected
to have thrombocytopenia

• Accurate patient identification is fundamental in all healthcare interactions. This involves positive
patient identification at the time of taking any blood sample. It is also important when carrying
out tasks such as writing in notes or on a prescription chart

Recommendations
• Training in major haemorrhage protocols should be multidisciplinary and include all staff involved
when MHP is activated

• Training should emphasise that group O red cells are only used when group-specific or
crossmatched red cells are not readily available

Action: Hospital transfusion teams

Introduction
There were 127 reports of avoidable transfusions, similar to the 121 reported in 2022. Components
involved were 109 red cells, 15 platelets, 2 FFP and 1 cryoprecipitate.

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Note that where avoidable transfusions cause a reaction in a patient, such as a febrile, allergic or
hypotensive reaction or TACO, these are included in the corresponding reaction chapter rather than here.
The total number of transfusions reported to SHOT which were felt to be avoidable is therefore greater.

Deaths related to transfusion n=0

There were no deaths related to avoidable transfusions in 2023.

Major morbidity n=0

There were no patients suffering major morbidity because of an avoidable transfusion in 2023.

Classification of avoidable transfusions n=127

Table 12b.1:
Plasma
Group Red cells Platelets Total reports Classification
components
of avoidable
Flawed decision 32 7 2 41
transfusions by
error type and
Appropriate decision, inappropriate component 37 0 0 37
blood component
(n=127)
Decision based on inaccurate results 25 5 1 31

Failure to respond to change in circumstances 7 2 0 9

Transfusion without decision 7 1 0 8

Transfusion necessitated by equipment failure 1 0 0 1

Total 109 15 3 127

Flawed decision n=41

Cases of flawed decision included: transfusion for haematinic deficiency (n=15), transfusion of multiple
units without reassessment (n=4), transfusion outside of guidelines without clinical justification (n=12: 6
of which were platelets), overestimation of blood loss (n=5), transfusion of someone who had withheld
consent (n=3), misinterpretation of thromboelastography (n=1).

Case 12b.1: Unnecessary empirical transfusion given for upper gastrointestinal bleeding
A patient with alcoholic liver disease presented after vomiting blood at home. They were
haemodynamically stable, but two units of red cells were transfused without any Hb check. The
post-transfusion Hb was 125g/L.

The results suggest this patient had not lost a volume of blood sufficient to require transfusion. The
2022 National Comparative Audit of upper gastrointestinal bleeding, which is expected to be released
later in 2024, has highlighted that overtransfusion is common in this patient group and is associated
with adverse patient outcomes (Booth 2024, personal communication. 13 March).

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Learning point
• Not all patients presenting with bleeding require transfusion. Unless there is haemodynamic
instability, a Hb check should be performed first, and restrictive thresholds applied outside of
major haemorrhage

Appropriate decision, inappropriate component n=37

These were all avoidable use of group O red cells.

In 7 patients there was delay in sending a group and screen sample, and in 4 there were laboratory
delays in sample processing.

In 15 cases, crossmatched blood was available, in 5 of these the laboratory was not told that the
patient needed blood urgently, and in 10 the clinical team collected group O units in error. There is a
misconception that group O is the correct component to be given in all emergencies.

Case 12b.2: Lack of understanding of appropriate use of O D-negative red cells

The doctor caring for a trauma patient was not aware that crossmatched red cells were available
and requested O D-negative emergency units. The porter delivered named patient units from the
laboratory, but the nurse rejected these twice as she was expecting emergency O D-negative units
rather than named patient units (D-positive). The nurse did not check the compatibility label which
confirmed the units supplied were for that patient.

Learning point
• The whole multidisciplinary team need to understand the role of group O emergency units, in
particular that these are to use only to preserve life until crossmatched units are available

In 5 cases there were problems with collection of crossmatched units, though this also highlights
resilience in the system protecting the patient from delays to transfusion. Two reports described errors
in IT systems preventing access to crossmatched units and 3 patients were given emergency group O
units when transfusion was not urgent.

Decision based on inaccurate result n=31

Cases where decisions were based on inaccurate results included: FBC sample taken from a drip arm
(n=9), inaccurate point-of-care sample (n=6), use of previous results (n=4), platelet clumping (n=4), WBIT
in FBC sample (n=3), wrong patient’s result used (n=2), analyser error (n=3).

Learning point
• Wrong blood in tube is not only significant for transfusion samples. WBIT in FBC or biochemistry
samples can result in inappropriate patient treatment. Positive patient identification is essential
before taking any sample

Case 12b.3: Platelet clumping in an oncology patient results in two unnecessary platelet
transfusions
A FBC from a patient with leukaemia showed a significant drop in platelets compared to the previous
day. The analyser flagged possible platelet aggregates, but the result was released. A blood film was
made but only examined routinely the next day. This showed platelet clumping, and the count was
visually normal. By this time the patient had been transfused with platelets. Another sample sent the
next day again reported low platelets. No blood film was made, and a further platelet transfusion
was given. The post-transfusion platelet count was 232x109/L.

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ERROR REPORTS ANNUAL SHOT REPORT 2023

Learning points
• Thrombocytopenia should be confirmed on a blood film even when a patient has a condition
compatible with a low platelet count. Marked fluctuations in the platelet count should raise
suspicion of a spurious result

• Review of blood film to confirm laboratory results in a timely manner can avoid unnecessary or
incorrect treatment

Case 12b.4: Failure to correctly identify the patient at the time of authorising the
transfusion leads to transfusion of the wrong patient
A doctor had reviewed the FBC for patient A and a red cell transfusion was indicated. The doctor
mixed up two patients’ names and results and authorised transfusion for patient B in error. Patient
B’s Hb was 100g/L and they received a red cell unit they did not require.

Learning point
• Patient identification errors resulting in inappropriate treatment can occur without the patient being
present. It is essential to correctly identify the patient during any interaction

Failure to respond to a change in circumstances n=9

Cases where there was a failure to respond to change in circumstances included: transfusion given before
a procedure which was cancelled (n=3), units authorised ‘just in case’ for surgery transfused routinely
(n=1), authorisation written in advance and recent results not checked (n=1), transfusion already given
(n=2), change in decision not communicated (n=1).

One patient was given a transfusion as part of a trial protocol but was subsequently found to be ineligible
for the trial.

Transfusion without decision n=8

Seven patients received a transfusion without any completed authorisation. Three of those were patients
regularly attending a day unit, and it is notable that one reporter cited staff shortage due to the junior
doctors strikes as a contributory factor.

One patient had a red cell transfusion authorised rather than albumin as a result of a verbal request.

Transfusion necessitated by equipment failure n=1

Malfunction of a haemodialysis machine resulted in a patient losing 200-300mL of blood into the circuit
and a red cell transfusion was then required.

Near miss avoidable transfusions n=3

These included 1 drip arm sample, detected due to abnormal biochemistry results taken at the same
time, 1 multiple unit transfusion stopped when a family raised concerns and 1 inappropriate use of group
O serendipitously blocked due to incorrect use of the remote issue refrigerator.

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Conclusion
Avoidable transfusions constitute a diverse group, but lack of knowledge, failure to question unusual
results and failure of correct patient identification emerge as recurring themes. Creating additional
opportunities for checks and challenge, for example use of computerised decision support and
empowering laboratory and nursing staff to question inappropriate or unusual requests can increase
the chance of errors being corrected before transfusion proceeds.

Recommended resources
E-learning modules:

Anaemia
Includes modules ‘Anaemia - the only introduction you need’, ‘Anaemia in primary care
patients’, ‘Anaemia in hospital patients’ and ‘Anaemia of inflammation and chronic
disease’. Accessible via:
https://hospital.blood.co.uk/training/clinical-courses/

Blood component use in major haemorrhage

https://www.e-lfh.org.uk/programmes/blood-component-use-in-major-haemorrhage/

The NHSBT O D-negative toolkit

https://hospital.blood.co.uk/patient-services/patient-blood-management/o-d-negative-red-cell-
toolkit/

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ERROR REPORTS ANNUAL SHOT REPORT 2023

Under or Overtransfusion n=20 12c

Authors: Paula Bolton-Maggs, Catherine Booth and Simon Carter-Graham

Definition:
A dose inappropriate for the patient’s needs, excluding those cases which result in TACO and
usually resulting in a haemoglobin or platelet level significantly outside the intended target range.
Infusion pump errors leading to under or overtransfusion with clinical consequences (if no clinical
consequences, then it is reportable as a handling and storage error).

Key SHOT message

• As in previous years, more than half the cases of overtransfusion were in children (8/14)

Recommendations
• Paediatric transfusion protocols should be readily accessible to all clinical staff

• Hospitals should have clear guidelines for patients being transferred between hospitals to reduce
the risk of adverse outcomes

Action: Hospital transfusion teams

Introduction
The number of reports (20) is similar to last year (18). In 2023, there were 14 reports of overtransfusion
and 6 of undertransfusion. The majority were clinical incidents (19/20).

Many cases were reported in children, 9/20. Eight of these were overtransfused and 1 was undertransfused.

Deaths related to transfusion n=1

Case 12c.1: A patient died following surgery where overtransfusion was justified
Shortly after an uneventful elective surgery (exchange of ureteric stents), the patient developed
hypotension and tachycardia and was only minimally responsive to intervention (including intravenous
fluids and vasopressors). The abdomen appeared distended, and the patient began complaining of
back pain. The patient was thought to have major haemorrhage and was transfused three units of
red blood cells and two units of FFP (emergency MHP). CT showed no evidence of bleeding, but
there was evidence of pulmonary oedema. The patient was transferred to critical care and remained
extremely unstable. TACO was considered but not supported by bedside echocardiography.
Sadly, the patient died. Subsequently blood cultures from the patient grew E. coli. This death was
referred to the coroner who concluded multi-organ failure, E Coli urosepsis with chronic ureteric
obstruction caused the patient’s death. The blood transfusion could have contributed to the patient’s
deterioration, but the relationship to the patient’s outcome was not certain.

Initial investigation by hospital transfusion team felt this was unlikely to be TACO/TRALI or anaphylaxis
to blood components. However, in the absence of an identifiable source of bleeding and rise in Hb from

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 ANNUAL SHOT REPORT 2023 ERROR REPORTS

114 to 184g/L, it was concluded that this was a clinically justified overtransfusion where the anaesthetist
had substantial grounds to believe the patient was experiencing major haemorrhage.

Major morbidity n=2

A child received a full adult unit of red cells (300mL) when the correct volume would have been 150mL.
The post-transfusion Hb was 190g/L. As a result, the child was admitted to ICU overnight and required
venesection.

An adult with a platelet count of 27x109/L who presented with haematuria received four platelet pools
inappropriately prescribed by a junior doctor without adequate knowledge; only one was indicated.
There was misunderstanding following discussion between the doctor and haematologist. The patient,
already with pulmonary oedema, developed shortness of breath and required admission to ICU for 3
days. The patient later died but this was unrelated to the transfusion.

Overtransfusion n=14
More than half of the reported cases (8/14) were in paediatric patients. These are discussed in more
detail in Chapter 24, Paediatric Cases.

Six adults received excess transfusion, 1 caused by a WBIT.

Case 12c.2: WBIT in FBC sample impacts two patients

A patient was transfused based on a wrong FBC result involving incorrectly labelled blood samples.
Labels for Patient 1 were printed, but the phlebotomist was unable to get a sample from the patient.
At the same time, there was a request for bloods to be taken from Patient 2 but the IT system
defaulted to the Patient 1’s record following an incorrect hospital number data entry. This resulted
in labels belonging to Patient 1 being printed. PPID was not undertaken correctly at the time of
phlebotomy, and the incorrect labels were attached to the FBC sample which contained Patient
2’s blood.

The FBC results were issued against Patient 1. The laboratory staff noticed the discrepant Hb result
in relation to the previous results from this patient but attributed this to surgery because the request
had originated from a surgical ward. The junior medical and nursing staff had also discussed the
discrepancy of both Hb and mean cell volume but the possibility of WBIT was not considered. Patient
1 was unnecessarily transfused a unit of red cells resulting in a post-transfusion Hb of 151g/L with
no adverse symptoms. Patient 2, whose Hb had been 91g/L fell to 71 then 69g/L resulting in a delay
before they were transfused. A mismatch between workload, staff provision, an ineffective IT system
and communication factors were noted to be contributory factors in this incident.

Case 12c.3: Hypotension attributed to GI bleeding results in overtransfusion

An elderly woman with pre-existing cardiac failure and poor renal function suffered a major GI bleed
requiring a red cell transfusion and endoscopy which confirmed arterial bleeding from a duodenal
ulcer. She was stabilised but the following morning had hypotension. No formal laboratory sample
was taken between the first transfusion and the second the day after. An urgent Hb was recorded
mistakenly as 49g/L but on the venous gas was 119g/L. Based on the erroneous result, she received
six units of red cells; her Hb rose to 198g/L and she required venesection. CT angiogram showed no
evidence of bleeding. She was admitted to ICU following IR treatment with gastroduodenal artery
coil. Four days later she returned to the ward, Hb 152g/L. Although she subsequently died this was
not related to the overtransfusion.

Learning point
• Hypotension can have different causes and is not always due to bleeding. Thorough evaluation
of the patient is crucial for guiding appropriate management. This will ensure the patient receives
the care they need promptly and effectively

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Haematinic deficiency n=1

A child with a Hb of 35g/L due to iron deficiency was intentionally transfused to Hb 96g/L and at a rate
(6.13mL/kg/hr) greater than recommended (3-5mL/kg/hr). Iron deficiency is very well tolerated in young
children. A smaller volume at a slower rate would have been more appropriate, but not every child, even
with such a low Hb, requires transfusion as they are often very chronically anaemic.

There were a further 16 avoidable transfusions in patients with haematinic deficiencies, see Chapter
12b, Avoidable Transfusions.

Undertransfusion n=6
Of the 6 reports of undertransfusion, 2 involved FFP. In 1 case, two bags were given instead of three and
in the other case one bag with 250mL of FFP was issued by the laboratory instead of the 1L requested
resulting in delay of a planned procedure.

There were 3 reports of red cell undertransfusion, 1 in a child. A sample was run as a neonatal one,
but the child was over a year of age and a paedipack was issued instead of a full unit. Another was
in a patient whose target Hb was >100g/L because of radiotherapy. The patient received only one of
five units of red cells resulting in failure to achieve the target. The 3rd case is described in Case 12c.4.

A patient with leukaemia failed to receive granulocytes as they had not been prescribed and were
therefore wasted. There was no harm to the patient.

Case 12c.4: Splenic rupture with major haemorrhage requiring interhospital transfer
An elderly man on oral anticoagulants developed abdominal pain found to be caused by splenic
rupture. He required emergency transfer to another hospital site for IR. Transfusion of red cells was
started and planned to continue throughout the transfer. He also received PCC and tranexamic
acid. There was no nurse available to accompany the patient, and the paramedics did not know
how to manage the infusion pump when it stopped working and the transfusion was not completed.
The transfusion laboratory at the transferring hospital had not been informed of the transfer, so
the available crossmatched red cell units and patient sample were not sent with him. During the
IR procedure he was peri-arrest and received emergency group O D-negative units and FFP. The
splenic embolisation was successful and he was transferred to a ward.

The report noted that there was a lack of clarity on inter-site transfer for patients who require intervention.
There were multiple handovers and unclear information among teams. Such transfers are known to be
associated with risks of adverse events (Haji-Michael, 2005). The laboratory protocol for transfer of red
cell units with patients was not followed. Guidelines are available for interhospital transfer noting the
importance of appropriate equipment and personnel (AAGBI, 2006; Ahmed & Majeed, 2008; Warren,
et al., 2004).

Learning points
• Transfer of seriously ill patients between sites carries additional risks; ideally patients should be
accompanied by medical or nursing staff

• Handovers concerning seriously ill patients are essential and should be concise and accurate

Near miss n=1

A child avoided an excessive transfusion because an error in the prescription was detected by the staff
member undertaking the pre-administration check.

Conclusions
Errors in paediatric transfusion continue to be a cause for concern. Transfusion training should ensure
that clinicians authorising transfusions understand the use of all blood components including indications,
monitoring, recognising, and managing adverse reactions.

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Ensuring safety when transferring patients between hospitals involves careful coordination and
communication between clinical teams, verifying patient information, transport with appropriate staff
accompanying to monitor and manage patients during transfer. Clear protocols for communication and
continuity of care are essential to minimise risks and ensure a smooth transition for the patient.

Finally, all transfusion decisions must be made after carefully assessing the risks and benefits of transfusion
therapy. Clinical and laboratory staff must work collaboratively and in a co-ordinated fashion to be able
to deliver individualised, holistic, patient-centred care.

Recommended resources
SHOT Bite No.4: Paediatrics
https://www.shotuk.org/resources/current-resources/shot-bites/

BSH guidelines for paediatric transfusion

https://b-s-h.org.uk/guidelines/guidelines/transfusion-for-fetuses-neonates-and-older-children

Guidance on: Transfer of the critically ill adult

https://ics.ac.uk/resource/transfer-critically-adult.html

References
Ahmed, I. & Majeed, A., 2008. Risk management during inter-hospital transfer of critically ill patients: making the journey
safe. Emergency Medicine Journal, 25(8), pp. 502-505. doi: 10.1136/emj.2007.054361.

Association of Anaesthetists of Great Britain and Ireland (AAGBI), 2006. Inter-hospital transfer of the critically-ill patient in
the Republic of Ireland, London: AAGBI. doi: http://dx.doi.org/10.21466/g.I-HTOTC.2006.

Haji-Michael, P., 2005. Critical care transfers – a danger foreseen is half avoided. Critical Care, 9(4), pp. 343-344. doi:
https://doi.org/10.1186/cc3773.

Warren, J. et al., 2004. Guidelines for the inter- and intrahospital transport of critically ill patients. Critical Care Medicine,
32(1), pp. 256-262. doi: 10.1097/01.CCM.0000104917.39204.0A.

108 12c. Under or Overtransfusion

ERROR REPORTS ANNUAL SHOT REPORT 2023

Incidents Related to Prothrombin

Complex Concentrates n=23 12d
Authors: Paula Bolton-Maggs, Josephine McCullagh and Simon Carter-Graham

Definition:
Hospitals are asked to report incidents related to PCC infusion where there was delay or
inappropriate transfusion. (Allergic reactions should be reported to the MHRA through the yellow
card scheme, https://yellowcard.mhra.gov.uk/).

Key SHOT messages

• PCC administration is an emergency treatment used for reversal of oral anticoagulants (warfarin
and DOAC) which should be started within an hour of the decision being made and before the
patient is transferred to other wards or departments

• Patients with suspected ICH are at high risk of death or serious sequelae and require urgent
anticoagulant reversal

Recommendations
• The ED should ensure they have a protocol with clear instructions for dose and administration of
PCC. Staff should be appropriately trained in their use

• A standardised single first dose for emergency use should be adopted to reduce PCC administration
delays in urgent situations

• Use of PCC should be regularly audited for timeliness and appropriateness

Action: Medical directors, hospital transfusion teams, audit leads

Introduction
A total of 23 cases were reported in this category. Most PCC incidents were reported in the elderly
population, median age 85 years. Only 1 patient was under 70 years of age. There were 17/23 (73.9%)
reports of delayed PCC infusion. Other errors included inappropriate doses, either under or over
recommended units, infusion pumps set at the wrong rate and lack of trained staff to administer the PCC.

All patients were taking anticoagulants, either warfarin or apixaban/edoxaban. Nine patients had ICH,
5/9 following falls. Six patients had GI bleeding.

Deaths related to transfusion n=4

Four patients died (all on warfarin) possibly (n=3) or definitely (n=1) related to the delay in administration
of PCC. This case has been described in Case 12d.1.

Case 12d.1: Failure to reverse warfarin and inadequate red cell transfusion

An elderly person was admitted with a suspected cerebrovascular accident which was not confirmed
on CT. However, they were found to have a Hb of 44g/L and very high INR (confirmed on repeat
testing). The patient received a single unit of red cells but no reversal of the high INR. They had

12d. Incidents Related to Prothrombin Complex Concentrates 109

 ANNUAL SHOT REPORT 2023 ERROR REPORTS

epistaxis earlier in the day but no other bleeding. No bleeding source was sought. The patient collapsed
and died 15 hours after admission. The patient was on an acute ward which was very short staffed
and usually relied on bank and agency staff.

Of the 3 deaths with possible imputability, 1 was a patient with ICH where the long delay in receiving PCC
(8 hours) was associated with expansion of the haematoma. An elderly patient fell downstairs sustaining
a head injury with confirmed ICH, and the PCC administration was delayed for 5 hours. Another elderly
patient on warfarin was admitted with GI bleeding where PCC was delayed by 3.5 hours due to a delay
in decision-making and incorrect use of the recently implemented electronic prescribing system.

Learning point
• The finding of a high INR should prompt urgent communication to the clinical team and appropriate
actions taken especially when patients are on anticoagulants. If a decision has been made for
anticoagulant reversal with PCC, this should be administered without delay

Major morbidity n=0

There were no patients that suffered major morbidity in 2023 as a result of the PCC administration.

Fixed dose PCC for emergencies

Delay can be reduced by using a fixed emergency dose avoiding both the need for finding the weight
and use of calculations. Patients on warfarin should also receive vitamin K and follow up of the INR to
ensure reversal and to determine if further PCC is required.

Continued confusion about dose and rate of infusion suggest that a fixed dose regimen might be safer.
The literature demonstrates good correction of the INR in most (Bizzell, et al., 2021) including patients
with ICH with a fixed dose of 2000IU (Dietrich, et al., 2021). A recent systematic review comparing fixed-
versus variable-dose 4F-PCC included three randomised trials and 16 cohort studies with extracranial
haemorrhage as the main indication. The authors concluded that fixed dose provides benefits in terms
of dose reduction, more rapid administration, better haemostasis with reduced mortality and fewer
thromboembolic events (Alwakeal, et al., 2024).

One UK centre has used a fixed dose of 1000IU for both warfarin and DOAC reversal since 2017
with clear benefit (Davies, et al., 2019). Their protocol provides for PCC removal from the refrigerator
without laboratory or haematology clinical staff approval. A significant reduction in time from request to
administration was demonstrated (for warfarin, mean 48 compared with 126 minutes). No significant
difference was noted in mortality for standard dose (13%) and fixed dose (3%) (p=0.2117), although the
data suggest that a fixed-dose regime may reduce mortality risk. Dose reduction resulted in significant
financial savings. No inappropriate use occurred.

Further evidence is presented in Chapter 6, Acknowledging Continuing Excellence in Transfusion (ACE),

Case 16, where a fixed-dose regimen (1000IU) was introduced to improve management of patients
with ICH and GI bleeding. Subsequent local audit results identified that 67% of patients received PCC
within 1 hour of the decision being made compared with 36% pre implementation of the project. Patient
survival rate has increased to 86% from 53% pre implementation. In 43% of cases, the initial dose of
1000IU of PCC was sufficient to reverse the INR without need for further PCC.

Previous publications have also supported a fixed-dose approach. Haemostatic efficiency was shown
in an open-label, multicentre, randomised clinical trial. Patients with non-intracranial bleeds requiring
vitamin K reversal with 4F-PCC were allocated to either a 1000IU fixed-dose of 4F-PCC or a variable dose
based on weight and INR. Effective haemostasis was achieved in 87.3% (n=69 of 79) in fixed and 89.9%
(n=71 of 79) in the variable dosing cohort. Median door-to-needle times were reduced to 109 minutes
(range 16 to 796) in fixed compared with 142 (17 to 1076) for the variable dose (P=.027). An INR < 2.0
at 60 minutes after 4F-PCC infusion was reached in 91.2% versus 91.7% (P=1.0) (Abdoellakhan, et al.,
2022). Another meta-analysis of fixed-dose versus variable-dose of PCC reviewed data from 10 studies

110 12d. Incidents Related to Prothrombin Complex Concentrates

ERROR REPORTS ANNUAL SHOT REPORT 2023

including 988 patients. Fixed-dose PCC was associated with reduced mortality and a shorter order-to-
needle time. These authors advocated further studies focusing on clinical outcomes (Mohammadi, et
al., 2022). It is not clear what the optimal fixed dose should be. Whether a fixed-dose or weight-based
regimen is used, follow up of the INR for patients on warfarin (who should also receive vitamin K) is
essential to ensure the dose was adequate and to determine if further PCC is required.

Conclusion
Delayed administration is the most frequent cause for PCC incident reports (73.9%). PCC are an
important treatment for immediate reversal of vitamin K antagonists and other oral anticoagulants and
should be given immediately a decision is made, and certainly within an hour (NHSE, n.d.). All medical
staff involved in the acute care of patients with suspected serious haemorrhage, particularly ICH, who
are eligible for reversal should ensure that they know how to obtain and how to administer PCC. Delay
can contribute to patient death.

Recommended resource
CAS Alert - Preventing transfusion delays in bleeding and critically anaemic patients
https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103190

References
Abdoellakhan, R. A. et al., 2022. Fixed Versus Variable Dosing of Prothrombin Complex Concentrate for Bleeding
Complications of Vitamin K Antagonists—The PROPER3 Randomized Clinical Trial. Annals of Emergency Medicine,
79(1), pp. 20-30. doi: https://doi.org/10.1016/j.annemergmed.2021.06.016.

Alwakeal, A. et al., 2024. Fixed- Versus Variable-Dose Prothrombin Complex Concentrate for the Emergent
Reversal of Vitamin K Antagonists: A Systematic Review and Meta-Analysis. Critical Care Medicine. doi: 10.1097/
CCM.0000000000006212.

Bizzell, A. C., Mousavi, M. K. & Yin, E., 2021. Fixed- versus variable-dose prothrombin complex concentrate protocol
for vitamin K antagonist reversal. International Journal of Haematology, 114(3), pp. 334-341. doi: 10.1007/s12185-021-
03176-w.

Davies, J. et al., 2019. Fixed Dose Prothrombin Complex Concentrate for Direct Oral Anticoagulant and Low Molecular
Weight Heparin Reversal: A Rapid and Effective Solution. Harrogate, British Blood Transfusion Society (BBTS).

Dietrich, S. K., Mixon, M. A. & Rech, M. A., 2021. Fixed-dose prothrombin complex concentrate for emergent warfarin
reversal among patients with intracranial hemorrhage. The American Journal of Emergency Medicine, Volume 49, pp.
326-330. doi: 10.1016/j.ajem.2021.06.032.

Mohammadi, K., Yaribash, S., Sani, M. A. & Talasaz, A. H., 2022. Efficacy and Safety of the Fixed-Dose Versus
Variable-Dose of 4-PCC for Vitamin K Antagonist Reversal: A Comprehensive Systematic Review and Meta-Analysis.
Cardiovascular Drugs and Therapy, 36(3), pp. 533-546. doi: 10.1007/s10557-021-07192-0.

NHS England (NHSE), n.d. Delay in treatment with prothrombin complex concentrate (PCC). [Online]
Available at: https://www.england.nhs.uk/patient-safety/patient-safety-insight/learning-from-patient-safety-events/
how-we-acted-on-patient-safety-issues-you-recorded/delay-in-treatment-with-prothrombin-complex-concentrate-
pcc/#:~:text=PCC%20are%20human%20blood%20produc (Accessed 26 April 2024).

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 ANNUAL SHOT REPORT 2023 ERROR REPORTS WITH NO HARM

13 Near Miss (NM) Reporting n=1420

Author: Vera Rosa

Definition:
A ‘near miss’ event refers to any error which if undetected, could result in the determination of
a wrong blood group or transfusion of an incorrect component, but was recognised before the
transfusion took place.

Abbreviations used in this chapter

ADU Avoidable, delayed or under/overtransfusion SAE Serious adverse event
HSE Handling and storage error SOP Standard operating procedure
IBCT Incorrect blood component transfused SRNM Specific requirements not met
Ig Immunoglobulin UKTLC United Kingdom Transfusion
NM Near miss Laboratory Collaborative
NPSA National Patient Safety Agency WBIT Wrong blood in tube
RBRP Right blood right patient WCT Wrong component transfused
RCA Root cause analysis

Introduction
Near miss events account for the largest category of cases reported to SHOT in 2023, 1420/3833
(37.0%). This is an increase from the previous two years, 54 more NM cases compared to 2022 (n=1366)
and 265 compared to 2021 (n=1155) (Figure 13.1). Near miss events cover all SHOT categories which
could have resulted in a SAE if the error had not been identified prior to transfusion or blood product
administration. In 2023, in each SHOT category, there was a slight decrease in the number of NM.
However, there was an increase of errors where a component was transfused in the equivalent categories.

112 13. Near Miss (NM) Reporting

ERROR REPORTS WITH NO HARM ANNUAL SHOT REPORT 2023

figure 13.1
Figure 13.1: A
decade of NM and
WBIT Other NM NM as % of total reports
WBIT reports 2014-
2023
1600 50%
43.6%
37.0%
41.5% 42.1% 39.0% 45%
1400 38.7%
38.7% 37.8%
36.5% 434 40%
1200 35.2%
659 476 35%
570
1000 463 507 586
421 30%
481 457
800 25%

20%
600
986 15%
890
400 780 776 789 792
686 728 734
673 10%
200
5%

0 0%
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

NM=near miss; WBIT=wrong blood in tube

The largest number of NM in a single category continues to be WBIT events accounting for 986/1420
(69.4%). This is an increase from 2022 (n=890/1366, 65.2%). There was also an increase in NM anti-D
Ig errors with 41/1420 (2.9%) cases. In the remaining SHOT categories, there was a slight decrease in
the number of NM reports as shown in Table 13.1.

SHOT category Number of cases in 2022 Number of cases in 2023 Variance Table 13.1:
Comparison of
WBIT 890 986 +96
the NM per SHOT
HSE 140 138 -2
category reported
IBCT-WCT 115 106 -9
to SHOT in 2022
RBRP 118 99 -19
and 2023
IBCT-SRNM 52 46 -6
Anti-D Ig 37 41 +4
ADU 14 4 -10
Total 1366 1420 +54

NM events are often overlooked as they do not cause patient harm. However, the risk of error occurring
is present, and recognising, reporting, and investigating NM are vital to identify gaps in processes and
risk factors. Understanding the conditions when NM occur allows implementation of corrective and
preventative actions to improve patient safety. NM should be investigated effectively similar to how
adverse events and reactions are investigated.

In 2023, there were 1027/1420 (72.3%) NM where RCA or other equivalent formal investigations were
carried out and 1215/1420 (85.6%) where the NM had been reviewed. Of the NM cases reviewed,
in 120/1215 (9.9%) events resulted in changes in transfusion procedures and policies. These were
clarification of and designing comprehensive SOP as well as implementation of checklists or additional
checking steps. Of the 393 cases where RCA or equivalent was not carried out, 11/393 (2.8%) stated
‘not performed as there wasn’t patient harm involved’ as the reason. Including additional answers such
as ‘not required’, ‘not appropriate’, or ‘not part of Trust policy’ increased this number to 45/393 (11.5%).
In 1 case, the incident had not been investigated as the poor practice was accepted to be the norm
and as such, an investigation was deemed as not necessary.

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 ANNUAL SHOT REPORT 2023 ERROR REPORTS WITH NO HARM

SHOT has been promoting and encouraging the learning from NM which are considered as ‘free lessons’,
giving the opportunity to learn and share the learning without patient harm. The learning from NM should
not be under-valued but acknowledged as a preventative warning of risks for patient harm. Case 13.1
illustrates how investigating a NM event supported improvements in the transfusion electronic system.

Case 13.1: Near miss helps to identify safety issues with requesting electronic system

A unit of red cells was collected by a porter using the porter electronic system. The unit collected was
for a different patient. Both patients had the same surname, however no other patient details matched
the blood request. When the blood component arrived at the ward and the details were checked, the
error was identified and reported to the laboratory. The red cell unit was returned to the laboratory.

Investigation of this incident identified safety concerns with the porter’s electronic system which was found
to be unfit for purpose. The request using the electronic system could be sent without patient-specific
information from the ward which led to the error. Poor compliance and different practices between sites
within the organisation were also identified. The case was reviewed by the hospital transfusion team,
hospital transfusion committee and facilities management forum. Safety issues were cascaded via
huddles, strategic clinical networks were created, and a scoping exercise was undertaken to establish
required improvements. A new SOP and flow chart was developed outlining details of the new processes
to be followed. A communications package was developed to inform all parties of the new system in
place. Porters were advised not to collect any blood components without complete patient information.
A new escalation system is to be implemented to deal with these issues as well as an audit schedule
to highlight ongoing issues and address them at ward level.

It is encouraging to see how meticulously this NM event was investigated and improvement actions
implemented. The team’s commitment to excellence and collaboration resulted in valuable lessons
learned contributing to continuous improvement efforts.

Learning point
• Investigation of NM helps identify causes of errors and contributory factors before patient harm
occurs. A thorough and complete investigation can lead to changes in processes, systems and
policies to improve transfusion safety

Discussion of near miss errors per SHOT category

NM cases have been reviewed and discussed in each relevant chapter for this Annual SHOT Report
and Table 13.2 shows the chapter that include NM events according to the current SHOT definitions.
Table 13.2: Category Discussed in chapter Number of reports Percentage of cases
Categorisation of WBIT Chapter 13a 986 69.4%
all NM according to HSE Chapter 11 138 9.7%
SHOT definitions in IBCT-WCT Chapter 10 106 7.5%
2023 (n=1420)
RBRP Chapter 14 99 7.0%
IBCT-SRNM Chapter 10 46 3.2%
Anti-D Ig Chapter 9 41 2.9%
ADU Chapter 12 4 0.3%
Total 1420 100%

114 13. Near Miss (NM) Reporting

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Conclusion
It is important to recognise that learning from NM is as useful as learning from incidents without the
psychological and physical impact of an incident (Woodier, et al., 2023; Jung, et al., 2021). The lessons
learnt from NM can lead to improvements within healthcare organisations, increasing patient safety
by allowing sharing of the lessons learnt as well as the actions implemented to mitigate the risks
(NPSA, 2004). Each organisation should facilitate and encourage a reporting culture, where staff feel
psychologically safe to report these incidents without fear of blame or negative consequences (Woodier,
et al., 2023; NPSA, 2004; Caspi, et al., 2023; Jung, et al., 2021). This involves a proactive approach
of investigating incidents focused on systems rather than on individuals (NPSA, 2004; Woodier, et al.,
2023). The results from the 2023 SHOT and UKTLC transfusion laboratory culture survey demonstrated
that laboratory staff are still being a target of incivility and disciplinary action upon raising safety concerns
or following incident reporting (SHOT, 2024). Recommendations have been published within the report
to help organisations create a psychological safety culture for staff. Organisations must implement and
embed investigation of NM events as part of their policies and facilitate resources for staff to understand
the potential for improving patient safety when investigating NM.

Recommended resources
Wrong Blood In Tube (WBIT) investigation template
https://www.shotuk.org/resources/current-resources/

SHOT Bite No. 17: Learning from Near Misses (NM)

SHOT Bite No. 23: Civility in Healthcare
SHOT Bite No. 24: Speaking up for safety
SHOT Bite No. 25: Safety-I and Safety-II
https://www.shotuk.org/resources/current-resources/shot-bites/

References
Caspi, H., Perlman, Y. & Westreich, S., 2023. Managing near-miss reporting in hospitals: The dynamics between staff
members’ willingness to report and management’s handling of near-miss events. Safety Science, 164(4), p. 106147. doi:
https://doi.org/10.1016/j.ssci.2023.106147.

Jung, O. S. et al., 2021. Resilience vs. Vulnerability: Psychological Safety and Reporting of Near Misses with Varying
Proximity to Harm in Radiation Oncology. The Joint Comission Journal on Quality and Patient Safety, 47(1), pp. 15-22.
https://doi.org/10.1016/j.jcjq.2020.09.005.

National Patient Safety Agency (NPSA), 2004. Seven steps to patient safety - The full reference guide. [Online] Available
at: https://www.publichealth.hscni.net/sites/default/files/directorates/files/Seven%20steps%20to%20safety.pdf
(Accessed 12 February 2024).

Serious Hazards of Transfusion (SHOT), 2024 SHOT Surveys. [Online] Available at: https://www.shotuk.org/resources/
current-resources/shot-surveys/ (Accessed 26 April 2024).

Woodier, N., Burnett, C. & Moppett, I., 2023. The Value of Learning From Near Misses to Improve Patient Safety: A
Scoping Review. Journal of Patient Safety, 19(1), pp. 42-47. doi: https://doi.org/10.1097/pts.0000000000001078.

Woodier, N., Burnett, C., Sampson, P. & Moppett, I., 2023. Patient safety near misses – Still missing opportunites to
learn. Journal of Patient Safety and Risk Management, 0(0), pp. 1-7. doi: https://doi.org/10.1177/25160435231220430.

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 ANNUAL SHOT REPORT 2023 ERROR REPORTS WITH NO HARM

Near Miss - Wrong Blood in Tube

13a (WBIT) n=986

Authors: April Molloy, Paula Bolton-Maggs, Vera Rosa and Simon Carter-Graham

Definition:
Blood is taken from the wrong patient and is labelled with the intended patient’s details.

Blood is taken from the intended patient but labelled with another patient’s details.

Abbreviations used in this chapter

cffDNA Cell-free fetal deoxyribonucleic acid PPID Positive patient identification
HSSIB Health Services Safety Investigations Body WBIT Wrong blood in tube
ID Identification Wi-Fi Wireless fidelity

Key SHOT messages

• Correct patient identification remains a key safety measure and patients should be encouraged
to participate in critical identification steps

• Identification bands are an essential safety precaution. These must be applied carefully and correctly

• The labelling of neonatal samples taken from the umbilical cord is prone to error when the sample
is taken from the placenta away from the mother

• A high proportion of WBIT continue to be reported from maternity areas, this could be due to
multiple factors which need to be investigated locally and addressed to improve patient safety

Recommendations
• Training about patient identification bands should be reviewed and their importance emphasised

Action: Education teams, hospital transfusion teams and maternity leads

• In line with the HSSIB recommendations, local organisations should review and identify system-wide
requirements for scanning in positive patient identification since the use of scanning technology
can help to reduce misidentification incidents

Action: Hospital chief executives and medical directors

Introduction
For the third consecutive year, there has been an increase in WBIT near miss incident reports, 986
cases in 2023 (890 cases in 2022, 734 cases in 2021) see Figure 13.1 in Chapter 13, Near Miss (NM)
Reporting. The majority were routine samples, 810/986 (82.2%) and 78/986 (7.9%) were classed as
urgent or emergency. Cases from maternity departments account for 388/986 (39.4%) reports. WBIT
continues to represent the largest proportion of near miss events, 986/1420 (69.4%).

116 13a. Near Miss – Wrong Blood in Tube (WBIT)

ERROR REPORTS WITH NO HARM ANNUAL SHOT REPORT 2023

What errors lead to WBIT?

WBIT errors continue to result from the same two leading causes: failure to identify the patient correctly
at phlebotomy, 434/986 (44.0%) and labelling the blood samples away from the patient, 285/986
(28.9%). These two errors continue to be reported every year. Of concern, both errors occurred together
in 170/719 (23.6%) of the reports.

Where reported, routine group and screen samples, 856/961 (89.1%) were most commonly implicated.
The overall number for crossmatch samples was 105/961 (10.9%) with a small number, 21/105 (20.0%),
required for an emergency transfusion.

Patient ID bands, when used accurately, should help to prevent errors. Ten incidents were reported
with ID band errors: failure to apply ID bands (3), wrong band attached to patient (2), patient not
correctly identified when band applied (3), patient wrongly identified at admission (1) and 1 case where
case records had been merged with another patient of the same name but different date of birth and
ID number. Care must be taken to avoid patient misidentification. Forty-four incidents were reported
involving patients with identical or similar names. PPID using first name, surname, date of birth and a
unique patient identification number is key to safe practice. Case 13a.1 illustrates the importance of
PPID. Patient ID bands are crucial to prevent errors in healthcare settings by ensuring accurate patient
identification during procedures, treatments including transfusions and administration of medication.

Venepuncture requires concentration and attention to detail. In 1 case, the doctor was distressed by
a toxic safety culture in the ward with bullying and interruption, which resulted in a WBIT. Civility in
healthcare has been shown to have an impact on patient safety. Incivility contributes to an increased
risk of incidents and negative consequences in staff wellbeing and psychological safety (Civility Saves
Lives, 2022).

Case 13a.1: Patient care documented on the wrong patient record

A patient queried why they were being called by another name. The patient’s pregnancy records
had been uploaded incorrectly to another non-pregnant patient’s notes. Previous clinical notes and
booking in bloods were undertaken under incorrect patient details/records. The patient had not been
positively identified at the previous appointment.

Learning points
• Care must be taken to ensure the correct ID band is applied to the right patient

• PPID, sample taking, and labelling should always be a single, continuous process carried out
beside the patient

• Involving the patient in their own care by encouraging them to confirm their identity, where possible,
and confirming their details on the sample will help reduce errors

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 ANNUAL SHOT REPORT 2023 ERROR REPORTS WITH NO HARM
figure 13a.1

Figure 13a.1:
Primary errors
leading to WBIT in
2023 (n=986)

434 Patient not identified

19%
correctly at
phlebotomy
285 Sample not labelled
1% Patient next to the patient
identification &
7% 68 Sample not labelled
sample labelling by the person taking
44%
errors the blood sample
80.4% 6 Pre-labelled sample
tube used
193 Other/no details
provided
29%

Detecting the primary error can be challenging in historical WBIT i.e., when the initial error occurred
some years ago.

The majority of errors were detected by laboratory staff, 830/986 (84.2%), while clinical teams identified
the incident in 120/986 (12.2%) cases. In the remaining 36 cases the error was identified by other
healthcare professionals, or the information was not 13a.2
figure provided.
Figure 13a.2: Point
in the process
where the error was Detected before booking in 50
detected in WBIT
reported in 2023
(n=986) After booking in but prior to testing 32

During testing 342

At authorisation of results 471

At collection from the laboratory 2

At pre-administration checking 2

Other 77

Not given 10

118 13a. Near Miss – Wrong Blood in Tube (WBIT)

ERROR REPORTS WITH NO HARM ANNUAL SHOT REPORT 2023

Case 13a.2 highlights the importance of PPID.

Case 13a.2: Patient not adequately identified prior to phlebotomy

The hospital transfusion laboratory received two samples for a patient with no previous blood
transfusion history. The samples and the request forms were correctly labelled and processed.
However, ward staff later called the laboratory to say the samples had been taken from the wrong
patient. The doctor realised the mistake when the nurse was placing the wristband on the patient.
The patient had a similar name and date of birth as the intended patient and was without a wristband
at the time of sample collection.

This incident highlights the importance of PPID at phlebotomy; in this instance, PPID did not occur
on two occasions (two samples were sent), or two samples were taken during the same phlebotomy.

Learning point
• Sending two samples from the same venepuncture could prove to be fatal if the wrong patient is
bled or the correct patient bled but another patient’s details are used. The samples taken from
the same venepuncture will group identically and could lead to a potential ABO-incompatible
transfusion

ABO-incompatibility
In 536 cases, blood group data was provided. If these WBIT had not been detected, 256/536 (47.8%)
patients could have received ABO-incompatible blood components with a risk of serious harm or death
(Table 13a.1).

Group of the blood component that might have been transfused

A B AB O Compatible Incompatible
A 44 30 8 119 163 38
blood group
Patient

B 22 6 6 38 44 28
AB 6 2 1 12 21 0
O 131 44 15 52 52 190
Totals 203 82 30 221 280 256

Case 13a.3 illustrates the importance of undertaking a group-check sample correctly to avoid potential
ABOi transfusions.

Case 13a.3: Failure to accurately identify patients leads to NM-WBIT

A doctor planned to take two group and screen samples from a patient that did not have a blood
group history recorded in the laboratory. The samples were taken 10 minutes apart, but one was
taken from the correct patient and the other was inadvertently taken from a different patient. The
request forms were completed prior to taking the samples and the doctor did not check the patients'
identities or their ID bands. Samples were then labelled away from the patient’s side.

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 ANNUAL SHOT REPORT 2023 ERROR REPORTS WITH NO HARM

Testing revealed that the first sample grouped as O D-positive, and the second taken 10 minutes later
grouped as A D-positive. Two repeat samples had to be obtained from the right patient to ascertain
their correct blood group. There was a lack of medical staff on duty and the doctor involved was the
only doctor on duty at the time, with multiple competing tasks to complete. There were no delays
to transfusion, or any other adverse outcome reported as a result of this WBIT.

It is crucial to recognise that WBIT errors, where the blood in the tube is not that of the patient identified
on the label, may lead to catastrophic outcomes, such as death from ABO-incompatible red cell
transfusion. Transfusion is a multi-step, multidisciplinary process requiring diligence, accurate ID checks
and accurate documentation. Errors continue to occur despite multiple interventions (education, training,
competency testing, guidelines, and use of IT systems). Although this is focusing on WBIT in relation
to blood transfusion, all pathology samples should be identified and linked to the correct patient with
the same degree of care. Improving staff awareness and consideration of human factors is essential.

Sampling
Consistent with previous years, midwives, nurses, and doctors, constitute the largest groups of staff
involved in collecting WBIT transfusion samples as outlined in Figure 13a.3.

Figure 13a.3:
Numbers of
different healthcare
Midwife 282
professionals who
took blood samples
Nurse 230
resulting in WBIT in
2023 (n=986) Doctor 145

Healthcare assistant 124

Unknown 101

Phlebotomist 61

Other 37

Temporary/locum/
6
agency staff

Table 13a.2 shows the primary errors in the different healthcare professional groups. It is notable that
the most common error for phlebotomists (74.5%) was failure to correctly identify the patient.

120 13a. Near Miss – Wrong Blood in Tube (WBIT)

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Table 13a.2
Healthcare
Primary error Midwife Nurse Doctor Phlebotomist
assistant Primary errors
Patient not identified 118 (51.8%) 110 (53.4%) 59 (45.4%) 74 (65.5%) 38 (74.5%) associated with
correctly at phlebotomy WBIT in different
Sample not labelled 88 (38.6%) 84 (40.8%) 55 (42.3%) 26 (23.0%) 10 (19.6%) professional groups
next to the patient in 2023
Sample not labelled by 19 (8.3%) 11 (5.3%) 16 (12.3%) 11 (9.7%) 3 (5.9%)
person taking the blood
Pre-labelled sample tube 3 (1.3%) 1 (0.5%) 0 2 (1.8%) 0
used
Total 228 206 130 113 51

Maternity cases n=388

Maternity departments and antenatal clinics appear to be high-risk areas for transfusion errors. Of WBIT
cases reported in 2023, 388/986 (39.4%) occurred in obstetrics/maternity. These incidents included
61 errors involving neonates:

• Mother and cord mix ups (n=52)

• Confusion in sampling twins (n=9)

Serial Annual SHOT Reports continue to highlight the need for improved processes for labelling of cord
blood samples and the risk of WBIT when labelling the infant’s umbilical cord sample after the placenta
had been moved away from the patient’s side, as reflected in Case 13a.4.

Case 13a.4: A baby’s blood group not as predicted from cffDNA result

A mother noted that her baby’s blood group result (D-positive) did not correspond with the cffDNA
result (predicted D-negative). The placenta had been discarded into the general placenta bucket
with others, placed in individual plastic bags but unlabelled. No cord bloods were taken. A second
midwife retrieved what she thought was the correct placenta from the bin, took a cord sample and
sent it to the hospital transfusion laboratory. Repeat bloods from the baby confirmed the sample
from the retrieved placenta was a WBIT.

Case 13a.5: Cord sampling mix-up

Cord bloods were taken in the labour ward from newborn twins. Twin 1 grouped as A D-negative
and Twin 2 as O D-negative. Subsequent samples were taken for Twin 1, which grouped as O
D-negative. Repeat bloods confirmed WBIT from cord sampling at delivery. The staff member taking
samples at delivery had not undertaken transfusion training and was unaware that they were not to
use pre-labelled tubes.

Learning points
• Particular care must be taken in labelling cord blood samples. This should be done before the
placenta is removed from the mother’s side

• Samples from twins must be fully identified; they will have the same date of birth and surname,
but the different ID numbers should be included

Human factors
Review of human factors questions showed that there was a mismatch between staffing levels and
workload in 353/986 (132 did not answer) and communication issues in 186 (134 did not answer).
Problems in both these areas contributed to 100 WBIT cases.

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 ANNUAL SHOT REPORT 2023 ERROR REPORTS WITH NO HARM

Conclusion
Misidentification of patients has been highlighted by a National Learning Report (HSSIB, 2024). PPID is
seen as a routine task, but is common, complex, and critical for patient safety. The report highlights the
need to improve patient safety by seeking to better understand and address the risks associated with
PPID through a safety management system approach. SHOT reporting shows that this is a continuing
problem in blood transfusion with significant risk to patient safety. The increasing trend and number of
multiple errors is concerning. Although the HSSIB report recommends further development of scanning
technology, this must be set up properly with adequate staffing to support it. In 1 case, a WBIT occurred
when labels were printed for multiple patients away from the bedside due to an inadequate number of
printers and issues with Wi-Fi.

Regardless of whether patient identification is manual or electronic, it is imperative that this is correctly
determined. This is the simplest way of involving the patients in their own care and can prevent adverse
clinical outcomes. Appropriate minimum identification criteria should be established and adhered to.
WBIT events should be monitored, investigated using human factors principles and appropriate mitigating
actions implemented.

Recommended resources
Webinar on accurate and complete patient identification for safe transfusion in adults
Webinar on accurate and complete patient identification for safe transfusion in paediatrics
https://www.shotuk.org/resources/current-resources/webinars/

SHOT Bite No. 17: Learning from Near Misses (NM)

SHOT Bite No. 23: Civility in Healthcare
https://www.shotuk.org/resources/current-resources/shot-bites/

Wrong Blood In Tube (WBIT) Investigation template

https://www.shotuk.org/resources/current-resources/

Civility saves lives

https://www.civilitysaveslives.com/

National Comparative Audit – 2022 Audit of Blood Sample Collection and Labelling
https://hospital.blood.co.uk/audits/national-comparative-audit/

References
Civility Saves Lives, 2022. Civility Saves Lives. [Online] Available at: https://www.civilitysaveslives.com/
(Accessed 29 February 2024).

Health Services Safety Investigations Body (HSSIB), 2024. National learning report: Positive patient identification. [Online]
Available at: https://www.hssib.org.uk/patient-safety-investigations/positive-patient-identification/national-learning-
report/ (Accessed 08 April 2024).

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Right Blood Right Patient (RBRP) n=259 14

Authors: Caryn Hughes, Nicola Swarbrick, and Victoria Tuckley

Definition:
Incidents where a patient was transfused correctly despite one or more serious errors that in
other circumstances might have led to an incorrect blood component transfused (IBCT).

Abbreviations used in this chapter

BMS Biomedical scientist PTR Patient transfusion record
EBMS Electronic blood management system RBRP Right blood right patient
EPR Electronic patient record RCA Root cause analysis
LIMS Laboratory information management system TACO Transfusion-associated circulatory overload
PID Patient identification

Key SHOT messages

• Effective use of pre-administration checklists play an important role in detecting PID errors prior
to transfusion. Where noncompliance is detected, appropriate actions must be taken to ensure
accurate and complete PID prior to commencing the transfusion

• Most laboratory errors could have been prevented by using a laboratory exit check highlighting
the importance of safety checks at critical steps in the transfusion pathway

• RBRP errors have the potential to result in incorrect component transfusion in other circumstances

Recommendations
• The key recommendations from the 2021 Annual SHOT Report remain pertinent: importance of PID,
laboratory exit checks, collection checks, and pre-administration checklist (Narayan, et al., 2022)

• RBRP errors should be investigated with the same rigour as incidents where patient harm occurred,
as they highlight deficiencies in the process where harm was narrowly avoided

Action: All staff in transfusion, hospital risk departments, all staff investigating transfusion
incidents

• Electronic systems should be used to their full potential to prevent RBRP errors

Action: Senior hospital managers, hospital transfusion committees, hospital transfusion

teams

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Headline data 2023 RBRP reports by year

264 259
227
216 216 216
200 207
187
169
Number of reports n=259
Deaths n=0
Major morbidity n=0

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Demographic data Blood component data

Red cells n=231

Platelets n=14
Plasma n=9
Multiple components n=4
Male Female Adults Paediatric
n=137 n=109 n=234 n=11 Cryoprecipitate n=1
Unknown n=13 Unknown n=14

Introduction
There were 259 cases reported in 2023, a slight decrease from 2022 (n=264). Clinical cases accounted
for 193/259 (74.5%) and laboratory cases 66/259 (25.5%). Clinical cases increased from 73.1% in 2022
and laboratory cases decreased from 26.9%.

Figure 14.1:
Breakdown of
RBRP reports in
2023 (n=259)
Laboratory 66

Clinical 193

Overview of RBRP errors

Most laboratory reports were due to component labelling, 36/66 (54.5%) and errors with patient
demographic details, 17/66 (25.8%). Of the labelling errors, 25/36 (69.4%) were due to transposed
labels between units intended for the same patient. Sample receipt and registration errors accounted for
27/66 (40.9%) laboratory reports, with 17 demographic data entry errors and 7 cases where available
information was not heeded. Most laboratory errors, 61/66 (92.4%) could have been detected by using
a laboratory exit check such as PAUSE (Narayan, et al., 2022).

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Clinical RBRP reports were mainly due to PID errors at sample taking, 75/193 (38.9%) and 17/193
(8.8%) errors at administration which included 9 patients who were transfused without a wristband. In
53/193 (27.5%) cases, the primary error was in the prescription and 23/193 (11.9%) related to incorrect

14
details on the transfusion request. Collection errors accounted for 12/193 (6.2%) cases and of these
6/12 (50.0%) were because of PID errors.

The largest number of errors in RBRP occurred at sampling, 75/259 (29.0%) followed by prescription
errors, 56/259 (21.6%) and component labelling errors accounted for 37/259 (14.3%) (Figure 14.2).
Figure 14.2:
RBRP classified
Sample taking 75 by the step in the
transfusion process
Request 23
where the primary

Prescription 56 error occurred in

2023 (n=259)
Sample receipt and registration 27

Component selection 2

Component labelling 1 36

Collection 12
Clinical
Administration 17 Laboratory

Miscellaneous 9 1

Patient identification (PID) errors n=150

Errors with patient demographic details, in the laboratory and clinical settings, accounted for 150/259
(57.9%) of all RBRP errors. PID errors occurred throughout all steps of the transfusion process, with
92/150 (61.3%) due to sample and request form transcription errors in the clinical area. Laboratory
errors accounted for 25/150 (16.7%) where the patient identification information was not heeded, or
data was incorrectly entered into LIMS.

Case 14.1: Blood component transfused despite PID/compatibility label mismatch

A group and screen sample was incorrectly labelled for the intended patient and a unit of red cells was
issued and transfused with incomplete details. The clinical staff contacted the transfusion laboratory
and queried the name discrepancy. The BMS said the blood component was safe to transfuse and
incorrectly told the clinical team it was a middle name instead of the second part of the forename.
The sample should have been rejected and the blood component recalled. The RCA concluded that
the patient details on the sample were taken from the EPR not the patient’s ID band. The two-part
forename was assumed to be a middle name and not included on the sample. A contributing factor
was that the discrepancy between the request form and sample was not detected.

This demonstrates how inaccurate PID at the sampling step impacts on the safe administration of a blood
component. It highlights the importance of labelling samples directly from the patient’s ID band which
must be attached to the patient. Assumptions were made by the BMS with regards the patient’s name
and there was no check against the request form and sample label, which would have detected the error.

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 ANNUAL SHOT REPORT 2023 ERROR REPORTS WITH NO HARM

Clinical RBRP errors n=193

Prescription errors n=56

Of the 193 clinical errors, 56/193 (29.0%) were related to prescription errors, where 8 errors had incorrect
patient details on the prescription. A pre-administration checklist had been used in 38/56 (67.9%) cases
but failed to detect the error.

Case 14.2: No patient identifiers on the prescription

Due to an incomplete record of traceability, a copy of the PTR was requested as evidence of
transfusion. Only the actual prescription section of the PTR had been completed without patient
details on either the front or the back of the PTR to indicate which patient the prescription was for.
The prescriber had not completed the patient details on the consent section, TACO pre-transfusion
risk assessment, indication for transfusion and pre-transfusion results. Despite the prescription being
incomplete, both units of red cells were administered to the patient by an external agency nurse who
was not trained to administer transfusions in the hospital.

There were multiple cumulative errors in this case, any of which could have resulted in an IBCT. RBRP
cases provide free learning opportunities to rectify patient safety issues before harm occurs and should
be investigated to the same extent as patient harm incidents.

Pre-administration checklists
Total clinical RBRP errors:

• 121/193 of errors used a pre-administration checklist, but failed to detect the error

• 4/193 had a checklist available but did not use it

• 27/193 did not have a pre-administration checklist implemented in their organisation

• 41/193 stated a checklist was not applicable, or did not answer the question

Laboratory RBRP errors n=66

There were 66 laboratory errors, most of which were due to component labelling errors (36/66) and
sample receipt and registration errors (27/66).

Component labelling errors n=36

Labelling errors were mainly due to transposition of labels between units for the same patient (25/36).

Sample receipt and registration errors n=27

Sample receipt and registration errors were mainly due to patient identification errors at the booking in
stage leading to errors on the compatibility label (26/27). These errors were mostly due to demographic
data entry errors (17/26) and available information on the sample or request form not heeded (7/26).
Case 14.3 illustrates a data entry error resulting in incorrectly labelled red cells being transfused.

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ERROR REPORTS WITH NO HARM ANNUAL SHOT REPORT 2023

Case 14.3: PID amended in error by laboratory and assumptions by clinical area led to
unit of red cells being transfused
A BMS erroneously amended a patient’s forename in LIMS in error to the name of the patient’s ward.
The forename field was adjacent to location field in LIMS on the patient registration page. This led
to the unit being issued with the compatibility tag stating the incorrect forename and resulted in a
compatibility tag and ID band mismatch at the bedside. A new ID band with the patient’s name as
the name of the ward was then printed (EPR had automatically been updated by LIMS) and used to
transfuse the patient. Using the new ID band would not have alerted the staff to a mismatch on the
EBMS which was then used to confirm patient identification.

The ward nurse noticed the patient’s forename read as the ward name on EPR and the compatibility
tag. This patient had restrictions on family members being aware they were in hospital and information
being passed on to them. The nurse mistakenly attributed the change in name was to protect their
identity. The staff nurse therefore printed a new ID band which was then used to transfuse the
patient. As all other identifiers matched, they reported being confident that this was the correct
patient.

Whilst it is encouraging to see interoperability between LIMS and EPR systems, proper process and
restrictions should be in place for how and who can make amendments to patient identifiers.

Contributory factors to RBRP errors

Considering the human contribution to system failures and investigating the reasoning and behaviour of
individuals, rather than attributing the error itself, facilitates change for reducing the potential for errors
(Woods, et al., 1994). These identified that causative factors can be addressed through changes in
practice and local working environments (Improvement Academy, 2022).
figure 14.3
Analysis of the contributory factors in RBRP errors identified several commonalties between the clinical
and laboratory settings (Figure 14.3).
Figure 14.3:
Contributory
38 factors in RBRP
Ineffective use of checklists 121 errors reported in
2023 (n=259)
13
Issues or gaps with staff skills or knowledge 50

Staff member competency asssesed for task 59

related to error 72

19
Staff member was lone working 42 Laboratory
Clinical
36
Error involved information technology (IT) 72

41
Occurred during working hours 104

Near miss RBRP cases n=99

There were 99 near miss RBRP incidents, 19/99 (19.2%) originated in the clinical area and 80/99 (80.8%)
in the laboratory. Component labelling errors, 71/80 (88.8%) accounted for the majority of cases in the
laboratory. In the clinical area, sampling errors, 10/19 (52.6%) were the most reported. A high number
of cases, 71/99 (71.7%), were detected at pre-administration checks, with 57/99 (57.6%) using a formal
pre-administration checklist.

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 ANNUAL SHOT REPORT 2023 ERROR REPORTS WITH NO HARM

Figure 14.4:
RBRP near miss
events in 2023 Labelling errors 3 71

by subcategory
for clinical and Patient ID errors 11 8

laboratory errors
Electronic 2 1
(n=99) administration errors Laboratory
Prescription errors 2 Clinical

No ID band 1

ID=identification

Learning points
• All staff involved in the transfusion process should be aware of how to undertake accurate and
complete PID checks

• Sample labelling must be undertaken at the patient’s side using the ID band attached to the patient

• Pre-administration processes must include checking the patient’s identity against the prescription
and the blood component compatibility label

Conclusion
Patient identification is complex but remains fundamental to ensuring patient safety (HSSIB,
2024). Inaccurate and incomplete PID processes throughout the transfusion process can result in
significant harm. Despite the use of pre-transfusion checklists errors continue to occur. Sampling and
labelling errors remain undetected prior to transfusion, highlighting many deficiencies in clinical and
laboratory processes. The lack of appropriate checks at the collection and administration (including
prescription) steps resulted in missed opportunities to detect some RBRP errors. While transfusion
procedures may differ between establishments, there are essential common checks that must be
undertaken which could reduce the number of RBRP (and incorrect blood component transfused)
incidents. Sampling, collection, and pre-administration checks should follow British Society for
Haematology guidelines (Robinson, et al., 2018). The use of correctly configured information technology
can act as an additional safety barrier to help detect and reduce RBRP errors.

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Recommended resources
SHOT Video: The Pre-administration Blood Component Transfusion Bedside Check 2020
https://www.shotuk.org/resources/current-resources/videos/

SHOT PAUSE checklist

SHOT Safe Transfusion Practice: Transfusion Checklist
https://www.shotuk.org/resources/current-resources/

SCRIPT Using Information Technology for Safe Transfusion

https://www.shotuk.org/resources/current-resources/script/

References
Improvement Academy, 2022. Yorkshire Contributory Factors Framework. [Online]
Available at: https://improvementacademy.org/resource/yorkshire-contributory-factors-framework/ (Accessed 01 March
2024).

Narayan, S. et al., 2022. The 2021 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. doi: https://doi.org/10.57911/QZF9-XE84.

National Services Safety Investigations Body (HSSIB), 2024. National learning report: Positive patient identification.
[Online] Available at: https://www.hssib.org.uk/patient-safety-investigations/positive-patient-identification/national-
learning-report/ (Accessed 08 April 2024).

Robinson, S. et al., 2018. The administration of blood components: a British Society for Haematology Guideline.
Transfusion Medicine, 28(1), pp. 3-21. doi: https://doi.org/10.1111/tme.12481.

Woods, D. D., Johannesen, L. J., Cook, R. & Starter, N. B., 1994. Behind human error: cognitive systems, computers,
and hindsight. Ohio: Crew Systems Ergonomics Information Analysis Center.

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Laboratory Errors n=742 (535

15 transfused errors and 207 near miss)

Authors: Victoria Tuckley, Nicola Swarbrick, Peter Baker and Heather Clarke

Abbreviations used in this chapter

ABOi ABO-incompatible ICU Intensive care unit
APML Acute promyelocytic leukaemia Ig Immunoglobulin
BMS Biomedical scientist LIMS Laboratory information management system
cffDNA Cell-free fetal deoxyribonucleic acid MHRA Medicines and Healthcare products Regulatory
EBMS Electronic blood-management system Agency
ED Emergency department PCC Prothrombin complex concentrate
EI Electronic issue PTT Pre-transfusion testing
EQA External quality assessment RBRP Right blood right patient
FBC Full blood count SCD Sickle cell disease
FFP Fresh frozen plasma SOP Standard operating procedure
Hb Haemoglobin SRNM Specific requirements not met
HCPC Health and Care Professions Council UK United Kingdom
HDU High dependency unit UK NEQAS UK National External Quality Assurance Scheme
HSE Handling and storage errors UKTLC UK Transfusion Laboratory Collaborative
IBCT Incorrect blood component transfused WCT Wrong component transfused
IBGRL International Blood Group Reference Laboratory

Key SHOT messages

• IBCT-SRNM events were the most common category of transfused laboratory errors accounting
for 156/535 (29.2%) in 2023

• The most common category of transfused laboratory errors occurred at the testing step, 192/535
(35.9%)

• Major morbidity due to sensitisation to the K antigen continues to occur (n=4 in 2023)

• Laboratory delays contributed to 1 patient death (imputability-probable), and 3 cases of major

morbidity in 2023

• Many incidents were related to insufficient staff knowledge in non-routine situations

• Common contributory factors include staff shortages, poor skill mix, lone working, education,
ineffective IT, communication issues and poor safety culture

Recommendations
• Patients should not die or suffer harm from avoidable delays in transfusion. Where transfusion
needs are complex, laboratory staff should have access to and follow specialist advice to provide
the most suitable component available. Hospital policies and processes must reflect this

• Staff must have protected time for training and education to provide a safe service

130 15. Laboratory Errors

ERROR REPORTS COMPOSITE CHAPTERS ANNUAL SHOT REPORT 2023

• Bespoke operational roles should be considered for project/change implementation to ease the
pressure on routine staff

• Policies for lone working should be reviewed to identify when extra support or reallocation of
tasks are required

• A just and learning safety culture should be implemented to improve the safety of patients and
staff members, and to ease the existing recruitment and retention pressures in the laboratory

Action: Transfusion laboratory managers

Introduction
There has been an increase in laboratory errors which resulted in transfusion, 535/1764 (30.3%) of
total errors in 2023 compared to 431/1542 (28.0%) in 2022. Laboratory near misses were 207 in 2023
compared to 220 in 2022. The largest category of laboratory errors were IBCT-SRNM events, 156/535
(29.2%), which remains a consistent theme within laboratory errors (Figure 15.1). There was also an
increasing trend in giving the incorrect blood group to patients undergoing haematopoietic stem cell
transplants. Please see further information figure 15.110, Incorrect Blood Component Transfused
in Chapter
(IBCT) and 'Recommended resources'. Human factors related to laboratory errors are discussed in the
supplementary information on the SHOT website (https://www.shotuk.org/shot-reports/report-summary-
and-supplement-2023/).

Figure 15.1:
Laboratory errors
and near misses by
Transfused errors
156 reporting category
Near miss
in 2023 (n=742)

83 86
80
71 66
56

33 32 34
28
13
0 0 1 0 3 0
le

lg
n
M

RP

C
d
CT

SE

io
ab
RN

ye

PC

D
us
RB
-W

ti -
id
la
-S

sf

An
o
De
CT

Av

an
CT
IB

r tr
IB

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Un

IBCT-WCT=incorrect blood component transfused-wrong component transfused; IBCT-SRNM=IBCT-specific requirements not met;
HSE=handling and storage errors; RBRP=right blood right patient; PCC=prothrombin complex concentrate; Ig=immunoglobulin

In 2023, categorisation of errors at the component labelling, availability and handling and storage
transfusion step, have been separated into three constituent steps to gain focused learning. These are
now categorised as component labelling errors, availability errors, and handling and storage errors. Errors
occurring at the testing step are, as in previous years, the highest source of error within the laboratory
192/535 (35.9%) (Figure 15.2).

15. Laboratory Errors 131

 ANNUAL SHOT REPORT 2023 ERROR REPORTS COMPOSITE CHAPTERS

figure 15.2
Figure 15.2:
SHOT laboratory
0 50 100 150 200
data across all
categories showing Sample receipt and 6 10 27
registration
the stage in the
transfusion process Testing 10 92 17 8 63
where the primary
error occurred Component selection 52 48 4 18
(n=535)

Component labelling 36

Availability 20 29

Handling and storage 61

Miscellaneous 3

IBCT-WCT RBRP PCC

IBCT-SRNM Delayed Anti-D Ig
HSE Avoidable Undertransfusion

IBCT-WCT=incorrect blood component transfused-wrong component transfused; IBCT-SRNM=IBCT-specific requirements not met;
HSE=handling and storage errors; RBRP=right blood right patient; PCC=prothrombin complex concentrate; Ig=immunoglobulin
Note: numbers <3 are too small to be annotated on the figure

Deaths related to transfusion n=1

There was 1 death in 2023 where there was a delayed transfusion caused by an error during haematology
testing (imputability 2).

Case 15.1: Death probably related to delay in platelet transfusion, due to laboratory results
being suppressed pending film review
A patient with undiagnosed APML presented in the ED at 9pm on day 1. An FBC sample showed a
Hb of 39g/L, white cell count of 86x109/L and platelet count of 15x109/L. Results were reviewed by
BMS 1 who had not been signed off on FBC validation whilst BMS 2 was taking a break. A routine
blood film was requested, and an urgent review was not flagged. The platelet count was not visible
to clinical staff, as reporting parameters required it to be confirmed by blood film. The FBC result was
not phoned through to the clinical area. Red cell transfusion commenced around 03:00 on day 2. The
high white cell count was referred by the ED to the clinical haematology department using the routine
referral system, and was not flagged as urgent, therefore it was not viewed by the haematology team
until 11:00 on day 2. After seeing this result the blood film was reviewed urgently, and the diagnosis
of an acute leukaemia was made. The critically low platelet count and diagnosis was available to the
clinical teams at around 11:20 on day 2. There was over a 12-hour delay in the diagnosis of an acute
leukaemia and commencement of urgent chemotherapy. This also caused a delay in coagulation
testing, which was requested around 12:30 on day 2 and the fibrinogen result was 1.8g/L. However,
when the fibrinogen level dropped to 1.2g/L on day 3 this was not escalated as an urgent referral as
it was above the local threshold for telephoning results. Cryoprecipitate was not administered for
another 7.5 hours after the result was available on day 4. Treatment was initiated urgently with blood
component support, but the patient developed a subdural haemorrhage and died.

Upon investigation, there was a communication failure between the BMS staff. BMS 2 originally requested
that BMS 1 looked at the FBC results and make any blood films that were needed. This was interpreted
as being asked to validate the results. Local action was to remind BMS 1 to act within their scope of
responsibility. Within the laboratory, inadequate staffing levels and skill mix had already been raised
within the organisational risk register and has subsequently been escalated to the divisional director.

132 15. Laboratory Errors

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APML is a specific form of acute leukaemia characterised by severe coagulopathy which can rapidly
lead to death through haemorrhage. The provisional diagnosis can be made based on the appearance
of the blasts on the blood film. If suspected, specific APML therapy will be given immediately. For this
reason, all patients newly presenting with suspected leukaemia in the ED require a coagulation screen
and discussion with haematology urgently, so that appropriate treatment can be initiated.

Learning points
• Staff should never be expected to perform tasks they do not feel they have sufficient knowledge
or expertise to do

• Clinicians who order blood tests have a responsibility to follow up and review test results so as
to initiate appropriate management

• Provision of essential blood components for patients may depend on timely availability of relevant
haematology/coagulation test results, necessitating prompt release of these results

Major morbidity n=7

There were 7 cases where laboratory errors contributed to major morbidity, 4 cases of IBCT-SRNM
causing sensitisation to the K antigen in patients of childbearing potential, and 3 cases of delays, 2 of
which caused admission to the ICU or HDU, and 1 case where a patient went into peri-arrest before
being given red cells (Case 15.2).

Case 15.2: Communication failure causes delay and major morbidity

A patient with SCD and a Hb of 45g/L was admitted in crisis. The patient had a progressive
anaemia with multiple antibodies therefore frozen red cells were ordered from the Blood Service.
The following morning, the patient deteriorated with peri-arrest, hypoxia and acidosis. One red cell
unit was transfused at 08:00. The transfusion consultant advised to administer further red cell units
although fully compatible units would not be available for some hours. The laboratory was advised
by the consultant haematologist to select ABO, Rh, K matched red cells at 09:00. The laboratory
was contacted at 11:30 to ask about availability of the blood. The patient was finally transfused after
midday and recovered from this episode. The transfusion delay was caused by communication
failure, poor venous access for sampling and staff inexperience with issuing the best available red
cells due to the presence of multiple red cell antibodies. The staff are now aware that if blood is
required urgently the clinical team can request red cells to be issued using concessionary release
before testing is complete.

Learning point
• Guidance for concessionary release should be detailed within an SOP and should form part
of competency-assessments or scenario-based training drills within the laboratory (Milkins, et
al.,2013; Stanworth, et al., 2022)

Further cases of laboratory errors impacting upon delays can be found in Chapter 12a, Delayed
Transfusions.

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ABO-incompatible transfusions n=2

Two laboratory errors resulted in ABOi FFP transfusions, one to an adult and the other to a child. Both
errors occurred at the component selection step.

The 1st case involved transfusion of four group O FFP to a group B patient during a major haemorrhage
protocol activation. The patient suffered no adverse effects. In the 2nd case, 5mL of group O high-titre
negative FFP was transfused to a neonate who was group A. They appeared to be group O upon testing
of one sample only (policy stipulates two groups required for this action); however, the laboratory was
subsequently informed that the patient had been transferred and had received one unit of group O
emergency red cells at a previous site. These cases are discussed in more detail in Chapter 10, Incorrect
Blood Component Transfused (IBCT).

Laboratory themes 2023: Laboratories under increasing pressure

Many complex and interacting themes were observed within the laboratory data in 2023. These are
similar to those observed in 2022, with additional pressures being observed, presenting an increasingly
complicated picture (Figure 15.3).

Figure 15.3:
Additional Increasing workload, mismatched Gaps in staff knowledge and
pressures on with staff available to do the work training - not knowing 'why'
transfusion
Staffing issues: vacancies with staff
laboratories evident Poor safety culture recruitment/retention issues
in 2023 SHOT data
Abbreviated training Excessive training burden on
remaining staff
Staffing and
Post-pandemic pressures training issues Staff delivering training lacking
leading to increased workload contributing to the necessary expertise to do so
laboratory errors

Challenges with recruitment Lack of time to complete

and retention (most pressure at specialist qualifications
AfC band 6)
Staff needing time for extra training when
Changes in IT appointed worsening the staffing issue

Transfusion topics deprioritised Lack of transfusion theory in

during BMS registration training undergraduate degrees

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Errors by step in the transfusion process

Table 15.1:
Transfusion step Pressure points Learning points
Laboratory errors

Sample receipt and by step in the

The use of end-to-end electronic systems should
registration n=64 Data entry and information not being transfusion process
prevent most transcription errors and allow pertinent
inputted into the LIMS from the (n=742)
clinical information to be automatically transmitted
request form
46 errors↑ 18 NM↔ to LIMS

Testing n=206 LIMS should have appropriate controls to prevent

issue of blood components without appropriate
testing, in the absence of a clinical concession
Errors mostly due to failure to follow
procedure 101/192 (52.6%)
192 errors↑ 14 NM↓
All incorrect cffDNA results should be reported to
SHOT

Incomplete knowledge of several Laboratories should have clear procedures for blood
Component selection transfusion principles including grouping requirements in transplant patients
n=197 • Group changes in transplant
patients Laboratories should have a clear procedure for
• Patient groups requiring concessionary release and be aware of when
phenotype-matched components to escalate potential delays in obtaining blood
126 • Anti-D and anti-K components to clinical teams
71 NM↑↑
errors↑↑

Component labelling errors were Label verification software can detect many
mostly detected by a formal bedside component labelling errors before the component is
Component labelling checklist, 51/74 (68.9%) released to the clinical area
n=115*
Many incidents stated label The use of a laboratory exit checklist or pre-
verification software could have administration checklist can assist in identifying
detected the error earlier, or that it component labelling errors
41 errors 74 NM
was in place but not used
Laboratories should have a clear procedure for
concessionary release and be aware of when
Component availability Communication in emergencies
to escalate potential delays in obtaining blood
n=66* components to clinical teams
Lack of clear procedures to return
blood components which no longer
Clear communication between laboratory staff and
meet requirements (e.g., expired
clinical teams is vital to prevent transfusion errors.
component or expired sample)
Policies, procedures, and advice from experts
should be easily accessible
Please also see Case 15.5 in the
54 errors 12 NM
supplementary information
Patients should never be transfused unnecessarily
when not clinically indicated to avoid wastage of
blood stocks

Component handling Laboratories should have clear procedures

and storage n=78* Timely response to temperature-
regarding component quarantine and return to
monitoring software
stock parameters
67 errors 11 NM

There were an additional 9 errors and 7 NM classed as ‘miscellaneous’ which are discussed in the supplementary
information on the SHOT website (https://www.shotuk.org/shot-reports/report-summary-and-supplement-2023/)
*These transfusion steps are new for 2023 therefore comparison with previous data is not available

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Sample receipt and registration errors resulted in:

• Compatibility labels with incorrect patient information due to data entry errors
• Patients receiving components which were not irradiated, or were of the incorrect blood group
due to not identifying information on the request form and/or LIMS

Testing errors resulted in:

• Patients receiving blood components prior to testing being completed
• Incorrect management of anti-D Ig due to incorrect cffDNA screening predictions
• Delays in provision of blood components
• NM errors mostly resulted in potential incorrect management of anti-D Ig

Component selection errors resulted in:

• Incorrect group components being transfused to transplant patients
• Provision or potential provision of components which were; incorrect phenotype/not antigen-
negative, K-positive to patients of childbearing potential and not irradiated
• Incorrect provision of anti-D Ig to patients with immune anti-D or to those with a D-negative infant

Component labelling errors resulted in:

• Transposition of labels on blood components intended for the same patient
• NM errors mostly resulted in potential RBRP errors

Component availability errors resulted in:

• Delays in provision of blood components, or expired blood components being available when
they should have been discarded

Component handling and storage errors resulted in:

• Transfusion or potential transfusion of components with incomplete cold chain or reservation
period exceeded

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Abbreviated and accelerated training

The results of the UKTLC survey 2022 showed increasing recruitment and retention issues within the
transfusion laboratory workforce, with concerns raised relating to the number, suitability, and calibre of
applicants for HCPC registered roles. Most respondents felt that newly qualified HCPC registered BMS
had a poor level of transfusion education. These recruitment and retention issues are occurring alongside
an increase in workload (60.8% saw an increase in workload). A concerning trend of ‘abbreviated and
accelerated training’ has been observed within reports submitted to SHOT, in which staff are being
allowed to work alone and outside of routine hours with only selected competency-assessments
completed. In these circumstances there may also be a delay in receiving additional training required,
as once a staff member is ‘signed off’ for lone working they are traditionally compliant with all training
requirements. In environments when staffing provision is already at critically low levels any further training
may ‘slip through the net’. This compounds the initial risk of working without adequate knowledge for
all tasks. Similar concerns have been noted with approved abbreviated training programmes for junior
doctors (Chivers, 2023).

Cases 15.6 and 15.7 in the supplementary information for this chapter highlights errors where staff were
allowed to participate in lone working before they were fully trained.

Lone working
Laboratory data in 2023 showed that errors occur at a disproportionate rate when individuals were lone
working. A total of 431 reports provided an answer to the question ‘Was the member of staff lone-working
at the time of the incident’, with 160/431 (37.1%) staff lone-working. Lone working is usually instigated
outside of core hours when the workload is anticipated to be lower than in the routine working day. The
UKTLC standards 2024 state that staff should have access to specialist transfusion laboratory advice
outside of routine working hours (Dowling, et al., 2024), however in the UKTLC survey 2022, 45.9% had no
formal arrangement for support. Lone working may be considered a risk factor for transfusion errors, and
laboratories may wish to evaluate when lone working is necessary, or other methods to alleviate pressures
when a member of staff is working by themselves. Case 15.3 describes how many different laboratory
pressures may be influencing inadequate testing and substandard patient care.

Case 15.3: Lack of staff knowledge leads to inappropriate editing of results and incomplete
testing when lone working
A sample was received from a patient requiring red cell transfusion postoperatively when the BMS
was lone working in the laboratory. The analyser flagged the sample as haemolysed, and the results
were validated and accepted by the BMS rather than being rejected, as the BMS did not know how
to reject a haemolysed sample. There was no result in the patient reverse group (B cells) and the BMS
inappropriately amended the result to a 3+. The LIMS excluded the patient from EI and highlighted the
requirement for a serological crossmatch due to the group amendment. The BMS was unaware that a
modification would de-select EI and entered a negative reaction (compatible) into the crossmatch result,
even though no test had been performed, due to the patient not having any antibodies or alert flags.

Although the BMS was deemed competent, they were bank staff who did not routinely work core hours
and were previously employed as a transfusion BMS within the organisation. This incident happened
over a weekend where there was no second checker available. The reporter identified that samples
prior and after this incident were suitable for EI suggesting there was a primary issue with the sample
being tested at the time.

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This case illustrates the importance of laboratory staff having regular knowledge updates and practical
time within the laboratory. The UKTLC standards 2024 state that all staff should have a minimum of 10
routine working days within the laboratory, so that they can be informed of changes in practice and receive
appropriate support from senior staff (Dowling, et al., 2024).

It also illustrates that competency-assessment can often be a point of weakness if it is completed as

a one-off tick box exercise. Scenarios and questions within competency-assessments should also be
regularly updated in light of changes in practice or following learning from patient safety incidents. The 2019
UPTAKE model of competency-assessment can be found in the 'Recommended resources' for this chapter.

IT implementation
In 2023, 287/535 (53.6%) of all laboratory error reports were assessed to have an IT component, with
the most common reason for this being cited as a lack of functionality to support safe practice.

Many laboratories in the UK are undergoing IT implementation projects – either through the introduction
of electronic blood-management systems, integration with new electronic patient record or new LIMS
systems. Introduction of new IT systems can temporarily increase the workload pressures within the
laboratory along with challenges relating to migrating data and changes in functionality from older
systems. These factors may temporarily increase the risk of errors occurring when there is no extra staffing
provision or expertise made available to manage such projects. New guidelines relating to IT within the
transfusion laboratory have recently been published and can be used as a source of information for any
laboratories implementing new IT systems (Staves, et al., 2024).

Safety culture in the transfusion laboratory

In November 2023 a survey was undertaken by SHOT and the UKTLC, with input from the MHRA
haemovigilance team, to examine safety culture within transfusion laboratories in the UK. Many of the
results were concerning. The recommendations from the survey report should be implemented to improve
safety culture within laboratories. A link to the survey summary can be found in the 'Recommended
resources' for this chapter.

Case 15.4 below illustrates the impact of a poor safety culture on staff decision-making and the potential
to generate error.

Case 15.4: Laboratory safety culture and leadership issues influence a component
selection error
A patient with thalassaemia received red cells which did not match their Rh and K phenotype.
The requirement for phenotype-matched components was recorded in the LIMS (despite an initial
mistaken diagnosis of sickle cell disease being communicated). An additional step to highlight this
requirement in the patient notes field on the LIMS was not completed which resulted in the BMS

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not selecting phenotype-matched red cells.

During investigation the BMS stated they were multi-tasking and rushing, and the event happened
at a weekend when there were less staff available than normal. The report stated that staff do not
have the correct amount of protected time to develop their knowledge and are less prepared to
deal with complex cases. Additionally, the BMS stated they felt they were ‘being watched’ and there
was a blame culture within the laboratory. Leadership and staffing issues within the laboratory had
been identified during a recent inspection. Corrective actions included updating SOP for issuing
phenotype-specific blood and potential changes to LIMS but did not mention culture issues identified.

It is encouraging to see that systemic problems were identified and specific actions were put in place,
however the impact of poor leadership and culture cannot be underestimated.

Conclusion
Transfusion laboratories are under escalating pressures, and this is reflected in the steep increase in
laboratory errors in 2023. It is evident that many of these events were preventable and would potentially
not have occurred in periods of proper staffing and resource allocation. There has been a reduction in
staffing availability, change in education of newly qualified staff and increased workload alongside many
necessary improvement projects. Transfusion laboratory professionals need to be appropriately supported
so they may continue to provide high-quality patient-centred services.

Concerning results observed in the 2023 laboratory culture survey may be a direct result of this increased
pressure and a service approaching breaking point. It is essential that staff members are able to
acknowledge and escalate when patient and professional safety concerns arise. In the face of a challenging
working environment, staff members should feel valued for the lifesaving work they do every day.

Despite these challenges, laboratory staff are working tirelessly to provide support to patients. There are
4 cases within Chapter 6, Acknowledging Continuing Excellence in Transfusion (ACE) which illustrate
excellent communication, collaboration and focus on patient safety by transfusion laboratory staff.

SHOT would like to acknowledge the unwavering commitment, dedication, and tireless efforts by all
staff in transfusion especially in the laboratories, who work under immensely stressful situations to save
and improve lives.

UK Transfusion Laboratory Collaborative update

Authors: Kerry Dowling and Jennifer Davies
The UKTLC continues to work in partnership with key stakeholders in the transfusion process aiming
to improve transfusion safety. This year the 2023 UKTLC standards have been published in Transfusion

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Medicine and have been welcomed by the laboratory community. The standards aim to help laboratories
in four main areas (staffing, education, IT and a just culture). The standards are evidence based to
reduce errors occurring in the transfusion laboratory and were updated to reflect changes in practice
and support transfusion laboratories with current challenges.

The 2022 UKTLC survey highlighted staffing, workload, and education challenges, this is reflected in
the laboratory errors reported to SHOT. Gaps in transfusion knowledge, lack of specialised staffing
resource and inability to meet staffing levels required in capacity plans impacts the laboratories’ ability
to provide a safe and stable service. Positively, 86.5% of the survey respondents had a capacity plan
in place, however respondents noted a lack of compliance with the plan and highlighted deficiencies in
both staffing numbers and skill mix. Where capacity plans are not met escalation to Trust/Health Board
management is required detailing the risks and impacts with reference to the requirements of BSQR 2005.

The 2023 culture survey has highlighted further concerns with a theme of incivility in the working place,
a lack of psychological safety and a pressure to present an inaccurate assessment of the severity of
incidents. This coupled with the staffing and workload pressures is a cause for concern for transfusion
safety. Recommendations have been released in response to this survey and the UKTLC is working
with partners to highlight these issues.

The implementation of IT systems such as ‘electronic blood-management systems’ remains a challenge

for hospitals as demonstrated by the UKTLC survey where a third of respondents had no EBMS in place.
The 2023 UKTLC standards recommend implementation of these systems to their full functionality to
support safe transfusion practices.

In May 2023, the UKTLC survey findings and new standards were publicised in two webinars. A joint
UKTLC, SHOT and MHRA webinar in June 2023 explored key aspects of incident investigations,
regulatory framework, the use of human factors and ergonomics, and the importance of effective
interventions. Recordings of these webinars can be accessed on the UKTLC page of the SHOT website
(https://www.shotuk.org/resources/current-resources/uktlc/), along with other resources, including
survey results and tools for compliance with the standards.

This year, the UKTLC will continue to work with key partner organisations to help laboratories improve
transfusion safety including staff education and IT strands of work.

UK NEQAS update
Authors: Richard Haggas and Claire Whitham, UK NEQAS BTLP
Participation in EQA offers the chance to learn from errors. The errors made in EQA exercises can be
viewed as ‘free lessons’, as appropriate corrective action can be taken before the error occurs with a
clinical sample.

As in other years, ‘procedural’ errors (errors caused by sample or result transposition, and/or data
transcription into the UK NEQAS website) continue to be a significant cause of penalty during 2023. On
this occasion, there were ABO grouping errors made, when during a PTT ‘R’ exercise, one laboratory
labelled the samples and recorded the results in a non-standard order, and this was not noticed during
data entry. Compounding this grouping error, the laboratory also reported two incorrect phenotypes
and the theoretical deselection of a donor unit due to the blood group being incorrect. Three other

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laboratories, across more than one exercise, recorded correct grouping reactions but reported an
incorrect blood group interpretation. Since ABO/D grouping and antibody screening tests are largely
automated, with automatic transmission of results to the laboratory information management systems
(LIMS), the errors seen in EQA for these tests may not be fully representative of a similar error in a clinical
situation, where the automated processes are functioning as intended. However, during analyser and/
or LIMS downtime, these procedural errors acquire a greater significance in terms of risk to the patient.

‘Procedural’ errors also account for a high proportion of missed compatibility and missed incompatibility
during crossmatching. During the PTT ‘R’ exercises, several laboratories made errors in crossmatching
due to various factors; these include incorrectly labelling the samples when booking into the LIMS, making
data entry errors, and transposing samples during testing. Where tests are still performed manually,
with no automated transmission of results to the LIMS, the risks of procedural errors are a constant that
should be mitigated as far as possible. Although most LIMS will prevent the issue of ABO-incompatible
units, when IT systems fail this safeguard is not available and manual checking of groups on donations
is required. This is also the situation with EQA samples, and it is important to check the group of donors
prior to making decisions on theoretical compatibility. When testing samples, or entering data for EQA
samples, it is important to check that the data is being recorded and transcribed against the correct
patient or donor; this also applies to the positive identification of the sample being tested, data entry
of results of manual testing of clinical samples into a LIMS, or in the event of LIMS downtime. Care
should be taken to confirm the identity of all samples before testing. For clinical samples, this requires a
full check of the patient demographic details to ensure that results are assigned to the correct patient.
EQA samples should be subject to the same process with a check of the patient number and exercise
code on each sample.

Like ABO and D grouping, antibody screening sees very low error rates. Although few in number, false-
negative antibody screens can have a significant impact, particularly in laboratories employing electronic
issue as a means of establishing compatibility. As in 2022, there was a repeat occurrence of a laboratory
obtaining negative reactions during the initial screen for a plasma sample containing an antibody. Repeat
testing after the closing date showed expected results; an investigation showed the original result had
a low liquid level flag which had not been actioned as per the local policy. Flags against reactions or
results on an analyser are intended to draw attention to a problem with testing, and laboratories should
have a policy in place for handling all flags to ensure invalid results are not accepted.

Interestingly, this year there have been a small number of examples of donor unit deselection, on grounds
that are out with the BSH guidance (Milkins, et al., 2013). Two laboratories deselected two group O
D-negative r”r (cdE/cde) donors for a 92-year-old male with a blood group of A D-negative and no
alloantibodies. Both laboratories indicated they did not want to select E positive red cells for a D-negative
patient; this deselection went against their laboratory policy. Additionally, one further laboratory reported
two group O D-negative K-positive donors as incompatible with a male patient with blood group B
D-positive and no alloantibodies. According to this BSH guideline, there is no requirement to deselect
r”r donor units for issuing to D-negative male patients, or K-positive donor units to male patients, when
no alloantibodies are detected, unless the clinical details indicate a specific requirement to do so. Doing
this may reduce the availability of rr (cde/cde) units, and K-negative units respectively, for patients who
require them to prevent potential sensitisation.

Recommended resources
UKTLC standards
https://onlinelibrary.wiley.com/doi/10.1111/tme.13029

SCRIPT Using Information Technology for Safe Transfusion

https://www.shotuk.org/resources/current-resources/script/

2023 SHOT, MHRA and UKTLC laboratory culture survey summary

https://www.shotuk.org/resources/current-resources/shot-surveys/

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UPTAKE model of competency-assessment (page 107, 2019 Annual SHOT Report)

https://www.shotuk.org/shot-reports/report-summary-and-supplement-2019/

SHOT Bite 24: Speaking up for patient safety

https://www.shotuk.org/resources/current-resources/shot-bites/

PAUSE checklist
The laboratory component labelling and exit check
https://www.shotuk.org/resources/current-resources/

Concessionary release example template (Appendix 9)

https://onlinelibrary.wiley.com/doi/epdf/10.1111/j.1365-3148.2012.01199.x

References
Chivers, D. J., 2023. Rapid Response: Shortened undergraduate training will put more pressure on already overworked
Junior Doctors. BMJ, Volume 381, p. 1422. Available at: https://www.bmj.com/content/381/bmj.p1422/rr-1 (Accessed
27 June 2024)

Dowling, K. et al., 2024. UK Transfusion Laboratory Collaborative: Minimum standards for staff qualifications, training,
competency and the use of information technology in hospital transfusion laboratories 2023. Transfusion Medicine,
34(1), pp. 3-10. doi: https://doi.org/10.1111/tme.13029.

Milkins, C. et al., 2013. Guidelines for pre-transfusion compatibility procedures in blood transfusion laboratories.
Transfusion Medicine, 23(1), pp. 3-35. doi: https://doi.org/10.1111/j.1365-3148.2012.01199.x.

Narayan, S. et al., 2020. The 2019 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. doi: https://doi.org/10.57911/5NG7-MJ28.

Stanworth, S. J. et al., 2022. Haematological management of major haemorrhage: a British Society for Haematology
Guideline. British Journal of Haematology, 198(4), pp. 654-667. doi: https://doi.org/10.1111/bjh.18275.

Staves, J. et al., 2024. Guidelines for the specification, implementation and management of IT systems in hospital
transfusion laboratories. Transfusion Medicine, 34(2), pp. 81-166. doi: https://doi.org/10.1111/tme.13027.

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Errors Related to Information

Technology (IT) n=541 16
Authors: Megan Rowley and Jennifer Davies

Definition:
This chapter includes transfusion adverse events that relate to laboratory information management
systems as well as other information technology systems and related equipment used in the
delivery of hospital transfusion services.

Cases selected include events where IT systems may have caused or contributed to the errors
reported, where IT systems have been used incorrectly. Where the corrective and preventive
action suggested by hospitals in response to errors included IT solutions, these have been
included.

Abbreviations used in this chapter

BSH British Society for Haematology SCRIPT SHOT collaborative reviewing and reforming
CAPA Corrective and preventative action IT processes in transfusion
EBMS Electronic blood management system SRNM Specific requirements not met
EPR Electronic patient record UK United Kingdom
HSE Handling and storage error UK NEQAS UK National External Quality
IBCT Incorrect blood component transfused Assurance Scheme
LIMS Laboratory information management system UKTLC UK Transfusion Laboratory Collaborative
NHS National Health Service WBIT Wrong blood in tube
RBRP Right blood right patient WCT Wrong component transfused

Key SHOT messages

• There is increasing recognition that IT systems can prevent recurrence of errors in clinical and
laboratory transfusion practice thereby improving patient safety. It is important to note however
for this to happen, IT should be implemented correctly, or existing systems modified appropriately

• The learning from the implementation of new transfusion-related IT systems should be shared with
others through the SCRIPT group and SCRIPT resources can be used to support and educate all
those involved in procurement, implementation and operation of these IT systems

Recommendations
• Undertake a gap analysis for all existing transfusion-related IT systems and automation against the
updated UKTLC standards (standard 3) (Dowling, et al., 2024) and the updated BSH guidelines
for the specification, implementation, and management of IT systems in hospital transfusion
laboratories (Staves, et al., 2024). A gap analysis tool has been provided by BSH

• The specification of new IT systems and upgrade of existing systems should be undertaken with
reference to updated BSH guidelines for the specification, implementation, and management of
IT systems in hospital transfusion laboratories (Staves, et al., 2024)

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• When introducing new IT systems across any part of the transfusion pathway, human factors and
ergonomics should be considered to gain all the possible benefits of technology for staff, as well
as for patient safety

Action: Laboratory managers, IT professionals, hospital transfusion teams

SHOT Collaborative Reviewing and reforming IT Processes in

Transfusion
The SHOT SCRIPT group formed in 2019, continues to work to improve transfusion safety through
improved IT systems and practices. Many resources have been added to the webpage to support
organisations with purchasing, validating, and implementing IT systems that support safe transfusion
practice, including LIMS, EBMS and EPR systems. The interactive document ‘Using Information
Technology for Safe Transfusion’ has been designed to support organisations in identifying how IT could
be used across all SHOT 10 steps. SCRIPT resources now include educational cases relating to IT, and
a short IT video is available on the webpage. In 2023 the SCRIPT group published the SCRIPT survey
focussing on LIMS: Laboratory information management systems: Are we ready for digital transformation?
(Davies, et al., 2023). The BSH IT guidelines have now been published, including a gap analysis tool for
local compliance monitoring (Staves, et al., 2024). SCRIPT continue to work with key stakeholders to
improve uptake and use of IT systems in transfusion, including UK NEQAS, IT suppliers and the NHS
England (Transfusion Transformation project).

Introduction
The number of IT errors in 2023 have increased by 39.8% (2023 n=541, 2022 n=387). Of the cases
included in the IT chapter the question ‘Did IT contribute to this error?’ was answered by the majority
of reporters. Only 156/541 (28.8%) said ‘YES’, IT did contribute which means that 71.2% of IT cases
were not identified by the reporters themselves. The question ‘Could the error have been prevented by
using IT?’ was answered by 463 reporters, of whom 222 (47.9% of respondents) said ‘YES’ therefore
identifying need for greater use of technology. Not only did the expanded IT questions provide additional
information about the type and providers of IT systems in use, and the nature of the IT contribution to
errors, but there was greater reflection on possible IT solutions. Further information can be found in
supplementary Table 16.4 on the supplementary information on the SHOT website (https://www.shotuk.
org/shot-reports/report-summary-and-supplement-2023/).

Table 16.1:
Laboratory Total cases
Categories Primary reporting category Clinical errors
errors 2023
containing errors Incorrect blood component transfused laboratory (IBCT-WCT) 58 20 78
related to IT in 2023 Special requirements not met (IBCT-SRNM) 112 51 163
(n=541) Right blood right patient (RBRP) 30 56 86
Avoidable, delayed and under/overtransfusion (ADU) 19 50 69
Handling and storage errors (HSE) 45 100 145
Total 264 277 541

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Table 16.2:
Other cases with IT errors
Other categories
Anti-D immunoglobulin errors 68
containing errors
Near miss 148
related to IT in 2023
WBIT 224
(n=440)
Total 440

Flags, alerts, and warnings n=194

The largest group of clinical and laboratory errors related to IT systems are due to flags, alerts, and
warnings as well as the use of logic rules and algorithms within the software. In 66 cases, alerts and
warnings were in place but not heeded; in 56 cases, flags were not updated or were removed in error;
in 72 cases, the available flags or logic rules were not used. Cases related to the LIMS are addressed
within Chapter 15, Laboratory Errors.

In the clinical area, at the point of blood collection and at patient’s side, EBMS are used to identify the
right component for the right patient. The lack of clarity of alerts can cause messages to be overlooked
or misunderstood by clinical operators. Also, staff in the laboratory are not always able to support clinical
staff who contact them with queries about error messages. This may sometimes be due to lack of
familiarity or inadequate training but also, particularly with lone workers, be due to competing priorities.

Case 16.1: Alert on EBMS overridden twice

The wrong platelet pack from a two-unit donation was issued electronically and the discrepancy
between codes was highlighted by the EBMS at the point of collection. The laboratory re-issued the
same unit, but the discrepancy remained, so the alert was overridden without identifying or resolving
the source of the error. The same discrepancy was highlighted at the pre-administration check and
again was overridden, and the unit transfused. This error came to light when the second pack from
this donation could not be issued because it had already been fated as ‘transfused’. This highlights
the importance of understanding the exact nature of the error message and effective troubleshooting
before proceeding with transfusion.

Learning points
• Error messages should be both clear and specific. It is important that both clinical and laboratory
staff understand what action to take in response to an error message so that patient safety is
maintained, and delays are minimised

• Training in the use of clinical and laboratory IT systems must include troubleshooting advice. When
a problem has been identified, this should be investigated and resolved appropriately. The learning
from the incident should be disseminated widely and added to any future training resources

Interoperable IT systems n=55

The recently updated UKTLC standards and BSH guidelines highlight the importance of interoperable IT
systems to reduce the risk of transcription errors and to ensure that all clinical and laboratory information
to support a patient’s transfusion is available (Dowling, et al., 2024; Staves, et al., 2024). It is also
important that data on previous LIMS or a merged/networked LIMS is accessible. There were 23 reports
of patient ID discrepancies between the LIMS and the EPR which resulted from an IT error although
blood components were issued to the right patient; 24 reports where there was failure to link, merge or

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 ANNUAL SHOT REPORT 2023 ERROR REPORTS COMPOSITE CHAPTERS

reconcile computer records on different systems; 8 reports of WCT or SRNM where historical data was
available on an IT system, but the record was not accessed.

Errors arising from use of IT systems including EBMS n=98

These errors related to the functionality of computer systems, both LIMS (n=23) and EBMS (n=44)
as well as errors arising from manual processes such as selecting the wrong record (n=7) or entering
data incorrectly into an IT system (n=24). It is advisable when implementing or updating IT systems to
ensure that there is appropriate validation to ensure the systems work as intended. With updated BSH
guidance available, checking existing systems against the guidance using the gap analysis tool provided
will highlight any lack of functionality that may need addressing. Where any unexpected errors occur or
IT systems do not function as specified, contact with the manufacturer is essential to highlight the faults
so that all users of the system can benefit from any improvements.

IT system and other equipment failure n=130

BSH guidelines highlight the importance of having a documented contingency plan for planned or
unplanned IT downtimes, which may be isolated to one system or may affect whole networks (Staves, et
al., 2024). The UKTLC standards recommend that the plan must be ‘accessible and easy to implement
and be included in staff training and competency assessments’ (Dowling, et al., 2024). There were 23
reports of errors due to failure of IT systems during both planned and unplanned downtime and one
notable feature was the potential for failure of communication before, during and after such incidents.
Good downtime processes can always be improved by incorporating learning from errors and incidents.
Having a short script, action list or aide memoire to support staff through unfamiliar downtime processes
has been implemented with some success.

Other equipment failure (n=107) is included in this category, and this includes infusion pumps, refrigerators,
and temperature-monitoring systems. These are discussed further in Chapter 11, Handling and Storage
Errors (HSE).

Learning point
• Action cards, scripts or aide memoires can be rapidly and consistently deployed to support
processes in planned and unplanned downtime

IT systems as CAPA n=64

It is encouraging to see new clinical and laboratory IT systems in place, or in advanced stages of
implementation, although some of the errors reported relate to these new systems. When analysing the

146 16. Errors Related to Information Technology (IT)

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2023 reports we have identified where a new or upgraded IT system has been suggested as CAPA.
This includes systems that have been specified, procured and are at various stages of implementation
and cases where additional IT functionality is identified as necessary to reduce the likelihood of an
error occurring. Some CAPA were clearly aspirational with no specific funding identified or capacity to
implement systems that have the potential to prevent the errors reported. This has always been part of
the definition for inclusion, but it is notable that more consideration is being given to the safety benefits
of IT systems. Approximately half of these were systems that had already been specified, procured, or
implemented and would have prevented the errors, had they been fully operational. The other systems
were identified with the comment that there was either no funding or no capacity to implement systems
that may have prevented the errors reported.

IT errors relating to Anti-D Ig n=68

These are discussed further in Chapter 9, Adverse Events Related to Anti-D Immunoglobulin (Ig).

Near miss WBIT n=224

A total of 224 near miss WBIT were IT related, and a further 148 near miss events in other categories also
involved IT. IT was recognised as being a method to reduce errors in 124/224 (55.4%) of WBIT cases,
with many reporters noting lack of funding and resource capacity being a barrier to obtaining electronic
sample labelling systems. IT was in place but not used correctly in 49/224 (21.9%) cases, IT was in
place but not used in 29/224 (12.9%) cases. Where patient blood groups were reported (n=122), 70/122
(57.4%) had the potential to result in an ABO-incompatible transfusion. A formal incident investigation,
where this question was answered, was performed in 163/224 (72.8%) cases.

Other near miss IT-related events n=148

The majority of IT-related near miss events were seen in the IBCT-WCT, RBRP and HSE reporting
categories (Figure 16.1). For IBCT-WCT errors, where the blood group of the component and recipient
were reported (n=30), 6 of these cases would have led to an ABO-incompatible transfusion. Errors
originated in the laboratory, 84/148 (56.8%) and the clinical setting, 64/148 (43.2%). In 94/148 cases,
the reporter stated that IT did not contribute to the error. In 23/94, the reporter did not consider that IT
could have prevented the errors. Review of the 23 cases noted that IT was implicated, with common
themes including failures to heed IT warnings, IT systems not being updated and staff over-reliance on
IT. It is encouraging to note that a formal incident investigation was carried out in 117/148 (79.1%) of
cases where this question was answered.

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 ANNUAL SHOT REPORT 2023 ERROR REPORTS COMPOSITE CHAPTERS
figure 16.1

Figure 16.1: Near

miss events related
to IT by SHOT 42
reporting category
in 2023 (n=148) 37
36

20

13

IBCT-WCT RBRP HSE IBCT-SRNM Anti-D Ig

IBCT-WCT=incorrect blood component transfused-wrong component transfused; IBCT-SRNM=IBCT-specific requirements not met;
HSE=handling and storage errors; RBRP=right blood right patient; Ig=immunoglobulin

Recommended resources
UKTLC Standards (2023) Standard 3 - Information Technology
https://www.shotuk.org/resources/current-resources/uktlc

Using Information Technology for Safe Transfusion

https://www.shotuk.org/resources/current-resources/script/

References
Davies, J. et al., 2023. SHOT UK Collaborative Reviewing and Reforming IT Processes in Transfusion (SCRIPT) survey:
Laboratory information management systems: Are we ready for digital transformation?. Transfusion Medicine, 33(6), pp.
433-439. doi: https://doi.org/10.1111/tme.13010.

Dowling, K. et al., 2024. UK Transfusion Laboratory Collaborative: Minimum standards for staff qualifications, training,
competency and the use of information technology in hospital transfusion laboratories 2023. Transfusion Medicine,
34(1), pp. 3-10. doi: https://doi.org/10.1111/tme.13029.

Staves, J. et al., 2024. Guidelines for the specification, implementation and management of IT systems in hospital
transfusion laboratories: A British Society for Haematology Guideline. Transfusion Medicine, 34(2), pp. 81-166. doi:
https://doi.org/10.1111/tme.13027.

148 16. Errors Related to Information Technology (IT)

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ERROR
REACTIONS
REPORTS:
IN PATIENTS
Human Factors

Chapter Page
REACTIONS IN PATIENTS
17 Febrile, Allergic and Hypotensive Reactions (FAHR)................................ Catherine Booth and Jayne Peters 150
18 Pulmonary Complications................................................................................. Oliver Firth and Sharran Grey 158
a. Transfusion-Associated Circulatory Overload (TACO).............................................................. Sharran Grey 164
b. Pulmonary Complications of Transfusion: Non-TACO....................................... Tom Latham and Oliver Firth 173
19 Haemolytic Transfusion Reactions (HTR)............................................. Tracey Tomlinson and Anicee Danaee 180
20 Uncommon Complications of Transfusion (UCT).................................... Caryn Hughes and Shruthi Narayan 188
21 Transfusion-Transmitted Infections (TTI).............. Tali Yawitch, Katy Davison, Heli Harvala and Su Brailsford 192
22 Post-Transfusion Purpura (PTP)................................................................................................... Tom Latham 205

149
 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Febrile, Allergic and Hypotensive

17 Reactions (FAHR) n=336

Authors: Catherine Booth and Jayne Peters

Definition:
The reactions assessed are isolated febrile type (not associated with other specific reaction
categories), allergic and hypotensive reactions occurring up to 24 hours following a transfusion
of blood or components, for which no other obvious cause is evident.

Abbreviations used in this chapter

BSH British Society for Haematology HLA Human leucocyte antigen
EASL European Association for the Study of the Liver IgA Immunoglobulin A
FAHR Febrile, allergic and hypotensive reactions IHN International Haemovigilance Network
FFP Fresh frozen plasma ISBT International Society for Blood Transfusion

Key SHOT messages

• The number of FAHR cases reported to SHOT is increasing, with a higher proportion of severe
cases

• Inappropriate use of steroids and antihistamines continue to be seen with staff not using the
patient’s symptoms and signs to differentiate allergic from febrile reactions. These reactions are
distinct and require different investigations and treatment

• Repeat compatibility testing is often carried out unnecessarily following allergic reactions or
reactions to platelets or plasma components

Recommendations
• Give appropriate targeted treatment and if needed, preventative cover for future transfusion (Soutar,
et al., 2023), as indicated below:

Table 17.1: Targeted treatment for febrile and allergic transfusion reaction

Reaction Treatment Prevention of recurrent reactions

Febrile Paracetamol Paracetamol 60 minutes before anticipated time of reaction
If previous reaction with apheresis platelets try pooled platelets
Antihistamine (steroid should
(suspended in PAS)
not be used routinely) If
Allergic If reactions continue, give pre-transfusion antihistamine;
anaphylaxis, adrenaline is
If reactions continue, consider washed platelets/red cells; for FFP
essential
try a pooled component e.g., solvent-detergent treated plasma

• Haematology registrars should receive training in classification, appropriate investigation and

management of transfusion reactions in the laboratory induction at the start of their programme

Action: Hospital transfusion team, Haematology training programme directors

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Headline data 2023 FAHR reports by year

343
321 318 336
296 284 288 294
253
Number of reports n=336 238

Deaths n=0
Major morbidity n=119

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Demographic data Blood component data

Red cells n=192

Platelets n=99
Plasma n=28
Male Female Adults Paediatric
Cryoprecipitate n=1
n=175 n=161 n=300 n=36 Multiple components n=14
Granullocytes n=2
Unknown n=0 Unknown n=0

Introduction
Reactions are classified according to the ISBT/IHN definitions, which are summarised below in Table
17.2, and have been adopted by BSH (Soutar, et al., 2023). Mild reactions are not reportable to SHOT.

SABRE Table 17.2:

CURRENT IHN/SHOT/B(C)SH CLASSIFICATION OF ACUTE TRANSFUSION REACTIONS
classification Classification of
1=Mild 2=Moderate 3=Severe reactions
A temperature ≥ A rise in temperature of 2°C
38°C and a rise A rise in temperature of 2°C or more, and/or rigors, chills,
between 1°C or more, or fever 39°C or over or fever 39°C or over, or other
and 2°C from and/or rigors, chills, other inflammatory symptoms/signs
Febrile type Other/febrile
pre-transfusion inflammatory symptoms/signs such as myalgia or nausea which
reaction FAHR
values, but such as myalgia or nausea precipitate stopping the transfusion,
no other which precipitate stopping the prompt medical review AND/
symptoms/ transfusion OR directly results in, or prolongs
signs hospital stay
Bronchospasm, stridor, angioedema
or circulatory problems which require
urgent medical intervention AND/
OR, directly result in or prolong
Wheeze or angioedema with
Transient hospital stay, or Anaphylaxis Anaphylaxis/
Allergic type or without flushing/urticaria/
flushing urticaria (severe, life-threatening, generalised hypersensitivity/
reaction rash but without respiratory
or rash or systemic hypersensitivity reaction allergic/FAHR
compromise or hypotension
with rapidly developing airway AND/
OR breathing AND/OR circulation
problems, usually associated with
skin and mucosal changes)
Reaction
Features of Features of both allergic and
with both Features of both allergic and febrile *Other/mixed
mild febrile febrile reactions, at least one
allergic reactions, at least one of which is in febrile/allergic
and mild allergic of which is in the moderate
and febrile the severe category. FAHR
reactions category
features
Isolated fall in systolic blood
pressure of 30 mm Hg or more Hypotension, as previously defined,
occurring during or within one leading to shock (e.g., acidaemia,
Other/
Hypotensive hour of completing transfusion impairment of vital organ function)
hypotensive
reaction and a systolic blood pressure without allergic or inflammatory
FAHR
80 mm or less in the absence of symptoms. Urgent medical
allergic or anaphylactic systems. intervention required
No/minor intervention required
*This category may include mild symptoms/signs of one reaction type providing the other category is either moderate or severe

17. Febrile, Allergic and Hypotensive Reactions (FAHR) 151

 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Total number of FAHR reactions n=336

The total number of reports submitted in 2023 was the highest in the last 5 years. This was due to an
increase in reported febrile reactions to red cells in adults. There was no change in the total number of
allergic reactions, or in reactions in children.

While there has been an increase in the absolute number of cases reported in 2023, no significant
difference was noted in the proportion of FAHR cases to the total reports received (336/3833, 8.8% in
2023 as compared to 294/3499, 8.4% in 2022).

Deaths related to transfusion n=0

There were no transfusion-related deaths reported in 2023.

Major morbidity n=119

The ISBT/IHN classification of a severe reaction has been used to define major morbidity.

Reactions are categorised in Table 17.3.

Table 17.3: Moderate Severe Total

Classification of Febrile 136 27 163
FAHR in 2023 Allergic 50 73 123
Mixed allergic/febrile 24 13 37
Hypotensive 7 6 13
Total 217 119 336

figure
In all reaction types, there has been an increase 17.1
in the number and proportion of reactions classified
as severe. The overall proportion of severe reactions rose from 77/294 (26.2%) in 2022 to 119/336
(35.4%) in 2023.

Figure 17.1:
Proportion of 70
reactions classified
60
as severe 2019-
Proportion of severe reactions (%)

2023
50

40

30

20

10

0
Febrile Allergic Mixed Hypotensive

2019 2020 2021 2022 2023

Of note, in 24 of the 119 reactions classified as severe in 2023, this was primarily because the patient
was admitted, or hospital stay was prolonged. This proportion is similar to 2022.

Reactions in IgA deficient patients n=4

There were 4 reactions, all to red cells, reported in 3 patients who were subsequently discovered to
have severe IgA deficiency. Two were confirmed to have anti-IgA antibodies; the 3rd patient had not

152 17. Febrile, Allergic and Hypotensive Reactions (FAHR)

REACTIONS IN PATIENTS ANNUAL SHOT REPORT 2023

been tested. All 3 patients suffered febrile-type reactions with marked systemic upset. Two were classic
hyperacute reactions which presented within 10 minutes of starting transfusion. One of these patients
gave a history of reaction to transfusion 6 years previously. The 3rd patient developed fever, rigors,
tachycardia, hypotension, and a drop in oxygen saturations after 100mL had been transfused. They
developed an identical reaction when a second transfusion was attempted 24 hours later.

It is recommended that these patients receive washed components for future red cell or platelet
transfusions, provided this does not risk delaying an urgent transfusion (Latham, 2019).

Anaphylactic reactions n=50

Fifty severe allergic reactions were reported which required the use of adrenaline, compared to 36 in
2022. Of these, 22 were routine transfusions; 24 occurred on general wards, 2 in outpatients and 1
in a community setting. Children were disproportionately represented: 12/50 (24.0%) cases were in
patients under 18 years.

Case 17.1: Inappropriate use of FFP prior to liver biopsy results in an anaphylactic reaction

A patient was given FFP prophylactically prior to liver biopsy due to prolonged international
normalised ratio. They developed itching, wheeze, angioedema, and a drop in oxygen saturations
requiring the anaphylaxis pathway.

Learning points
• All areas administering blood components need to be appropriately equipped and staff trained to
manage a severe acute reaction. This includes settings where transfusion is given in the community

• FFP should not be given in patients with chronic liver disease and deranged clotting tests prior
to invasive procedures, as these tests do not correlate well with bleeding risk (Bent & Das, 2023;
EASL, 2022)

One patient was reported to have suffered life-threatening reactions to multiple transfusions. In response,
the Blood Service worked to develop a series of non-standard components to systematically reduce
exposure to potential allergens, including triple-washed, mannitol free units. Eventually it was established
that the reactions were unrelated to transfusion and were in fact felt to be self-induced.

This highly unusual case demonstrates the importance of careful consideration of the categorisation and
pathogenesis of transfusion reactions, and of sometimes unexpected diagnoses. It also demonstrates
the potential to develop and transfuse non-standard components if required in extreme situations.

17. Febrile, Allergic and Hypotensive Reactions (FAHR) 153

 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

figure 17. 2
Figure 17.2:
Type of reaction by component
Reactions by
component type in This remains
100% similar to previous3 reports; see1Figure 17.2. Red cells are usually associated with febrile-
7
1
2023 (n=336) type reactions, 138/192
14 (71.9%) whereas plasma
2 components and platelets more commonly cause
90%
allergic reactions, 24/29 (82.8%)
20 and 54/99 (54.5%) respectively.
21
80%
12 1
Hypotensive
70%
Mixed allergic/febrile
Percentage of reactions

28 8
16 Anaphylactic/severe
60%
allergic
50% Moderate allergic
Febrile
40% HLA-matched
138 26
Washed platelets
30%
SD-FFP
1
20% 8 4

10% 22

2 1
0%
Red cells (192) Platelets (99) Plasma/cryo (29) Granulocytes (2) Multiple
components (14)
Component type

HLA=human leucocyte antigen; cryo=cryoprecipitate; SD-FFP=solvent detergent treated fresh frozen plasma

The incidence of allergic reactions was 2.7 times higher in apheresis platelets compared to pooled
platelets, which relates to their higher plasma content (Estcourt, et al., 2017). The incidence of febrile
reactions was identical in the two component types (Figure 17.3).

The first step for subsequent transfusions for a patient experiencing a mild to moderate allergic reaction
to apheresis platelets should be to switch to a pooled component.

Figure 17.3:
Incidence of
reactions as a 0.0263 Febrile Allergic
percentage of
Reactions as % of units issued

platelet units
issued in 2023

0.0099

0.006 0.006

Apheresis Pooled

Analysis of reactions remains comparable to previous years in the following characteristics (Table 17.4).

154 17. Febrile, Allergic and Hypotensive Reactions (FAHR)

REACTIONS IN PATIENTS ANNUAL SHOT REPORT 2023

Table 17.4:
Recipient or transfusion characteristic Percentage
Characteristics of
Age distribution 89% of patients were aged 18 years or over
FAHR
Sex 52% were male
Urgency of transfusion 58% were given routinely
Timing of transfusion 68% occurred within standard hours
Location 60% were on wards and 12% in outpatient/day case units

Treatment of reactions
An antihistamine with or without steroid continues to be used inappropriately to treat reactions with only
febrile/inflammatory type symptoms and/or signs. The proportion of patients mismanaged in this way
was the lowest for the last 5 years; see Table 17.5.
Table 17.5:
Number of febrile
Year Medication stated Antihistamine and/or steroid Reported treatment
reactions
of febrile reactions
2023 163 163/163 (100%) 61/163 (37.4%)
2019-2023
2022 132 130/132 (98.5%) 61/130 (46.9%)
2021 174 155/174 (89.1%) 61/155 (39.3%)
2020 166 140/166 (84.3%) 58/140 (41.4%)
2019 146 130/146 (89.0%) 62/130 (47.7%)

Subsequent management
In 20 cases, a plan was made to give antihistamine and steroid prior to future transfusions, and in a
further 7 cases, the report suggested use of ‘pre-medication’. Three of these patients had experienced
febrile reactions.

Learning points
• Steroids are not recommended for the prevention of allergic reactions, and neither steroids nor
antihistamine have any role in preventing febrile reactions

• Repeated doses of steroids can cause immunosuppression and other complications such as
diabetes (Yeates & Charlton, 2023)

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Investigation
Laboratory investigations should be tailored to the reaction type.

Of the 123 reactions with purely allergic features, 51 (41.5%) were unnecessarily investigated with repeat
compatibility testing and in 31 (25.2%) blood cultures were taken from the patient. The blood component
was sent for culture in 10 cases, all of which were negative.

Inappropriate red cell serological testing was performed in 46/135 (34.1%) patients having reactions to
platelets or plasma components.

Case 17.2: Inappropriate investigation and management of a febrile platelet reaction

A patient with lymphoma developed fever and rigors on their way home after an outpatient platelet
transfusion. They returned to hospital and were treated with hydrocortisone and chlorphenamine.
Repeat group and screen was sent but no blood cultures were performed.

The treatment given for this febrile platelet reaction was directed against an allergic reaction, while
investigation was for a febrile reaction to red cells. In a febrile potentially immunocompromised patient,
blood cultures to exclude an intercurrent infection would have been appropriate.

Case 17.3: Inappropriate investigation and follow-up plans for a patient after an allergic
reaction to FFP

A patient developed itching and eye swelling during transfusion of FFP in the context of major
haemorrhage. They were appropriately treated with an antihistamine and their symptoms settled.
They were investigated with a repeat group and screen and because of this reaction, a flag was
placed on their record to require a serological crossmatch (rather than electronic issue) for future
transfusions.

Learning points
• Red cell antibodies do not cause allergic transfusion reactions or reactions to platelets or plasma
components. Repeat compatibility testing is not required in these scenarios

• Unnecessary investigations add to the demand on the laboratory at a time when staffing is almost
universally stretched and cause avoidable delays in provision of blood components for future
transfusions

Conclusion
Febrile, allergic, and hypotensive reactions are an unavoidable and unpredictable risk of transfusion.
Although all patients recovered fully from the acute episode, 2023 saw a higher proportion of clinically
severe reactions. Clinicians have a duty not to cause additional harm by giving inappropriate treatment.
Haematology teams need to be well educated so they are confident to advise on appropriate, immediate,
and subsequent management and relevant investigations. A survey of UK haematology registrars in
2023 found that only 53% felt that their training equipped them to give safe clinical transfusion advice
to colleagues in other specialties (Booth 2024, personal communication. 13 March).

It is encouraging that the proportion of febrile reactions treated inappropriately with antihistamine and/or
steroids has reduced in 2023, and it is hoped this improvement will be maintained in future years. There
remains overuse of hydrocortisone for prevention of reactions, contrary to guidelines, and unnecessary

156 17. Febrile, Allergic and Hypotensive Reactions (FAHR)

REACTIONS IN PATIENTS ANNUAL SHOT REPORT 2023

repeat compatibility testing for allergic and non-red cell reactions. The key message remains the need
to use the patient’s symptoms and signs to distinguish febrile from allergic reactions and to tailor
investigation and management accordingly.

Recommended resources
SHOT Bite No. 5: FAHR
https://www.shotuk.org/resources/current-resources/shot-bites/

SHOT FAHR video

https://www.shotuk.org/resources/current-resources/videos/

Haematology Curriculum for Higher Medical Training Blood Transfusion Training Guidance
https://www.thefederation.uk/training/specialties/haematology

References
Bent, C. & Das, R., 2023. Joint guidance from the British Societies of Interventional Radiology and Haematology
on managing Bleeding Risk during Procedures in Interventional Radiology, UK: British Society for Haematology
(BSH). Available at: https://b-s-h.org.uk/media/udvdcvhh/bsir-bsh-ir-bleeding-risk-guidance-2022.
pdf?cf=638107532702030000 (Accessed 4 February 2024).

Estcourt, L. J. et al., 2017. Guidelines for the use of platelet transfusions. British Journal of Haematology, 176(3), pp.
365-394. doi: https://doi.org/10.1111/bjh.14423.

European Association for the Study of the Liver (EASL), 2022. EASL Clinical Practice Guidelines on prevention and
management of bleeding and thrombosis in patients with cirrhosis. Journal of Hepatology, 76(5), pp. 1151-1184. doi:
https://www.journal-of-hepatology.eu/article/S0168-8278(21)02033-X/fulltext.

Latham, T., 2019. Investigation and clinical management of suspected reactions to immunoglobulin A (IgA), England:
NHSBT clinical guideline. Available at: https://hospital.blood.co.uk/clinical-guidelines/nhsbt-clinical-guidelines/
(Accessed 4 February 2024).

Soutar, R. et al., 2023. Guideline on the investigation and management of acute transfusion reactions. British Journal of
Haematology, 201(5), pp. 832-844. doi: https://doi.org/10.1111/bjh.18789.

Yeates, L. & Charlton, A., 2023. Management of platelet transfusion reactions within the northern centre for cancer care
(abstract). Transfusion Medicine, 33(S1), pp. 52-53. doi: https://doi.org/10.1111/tme.13005.

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18 Pulmonary Complications n=205

Authors: Oliver Firth and Sharran Grey with input from other members of the Pulmonary
Working Expert Group

Abbreviations used in this chapter

ISBT International Society of Blood Transfusion TACO Transfusion-associated circulatory overload
IV Intravenous
MHRA Medicines and Healthcare products
Regulatory Agency

Key SHOT messages

• Pulmonary complications of transfusion remain a leading cause of transfusion-related mortality
and morbidity, contributing to 20/38 (52.6%) transfusion-related deaths reported to SHOT in 2023

• TACO-related deaths rarely occur in the absence of risk factors, with a median of four TACO risk-
assessment criteria present in each case

• Management of TACO risk is hindered by underutilisation of the risk-assessment tool, low rates of
risk identification, and frequent failure to translate risk assessments into proactive management
plans

• Utilisation of the SHOT TACO incident investigation tool is high and steadily increasing

The recommendations from previous years continue to be relevant and specific recommendations are
also covered in the individual chapters.

Recommendations
• All cases with pulmonary complications up to 24 hours post transfusion should be reported to
SHOT with as much information as possible to ensure adequate inference and effective learning

Action: All SHOT reporters, national blood transfusion committees, hospital transfusion
teams

• TACO risk assessment of all patients needing transfusions will help institute appropriate, timely
mitigating actions to prevent or reduce the severity of pulmonary complications. Prompt recognition
with appropriate investigations and accurate diagnosis will help improve morbidity and mortality

• A structured review and incident investigation should be undertaken for every case of TACO to
optimise organisational and individual patient-safety measures

Action: All staff involved in transfusion

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Headline data 2023 Pulmonary reports by year

172
160
TACO Non-TACO 149
139
131
110
Number of reports n=205 91 89 86 92

Deaths n=20
52
Major morbidity n=30 23 24
39
30 33
11 6 10 9

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Demographic data Blood component data

Red cells n=160

Platelets n=10
Plasma n=8
Granulocytes n=2
Male Female Adults Paediatric
n=81 n=124 n=199 n=4 Cryoprecipitate n=1
Multiple components n=24
Unknown n=2

Introduction
Transfusion-related pulmonary complications contribute significantly to death and major morbidity. Patients
with respiratory complications are often elderly with multiple comorbidities which could all contribute.
Pulmonary complications present diagnostic and therapeutic challenges with mainly supportive measures
available and paucity of specific therapies. Like in the recent years, the pulmonary cases which do not
meet ISBT TACO criteria (Wiersum-Osselton, et al., 2019) have been consolidated into a single chapter.
The approach acknowledges that multiple factors could have contributed to the reaction, and this has
been explored further in the non-TACO chapter.

TACO is the leading cause of transfusion-related deaths over the past decade. In addition, SHOT data
also suggests that fluid overload contributes to most pulmonary reactions which do not meet TACO
criteria. A national patient safety alert to address the rising deaths from TACO has been released (MHRA
and SHOT, 2024).

The analysis below evaluates 10 years of data from 2014-2023 provided to SHOT regarding TACO-related
deaths. The data has been used to evaluate the presence of TACO risk factors, recognition of risk by
clinicians, the use of TACO mitigation strategies, the use of risk assessment and incident investigation
tools, and institutional learning following TACO-related deaths.

Prevalence of pre-transfusion TACO risk factors

Retrospective application of the TACO risk assessment tool showed that 88/93 (94.6%) cases had
identifiable TACO risk factors pre transfusion. Among the 5 cases where none could be identified, 2
lacked data, 2 likely had undocumented cardiac risk factors, leaving 1 case where no formal risk factors
could be identified despite comprehensive data. Having a single TACO risk factor was uncommon and
seen in only 8/93 (8.6%) of patients, with a median of four TACO risk factors present per patient. Table

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

18.1 illustrates the unadjusted prevalence of TACO risk factors. A scoring system was applied: where
the risk factor was absent (0), present but incidental (1), or an active contributor to admission (2). This
highlighted positive fluid balance as being both the most prevalent and clinically significant risk factor.
Scoring made one further change to the overall ranking of the TACO risk factors, elevating severe
anaemia in significance from 6th to 3rd. A yearly average of the number of TACO risks and comorbidities
per patient, is shown in Figure 18.1, which demonstrates an increasing trend in general comorbidities
and TACO risk over the period.
Table 18.1: The SHOT TACO risk-assessment category Frequency
prevalence of IV fluids in the past 24 hours 59/93 – 63%
each ‘TACO risk’
Clinically significant positive fluid balance 55/93 – 59%
as outlined in
the SHOT risk- Heart failure or related cardiac disease 42/93 – 45%
assessment tool Renal impairment 39/93 – 42%
among TACO-
Hypoalbuminaemia 37/93 – 40%
related deaths over
the past decade Severe anaemia 36/93 – 39%
Peripheral oedema 30/93 – 32%
Regular diuretic use 29/93 – 31%
Undiagnosed respiratory symptoms 20/93 – 22%
Pre-existing pulmonary oedema 15/93 – 16%

Figure 18.1: The

number of TACO 10
risk factors and
9
graded TACO
vulnerability among 8

TACO-related 7
deaths reported to
6
SHOT 2014-2023
5

0
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

General vulnerability (graded co-morbidities)

Number of TACO risks (risk assessment tool)

TACO=transfusion-associated circulatory overload

Utilisation of the TACO risk-assessment tool

The TACO risk assessment was introduced in 2016, and data collected on its use since 2019. Analysis
of the use of the TACO risk-assessment tool was possible in 54 of the 93 cases. Adoption of the risk
assessment was initially slow, and rates of use have plateaued, with it being used in 35-40% of the most
recent cases of TACO-related death (Figure 18.2). Where the tool was used, clinicians identified TACO
risks in 11/20 (55.0%) patients, while retrospective application of the tool to these cases identified risks
in 18/20 (90.0%). Reporting through the SHOT questionnaire on TACO risk factors has two questions,
first whether the clinician identified TACO risks, and second which risks were identified. Due to a paucity

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in data submission for this second question, it was not possible to assess the correlation between the
risks identified through retrospective application of the risk assessment, and those recognised by the
clinicians.

Figure 18.2:
50 Cumulative
incidence of usage
45 of the SHOT TACO

40 risk-assessment
tool in TACO-
Cumulative incidence (%)

35 related deaths
2019-2023
30

25

20

15

10

0
2019 2020 2021 2022 2023

Preventability and TACO mitigation strategies

The data set was reviewed to assess potential preventability of TACO. In 84/93 (90.3%) cases potential
mitigating actions were not undertaken, and in 64/84 (76.2%) cases there was more than one mitigation
possible. Table 18.2 illustrates the frequency of the potential recommended mitigation strategies. Of
the 9 cases where no additional mitigations could be recommended, 2 were transfusions in the context
of major haemorrhage, where assigning mitigations is challenging, and 2 were transfusions in patients
approaching the end of their life, where transfusion-related imputability was low. The final 5 cases
consisted of four examples where use of the TACO risk assessment led to optimal mitigation strategies
being employed, and 1 case with no reported TACO risk factors. While the data suggested a lower
average preventability rating in cases where the TACO risk assessment had been used (1.15 versus
1.38), this did not reach statistical significance (p=0.35 by Welch’s T-test).

Recommended unused mitigation Frequency Table 18.2:

Prophylactic diuretic Frequency of

57/93 – 61%
unused TACO
Fluid balance measurement 53/93 – 57%
mitigation
Single unit transfusion and review 36/93 – 39% strategies in
Body weight dosing 16/93 – 17% TACO-related
deaths 2014-2023
Vital sign monitoring 13/93 – 14%
Other e.g., alternatives to transfusion 20/93 – 22%

Review and institutional learning

Over the 10-year period, 58/93 (62.4%) of TACO-related deaths were reviewed formally, 26/93 (27.9%)
informally, and in 9/93 (9.7%) cases there was no evidence of review. The SHOT TACO incident
investigation tool was introduced in 2021 to aid the review process by providing a framework from which

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to work. Since its introduction there have been 20 TACO-related deaths. Initial uptake was slow, but its
usage has increased, with 60% of recent case reviews utilising the SHOT TACO incident investigation
tool to structure the review process (Figure 18.3). Institutional learning following review was demonstrated
in 20/93 (21.5%) cases with the learning objectives presented in Table 18.3.
Figure 18.3:
Rolling cumulative 100%

incidence of 90%
use of the SHOT
Percentage use in the last 5 cases (%)

TACO incident 80%

investigation tool
70%
for the previous 5
cases of TACO- 60%
related deaths
50%
2021-2023
40%

30%

20%

10%

0%

2021 2022 2023

Table 18.3: Category of improvement Frequency

Reported TACO pre-transfusion risk assessment related 11/20 – 55%
self-identified
Education for prescribers 7/20 – 35%
institutional
learning objectives Change in protocols/policies 6/20 – 30%
following TACO-
related deaths

Conclusion
This data set supports current understanding that TACO seldom occurs in the absence of risk factors,
and, in most instances multiple risk factors are present. Intravenous fluids, positive fluid balance, and
congestive cardiac failure are the most prevalent risk factors, and therefore nearly every case of TACO-
related death in the past 10 years had potential mitigation strategies that might have been suitable for
application. Mitigation strategies appear to be underutilised, and while this is partly due to low use of the
risk-assessment tool to guide practice, risks and potential mitigation strategies are commonly missed
even when it is used. The rising number of TACO-related deaths raise concerns around our ability to
recognise and manage patients at risk of TACO, but this data set may provide additional clarity. It shows
that in cases of TACO-related death, patients in 2023 have more pre-transfusion risk factors and a higher
vulnerability to TACO than 10 years ago. Possible explanations for this might include improvements in
our reporting of patient risks, or that our ability to prevent TACO-related deaths in lower risk patients
is improving. The increase in TACO-related deaths, therefore, may at least in part be due to increasing
numbers of transfusions in patients with greater complexity and higher comorbidity burdens. A similar

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pattern is seen in non-TACO pulmonary complications, and it is likely that wider adoption of TACO
risk-reduction measures will also prevent or mitigate many of these. Positive practice was evident from
the analysis, with a robust culture of review emerging, marked by increasing use of the SHOT TACO
incident investigation tool. It was notable that conclusions drawn following formal review of TACO cases
in hospitals mirror the deficiencies identified in this report, and the institutional learning it fosters appears
to recommend suitable corrective measures.

References
Medicines & Healthcare products Regulatory Agency (MHRA) and Serious Hazards of Transfusion (SHOT), 2024. Central
Alerting System: Reducing risks for transfusion-associated circulatory overload. [Online] Available at: https://www.cas.
mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103249 (Accessed 08 April 2024).

Wiersum-Osselton, J. C. et al., 2019. Revised international surveillance case definition of transfusion-associated

circulatory overload: a classification agreement validation study. The Lancet, 6(7), pp. e350-e358. doi: https://doi.
org/10.1016/s2352-3026(19)30080-8.

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Transfusion-Associated Circulatory
18a Overload (TACO) n=172

Author: Sharran Grey

Definition:
TACO is defined as acute or worsening respiratory compromise and/or acute or worsening
pulmonary oedema during or up to 12 hours† after transfusion, with additional features including
cardiovascular system changes not explained by the patient’s underlying medical condition;
evidence of fluid overload and a relevant biomarker¥.

† SHOT accepts cases up to 24 hours

¥ see Table 18a.1 for details of required and additional criteria for a surveillance diagnosis

Abbreviations used in this chapter

Hb Haemoglobin NBTC National Blood Transfusion Committee
HFIT Human factors investigation tool NPSA National Patient Safety Agency
ICU Intensive care unit NT-pro BNP N-terminal-pro brain natriuretic peptide
IDA Iron deficiency anaemia TACO Transfusion-associated circulatory overload

Key SHOT messages

• The number of TACO cases reported in 2023 is the highest to date. Although cases continue to
increase, there is likely to be a level of under-reporting

• The continued adoption of the TACO risk assessment is encouraging although analysis of the
data shows it is still under-used or used ineffectively

• TACO continues to be a major cause of transfusion-related mortality and morbidity

• Severe chronic anaemia (asymptomatic or minimally symptomatic) requires only minimal transfusion
(usually a single unit) followed by pharmacological treatment where appropriate. Non-bleeding
adult patients with severe chronic anaemia are particularly vulnerable to TACO even in the absence
of comorbidities that predispose to TACO

Recommendation
• Perform a gap analysis and implement the recommendations of the NPSA alert on TACO (MHRA
and SHOT, 2024). This incorporates ongoing SHOT recommendations and access to further
guidance and supporting resources

Action: Hospital Trusts/Health Boards

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Introduction
The TACO pre-transfusion risk assessment infographic (Figure 18a.1) was updated in the 2020 Annual
SHOT Report to make it suitable for incorporation into clinical documents. Following feedback from
reporters, a clarification has been added regarding the use of a prophylactic diuretic. The word ‘checklist’
has also been standardised to ‘risk assessment’.

Figure 18a.1: TACO

TACO Risk Assessment YES NO pre-transfusion risk
assessment
Does the patient have any of the following: diagnosis
of ‘heart failure’, congestive cardiac failure (CCF), severe aortic
stenosis, or moderate to severe left ventricular dysfunction?

Is the patient on a regular diuretic?

Does the patient have severe anaemia?

Is the patient known to have pulmonary oedema?

Does the patient have respiratory symptoms of
undiagnosed cause?
Is the fluid balance clinically significantly positive?
Is the patient receiving intravenous fluids
(or received them in the previous 24 hours)?
Is there any peripheral oedema?
Does the patient have hypoalbuminaemia?

Does the patient have significant renal impairment?

If Risks Identified YES NO

Review the need for transfusion (do the benefits outweigh the risks)?
Can the transfusion be safely deferred until the issue is investigated, treated or
resolved?
If Proceeding with Transfusion: Assign Actions TICK
Body weight dosing for red cells
Transfuse a single unit (red cells) and review symptoms
Measure fluid balance
Prophylactic diuretic prescribed (where appropriate/not contraindicated)
Monitor vital signs closely, including oxygen saturation
Name (PRINT):
Due to the differences in adult and neonatal
Role: physiology, babies may have a different risk for TACO.
Date: Time (24hr): Calculate the dose by weight and observe
the notes above.
Signature:

TACO=transfusion-associated circulatory overload

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Table 18a.1:
TACO surveillance definition
TACO surveillance
definition (adapted Patients classified with TACO (surveillance diagnosis) should exhibit at least one required criterion* with onset during or
up to 12 hours after transfusion (SHOT continues to accept cases up to 24 hours), and a total of 3 or more criteria i.e.,
from Wiersum-
*A and/or B, and total of at least 3 (A to E)
Osselton, et al.,
2019) * Required criteria (A and/or B)

A. Acute or worsening respiratory compromise and/or

B. Evidence of acute or worsening pulmonary oedema based on:
• clinical physical examination, and/or
• radiographic chest imaging and/or other non-invasive assessment of cardiac function

Additional criteria

C. Evidence for cardiovascular system changes not explained by the patient’s underlying medical condition,
including development of tachycardia, hypertension, jugular venous distension, enlarged cardiac silhouette
and/or peripheral oedema
D. Evidence of fluid overload including any of the following: a positive fluid balance; clinical improvement
following diuresis
E. Supportive result of a relevant biomarker, e.g., an increase of BNP levels or NT-pro BNP to greater than 1.5
times the pre-transfusion value

The number of cases reported in 2023 is the highest to date and is an increase of 12 cases from
2022 (n=160). Although the pathophysiology of the pulmonary complications of transfusion is not fully
understood, the evolving understanding of risk factors for TACO and the development of tools to mitigate
risks has advanced significantly in recent years. This chapter describes the demographics of patients
reported to have TACO, the adoption of risk-reduction strategies, and highlights areas for further focus
based on signals from the data and ongoing trends.

Deaths related to transfusion n=15

There were 15 deaths related to TACO in 2023, 2 of which were probably related (imputability 2), and 13
were possibly related (imputability 1). In 2022 there was 1 case that was definitely related to transfusion
(imputability 3). Although there are no cases that were evaluated as definitely related to transfusion
reported in 2023, the number of deaths has almost doubled compared to 2022 when there were 8,
which is a concerning signal in the data (Table 18a.2).

Major morbidity n=20

There were 20 cases of major morbidity in 2023 which is a slight reduction but broadly similar
compared to recent years.

Table 18a.2: Demographic Number of reports

Demographic
Deaths (imputability 3) 0
overview of TACO
cases in 2023 Deaths (imputability 2) 2

Deaths (imputability 1) 13

Major morbidity 20
Range: 2 months – 96 years (2 age under 18 years)
Age
Median: 75.5 years
Gender 104 female, 68 male
Female (n=45): average 64.7kg (range 42-95.5kg)
Body weight (adults)
Male (n=36): average 71.1kg (range 50.9-122kg)
Acute medicine=34, haematology=30,
Top 4 medical specialties
general medicine=14, emergency medicine=13
Bleeding patients (NBTC indication code R1 or
21
‘massive bleeding’ indicated) (NBTC, 2020)
Non-bleeding patients (other NBTC
151
indication codes or not stated)

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TACO is more commonly reported in elderly, non-bleeding patients but is seen across all age groups.
These data are consistent with previous years. There were 2 cases in the under-18 age group (age 2
and 3 months). TACO was reported more frequently in female patients and appears to be a consistent
characteristic compared to data from previous years. Weight was provided in 45 adult female cases,
with an average of 64.7kg (42-95.5kg). Weight was provided in 36 adult male cases, with an average
of 71.1kg (50.9-122kg). The apparent higher incidence of TACO in female patient may be attributed to
the lower average weight of female patients compared to male, and increased risk of TACO in patients
with lower body weight. This underlines the importance of weight-adjusted red cell dosing and single
unit transfusion, particularly in patients with lower body weight. Adult medical specialties, including
emergency medicine and haematology continue to be the most common specialties where TACO is
reported. This should be considered when targeting TACO education and mitigation plans.

Case 18a.1: TACO risks failed to be identified leading to missed opportunities and death

A female patient weighing 52kg with a Hb level of 68g/L was prescribed two units of red cells. She
had liver disease and sepsis with peripheral oedema. The cause of the anaemia was not clear, but
she was not actively bleeding, and the NBTC indication code assigned to the transfusion was R2
(acute anaemia). A TACO pre-transfusion risk assessment was completed, and the clinician did not
identify any risks, therefore no actions were assigned to mitigate TACO. The first unit of red cells
was given without issue and the second unit was commenced 4 hours later without a clinical review.
She became acutely unwell after the first hour, and an emergency call was made. She developed
dyspnoea and tachypnoea with oxygen desaturation to 90% from a previously normal level and
had tachycardia and systolic hypertension. The post-transfusion chest X-ray showed significant
pulmonary oedema. The NT-pro BNP was significantly raised however there was no pre-transfusion
value. An echocardiogram showed moderate left ventricular systolic dysfunction which had not been
previously reported. A fluid balance was not reported but there had been a 5kg increase in weight
post transfusion. Multiple doses of furosemide were given resulting in some diuresis, but respiratory
symptoms remained unchanged. ICU admission was required, and continuous infusion of diuretic
was administered, with morphine and antibiotics. The patient unfortunately died. Sepsis was clearly
a major factor however the transfusion was assessed as contributory to the death.

A local structured review was performed in the form of an audit of the TACO pre-transfusion risk
assessment completion, transfusions out-of-hours, and the single unit red cell policy.

Recommendations following the audit were broadly as follows:

• Education and training on single unit policy, transfusion triggers and Hb targets

• Review the operational use of the TACO risk-assessment tool

• Education on the TACO risk-assessment process

• Ensure the TACO risk assessment is applied to platelets and cryoprecipitate

• Additional education on stable patients with anaemia, overnight transfusion and adopting transfusion
reaction e-learning

This is an example of the TACO risk assessment being completed incorrectly resulting in missed
opportunities to prevent or mitigate TACO. The patient had peripheral oedema due to liver disease, sepsis,
and hypoalbuminemia: therefore, there were clear signs of pre-transfusion fluid overload. The patient
may have had previously undiagnosed heart failure which was uncovered by this episode of TACO. Had

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

this been correctly identified as a risk, several mitigation options could have been considered assuming
deferral of the transfusion to manage the pre-transfusion overload was not clinically appropriate. A single
unit policy or weight-adjusted red cell dosing would have prevented the transfusion of excessive and
unnecessary volume of red cells. The patient had not developed signs of TACO after the first red cell unit.
The patient was on a regular diuretic, and it may have been possible to give an additional prophylactic
dose. Fluid balance monitoring was not in place, and it was only apparent after the transfusion that there
was significant overload due to the increase in body weight when recorded post transfusion. The SHOT
structured TACO incident investigation tool does not appear to have been used in this case, however
actions concerning most of the preventable factors appear to have been identified.

Excessive red cell transfusion in non-bleeding adult patients with both chronic and acute anaemia
continues to be a significant feature in TACO cases, particularly in patients with lower body weight. The
team reporting this case should be commended for focussing education and training on transfusion
triggers and the use of single unit transfusions. Organisations are encouraged to consider system
changes such as embedding in electronic or other controlled processes to avoid the over-reliance on
staff knowledge alone.

Potentially preventable factors in cases of mortality n=15

Table 18a.3 and Table 18a.4 below describe the use of the TACO risk assessment in 2023 and a review
of potentially preventable factors following case review, with a summary of trends and themes which
are similar findings compared to data from previous years.
Table 18a.3: Use TACO risk assessment performed 9/15
of TACO risk
Risk(s) identified on TACO risk assessment 8/9
assessment in
Risk(s) NOT identified on TACO risk assessment
TACO-related 1/9
when present on case review
deaths in 2023 Risks(s) identified on TACO risk assessment fully
0/9
agree with risks present on case review
Hypoalbuminaemia (2); renal impairment (2); fluids
Instances of risks missed in the 6 cases where a
(3); cardiac impairment (1); peripheral oedema (2);
TACO assessment was NOT performed:
positive fluid balance (1)
Positive fluid balance (3); fluids (2), pulmonary
Instances of risks missed in the 9 cases where a oedema (2); likely fluids involved (1); cardiac
TACO risk assessment WAS performed: impairment (1); renal impairment (2);
hypoalbuminaemia (3); peripheral oedema (1)
TACO mitigations assigned 7/15
Mitigation measures performed as assigned/planned 5/7

Key themes include:

• Failure to perform TACO risk assessment in a significant number of cases, and risks missed in all
cases where the risk assessment was not performed. This is not limited to specific risks for TACO

• Risks not comprehensively identified in individual patients (additional risks were identified on case
review). This is not limited to specific risks for TACO

• Missed opportunities to assign TACO mitigation measures

• Failure to perform TACO mitigation measures as assigned/planned

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Table 18a.4:
3/15 (includes 1 case of iron deficiency anaemia that
Transfusion NOT indicated Preventable factors
could have been potentially treated with intravenous iron)
Indicated transfusions (n=12) that could have been 1/12 (pre-transfusion overload with no clear urgency for for TACO-related
deferred transfusion) deaths in 2023
Appropriate volume transfused 9/15 (clear evidence of overtransfusion in 2 cases)
Appropriate/close monitoring 14/15 (TACO not immediately recognised in 1 case)
Fluid balance monitoring 8/15
No prophylactic diuretic given 8/15
On regular diuretic (no additional prophylactic dose
4/15
given)
Diuretic identified as required but unable to ascertain
1/15
if given
No prophylactic diuretic and regular dose withheld 1/15
On regular diuretic and additional prophylactic dose
1/15
given
Structured case review 6/15

Key themes include:

• Some transfusions were inappropriate and could have been avoided altogether, including a case of
IDA that could have been treated with iron replacement

• One case could potentially have been deferred to address the pre-transfusion overload

• Inappropriate volume of red cells transfused with clear cases of overtransfusion. Evidence for lack of
application of weight-adjusted red cell dosing and single unit and review policy

• Fluid balance monitoring not performed in some cases. Unclear whether it was due to practical reasons
or an oversight

• No prophylactic diuretic was administered in most cases. It is not possible to ascertain whether this
was an oversight or that a diuretic was contraindicated. It is noted that there was some degree of renal
impairment in 9/15 cases which may have influenced the decision not to give a prophylactic diuretic

• The transfusion contributed to death to some extent in all 15 cases. There was evidence of a structured
review in only 6 cases, potentially leading to missed opportunities to improve practice and patient
safety

A recent 10-year review of the TACO deaths, as reported to SHOT highlighted that TACO is rarely seen
in the absence of risk factors identified on the pre-transfusion TACO risk assessment. This safety check
appears to be under-utilised and often inaccurately completed, leading to inadequate mitigation strategies.
Organisations are urged to implement SHOT recommendations to enhance patient safety (Firth, et al., 2024).

Transfusion management approach in non-bleeding adult patients: avoiding

the risks of mismanagement in severe chronic anaemia
Accurate identification of the cause of anaemia is a critical step in safe and appropriate transfusion
management. Acute anaemia is defined as anaemia of recent onset which is caused by bleeding, surgery,
or critical illness in a haemodynamically stable patient. It corresponds to NBTC indication codes R2 and
R3, the latter in the context of acute coronary syndrome. This contrasts with transfusion-dependent
anaemia (R4) which may be caused by bone marrow failure or haemoglobinopathy, and severe chronic
anaemia (e.g., caused by haematinic deficiency, or anaemia of chronic disease) (NBTC, 2020). There is no

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

universal Hb trigger or target for severe chronic anaemia. Physiological compensation means transfusion
is not likely to be required if the Hb is >70g/L. The transfusion of a single unit may be indicated to alleviate
symptoms in severe anaemia (Hb <70g/L) or prevent the acute complications of severe anaemia while
the underlying cause is treated e.g., iron replacement in iron deficiency anaemia.

SHOT data have shown that severe anaemia is an independent risk factor for TACO (Narayan, et al.,
2019) and these patients are vulnerable to overtransfusion leading to TACO-related deaths and major
morbidity. It is important that clinicians authorising transfusion understand the rationale for different
approaches to transfusion management, and the risks of not recognising acute versus chronic anaemia.
The presence of acute coronary syndrome and cardiac ischaemia in acute and chronic anaemia
present additional challenges and risks. The decision to transfuse further units to achieve a higher
Hb target in a patient with acute coronary syndrome/cardiac ischaemia should be balanced against
the increased risk of TACO and exacerbation of heart failure. Strategies that support this such as
education, training and process-embedded guidelines are key components of safe decision-making in
transfusion. Figure 18a.2 describes the transfusion management approach for non-bleeding adult patients
and details the specific approach that should be adopted for patients with severe chronic anaemia.

Conclusion
There has been slow adoption of the TACO pre-transfusion risk assessment tool since it was launched
but this is increasing steadily. While encouraging, the analysis of the data shows it is still under-used or
used ineffectively. Although there has been some uptake of the TACO structured incident investigation
tool, there are still missed opportunities to enhance patient safety. The SHOT HFIT questions, and the
analyses in the main chapter, are only included for reports in established error categories, but it can be
demonstrated that some reaction cases may also be error-based. For the first time this year, a TACO
case has been examined in the Human Factors and Ergonomics (HFE) supplementary information
using the HFIT main headings to examine the significance of HFE involved (https://www.shotuk.org/
shot-reports/report-summary-and-supplement-2023/).

Overtransfusion of red cells remains an issue which could be minimised by weight-adjusted or single
unit transfusion in non-bleeding patients. The transfusion management of patients with severe chronic
anaemia is concerning and continues to contribute to patient deaths due to excessive transfusion. There
are several strategies available to mitigate the risk of TACO based on many years of haemovigilance
data. Everyone involved in the transfusion process has a professional duty to protect patients from TACO
wherever possible. With an increasing number of TACO cases reported to SHOT year-on-year, including
instances of preventable deaths, a National Patient Safety Alert has been released UK-wide by SHOT
through the MHRA (MHRA and SHOT, 2024). This is intended to support and provide a structure for
organisations to implement measures to enhance safety and facilitate appropriate transfusion decisions.
The NBTC indication codes are also being reviewed currently and an updated version is expected to be
released in due course. Identifying risk-factors for TACO in vulnerable patients prior to transfusion helps
initiate appropriate mitigating measures. TACO deaths are potentially preventable.

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Figure 18a.2:
Transfusion
Anaemia in a non-bleeding adult patient: transfusion management management
approach in
non-bleeding
WHAT IS THE CAUSE OF THE ANAEMIA? – CRITICAL STEP adult patients

Chronic anaemia
Acute anaemia in a Chronic anaemia on a
(not on regular transfusion)
haemodynamically stable regular transfusion
patient explained by programme
recent bleeding, surgery
or critical illness Patient may be asymptomatic
or minimally symptomatic
despite severe anaemia and is R4: These patients should
haemodynamically stable have an individualised
R2: Hb R3: Hb Hb trigger/target
<70g/L <80g/L with Check the red cell
(Hb target ACS* indices on the FBC: Chronic bone marrow
70-90g/L) (Hb target Microcytic/hypochromic failure – Transfuse to
80-100g/L) suggesting iron deficiency maintain a Hb which
Macrocytic suggesting prevents symptoms.
B12/folate deficiency Hb 80g/L is a suggested
initial threshold which can
Use weight-adjusted red cell Anaemia of chronic disease is be adjusted if required
dosing/red cell dosage usually normocytic or
calculator (maximum 2 units microcytic/hypochromic Haemoglobinopathy –
with clinical review between
Transfuse to achieve
units), or single unit and Hb Confirm deficiencies with B12, disease control (under
check and clinical review folate, ferritin and iron profile direction of a
approach (serum iron, transferrin haemoglobinopathy
saturation) testing consultant)

Treat the underlying cause

or deficiency

Hb >70g/L Hb <70g/L
Transfusion Consider a single unit for severe
unlikely to be symptomatic anaemia or to prevent
required due to acute complications of severe
physiological anaemia while underlying cause is
compensation treated. ACS (see note below*)

TACO risk assessment

Consider any further mitigations if TACO risks are present

*The decision to transfuse further units to achieve a higher Hb target in a patient with ACS/cardiac
ischaemia should be balanced against the increased risk of TACO and exacerbation of heart failure

ACS=acute coronary syndrome; FBC=full blood count; Hb=haemoglobin; TACO=transfusion-associated circulatory overload

18a. Transfusion-Associated Circulatory Overload 171

 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Recommended resources
Example of weight-adjusted red cell dosing implemented in clinical practice
NHS MHRA and UKCA Marked blood transfusion Red Cell Dosage Calculator Software App
(rcdcalculator.co.uk)

TACO Incident Investigation Guidance Tool

TACO Risk assessment in alternative format for incorporation into clinical documents
https://www.shotuk.org/resources/current-resources/

SHOT Bite No. 11: Respiratory Symptoms During Transfusion

https://www.shotuk.org/resources/current-resources/shot-bites/

SHOT Video: TACO – Transfusion-Associated Circulatory Overload

https://www.shotuk.org/resources/current-resources/videos/
NPSA Alert (2024): TACO
National Patient Safety Alert: ​​Reducing risks for transfusion-associated circulatory overload​​
(NatPSA/2024/004/MHRA​) - GOV.UK (www.gov.uk)

Transfusion-Associated Circulatory Overload (TACO) Cumulative Data

https://www.shotuk.org/resources/current-resources/data-drawers/transfusion-associated-
circulatory-overload-taco-data-drawer/

National Comparative Audit of TACO

https://hospital.blood.co.uk/audits/national-comparative-audit/reports-grouped-by-year/transfusion-
associated-circulatory-overload-audit-2017/

References
Firth, O., Grey, S., Narayan, S. & Poles, D., 2024. Deaths attributable to transfusion- associated circulatory overload:
10-year review of serious hazards of transfusion (SHOT) data. British Journal of Haematology, 204(S1), pp. 63-64. doi:
https://doi.org/10.1111/bjh.19398.

Medicines & Healthcare products Regulatory Agency (MHRA) and Serious Hazards of Transfusion (SHOT), 2024. Central
Alerting System: Reducing risks for transfusion-associated circulatory overload. [Online]
Available at: https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAlert.aspx?AlertID=103249
(Accessed 08 April 2024).

Narayan, S., Grey, S., Bolton-Maggs, P. & Poles, D., 2019. Is severe anaemia an independent risk factor for TACO?
Case based discussions based on TACO reports to SHOT, the United Kingdom haemovigilance scheme (abstract). Vox
Sanguinis, 114(S1), p. 231. doi: https://doi.org/10.1111/vox.12792.

National Blood Transfusion Committee (NBTC), 2020. Indication Codes for Transfusion in Adults - An Audit Tool,
England: National Blood Transfusion Committee. Available at: https://nationalbloodtransfusion.co.uk/sites/default/
files/documents/2023-02/NBTC%20indication%20codes%20-%20Final%20-%20Jan%2020%20%28004%29.pdf
(Accessed 03 May 2024).

Wiersum-Osselton, J. C. et al., 2019. Revised international surveillance case definition of transfusion-associated

circulatory overload: a classification agreement validation study. The Lancet, 6(7), pp. e350-e358. doi: https://doi.
org/10.1016/s2352-3026(19)30080-8.

172 18a. Transfusion-Associated Circulatory Overload

REACTIONS IN PATIENTS ANNUAL SHOT REPORT 2023

Pulmonary Complications of
Transfusion: Non-TACO n=33 18b
Authors: Tom Latham and Oliver Firth

Definition:
Cases where there is a respiratory deterioration within 24 hours of transfusion which does not
meet ISBT TACO criteria, and which is not explained by the recipient’s underlying condition.

Abbreviations used in this chapter

ARDS Acute respiratory distress ICU Intensive care unit
CRP C reactive protein IRC International Revised Consensus
CT Computed tomography (TRALI definition)
CXR Chest X-ray RR Respiratory rate
FFP Fresh frozen plasma SaO2 Oxygen saturation
FiO2 Inhaled oxygen fraction SD-FFP Solvent detergent FFP
Hb Haemoglobin TACO Transfusion-associated circulatory overload
HLA Human leucocyte antigen TAD Transfusion-associated dyspnoea
HNA Human neutrophil antigen TRALI Transfusion-related acute lung injury
HR Heart rate

Key SHOT messages

• Pulmonary complications are often multifactorial

• Fluid overload is often suspected as a contributing factor even if cases do not meet TACO criteria

• Classification of a case as TRALI using international criteria does not imply or depend on the
presence of leucocyte antibodies in the blood donor

• The risk-benefit balance of transfusion should be carefully considered particularly in patients with
multiple risk factors for fluid overload and/or acute lung injury

Recommendation
• A structured TACO investigation tool should be used for all pulmonary complications

Action: All staff involved in investigating transfusion reactions

Introduction
In 2023, a total of 33 cases were included in the non-TACO category. Fifty-five cases were originally
submitted or transferred from other categories. Of these, 11 were withdrawn as they were either
of insufficient severity or due to the underlying condition, 10 cases were transferred to TACO and
1 was deferred pending investigation results. For more details, see the supplementary data tables
and information on the SHOT website (https://www.shotuk.org/shot-reports/report-summary-and-
supplement-2023/).

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Cases were classified using the IRC definitions of TRALI (Table 18b.1). Cases satisfying both TRALI and
TACO criteria (Wiersum-Osselton, et al., 2019) were categorised as ‘TRALI-TACO’ and cases satisfying
neither as ‘TAD’. The TAD category is subclassified into TAD-IC (cases which could not be classified
because of incomplete information reported) and TAD-C (cases where there was sufficient information
to judge that the case did not meet either TACO or TRALI criteria).

The final classification of cases with imputability is presented in Table 18b.2 and major morbidity and
mortality in Table 18b.3.
Table 18b.1:
TRALI type I - Patients who have no risk factors for ARDS and meet the following criteria:
International
a. i. Acute onset
revised consensus
classification of ii. Hypoxemia (P/F ≤300 or SpO2 < 90% on room air)
TRALI (Vlaar, et al., iii. Clear evidence of bilateral pulmonary edema on imaging (e.g. chest radiograph, chest CT, or ultrasound)
2019)
iv. No evidence of left atrial hypertension (LAH), or, if LAH is present, it if judged to not be the main contributor to
the hypoxemia
b. Onset during or within 6 hours of transfusion

c. No temporal relationship to an alternative risk factor for ARDS

TRALI type II - Patients who have risk factors for ARDS (but who have not been diagnosed with ARDS) or
who have existing mild ARDS (P/F of 200-300), but whose respiratory status deteriorates and is judged to
be due to transfusion based on:
a. Findings as described in categories a and b of TRALI type I and

b. Stable respiratory status in the 12 hours before transfusion

Table 18b.2: Final

Imputability
classification of
1-possible 2-probable 3-definite Total
non-TACO cases
Category TAD-C 7 8 1 16
TAD-IC 7 4 0 11
TRALI-TACO 0 0 1 1
TRALI type II 4 1 0 5
Total 18 13 2 33

Table 18b.3: Major morbidity and mortality

Non-TACO major
Major morbidity Death Total
morbidity and
Category TAD-C 6 2 8
mortality
TAD-IC 0 3 3
TRALI type II 4 0 4
Total 10 5 15

Deaths related to transfusion n=5

There were 5 deaths reported, all in the TAD category. All patients were severely unwell prior to transfusion.
Death was possibly (imputability 1) related to TAD in 3 cases and probably related (imputability 2) in 2
cases. In both imputability 2 cases, extensive investigation was not considered appropriate because the
patient was terminally ill. Fluid overload was clinically thought to have contributed to the deterioration
in all 5 cases, but they did not satisfy sufficient criteria to be classified as TACO. For more details and
a narrative summary of the deaths, see the supplementary information on the SHOT website (https://
www.shotuk.org/shot-reports/report-summary-and-supplement-2023/).

174 18b. Pulmonary Complications of Transfusion: Non-TACO

REACTIONS IN PATIENTS ANNUAL SHOT REPORT 2023

Major morbidity n=10

There were 10 cases of major morbidity (defined as requiring ventilation or ICU admission). Six were
classified as TAD-C and 4 as TRALI type II.

Case 18b.1: TAD-C - High suspicion of fluid overload not satisfying TACO criteria

A patient with decompensated liver disease, impaired left ventricular function, aortic stenosis, and
low albumin, was receiving diuretics for fluid overload. They developed respiratory distress and
crepitations during a two-unit FFP transfusion given to correct clotting abnormalities during an
endoscopy for bleeding varices. The CXR showed increased consolidation in the left lower lobe. The
risk of fluid overload was noted prior to transfusion. There was no immediate response to diuretic at
the time of the reaction, but the patient was given further diuretics in ICU. The patient was ventilated
overnight and improved by morning.

This case is included as it is emblematic of the challenges of transfusing unwell patients and of classifying
reactions in such cases. The patient was identified as being at high risk of tolerating fluid poorly but there
were also high risks of leaving clotting uncorrected during major bleeding. Appropriate treatment was
rapidly provided. The case was classified as TAD-C since insufficient criteria were present to classify as
TACO; the TACO criteria do not take account of pre-existing risk.

FFP transfusion to correct clotting in patients already fluid overloaded is a recurrent feature in cases
reported to SHOT; the balance of risk and benefit must be carefully considered. The use of alternatives
such as prothrombin complex concentrate is not recommended for routine correction of coagulation
abnormalities in liver disease but could have a favourable risk/benefit ratio in this situation.

TRALI and leucocyte antibody cases

Cases have been classified as TRALI using the IRC definition. The presence of leucocyte antibodies
plays no part in this definition. Antibodies however remain an established cause of TRALI, and one
which is potentially preventable. Cases which were positive for antibodies (HLA or HNA) are therefore
presented in parallel.

Cases meeting TRALI criteria n=6

Of the cases which met TRALI criteria, 5 were classified as TRALI type II. One case was classified as
‘TRALI and TACO cannot be distinguished’ and was positive for leucocyte antibodies, see Case 18b.3.
Most patients were unwell prior to transfusion and the transfusion reactions were of low imputability. A
summary of all cases meeting TRALI criteria is given in the supplementary data, Table 18b.5 (https://
www.shotuk.org/shot-reports/report-summary-and-supplement-2023/).

Case 18b.2: TRALI type II - Recurrent pulmonary reactions with SD-FFP

A patient was undergoing plasma exchange for suspected thrombotic thrombocytopenic purpura
(eventually confirmed as haemolytic uraemic syndrome). Respiratory deterioration occurred on three
successive occasions during exchange. CXR showed worsening bilateral changes and there was
a rising CRP, but the patient was not thought to have pneumonia. Renal function was normal and
there was a negative fluid balance and no features of fluid overload.

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

The case meets criteria for TRALI and the recurrent deterioration during successive procedures does
suggest a causative role for the transfusion. Investigation of the product for leucocyte antibodies is not
within the scope of the Blood Services and would have to be arranged by the manufacturer. SD-FFP
is a pooled product and pooling is generally considered to reduce the risk of antibody-mediated TRALI
through dilution of antibodies from any given donor (Sachs, et al., 2005). Product information does
include respiratory adverse events following SD-FFP, though acknowledges the difficulty in assigning
imputability. A recent study from the Netherlands suggested the incidence of cases meeting TRALI criteria
was reduced in critical care patients after changing to routine use of SD-FFP, although the difference
was not statistically significant (Klandermann, et al., 2022). SD-FFP is regulated as a medicine not a
blood component and is reported to the MHRA via the Yellow Card system but SHOT will accept cases
for review.

Cases with leucocyte antibodies n=1

Case 18b.3: TRALI/TACO with HLA class I antibody

A patient with pre-eclampsia but normotensive, low albumin, and peripheral oedema was transfused
one unit of red cells for postpartum haemorrhage following caesarean section. Dyspnoea developed
2-6 hours after transfusion, and oxygen saturation was 95% on oxygen (FiO2 not recorded). CXR
showed upper lobe diversion and a CT scan the following day confirmed pulmonary oedema. There
was no response to diuretic or haemodynamic change. Donor antibody testing showed HLA B45
antibodies cognate with the recipient. The patient made a complete recovery.

The case has been classified as TRALI/TACO since the case satisfies both TRALI and TACO criteria. The
finding of cognate antibody in the sole donor supports the idea that antibody has caused or contributed
to the reaction, although the association of HLA class I antibodies with TRALI is less strong than for
class II or granulocyte specificities.

Clinical features of reactions

Many recipients had pre-existing factors which could cause acute lung injury or difficulty tolerating
additional fluid (‘risk factors’ Figure 18b.1a) or had features reported at the time of transfusion indicating
fluid overload or cardiorespiratory strain (‘state factors’ Figure 18b.1b). Notably, over half of cases had
pre-existing risk factors for fluid overload and inflammatory conditions. Multiple risk factors were present
in many cases, with a median of 4 risk factors per case (Table 18b.4). It is not possible to investigate
whether individual risk factors entail a higher risk of pulmonary complications from this data in the
absence of a control group. Figure 18b.2 however shows that certain pairs of risk factors occurred more
commonly than expected statistically, suggesting the coexistence of multiple risk factors may have a more
than additive risk of transfusion reaction. Liver disease and inflammation particularly appear to interact
with other risk factors, consistent with an observation that sepsis and alcohol abuse were noted as risk
factors for acute lung injury in transfused critical care patients in a prospective study (Gajic, et al., 2007).

176 18b. Pulmonary Complications of Transfusion: Non-TACO

REACTIONS IN PATIENTS ANNUAL SHOT REPORT 2023

Figure 18b.1: Pre-

transfusion features
Shock/major
haemorrhage 6 3 24 of pulmonary cases

Low albumin 4 15 14 Figure 18b.1a: Risk

factors
Pulmonary 8 10 15
Pre-transfusion risk factor

Liver 3 2 28

Inflammation 12 14 7

Hb<70 9 24

Fluid 14 11 8

Cardiac 7 9 17

0 10 20 30
Count

Severity
Major Minor Absent

Figure 18b.1b:
State factors
SaO2<95% 10 18

RR>20 10 20

Positive fluid balance 17 16

or IV fluid
Pre-transfusion state

HR>100 7 26

Fluid overload 15 18

0 10 20 30
Count

Severity
Present Absent

Number of pre-transfusion state factors present Table 18b.4:

Number of factors
Number of pre- 0 1 2 3 4 Total
transfusion risk present per
1 0 1 1 0 0 2
factors present pulmonary case
2 1 2 0 2 0 5
3 1 1 1 1 1 5
4 1 4 2 2 0 9
5 1 3 1 1 2 8
6 0 1 2 1 0 4
Total 4 12 7 7 3 33

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Figure 18b.2:
Statistical
Factor coincidence
significance of Fluid
factor coincidence Fluid overload
(Fisher exact Hb<70/L p<0.00001
test with multiple HR>100
testing correction) Inflammation
Liver
Pulmonary p<0.001
Low albumin
Positive fluid balance or IV fluids
RR>20
SaO2>95
p<0.1
Shock/major haemorrhage
or IV fluids
Positive fluid balance
Cardiac
Fluid
Fluid overload

Low albumin
Hb<70/L

RR>20
SaO2>95
Pulmonary
HR>100
Inflammation
Liver

p>0.1

Hb=haemoglobin; HR=heart rate; RR=respiratory rate; SaO2=oxygen saturation

Data completeness and concordance with SHOT

recommendations
The proportion of cases classified as TAD-IC because there was insufficient information to apply the
TACO or TRALI criteria remains unsatisfying. This is not meant as a criticism of reporters or treating
clinicians, but an observation that the data needed to classify reactions using formal international
criteria seem to be challenging to provide in practice. This has been illustrated in the supplementary
chapter. More generally, only about 2/3 of reports were able to supply a full set of the recommended
transfusion observations and 9% were not able to supply any observations. These are long-established
recommendations. Only about a third of submissions reported the use of a TACO pre-transfusion risk
assessment or a structured investigation, as has been recommended by SHOT for several years. These
figures are similar to the 2022 Annual SHOT Report (Narayan, et al., 2023).

Conclusion
As in previous years, transfusion recipients suffering pulmonary complications are often complex with
multiple comorbidities across all reporting categories, with little to distinguish cases in different categories.
Antibody-associated cases and cases where the transfusion appears the sole contributor are rare. Fluid
overload is suspected as a contributory factor even in cases which do not meet TACO criteria; it is
important to remember that TRALI and TACO are haemovigilance reporting categories not pathological
diagnoses and examine all possibly preventable factors regardless of classification. The suggestion that
comorbidities, particularly liver disease, and inflammation, may interact synergistically to create increased
risk of tolerating transfusion poorly is worthy of further study.

Avoiding fluid overload and minimising transfusion remain the only approaches available to clinicians to
prevent pulmonary complications. The risk/benefit balance of transfusion should be carefully considered
in unwell patients, particularly those with multiple comorbidities.

178 18b. Pulmonary Complications of Transfusion: Non-TACO

REACTIONS IN PATIENTS ANNUAL SHOT REPORT 2023

Recommended resources
TACO Incident Investigation Guidance Tool
TACO Checklist: in risk assessment/checklist alternative format for incorporation into
clinical documents
https://www.shotuk.org/resources/current-resources/

SHOT Video: TACO

https://www.shotuk.org/resources/current-resources/videos/

SHOT Bite No. 11: Respiratory Symptoms During Transfusion

https://www.shotuk.org/resources/current-resources/shot-bites/

References
Gajic, O. et al., 2007. Transfusion-related acute lung injury in the critically ill: prospective nested case-control study.
American Journal of Respiratory and Critical Care Medicine, 176(9), pp. 886-891. doi: https://doi.org/10.1164/
rccm.200702-271oc.

Klanderman, R. B. et al., 2022. Incidence of transfusion-related acute lung injury temporally associated with solvent/
detergent plasma use in the ICU: A retrospective before and after implementation study. Transfusion, 62(9), pp. 1752-
1762. doi: https://doi.org/10.1111/trf.17049.

Narayan, S. et al., 2023. The 2022 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. doi: https://doi.org/10.57911/WZ85-3885.

Sachs, U. J., Kauschat, D. & Bein, G., 2005. White blood cell-reactive antibodies are undetectable in solvent/detergent
plasma. Transfusion, 45(10), pp. 1628-1631. doi: https://doi.org/10.1111/j.1537-2995.2005.00587.x.

Vlaar, A. P. et al., 2019. A consensus redefinition of transfusion-related acute lung injury. Transfusion, 59(7), pp. 2465-
2476. doi: https://doi.org/10.1111/trf.15311.

Wiersum-Osselton, J. C. et al., 2019. Revised international surveillance case definition of transfusion-associated

circulatory overload: a classification agreement validation study. The Lancet, 6(7), pp. e350-e358.doi: https://doi.
org/10.1016/s2352-3026(19)30080-8.

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Haemolytic Transfusion Reactions

19 (HTR) n=53

Authors: Tracey Tomlinson and Anicee Danaee

Definition:
Acute haemolytic transfusion reactions (AHTR) are characterised by fever, a fall in haemoglobin
(Hb), rise in bilirubin and lactate dehydrogenase (LDH) and a positive direct antiglobulin test
(DAT). They generally present within 24 hours of transfusion.

Delayed haemolytic transfusion reactions (DHTR), occur more than 24 hours following a
transfusion and are associated with a fall in Hb or failure to increment, rise in bilirubin and LDH
and an incompatible crossmatch not detectable pre transfusion.

Hyperhaemolysis is characterised by more severe haemolysis than DHTR, with haemolysis

affecting the transfused red cells and the patient’s own red cells; there is a decrease in Hb
to below pre-transfusion levels, which is often associated with a reticulocytopenia. It may be
triggered by a new red cell alloantibody, but frequently no new red cell antibody is identified.
Hyperhaemolysis can be divided into acute and delayed hyperhaemolysis.

Abbreviations used in this chapter

AHTR Acute haemolytic transfusion reaction ICU Intensive care unit
DAT Direct antiglobulin test IV Intravenous
DHTR Delayed haemolytic transfusion reaction IVIg Intravenous immunoglobulin
ED Emergency department LDH Lactate dehydrogenase
EPO Erythropoietin SCD Sickle cell disease
Hb Haemoglobin Sp-ICE Specialist Services Integrated
HTR Haemolytic transfusion reaction Clinical Environment

Key SHOT messages

• Avoidable transfusion/s continue to be reported resulting in patient death and major morbidity

• Poor communication contributes to incidents

• While there has been an increase in the number of cases of hyperhaemolysis reported in 2023,
it remains under-recognised and under-reported

Recommendations
• Effective communication is vital to maintain transfusion safety, this includes communicating the
reasons for, and risks of transfusion to the patient, communication between clinical areas and
communication between hospitals

Action: All staff involved in transfusion

• Provide as much information as possible to SHOT when reporting, including the investigations
performed, treatment modality and patient outcome

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Action: Haemovigilance reporters

• Do not withhold lifesaving transfusion, even if the patient has a history of alloantibodies, and carefully
monitor the patient for signs and symptoms of a haemolytic transfusion reaction

Action: Clinical staff involved in transfusion

• Laboratory protocols should include a full investigation for HTR which might include referring
samples when resources for testing are not available locally

Action: Laboratory staff involved in transfusion

Headline data 2023 HTR reports by year

59
53
49 49
46 46
44
Number of reports n=53
42
35 35

Deaths n=2
Major morbidity n=18

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Demographic data Blood component data

Red cells n=53

Platelets n=0
Plasma n=0
Multiple components n=0
Male Female Adults Paediatric
n=22 n=31 n=49 n=2

Unknown n=2

Introduction
A total of 53 cases have been included, 9 acute, 31 delayed reactions and 13 cases of hyperhaemolysis.
The total number of reactions reported is comparable to 2022 (49 cases), 2021 (44 cases) and 2020
(46 cases) but demonstrates a small increasing trend.

All reported cases occurred following red cell transfusions.

Age range and median

The patient’s age was not provided in 2 reports (1 male patient and 1 female patient). The age range
in the remaining cases was 12 to 95, with a median age of 47. This is shown in Figure 19.1, broken
down further by gender. HTR were reported in 2 paediatric patients. In 31/53 (58.5%) of the reactions
the patients were female.

19. Haemolytic Transfusion Reactions (HTR) 181

 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Figure 19.1: Age

range in males 100
and females
90
experiencing a HTR
in 2023 80

70

60
Age (years)

50

40

30

20

10

0
Female Male

Figure 19.1 is a box and whisker diagram showing the median age and the age range of patients experiencing a HTR reported to SHOT
separated by gender. The middle bar in the shaded box indicates the median age, the outer bars of the box represent the upper and lower
quartiles. The lines extending from the boxes (whiskers) indicate the lowest and highest values.

Deaths related to transfusion n=2

Two deaths related to the transfusion reactions were reported (imputability 2). Both reactions occurred
in patients with SCD.

Case 19.1: Fatal haemolytic transfusion reaction following unnecessary elective exchange
transfusion

A patient with SCD was scheduled for an exchange transfusion in advance of elective surgery. The
patient was informed that the surgery had been cancelled and despite this being communicated to
the patient in advance of the transfusion, this information was not communicated to the haematology
team and the exchange transfusion went ahead. Five days later the patient presented at the ED with
severe pain and symptoms consistent with a delayed HTR. The patient later collapsed and suffered
a cardiac arrest.

Case 19.2: Death attributed to hyperhaemolysis with delays in treatment

A patient with SCD and an existing heart condition presented to haematology outpatients with severe
pain 5 days post transfusion. The patient did not have an appointment and was told to go to ED
where they were admitted for suspected hyperhaemolysis and transferred to the ICU. The patient
was treated with IVIg, methylprednisolone and eculizumab and was showing signs of recovery when
they suffered cardiac arrest and died.

Major morbidity n=18

There were 18 cases reported in which the patient suffered major morbidity. SHOT considers that all
reported cases of probable hyperhaemolysis, where there is a significant fall in Hb, should be considered
as major morbidity. Following application of this criterion 6 cases of hyperhaemolysis reported with
‘minor morbidity’ were upgraded.

Hyperhaemolysis n=13
All 13 hyperhaemolysis cases reported occurred in patients with SCD. While the majority of
hyperhaemolysis cases continue to be reported in this patient group, hyperhaemolysis does occur in
other patient groups as shown in Table 19.1.

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Table 19.1:
Clinical condition Acute reaction Delayed reaction Total
Hyperhaemolysis
SCD 26 21 47
cases reported
T-cell lymphoma 1 0 1 between 2017 and

Dosai-Dorfman syndrome 1 0 1 2023

Myelodysplastic syndrome 0 1 1

Diamond-Blackfan anaemia 0 1 1

Myelofibrosis post transplant 1 0 1

Non-Hodgkin lymphoma 1 0 1

Total 30 23 53

While the number of hyperhaemolysis cases reported in 2023 was comparable to previous years, it
is suspected that hyperhaemolysis is still under-reported. This is partially attributed to the fact that
hyperhaemolysis can be difficult to diagnose with symptoms showing many similarities to DHTR and
vaso-occlusive crisis (Adkins, et al., 2020).

Hyperhaemolysis can be divided into acute and delayed hyperhaemolysis. Acute hyperhaemolysis occurs
within 7 days of transfusion and the DAT is usually negative. Delayed hyperhaemolysis occurs more
than 7 days post transfusion and the DAT is often positive. In contrast to a classical DHTR, in delayed
hyperhaemolysis both patient and transfused red cells are haemolysed (Danaee, et al., 2015). Six cases
reported the reactions occurred within the first 7 days post transfusion.

Treatment in hyperhaemolysis
SHOT started requesting information on the treatment used to manage patients experiencing
hyperhaemolysis in 2020. The aim is to provide a better understanding of practice nationally and improve
and share knowledge. Eculizumab has been licensed to treat ongoing brisk haemolysis (NHSE, 2020)
and was reported as being used in 1 case. SHOT data shows that patients are generally treated with
a combination of IVIg, IV steroids and EPO. A summary of the treatment methods reported is provided
in Figure 19.2. This demonstrates a move towards more aggressive treatment regimens with 12/13
(92.3%) patients receiving two or more different treatments in 2023.

Figure 19.2:
Treatments
13
used to manage
hyperhaemolysis

9 9

3 3

2 2 2 2

1 1 1 1 1 1 1 1 1 1

No treatment IVIg, IV steroids IVIg and IV IVIg and EPO IVIg only IV steroids Total HH
information provided & EPO steroids only reported

2020 2021 2022 2023

EPO=erythropoietin; HH=hyperhaemolysis; IV=intravenous; IVIg=intravenous immunoglobulin

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Clinical and laboratory signs and symptoms

Acute haemolytic transfusion reactions n=9

Alloantibodies to red cell antigens were identified in 7 of the 9 AHTR cases reported. The alloantibodies
implicated are shown in Figure 19.3.

Figure 19.3:
Alloantibodies
2 2 2
reported in AHTR
in 2023

1 1 1

Anti-Jk a Anti-Wr a Anti-D Anti-Fy a Anti-Js b no alloantibodies

detected

There were 2 cases reported in which no alloantibodies were detected. In 1 case the patient had a
strongly active warm autoantibody. In the other case the antibody screen was negative in both the pre-
and post-transfusion samples. The DAT was positive post transfusion but unfortunately an eluate was
not performed.

In 4 cases, antigen-positive red cells were transfused urgently following advice from specialist transfusion
medical staff.

The remaining case involved the presence of an anti-Jsb antibody.

Case 19.3: Acute haemolytic transfusion reaction in a patient with known anti-Jsb

A patient with a history of anti-Jsb was scheduled for major surgery with a high expected blood loss.
Jsb antigen-negative blood is rare, with 100% of caucasians being Jsb-positive (Reid, et al., 2012)
however two Jsb-negative units were provided from the Blood Service frozen blood bank and issued
to the patient. Some additional ‘best matched’ Jsb untyped units were also crossmatched on standby
in case of major blood loss which were placed in the theatre blood refrigerator in error. During the
surgery a one-unit top-up transfusion was prescribed. One unit of the ‘best matched’ red cells was
taken and transfused despite the compatible Jsb-negative units being available for transfusion. The
patient immediately started to exhibit symptoms of an acute transfusion reaction but recovered fully
following appropriate management.

184 19. Haemolytic Transfusion Reactions (HTR)

REACTIONS IN PATIENTS ANNUAL SHOT REPORT 2023

Learning points
• It is important that lifesaving transfusion is not withheld due to a history of alloantibodies. In urgent
clinical situations where suitable antigen-negative blood is not available it may be necessary to
transfuse blood which is positive for a confirmed antibody using concessionary release. An example
form is outlined in the BSH 2013 guideline, appendix 9 (Milkins, et al., 2013)

• Where patients have complex blood requirements, the transfusion plan should clearly define blood
availability and use

Delayed haemolytic transfusion reactions n=31

No clinical symptoms of a transfusion reaction were reported in 8/31 DHTR cases submitted to SHOT
and in all 31 cases a lack of sustained Hb increment following transfusion was described.

Antibodies were detected in 28/31 of the DHTR reported and in 25 of these cases, alloantibodies were
detected in the post-transfusion plasma that were not detected pre transfusion. In 5 of these cases,
the antibody specificity implicated had been previously reported on Sp-ICE. One case involved the
transfusion of antigen-positive emergency O D-negative red cells in an emergency.

Antibodies to the Kidd blood group system remain the most frequently implicated antibodies in DHTR
however in contrast to previous years, in 2023, there were more cases due to anti-Jkb than anti-Jka
(Figure 19.4).

Figure 19.4:
Alloantibodies
implicated in DHTR
8
in 2023

3 3

2 2

1 1 1 1 1 1

Anti-Jk b Anti-Jk a Anti-Fya Anti-M Anti-c Anti-E Anti-CR1 Anti-Jsa Anti-K Anti-N Anti-s Anti-U
related

19. Haemolytic Transfusion Reactions (HTR) 185

 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Unnecessary transfusions

There were 2 HTR reported in 2023 in patients whose transfusions were not indicated by current
guidelines. One of these cases resulted in a patient death and has been described earlier in this chapter.
The other transfusion was for a patient with iron deficiency.

There was 1 further case reported in which the reason for transfusion and patient consent was not
recorded in the patients notes and therefore the appropriateness of the transfusion cannot be assessed.

While the safety of transfusion continues to improve, it must be remembered that it is not without risks.
Care should be taken to ensure that transfusions are only given where indicated and supported by
published guidelines.

Learning point
• Transfusions should only be given where indicated and supported by published guidelines

Quality of data
Two potential cases had to be rejected due to insufficient information being available in the report to
allow confirmation. Further cases which were included had key information missing from the report that
limited the analysis of these cases. Examples of missing information included patient age, underlying
clinical condition, reason for transfusion and the outcome of the laboratory investigations performed.

Conclusion
HTR continue to be a cause of transfusion-associated reactions and it is important that both clinical
teams and patients are educated in the signs and symptoms of a HTR to allow their prompt management.

186 19. Haemolytic Transfusion Reactions (HTR)

REACTIONS IN PATIENTS ANNUAL SHOT REPORT 2023

Many HTR, especially DHTR, are largely preventable and local protocols should be in place to reduce the
risk, including the use of patient databases such as Sp-ICE, to identify historical antibody information.

All HTR should be reported to SHOT with as much information as possible provided to facilitate a better
understanding of gaps in management and inform recommendations to improve safety.

Recommended resources
SHOT Bite No. 8: Massive Haemorrhage Delays
SHOT Bite No. 15: Hyperhaemolysis
SHOT Bite No. 31: Sp-ICE
https://www.shotuk.org/resources/current-resources/shot-bites/

References
Adkins, B. D., Sharma, D. & Eichbaum, Q., 2020. Can we better predict delayed hemolytic transfusion reactions
and hyperhemolysis in sickle cell disease?. Transfusion and Apheresis Science, 59(2), p. 102681. doi: https://doi.
org/10.1016/j.transci.2019.102681.

Danaee, A., Inusa, B., Howard, J. & Robinson, S., 2015. Hyperhemolysis in Patients With Hemoglobinopathies: A
Single-Center Experience and Review of the Literature. Transfusion Medicine Reviews, 29(4), pp. 220-230. doi: https://
doi.org/10.1016/j.tmrv.2015.06.001.

Milkins, C. et al., 2013. Guidelines for pre-transfusion compatibility procedures in blood transfusion laboratories.
Transfusion Medicine, 23(1), pp. 3-35. doi: https://doi.org/10.1111/j.1365-3148.2012.01199.x .

NHS England (NHSE), 2020. Rituximab and eculizumab for the prevention and management of delayed haemolytic
transfusion reactions and hyperhaemolysis in patients with haemoglobinopathies. [Online] Available at: https://www.
england.nhs.uk/publication/rituximab-and-eculizumab-for-the-prevention-and-management-of-delayed-haemolytic-
transfusion-reactions-and-hyperhaemolysis-in-patients-with-haemoglobinopathies/ (Accessed 30 April 2024).

Reid, M. E., Lomas-Francis, C. & Olsson, M. L., 2012. Disease Association. In: The Blood Group Antigen FactsBook.
3rd ed. s.l.:Elsevier Ltd., p. 471.

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Uncommon Complications of
20 Transfusion (UCT) n=24

Authors: Caryn Hughes and Shruthi Narayan

Definition:
Pathological reaction or adverse effect in temporal association with transfusion which cannot be
attributed to already defined side effects and with no risk factor other than transfusion and do
not fit under any of the other reportable categories, including cases of transfusion-associated
hyperkalaemia.

Abbreviations used in this chapter

BSH British Society for Haematology ODP Operating department practitioner
Hb Haemoglobin SpO2 Oxygen saturation using pulse oximeter
IV Intravenous UCT Uncommon complication of transfusion
NEC Necrotising enterocolitis

Key SHOT messages

• Atypical complications of transfusion can occasionally occur, and reporting such cases helps
improve awareness and patient safety

• All relevant investigation findings, including laboratory test results are required by SHOT to enable
accurate categorisation and imputability to be assigned

Recommendations
• Reporters are encouraged to continue to report cases with unusual reactions to transfusion
including suspected cases of transfusion-associated neonatal NEC

• Investigations into suspected reactions should follow BSH guidelines (Soutar, et al., 2023)

• Information to raise awareness of unusual complications of transfusion should be incorporated

into clinical transfusion training

Action: Hospital transfusion committees, all staff involved in transfusion

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Headline data 2023 UCT reports by year

31

Number of reports n=24 24

Deaths n=2 14 15
13
11 12
Major morbidity n=1 5
9 8

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Demographic data Blood component data

Red cells n=20

Platelets n=4
Plasma n=0
Multiple components n=0
Male Female Adults Paediatric
n=10 n=13 n=17 n=6 Other n=0
Unknown n=1 Unknown n=1

Introduction
This category includes cases with uncommon reactions reported in patients with a temporal relation to
transfusion which cannot be classified into other categories. Patients often have multiple comorbidities
which may contribute to the complication noted. Reporting and analysing these helps to facilitate our ever-
evolving understanding of transfusion complications thereby improving the safety of transfused patients
through the implementation of appropriate risk-reduction measures. Occasionally, uncategorisable error
reports are included in UCT to ensure learning is captured and shared.

Deaths related to transfusion n=2

There were 2 deaths reported in this category, both recorded as imputability 1, possibly related to
transfusion.

Case 20.1: Acute transfusion reaction resulting in patient death

An elderly patient with myelodysplastic syndrome and chronic transfusion-dependent anaemia

developed sudden onset acute abdominal pain, along with associated nausea while receiving
a second unit of red cells in an outpatient setting. The red cells were compatible, and all pre-
administration checks had been performed as required. The transfusion was stopped immediately,
all observations were within normal range with no pyrexia, hyper or hypotension, tachycardia, or
bradycardia. The IV line was changed for IV saline. The patient was reviewed by the medical team and
given chlorphenamine IV and hydrocortisone IV. The unused blood was returned to the transfusion
laboratory along with the relevant blood samples. The unit was tested locally and was sent to
the Blood Service for further testing. The patient was admitted to the ward and was treated for a
transfusion reaction, further deterioration, and for suspected sepsis. The patient subsequently died,
and the case was referred to the coroner.

No further details on the outcome of the coroner’s investigation or laboratory findings were available to
SHOT. While the clinical picture could be multifactorial, the case has been included here in view of the
temporal relationship of the reaction with transfusion.

Case 20.2: Acute deterioration and death following a red cell transfusion in a neonate with
pre-existing comorbidities

A premature baby required intubation in the delivery room and was transferred to the neonatal
unit for respiratory support. The baby was noted to have acute respiratory distress syndrome,

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

hyperkalaemia, suspected sepsis, mild left pulmonary artery stenosis, anaemia of prematurity,
hyperglycaemia, acute bowel, possible NEC. On day 28 post delivery, anaemia was treated with
red cell transfusion based on a Hb of 84g/L. The transfusion event was uneventful but a concerning
change in the infants’ condition was noted later the same day with the presentation of a distended
tense abdomen. The infant continued to deteriorate, requiring additional interventions and support,
including re-intubation. The baby was diagnosed with a bowel perforation and worsening metabolic
acidosis. Despite all efforts, the baby died.

The likelihood that the death was related to the transfusion was originally reported with an imputability
of 3 (certain) however, based on the information provided, and following discussion with paediatric
haemovigilance experts, the imputability was downgraded to 1 (possible). This case is also described
in Chapter 24, Paediatric Cases, Case 24.1.

Major morbidity n=1

Case 20.3: Venous air embolism following inappropriate preparation of line prior to
transfusion
A postoperative patient in recovery required a recheck of Hb with a decision to transfuse red cells
if the Hb was <80g/L. The first Hb result was 83g/L but following repeating testing Hb was 78g/L
which deemed the transfusion necessary, and a unit of red cells was requested from the transfusion
laboratory. The first nurse was instructed to go on a break and a handover was given to the ODP
who would take over the patient’s care and initiate the transfusion. The ODP checked the blood
component with the authorisation/prescription and patient’s identification band and spiked the blood
bag with a giving set. The giving set included a warming device and extension line distal to the
warmer and attached to the patient’s IV cannula. The patient quickly presented with central chest
pains and a decreasing saturation - SpO2 to 50%.The transfusion was stopped, and a possible
transfusion-related reaction was suspected. It was noted that approximately 10cm of wide bore
extension tubing was clear and a rapid call was sent to the floor anaesthetist for medical assistance.
A transfused air embolus was confirmed. A rebreathing mask was applied at 15L of oxygen which
was changed to water circuit with positive end-expiratory pressure. The SpO2 increased to 96%.
Crystalloids were commenced and the patient was transferred to the high-dependency unit for level
2 care for further observation. The patient was visited by the attending consultant anaesthetist and
duty of candour was applied. The patient recovered and survived.

This case was initially reported as a handling and storage error, but after review, in view of adverse
patient impact, this case was transferred to the UCT category.

There was a complete and thorough investigation into this case. The investigation considered several
aspects including the presence of the handover documentation in the patient’s notes, staffing levels at the
time which were deemed to be safe and the environment, which was described as calm and free from
external distractions. Consideration was given to the use of infusion pumps which may have mitigated
some risk by the identification of air within part of the giving set. It was noted that the department
fostered an open culture and actively encouraged all members of the team to speak up when they had
concerns regarding patient safety. The surgical care pathway, anaesthetic charts, prescription, and
critical care notes were clearly documented and provided an accurate account of instructions, timeline,
and interventions. The ODP had attended training for blood transfusion however, this had occurred
during the COVID-19 pandemic, which meant that underpinning knowledge may not have been optimal.
Furthermore, the practitioner’s exposure to transfusion practice was minimal and it was recognised that
the gap in knowledge and skills contributed to the error.

Other UCT cases n=21

There were 3 paediatric cases, which were part of a cluster of 5 cases all from the same hospital and
were unusual transfusion reactions in multiply transfused patients. These reactions had common features
including rapid onset after small volume of red cells transfused, coughing, chest tightness, drowsiness
in 4/5, wheeze in 2/5. Four out of 5 patients received adrenaline. These are discussed in Chapter 24,

190 20. Uncommon Complications of Transfusion (UCT)

REACTIONS IN PATIENTS ANNUAL SHOT REPORT 2023

Paediatric Cases. Two of the 5 cases met the criteria for FAHR and are therefore included in Chapter
17, Febrile, Allergic and Hypotensive Reactions (FAHR). The other 3 cases, however, were atypical and
have therefore been assigned to UCT. Despite detailed review and investigation, no underlying common
cause for the cluster of reactions was identified. These cases highlight the importance of local review
of transfusion reactions by hospital transfusion teams as the fact that they all occurred at the same
location would not have been detected by SHOT.

Several other cases were reported in this category and have been detailed in the supplementary
information on the SHOT website (https://www.shotuk.org/shot-reports/report-summary-and-
supplement-2023/).

Learning points
• Patients experiencing new, unusual symptoms or signs associated with a transfusion must be
evaluated promptly and treated as expeditiously as possible to minimise the impact

• Clinical staff involved in transfusion must be adequately trained to recognise, and be encouraged
to report, uncommon complications of transfusion

• A defined process for reporting, reviewing, and trending non-typical complications of transfusion
will ensure learning from these events, inform practice, and improve transfusion safety

Conclusion
Patients receiving transfusions often have complex underlying comorbidities which may mimic or mask a
transfusion reaction. This makes it challenging for healthcare staff to assign accurate imputability of the
patient’s reaction/complication to transfusion. All staff involved in the transfusion process have an integral
part to play in the early identification, management, investigation and reporting of unusual reactions to
transfusion in neonates, children, and adults. Improving knowledge on recognising transfusion reactions
for all staff involved in the monitoring of transfusion recipients is vital for the early detection and treatment
of these to minimise the impact of the reaction and optimise transfusion safety.

Reference
Soutar, R. et al., 2023. Guideline on the investigation and management of acute transfusion reactions. British Journal of
Haematology, 201(5), pp. 832-844. doi: https://doi.org/10.1111/bjh.18789.

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Transfusion-Transmitted Infections (TTI)

21 n=4 (2 confirmed, 2 probable)

Authors: Tali Yawitch, Katy Davison, Heli Harvala, and Su Brailsford

Definition:
Included as a TTI if, following investigation, the recipient had evidence of infection post
transfusion, there was no evidence of infection prior to transfusion and no evidence of an
alternative source of infection.

AND

Either at least one component received by the infected recipient was donated by a donor who
had evidence of the same infection.

Or at least one component received by the infected recipient was shown to contain the agent of
infection. These may be identified because of infection in the recipient where transfusion is the
suspected source, and a post-transfusion infection reported to the Blood Services.

Alternatively, an infection in a recipient may be identified from lookback investigations which

are initiated when a donation from a repeat donor is identified as having markers of infection.
Archive samples are retrieved for retrospective testing, which may find a previous donation to
also be positive but with markers of infection below the detection level of routine screening. In
this case further work will be carried out to identify recipients.

Note that for the purposes of the European Union legislation, serious adverse reactions (SAR) are
defined as any reactions in patients that are ‘life-threatening, disabling or incapacitating, or which
result in, or prolongs, hospitalisation or morbidity’. These must be reported to the Medicines
and Healthcare products Regulatory Agency (a legal requirement). This includes all confirmed
transfusion-transmitted infections.

Abbreviations used in this chapter

AABB Association for the Advancement IU/L International units per litre
of Blood and Biotherapies JPAC Joint United Kingdom (UK) Blood Transfusion
ALT Alanine aminotransferase test and Tissue Transplantation Services
anti-HBc Antibodies to hepatitis B core antigen NAT Nucleic acid testing
anti-HBs Antibodies to hepatitis B surface antigen NHSBT National Health Service Blood and Transplant
BSH British Society for Haematology NIBTS Northern Ireland Blood Transfusion Service
CJD Creutzfeldt Jakob disease OBI Occult hepatitis B virus (HBV) infection
CMV Cytomegalovirus RNA Ribonucleic acid
DNA Deoxyribonucleic acid SaBTO Advisory Committee on the Safety of Blood,
EBV Epstein-Barr virus Tissues and Organs
EIAR Emerging Infectious Agents Report SACTTI Standing Advisory Committee on Transfusion
FDA Food and Drug Administration Transmitted Infection
FFP Fresh frozen plasma

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REACTIONS IN PATIENTS ANNUAL SHOT REPORT 2023

HAIRS Human Animal Infections and SAR Serious adverse reactions

Risk Surveillance group SARS-CoV-2 Severe acute respiratory syndrome coronavirus 2
HAV Hepatitis A virus SNBTS Scottish National Blood Transfusion Service
HBV Hepatitis B virus TMER Transfusion Medicine Epidemiological Review
HCV Hepatitis C virus TTI Transfusion-transmitted infections
HEV Hepatitis E virus UK United Kingdom
HIV Human immunodeficiency virus UKHSA United Kingdom Health Security Agency
HSV Herpes simplex virus vCJD Variant Creutzfeldt Jakob disease
HTLV Human T-cell lymphotropic virus WBS Welsh Blood Service
IgG Immunoglobulin G antibody WNV West Nile virus
IgM Immunoglobulin M antibody

Key SHOT messages

• It is important that any suspected TTI is reported to allow investigation, however, it should be
noted that confirmed or probable TTI are rare

• Suspected TTI should be discussed with the consultant microbiologist, virologist and/or other
infection diseases expert to confirm the diagnosis and following that, reported to the appropriate
UK Blood Service for further investigations

• The UK Blood Services store a sample from every blood donation for at least three years. Testing
can be done on these samples during this time if a TTI is suspected

• It is important that all healthcare professionals consenting patients for blood transfusion have
up-to-date knowledge of blood donation testing, and the extremely small but potential risk of
routine testing not detecting an infection in a donor that may enter the blood supply. For acute
HBV, HCV, and HIV infections this has been estimated to be less than 1 in 1 million donations
tested and confirmed and probable transmissions remain rare with very few numbers each year

• The UK Blood Services continue to monitor rates of infection in donors to sustain a safe supply
of blood components​

• SHOT data is used to inform policy and change it when necessary. Additional hepatitis B anti-
core testing has been introduced to reduce the risk of hepatitis B transmission from donors with
occult hepatitis B where viral levels may be below the level of detection by the previous routine
screening assays

Introduction
This chapter describes suspected TTI incidents investigated by the UK Blood Services and reported to
the UKHSA and NHSBT’s joint Epidemiology Unit’s surveillance scheme in 2023. Additionally, we report
on investigations where the UK Blood Services identify infection in a repeat donor and lookback to their
previous donation(s) for evidence of transmissions to recipients.

Summary of investigations in 2023

During 2023, the UK Blood Services investigated 113 suspected bacterial incidents, 1 suspected parasitic
incident and 26 suspected viral incidents (Figure 21.1).

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Figure 21.1:
Outcomes of
suspected TTI 140
reported to Reports for investigation

NHSBT/UKHSA
Epidemiology Unit
and investigated in 113 1 26
2023 in England, Suspected bacterial incidents Suspected parasitic incident Suspected viral incidents
Northern Ireland, reported and investigated reported and investigated reported and investigated

Scotland, and
Wales
97 16 1 1 2 8
Post-transfusion Not TTI Confirmed Confirmed TTI Probable TTI Undetermined
reactions with malaria (HAV) (HBV, HEV)
no evidence
of bacteria
on investigation
14 1
Not TTI Pending

TTI=transfusion-transmitted infection; HBV=hepatitis B virus

Please note:

A confirmed TTI is as per the definition with evidence that the virus/bacterium is indistinguishable on
molecular typing between patient and donor/donation.

• A probable TTI is as per the definition, but where molecular typing cannot be carried out to confirm
this.

• A possible TTI is as per the definition, but where prior infection or an alternative source could not
be completely excluded.

• Not a TTI is defined as an investigation that concluded the infection in the recipient was NOT caused
by transfusion, either as all indicated donors were traced and none of them were shown to be
infected; or there was no evidence of infection in the recipient; or they were shown to be infected
already prior to transfusion.

• A near miss is defined as either an infection was identified in the unit due to be transfused however
the unit was NOT transfused (e.g., bacterial growth seen in unit and returned to the bacteriology
laboratory prior to transfusion for investigation) or an infected donor calls post donation, and the
unit is recalled, and infection found in unit before it is transfused.

• An undetermined conclusion is when the investigation has been completed as far as possible,
however it is not possible to confirm or refute blood transfusion as cause of infection in recipient.

Deaths related to transfusion n=0

None of the patients with confirmed TTI investigated in 2023 were reported to have died.

Major morbidity n=4

There were 4 cases with major morbidity following investigations in 2023, as detailed below.

Case 21.1 - Confirmed HAV, cleared the infection

Case 21.2 - Probable HEV, cleared the infection with treatment

Case 21.3 - Probable HBV, chronic HBV infection, likely lifelong treatment

Case 21.5 - Confirmed malaria, clearing the infection after treatment

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Near misses n=0

There were no near misses reported in 2023.

Bacterial TTI reports in 2023

In 2023, no reported suspected bacterial TTI investigations were concluded to be confirmed, probable
or possible.

Since 2011, all four UK Blood Services have used the BacT/ALERT system for bacterial screening which
has been successful in reducing the risk of bacterial TTI, together with diversion and arm cleansing
(McDonald, et al., 2017). The details are described in Table 21.1.

Time of Volume Apheresis Time at Length of Table 21.1:

sampling (hour) sampled (mL) sample release (hour) screening Bacterial screening
NHSBT ≥36 2x8 Post-split 6 Day 7 methods used
NIBTS ≥36 16 Pre-split 6 Day 7 by the UK Blood
SNBTS ≥36 2x8 Pre-split 6 Day 7 Services

WBS ≥36 2x8 Post-split 12 Day 7

Bacterial TTI 1996-2023

Screening of platelet components cannot guarantee the absence of bacterial contamination. Packs
are released for issue as ‘negative-to-date’, which can be before bacteria have multiplied sufficiently to
trigger detection on screening. There have been 9 such near misses, all but one in platelet components,
reported between 2011 and 2023. Overall, of 37 incidents of bacterial transfusion-transmissions to
individual recipients, 30 have been caused by the transfusion of platelets, 7 by red cells and 1 by FFP
(Table 21.6) since reporting began in 1996. The introduction of bacterial screening of platelets, most
recently by England in 2011, has had a significant impact in the numbers of bacterial TTI.

Current BSH guidance recommends that patients are advised to report any symptoms that occur within
24 hours of transfusion although patients with confirmed bacterial TTI generally become unwell very
rapidly, often during transfusion (Soutar, et al., 2023). Clinical teams are reminded that any suspected
bacterial TTI should be discussed with the relevant blood service so that, if appropriate, packs can be
returned for culture and any other associated packs recalled.

Viral TTI reports in 2023

The number of viral TTI investigated in 2023 includes 2 reports where blood not tested for CMV was used
in an emergency where normally CMV negative blood should have been requested, hence retrospective
CMV testing was completed. These investigations are not further examined in the text of this chapter
due to them not fulfilling the definition of a TTI. They are instead described in Chapter 10, Incorrect
Blood Component Transfused (IBCT) of this Annual SHOT Report.

Case 21.1: Confirmed HAV transmission

Post-donation information prompted this lookback investigation. A regular donor developed

symptoms of acute hepatitis within two weeks of their most recent blood donation and was
subsequently diagnosed with a HAV infection. Both HAV IgM antibodies and RNA were detected in
their blood sample. The recipient was identified and followed up for HAV testing. The patient was
asymptomatic at the time of diagnosis of their HAV infection, they subsequently developed significant
transaminitis with a peak ALT of 730 IU/L. Donor and recipient virus sequences were identical, a
rare 1B subgenotype, confirming that this HAV infection was acquired via a red blood cell blood
transfusion. The implicated donor was deferred from donation for 6 months, but will be eligible to
donate, as HAV (like HEV) does not cause a chronic infection in healthy individuals. HAV infection
is generally very rare in the UK and hence blood donations are not routinely screened for this virus.
Testing for HAV (together with human parvovirus B19) will be undertaken by Blood Services in
England and Scotland from Spring 2024 to facilitate collection of plasma for fractionation.

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Case 21.2: Probable HEV transmission

A renal transplant recipient was diagnosed with HEV infection following abnormal liver function
tests. HEV infection of the transplanted organ had been excluded, hence it was considered whether
they might have acquired it via the plasma exchange or blood transfusions received during 2022.
A total of 86 donor exposures (2 reds cell units and 84 FFP units) were identified for investigations.
Archive samples from two of these donors tested positive for HEV RNA, but due to very low viral
loads, sequencing of donor viruses was not successful. HEV genotype 3c was identified in the stored
sample from the recipient. Due to a lack of sequence confirmation, this case is reported as a probable
transmission. Both donors have now resolved their infection and are eligible to return to donation.

Case 21.3: Probable HBV transmission

An older person was diagnosed with acute HBV infection during their hospital admission in December
2022. Blood transfusion was considered as the most likely source of their HBV infection. They had
received multiple transfusions six months prior to diagnosis of HBV; 33 donor exposures were
investigated. The archive samples obtained from two donors subsequently tested positive for anti-
HBc antibodies (note these donations were collected before the full implementation of anti-HBc
screening in England), one donor (donor 1) had evidence of past HBV infection with high levels of
anti-HBs antibodies (999 IU/ml) whereas another donor had HBV infection with low levels of anti-HBs
antibodies (donor 2). HBV DNA was not detected in either donor. It is probable that the recipient
acquired the hepatitis B infection via the blood transfusion from donor 2. Transmission could not be
confirmed but circumstantial evidence of this donor originating from the region where recombinant
genotype D/E is prevalent, the same genotype as that identified in the patient, further supports
transmission. The two anti-HBc positive donors have been removed from the donor panel.

Update on Viral TTI investigation reports from 2022

There were nine additional investigations from 2022 which were not reported in the 2022 report but
have since been finalised. These include 1 CMV, 2 HBV, 2 HCV, 2 HEV, 1 HSV and 1 toxoplasmosis
investigation, which were concluded as possible (n=1), not TTI (n=6) or undetermined (n=2).

Case 21.4: possible HCV transmission – result pending in the 2022 Annual SHOT Report

A recipient with transfusion dependent beta thalassaemia regularly transfused in the UK was noted
to have abnormal liver function tests in September 2021. Although it was initially considered to be
due to transfusion related iron overload, subsequent diagnosis of past HCV infection was made.
The patient had never been reported as HCV RNA positive, but antibody testing was suggestive of
past HCV infection. However, it is difficult to estimate when they actually acquired HCV infection as
the infection is known to remain asymptomatic for years, if not decades.

As this recipient had not been tested for HCV antibodies prior to 2021 and was not known to have
ever been HCV RNA positive, it is difficult to estimate when they acquired their HCV infection. Based
on their transfusion history over many decades, it is worth noting that the risk of acquiring HCV via
blood transfusion in the UK was highest before the screening for HCV antibodies was introduced
in 1991 and for HCV RNA in 1999. The residual risk of testing not detecting HCV has significantly
reduced since the screening was implemented, and the latest (2020-2022) estimates of residual
risk of HCV in the UK is approximately 1 in 64 million blood donations tested (JPAC, 2023). Testing
all previous donations was not possible as the archive samples no longer existed for the donations
taken prior to the implementation of screening. It is therefore possible that this individual acquired
the HCV infection via blood transfusion.

Confirmed viral TTI 1996-2023

The year of transfusion may be many years before the year in which the incident is investigated and/
or reported to SHOT due to the chronic nature, and possible late recognition, of some viral infections.
Since 1996, 33 confirmed transfusion-transmitted viral infections have been documented in the UK.
Among these, HBV (n=11) and HEV (n=12) were the most reported proven viral TTI. For HBV, this is

196 21. Transfusion-Transmitted Infections (TTI)

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partly because the ‘window period’, where an infectious donation from a recently infected donor cannot
be detected by the screening tests, is longer than for HCV or HIV, despite NAT screening of blood
donations. Since 2022, anti-core screening has been undertaken to reduce the risk of HBV transmission
from donors with occult HBV.

All except two of the 12 HEV transmissions were reported before the HEV RNA testing was introduced
in April 2017 in the UK (Harvala, et al., 2022), which has identified and removed 2932 HEV RNA positive
blood donations from the UK blood supply to end of 2023. The rate of HEV RNA detected among
donors is greater than other viral infections because it is generally acquired through food, and there is
no specific donor selection to minimise donations from those infected.

Parasitic TTI
In 2023, there was one parasitic TTI investigation for malaria. This was concluded to be a confirmed
transmission.

Case 21.5: Confirmed malaria

A malaria diagnosis in a recipient of multiple red cell transfusions with no overseas travel or other likely
risk initiated an investigation into the likely source of this infection. Testing of archive samples from
donations identified between February and September 2023 were shown to be negative on routine
screening for malaria antibodies. Despite negative initial screening results, samples from six donors
were subjected to further testing based on their clinical history, one of whom was identified with
Plasmodium malariae DNA in their blood sample and identified as the likely source of transmission.
Further work is ongoing to type the malaria found in the donor and recipient, but the donor has
been removed from the donor panel and appropriate medical review arranged. A lookback has been
initiated into previous donations given by this donor. To date the approach of discretionary malaria
antibody testing of donors based on travel history has been effective in preventing transfusion
transmission of malaria, the last reported transmission in the UK was in 2003. However, following
this transmission, current policies and procedures are being reviewed to see if any further mitigations
are required. The patient has received treatment and is clearing their infection.

Lookback investigations
Lookback investigations are initiated in England when regular donors are found to be newly positive for
a marker of infection, either seroconversion, post-donation information or introduction of a new test. In
2022 a new test for anti-HBc was introduced, and lookback investigations were initiated. During 2023,
NHSBT initiated investigations prompted by 20 donors with newly detected markers of infection known
to have previously donated (15 of those investigations are detailed below and shown in Table 21.2).
Archive samples were available for testing for 11 donors (3 HEV [2 from TTI investigation of Case 21.2],
4 OBI and 4 syphilis) but for 4 donors the most recent negative donation had been given more than
three years ago and therefore no archive was available for testing (1 EBV and 3 syphilis). Investigations
involved 30 previous donations, with 40 of 45 components issued known to be transfused.

Of the 40 recipients identified, 19 were alive and 17 were tested with none found to have evidence of
transmission. In lookback investigations, test results confirming negative recipient status include anti-HBc
negativity 6 months post transfusion for HBV, no treponemal antibodies detected for syphilis or no RNA
and IgG/IgM antibodies at 6 months post transfusion for HEV. In addition, lookback was commenced
for two donors with HTLV infection with a history of donating in the 1990’s, prior to leucodepletion and
before anti-HTLV screening was implemented. Although NHSBT were able to identify which hospital
these units had been issued to, hospitals have not been able to identify the possible recipients despite
their best efforts to date (Hewitt, et al., 2013). In addition, there were two malaria and one HIV lookbacks
initiated, information from these investigations is awaited.

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Table 21.2:
Summary EBV HEV OBI Syphilis Total
of lookback
Donors with a previous donation identified
investigations in 1 3 4 7 15
as positive in retrospective testing
England, 2023
Archive samples available for testing 0 3 4 4 11

Donations by these donors considered

1 3 19 7 30
here
Total components from these donations 1 4 26 14 45
FFP 0 0 5 2 7
Plasma for medicine 0 0 1 0 1
Platelets 0 2 1 6 9
Red cells 1 2 19 6 28

Not known 0 0 0 0 0
Components reported as transfused
1 4 24 11 40
(recipients transfused)
Recipient identified but deceased 0 3 10 7 20

Recipient identified and alive 1 1 13 4 19

Recipient status unknown 0 0 1 0 1

Recipients tested 1 1 13 2 17

Recipient tested positive 1* 0 0 0 1*

Recipients tested negative 0 1 12 2 15

Recipient test pending 0 0 1 0 1

* The recipient was IgG positive, which was not unexpected given their age so evidence of past EBV but unlikely due to the transfusion

In 2023, lookback data was only reported for England.

Other reports
Not all reports proceed to a full investigation if transmission can be ruled out, as in some examples below.

• If a recipient only tests positive for antibodies to infection, it is possible that passive transfer of
antibodies has occurred due to receipt of intravenous immunoglobulin. If passive transfer is
suspected, repeat testing should be carried out 4-6 weeks after the transfusion date. If it is the
passive transfer of antibodies, then reactivity should have resolved within this time, and the recipient
will not have any evidence of infection

• In recipients where only IgM antibodies are detected, reactivity for RNA/DNA and seroconversion
(e.g., IgG) would also need to be confirmed before TTI investigations commenced. This is because
IgM assays are often cross-reactive and non-specific, so isolated IgM reactivity is not usually
diagnostic

• In recipients with evidence of a chronic infection, previous negative results are desired. This is to
evidence transfusion as being the most likely source of infection

• For older cases of possible TTI, year of transfusion should be provided for the implicated transfusions
in addition to the unit numbers to enable effective investigation by the Blood Services

Residual risk of HBV, HCV, or HIV

The chance, or residual risk, of a potentially infectious HBV, HCV or HIV window period donation not
being detected on testing in the UK are estimated to be very low at less than 1 per million donations

198 21. Transfusion-Transmitted Infections (TTI)

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tested (Table 21.3) (JPAC, 2023). The window period is the time very early in the course of infection
when tests in use do not detect the virus but there may be a sufficient amount for transmission. The
calculations are made annually, but for HBV only consider the risk of non-detection of acute infections
and not the risk of non-detection of an OBI. The residual risk of HEV is not routinely calculated but has
been previously estimated to be considerably higher than for HBV, HCV, or HIV. However, while HEV is
a blood borne virus, the main route of transmission is zoonotic with humans generally exposed through
diet (Harvala, et al., 2022).

HBV HCV HIV Table 21.3: The

estimated residual
Number per million donations 0.63 0.02 0.03
risk (and 95%
95% confidence interval (0.46-1.61) (0.00-0.09) (0.00-0.08)
confidence interval)
At 1.9 million donations per year, testing will miss a
1 year 34 years 17 years that a donation
potentially infectious window period donation every:
entering the UK
Far fewer TTI are observed in practice than the estimated risks in Table 21.3 indicate, partly because the blood supply
estimates have wide uncertainty and the model used to calculate risk is based on the risk in all donations is a potentially
tested. The model does not incorporate pack non-use, recipient susceptibility to infection, or under- infectious HBV,
ascertainment/under-reporting, for example due to recipients dying from an underlying medical condition HCV, or HIV window
before a chronic asymptomatic viral condition is identified, or, in the case of HBV, an asymptomatic period donation:
acute infection. 2020-2022

Blood donation testing and surveillance

Every blood donation in the UK is tested for markers of HBV, HCV, HEV, HIV, HTLV (for new donors
and non-leucodepleted products for NHSBT and SNBTS and testing of all donors for NIBTS and WBS)
and syphilis, with some donations also tested for malaria, Trypanosoma cruzi and WNV, depending on
donor history. Information about donations tested and donors found positive is carefully monitored to
help assure safety for recipients (NHSBT and the UKHSA Epidemiology Unit, 2023).

Anti-HBc screening for blood donations was rolled out as part of routine screening across the UK in
2022 in response to a review carried out by SaBTO (SaBTO, 2023). This has already had an impact on
increased detection of potentially transmissible HBV from donors with OBI, which have been removed
from the blood supply. Lookback investigations involving the testing of archive samples from donors
with OBI continues and lookback investigations into the archive samples of hepatitis B core antibody
positive donors began in the UK in 2023. The WBS changed to individual HEV NAT screening for
apheresis donations during November 2022 and SNBTS are due to change to individual HEV NAT
screening for apheresis donors from April 2024. Testing of plasma for medicine donations for HAV and
B19 is anticipated to start in April 2024 in Scotland and England.

The HEV screening process is currently under review by SaBTO (SaBTO, 2024), the report is expected
to be published in 2024.

Emerging infections
The EIAR produced by the NHSBT/UKHSA Epidemiology Unit is distributed monthly. This is reviewed
by the SACTTI Horizon Scanning Team and may lead to further risk assessment and changes to the
donor selection guidelines, or other blood safety measures, where necessary (JPAC, 2023).

In 2023, arbovirus (dengue and WNV) outbreaks and spread, particularly within Europe continued to
be monitored carefully. WNV testing for travellers returning from France and Spain had to be extended
northwards to newly affected regions while blood donors returning from France and Italy are now
subject to either WNV testing or a 28-day deferral for dengue depending on the areas visited, increasing
complexity on donation sessions. In the UK, Usutu virus is being carefully monitored after spread in birds
was detected (UKHSA on behalf of the joint HAIRS, 2023).

There were no known cases of transfusion-transmitted SARS-CoV-2 infections reported to the Blood
Services in 2023 and there is still no evidence that SARS-CoV-2 is a TTI (Gates, et al., 2023).

21. Transfusion-Transmitted Infections (TTI) 199

 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

vCJD 2023
There were no vCJD investigations in 2023.

vCJD 1996-2023
Three vCJD incidents took place prior to the introduction of leucodepletion and other measures taken by
the UK Blood Services to reduce the risk of vCJD transmission by blood, plasma, and tissue products.
All these measures have been reviewed and endorsed by SaBTO (Department of Health and Social
Care, 2013).

Surveillance continues to look for any evidence that vCJD or CJD could still be transmitted via the
blood supply with no case of vCJD being identified for investigation since 2016 and no evidence
of sporadic CJD being transmitted by the blood supply (NCJDRSU, 2023). In 2022 both the
FDA in the United States and the Australian Red Cross Lifeblood announced the removal of their
blood donor deferral for people who had spent time in the UK between 1980 and 1996 (AABB,
2022) with the FDA also removing the deferral for people who have received a transfusion in the
UK since 1980. Further review of CJD safety measures in the UK is planned (SaBTO, 2024).

Table 21.4: Number

Year of Parvovirus vCJD or
of confirmed TTI Bacteria HAV HBV HCV HEV HIV Malaria Total
transfusion (B19) prion
incidents, by
1996 1 1 1 1 0 1(3) 0 0 1 6 (8)
infection in the UK,
1997 3 0 1 1 0 0 1 0 2 8
reported to SHOT,
with transfusions 1998 3 0 1 0 0 0 0 0 0 4

between October 1999 4 0 2 (3) 0 0 0 0 0 0 (1) 6 (8)

1996 and 2000 6 1 1 0 0 0 0 0 0 8
December 2023 2001 5 0 0 0 0 0 0 0 0 5
(Scotland included 2002 1 0 1 0 0 1 0 0 0 3
from October 1998 2003 2 0 1 0 0 0 1 0 0 4
2004 0 0 0 0 1 0 0 0 0 1
2005 1 1 1 0 0 0 0 0 0 3
2006 2 0 0 0 0 0 0 0 0 2
2007 2 0 0 0 0 0 0 0 0 2
2008 4 (6) 0 0 0 0 0 0 0 0 4 (6)
2009 2 (3) 0 0 0 0 0 0 0 0 2 (3)
2010 0 0 0 0 0 0 0 0 0 0
2011 0 0 1 (2) 0 1 (2) 0 0 0 0 2 (4)
2012 0 0 0 0 2 0 0 1 0 3
2013 0 0 0 0 0 0 0 0 0 0
2014 0 0 0 0 1 (2) 0 0 0 0 1 (2)
2015 1 0 0 0 5 (6) 0 0 0 0 6 (7)
2016 0 0 0 0 0 0 0 0 0 0
2017 0 1 0 0 0 0 0 0 0 1
2018 0 0 0 0 1 0 0 0 0 1
2019 0 0 0 0 1 0 0 0 0 1
2020 0 0 0 0 0 0 0 0 0 0
2021 0 0 1 (2) 0 0 0 0 0 0 1 (2)
2022 0 0 0 0 0 0 0 0 0 0
2023 0 1 0 0 0 0 1 0 0 2
Total number 37 (40) 5 11 (14) 2 12 2 3 1 3 76 (88)
of incidents (15) (4) (4)
(recipients)

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Table 21.5:
Year of Platelet - Platelets - Red blood Number and type
Cryoprecipitate FFP Total
transfusion apheresis pooled cells
of implicated
1996 0 0 0 4 4 8 components
1997 0 0 1 1 6 8 from confirmed
1998 0 1 2 0 2 5 TTI recipients in

1999 0 0 1 2 5 8 the UK, reported

to SHOT, with
2000 0 0 3 4 1 8
transfusions
2001 0 0 1 4 0 5
between October
2002 0 0 0 1 2 3
1996 and
2003 0 0 1 2 1 4 December 2023
2004 0 0 0 0 1 1 (Scotland included
2005 0 0 0 2 1 3 from October 1998)
2006 0 0 1 1 0 2
2007 0 0 0 0 2 2
2008 0 0 4 2 0 6
2009 0 0 2 0 1 3
2010 0 0 0 0 0 0
2011 0 4 0 0 0 4
2012 0 1 0 1 1 3
2013 0 0 0 0 0 0
2014 0 2 0 0 0 2
2015 1 3 0 2 1 7
2016 0 0 0 0 0 0
2017 0 0 1 0 0 1
2018 0 0 1 0 0 1
2019 0 0 1 0 0 1
2020 0 0 0 0 0 0
2021 0 1 0 0 0 2
2022 0 0 0 0 0 0
2023 0 0 0 0 2 2
Total number 1 13 19 26 30 89
of implicated
components

Table 21.6:
Total
number of Outcome of
Parvovirus vCJD or incidents
Bacteria HAV HBV HCV HEV HIV Malaria (total confirmed TTI
(B19) prion number incidents and
of
recipients) implicated
components by
Outcomes
infection in the UK,
Death due to,
or contributed to, 7 (8) 0 0 0 2 0 1 0 3 (4) 13 (15) reported to SHOT,
by TTI with transfusions
Major morbidity 5 (6) 2 5 (6) 0 8 (11) 2 (4) 2 1 0 25 (32) between October
Minor morbidity or 1996 and
25 (26) 3 6 (8) 2 2 0 0 0 0 38 (41)
not reported, or unkown December 2023
Implicated component types (Scotland included
Cryoprecipitate 0 0 0 0 1 0 0 0 0 1 (1) from October 1998)
Fresh frozen plasma 0 (1) 0 2 (4) 0 5 (8) 0 0 0 0 7 (13)

Platelets 30 (33) 3 1 (2) 0 4 1 (3) 0 0 0 39 (45)

Red blood cells 7 2 8 2 2 1 3 1 3 (4) 29 (30)

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Accompanying notes for Tables 21.4, 21.5 and 21.6

• Where applicable, number of recipients are included in brackets

• To the end of 2023, no routine blood donation screening has ever been in place for vCJD, HAV or
parvovirus B19

• HTLV screening began in 2002

• HEV RNA screening began in April 2017 in the UK and was not in place at the time of the documented
transmissions

• In the early malaria transmissions (1997, 2003), malaria antibody testing was not applicable at the
time according to information supplied at donation

• HCV investigations where the transfusion was prior to screening are not included in the above table

• The year of transfusion may be prior to year of report to SHOT due to delay in recognition of chronic
infection

• The 2 early HIV incidents (pre-1996 and in 1996) were associated with window period donations
(anti-HIV negative/HIV RNA positive) before HIV NAT screening was in place. A third window period
donation in 2002 was transfused to an elderly patient, who died soon after surgery. The recipient’s
HIV status was therefore not determined and not included

• In 2004 there was an incident involving contamination of a pooled platelet pack with Staphylococcus
epidermidis, which did not meet the TTI definition because transmission to the recipient was not
confirmed, but it would seem likely. This case was classified as ‘not transfusion-transmitted’

• The vCJD case in 1999 was found to have the same blood donor as one of the 1997 transmissions
and has therefore been counted as the same incident. Please note this was counted as two separate
incidents in previous reports

• A further prion case died but transfusion was not implicated as the cause of death. The outcome
was assigned to major morbidity instead because although there was post-mortem evidence of
abnormal prion proteins in the spleen the patient had died of a condition unrelated to vCJD and
had shown no symptoms of vCJD prior to death

• Data are checked regularly to ensure accuracy; however, these may be amended if new or additional
information is received

For further information or alternative breakdown of data please contact the National Coordinator for
Transfusion Transmitted Infections via the NHSBT/UKHSA Epidemiology Unit at
[email protected]

Conclusion
Investigations of 140 reports of possible TTI in 2023 resulted in the following: 1 confirmed malaria
transmission, 1 confirmed HAV, 1 probable HBV and 1 probable HEV TTI. The last reported bacterial
TTI was reported in 2015, the last HAV transmission was in 2017 and the last malaria transmission was
in 2003.

These low numbers of transmissions provide assurance of the safety of the UK blood supply as a result
of the effective methods and haemovigilance systems in place to reduce TTI. Policies and procedures
are constantly reviewed to see if any further mitigations are required to reduce this further, most recently
SaBTO have reviewed current testing for occult hepatitis B resulting in additional tests being introduced to
further reduce the risk of transmission of hepatitis B (SaBTO, 2023). During 2024 HAV and B19 screening
will start to be implemented by UK Blood Services to facilitate collection of plasma for fractionation.

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Recommended resources
Safe supplies 2022: Monitoring safety in donors and recipients. Annual Review from the
NHS Blood and Transplant and UK Health Security Agency Epidemiology Unit. London
October 2023
https://hospital.blood.co.uk/diagnostic-services/microbiology-services/epidemiology/

SHOT Video: Monitoring the safety of blood supply in the UK

https://www.shotuk.org/resources/current-resources/videos/

References
Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO), 2023. Guidance: Occult hepatitis B infection
in UK blood donors. [Online] Available at: https://www.gov.uk/government/publications/occult-hepatitis-b-infection-in-
uk-blood-donors (Accessed 18 April 2024).

Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO), 2024. SaBTO: Advisory Committee on the
Safety of Blood, Tissues and Organs (SaBTO) annual report 2022 to 2023. [Online] Available at: https://www.gov.uk/
government/publications/sabto-annual-report-2022-to-2023/sabto-advisory-committee-on-the-safety-of-blood-tissues-
and-organs-sabto-annual-report-2022-to-2023 (Accessed 17 April 2024).

Association for the Advancement of Blood & Biotherapies (AABB), 2022. Australia ends donor deferral for UK residency
and VCJD risk. [Online] Available at: https://www.aabb.org/news-resources/news/article/2022/07/25/australia-ends-
donor-deferral-for-uk-residency-and-vcjd-risk (Accessed 18 April 2024).

Department of Health and Social Care, 2013. Measures currently in place in the UK to reduce the potential risk of vCJD
transmission via blood. [Online] Available at: https://www.gov.uk/government/news/measures-currently-in-place-in-the-
uk-to-reduce-the-potential-risk-of-vcjd-transmission-via-blood (Accessed 18 April 2024).

Gates, S. et al., 2023. Investigating Blood Donors With Postdonation Respiratory Tract Symptoms During the Wild-Type,
Delta, and Omicron Waves of the Coronavirus Disease 2019 Pandemic in England. Open Forum Infectious Diseases,
10(10), p. ofad499. doi: https://doi.org/10.1093/ofid/ofad499.

Harvala, H., Reynolds, C., Brailsford, S. & Davison, K., 2022. Fulminant Transfusion-Associated Hepatitis E Virus
Infection Despite Screening, England, 2016-2020. Emerging Infectious Diseases, 28(9), pp. 1805-1813. doi: https://doi.
org/10.3201/eid2809.220487.

Hewitt, P. E., Davison, K., Howell, D. R. & Taylor, G. P., 2013. Human T-lymphotropic virus lookback in NHS Blood
and Transplant (England) reveals the efficacy of leukoreduction. Transfusion, 53(10), pp. 2168-2175. doi: https://doi.
org/10.1111/trf.12105.

21. Transfusion-Transmitted Infections (TTI) 203

 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

Joint United Kingdom Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee (JPAC),
2023. Position Statements. [Online] Available at: https://www.transfusionguidelines.org/document-library/documents/
jpac-position-statement-on-emerging-infections-may-2023/download-file/JPAC%20Position%20Statement%20on%20
Emerging%20Infections%20-%20May%202023.pdf (Accessed 17 April 2024).

Joint United Kingdom Blood Transfusion and Tissue Transplantation Services Professional Advisory Committe (JPAC),
2023. Position Statements. [Online] Available at: https://www.transfusionguidelines.org/document-library/documents/
jpac-position-statement-on-residual-risk-september-2023/download-file/JPAC%20Position%20Statement%20on%20
Residual%20Risk%20-%20September%202023.pdf (Accessed 17 April 2024).

McDonald, C. et al., 2017. Bacterial screening of platelet components by National Health Service Blood and Transplant,
an effective risk reduction measure. Transfusion, 57(5), pp. 1122-1131. doi: https://doi.org/10.1111/trf.14085.

NHS Blood and Transplant (NHSBT) and the UK Health Security Agency (UKHSA) Epidemiology Unit, 2023.
Epidemiology Unit. [Online] Available at: https://nhsbtdbe.blob.core.windows.net/umbraco-assets-corp/32414/safe-
supplies-2022_monitoring-safety-in-donors-and-recipients_accessible.pdf (Accessed 17 April 2024).

Soutar, R. et al., 2023. Guideline on the investigation and management of acute transfusion reactions. British Journal of
Haematology, 201(5), pp. 832-844. doi: https://doi.org/10.1111/bjh.18789.

The National CJD Research & Surveillance Unit (NCJDRSU), 2023. The Transfusion Medicine Epidemiology Review
(TMER). [Online] Available at: https://www.cjd.ed.ac.uk/projects/transfusion-medicine-epidemiology-review-tmer
(Accessed 18 April 2024).

UK Health Security Agency (UKHSA) on behalf of the joint Human Animal Infectious and Risks Surveillance (HAIRS)
group, 2023. Research and analysis: HAIRS risk assessment: Usutu virus. [Online] Available at: https://www.gov.uk/
government/publications/hairs-risk-assessment-usutu-virus/hairs-risk-assessment-usutu-virus (Accessed 17 April 2024).

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Post-Transfusion Purpura (PTP) n=1 22

Author: Tom Latham

Definition:
Post-transfusion purpura is defined as thrombocytopenia arising 5-12 days following transfusion
of cellular blood components (red cells or platelets) associated with the presence in the patient
of antibodies directed against the HPA (human platelet antigen) systems.

Abbreviations used in this chapter

ED Emergency department IVIg Intravenous immunoglobulin
HPA Human platelet antigen PTP Post-transfusion purpura

Headline data 2023 PTP reports by year

2
Number of reports n=1
Deaths n=0 1 1 1 1

Major morbidity n=1

0 0 0 0 0

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Demographic data Blood component data

Red cells n=1

Platelets n=0
Plasma n=0
Multiple components n=0
Male Female Adults Paediatric
n=0 n=1 n=1 n=0 Other n=0

Introduction
There was 1 case of PTP reported in 2023.

Deaths related to transfusion n=0

There were no deaths reported in this category in 2023.

Major morbidity n=1

Case 22.1: Post-transfusion purpura with HPA-1a antibody

A patient received one unit of red cells post-delivery. She presented to the ED 18 days later with
widespread petechiae and a platelet count of 3 x 109/L. HPA-5b antibodies were found in her plasma.
IVIg was administered and she made a complete recovery.

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 ANNUAL SHOT REPORT 2023 REACTIONS IN PATIENTS

The history and response to treatment is typical of PTP although the delay following transfusion is
unusual. Most cases present around 5-7 days after transfusion. Antibody-mediated PTP remains the
most likely explanation here, in the absence of any other reasons for severe thrombocytopenia. Anti-HPA
antibodies often increase in the weeks following delivery and it is possible that the delayed response may
represent a primary sensitisation due to the recent pregnancy rather than a pre-existing HPA antibodies.

Conclusion
PTP has become extremely rare since the introduction of universal leucodepletion. There have been 10
cases reported to SHOT over the last 11 years including this case. It remains an important diagnosis to
be aware of since it is readily treatable by IVIg and has implications for avoidance of further transfusion in
the recipient. Avoiding unnecessary transfusions, monitoring patients for delayed reactions and educating
patients about these potential risks are vital (Narayan, et al., 2021).

Recommended resource
SHOT Bite No.30: Post-transfusion purpura
https://www.shotuk.org/resources/current-resources/shot-bites/

Reference
Narayan, S., Poles, D. & Latham, T., 2021. Post-transfusion purpura - Insights from SHOT UK. Vox Sanguinis, 116(S1),
pp. 95-96. doi: https://doi.org/10.1111/vox.13117.

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SPECIAL
ERROR
REPORTS:
CLINICAL
Human Factors
GROUPS

Chapter Page
SPECIAL CLINICAL GROUPS
23 Cell Salvage (CS).......................................................................................................................Sarah Haynes 208
24 Paediatric Cases .................................................................................................. Anne Kelly and Helen New 214
25 Haemoglobin Disorders............................................................................ Asha Aggarwal and Joseph Sharif 228
26 Transfusion Errors in Transplant Cases .............................. Jennifer Davies, Vera Rosa and Shruthi Narayan 236
27 Immune Anti-D in Pregnancy....................................................................... Vera Rosa and Susan Robinson 243

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23 Cell Salvage (CS) n=26

Author: Sarah Haynes

Definition:
Any adverse events or reactions associated with cell salvage (autologous) transfusion methods,
including intraoperative and postoperative cell salvage (washed or unwashed).

Abbreviations used in this chapter

AAA Abdominal aortic aneurysm MHRA Medicines and Healthcare products Regulatory
BP Blood pressure Agency
CS Cell salvage NICE National Institute for Health and Care Excellence
ICS Intraoperative cell salvage PCS Postoperative cell salvage
IV Intravenous UKCSAG United Kingdom Cell Salvage Action Group
LDF Leucocyte depletion filter

Key SHOT messages

• Cell salvage is a safe and effective alternative to allogeneic blood when used correctly and
appropriate resources are available

• The risks associated with cell salvage are low but need to be considered and managed appropriately

• Most incidents reported to SHOT are avoidable, however, unforeseen reactions can occur, and
vigilance is necessary

Recommendations
• Cell salvage policies and procedures should include information on potential risks, including cell
salvage related hypotension and the simple measures that need to be taken should it occur

Action: Cell salvage leads, cell salvage practitioners and theatre teams

• Organisations should review their policies to confirm that they are up to date with current practices
and guidance

Action: Cell salvage leads, hospital transfusion teams, hospital transfusion committee

• Organisations should review local incident reporting processes to ensure cell salvage incidents
can be identified as blood transfusion related and inform the hospital transfusion team who should
be included in the investigation process

Action: Cell salvage leads, hospital transfusion teams, hospital transfusion committee,
governance leads

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Headline data 2023 CS reports by year

38

Number of reports n=26

26
Deaths n=0
23 23
20 20
16 17 17

Major morbidity n=3 9

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Demographic data Blood component data

Red cells n=26

Platelets n=0
Plasma n=0
Multiple components n=0
Male Female Adults Paediatric
n=7 n=19 n=24 n=2 Other n=0

Introduction
In 2023, 26 incidents were submitted by 16 different reporting organisations. One organisation submitted
5 reports, one organisation submitted 3 reports, four organisations submitted 2 reports, and the rest
submitted 1 each.

There were 2 reports related to paediatric patients, the rest were adult patients. The age range was
11-85 years, with 19 females and 7 males.

The greatest number of incidents reported were in obstetrics, vascular and orthopaedic (including spinal
and trauma) surgery (Table 23.1). There was an even split between elective (n=12) and emergency (n=14)
surgeries. This is in contrast with 2022 where most reports were from elective procedures.

There were 21 adverse events, of which 11 were attributable to avoidable errors, 10 machine/disposable
failures, and 5 adverse reactions all of which were hypotension not related to hypovolaemia. Of these
reactions, 4 occurred when using a LDF. Hypotensive reactions following reinfusion of cell salvaged
blood remain the most reported reactions.
Table 23.1: Cell
Specialty Elective Emergency Total
salvage cases by
Obstetrics 4 6 10
speciality in 2023
Vascular 2 4 6 (n=26)
Orthopaedic 3 1 4

Spinal 2 2

Trauma 1 1

Cardiac 1 1

General 1 1

Hepatobiliary 1 1

Total 12 14 26

Deaths related to transfusion n=0

There were no cases reported where a patient died because of cell salvage.

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Major morbidity n=3

In 3 cases, severe hypotension following infusion of salvaged red cells contributed to the need for
postoperative high-dependency care.

Types of cell salvage

All incidents related to the use of centrifugal washed cell salvage systems; 25 intraoperatively and 1 in
the postoperative setting.

Cell salvage adverse events n=21

There were 11 avoidable incidents and 10 equipment-related reports.

Avoidable errors n=11

In 2 cases, both emergencies, cell salvage was not available. This resulted in a potentially avoidable
transfusion of allogeneic red cells in an orthopaedic patient. In the second case, the patient died following
a ruptured AAA. It was difficult to assess the benefit that cell salvage could have provided.

Three incidents related to contamination of the collected blood which was then discarded. The
contraindicated substances aspirated were non-IV grade saline, chlorhexidine, and surgical glue
respectively.

In an elective caesarean section, blood was collected, processed and reinfusion was started when it
was realised that the set of disposables being used was a non-sterile set intended to be used for training
purposes only. The reinfusion was stopped immediately, and the remaining red cells discarded. As a
result of this incident, training materials are no longer kept near sterile consumables.

In another obstetric case, a new cell salvage device was being trialled for 2 weeks. The device was
used in a caesarean section over a weekend by an operator with limited training. The operator failed to
confirm the correct bowl size resulting in inadequate volumes of wash being used potentially affecting
the quality and safety of the red cells that were reinfused. This was only discovered when the machine
data was reviewed by the company representative later.

There were 2 similar incidents where the cell salvage device displayed a ‘long empty cycle’ warning,
indicating that the quality of the reinfusion product may have been compromised. The usual process
for dealing with this (rewashing with new disposables) was not followed, and red cell volumes of 194mL
and 244mL respectively reinfused with no discernible consequence.

Incidents occurred in the final 2 cases at the time of reinfusion. In an elective caesarean section, a 1500mL
blood loss was collected and processed. Unfortunately, the reinfusion exceeded the time permitted
according to local protocol and the remaining red cells were discarded. It was also stated that the blood
had coagulated in the bag, suggesting that inadequate anticoagulation or washing may have occurred.

In an emergency laparotomy for a ruptured spleen, massive blood loss was managed using a rapid
infusion device, and 866mL of salvaged red cells were given via a device that had a 250-micron inline
filter. Concern was raised that the salvaged red cells were not given back via a 40-micron filter as
specified by local policy.

Rapid infusion devices allow fast infusion of warmed fluids in circumstances where large volume
replacement is needed quickly. Generally, administration of salvaged red cells should meet the minimum
standards required for administration of allogeneic packed red cells. If an organisation routinely uses a
rapid infusion device for allogeneic red cells, then its use with salvaged red cells might also be acceptable
depending on the mode of action of the infusion device. If there is no guidance from the manufacturer
of the infusion device, a risk assessment should be undertaken bearing in mind that salvaged red cell
infusion bags contain air and are not manufactured to withstand pressurisation. Also of note is that
gravity-fed filters, such as the LDF, are not compatible with rapid infusion systems.

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Learning points
• Safe cell salvage practice relies on staff involved in the process having adequate knowledge and
understanding of their role. Vigilance, communication, and situational awareness is required

• Individuals must be either fully trained, or supported by someone who is, to use the cell salvage
equipment safely. This is applicable to all devices, including those being trialled

• In the absence of manufacturer’s guidance, a risk assessment should be performed when

considering the use of infusion devices with salvaged red cells

Equipment incidents n=10

There were 3 incidents where leaks in the cell salvage disposable set prevented satisfactory processing
of the collected blood and reinfusion of red cells to the patient. In 1 of these cases, a report was made
to the MHRA Yellow Card scheme. In the other 2 cases, it could not be determined whether damage
to the disposable set from mishandling had occurred. One of these cases involved a paediatric patient
undergoing spinal surgery who received a unit of allogeneic red cells which may have been avoided.

There were 5 machine issues, including power outages, error codes and sensor failures that made the
machines unusable. One of these incidents happened at setting up, allowing a replacement machine to
be found. A further 3 cases failed intraoperatively, causing loss of cell salvage completely on 1 occasion
and reduced contribution of cell salvage on 2 occasions. In another case, the device appeared to be
giving misleading fluid volume readings in relation to postoperative bleeding in a cardiac setting. This
was reported to the MHRA Yellow Card scheme.

In the final 2 cases, there were concerns over quality of the red cells for reinfusion as black particles
were seen in the reinfusion bag. One of these reports came from a centre where this is an ongoing issue
and a further MHRA report has been made.

Cell salvage adverse reactions n=5

There were 5 reports of adverse reactions, all of which comprised of severe hypotension on reinfusion
not related to hypovolaemia. These events occurred in 3 elective procedures (obstetric, orthopaedic, and
hepatobiliary surgeries) where a LDF was deployed. In 2 of these elective cases the reaction contributed
to the patient needing high-dependency care postoperatively.

Case 23.1: Hypotensive reaction in a patient receiving allogeneic and salvaged red cells

A patient was undergoing invasive internal surgery and experienced significant blood loss. Cell
salvage was being used and a major shock pack was requested. During transfusion of a unit of
red cells from the shock pack and the cell salvaged blood, a dramatic fall in BP from 90mmHg to
45mmHg was observed. This was managed with bolus infusions of adrenaline. It is not clear whether
the reaction was due to the allogeneic blood, or the salvaged red cells given through a LDF.

There were also 2 incidents of hypotension in emergency procedures, 1 in vascular surgery (without a
LDF), the other in obstetrics where high-dependency postoperative care was required.

The most reported adverse reaction associated with cell salvage is hypotension. The incidents this year
bring the total number of hypotensive reactions reported to SHOT since 2010 to 39. The majority of
these, but not all, also feature the use of LDF.

There are two areas of application where LDF have been routinely used. In surgery involving malignancy,
a LDF is used to reduce the potential risk of infusing malignant cells. In obstetrics, the theoretical risks of
amniotic fluid embolus were thought to be mitigated by use of these filters. Indeed, NICE guidance on
cell salvage in obstetrics stated that a LDF is nearly always used to reduce the amount of amniotic fluid
contaminants in the transfused blood to levels approaching those in maternal blood (NICE, 2005). There
has been no substantial revision of this guidance since publication. However, reports of hypotension
have more recently called into question the risks and benefits of the continued use of LDF in the obstetric

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setting. The MHRA produced a safety guidance one liner in January 2011 stating that hypotension was
a rare side effect of using LDF for cell salvage reinfusion, and the use of these filters for the purpose of
removing amniotic fluid contaminants was not validated (MHRA, 2011). A survey of practice published
by the UK cell salvage action group in 2015 found that of 73 hospitals using cell salvage in obstetrics,
66% continued to use the LDF, 22% sometimes used it and 12% never used it routinely (UKCSAG,
2015). The most recent professional guidance, published in 2018 by the Association of Anaesthetists,
did not recommend the routine use of LDF in obstetric practice (Klein, et al., 2018).

Learning points
• Hypotension is the most reported adverse reaction associated with cell salvage. The use of a LDF
is often (but not always) associated with this reaction

• If hypotension occurs, stop the infusion, and resuscitate with fluids and vasopressors if necessary
(the reaction may be transient). Consider resuming the infusion without the LDF

Conclusion
The safe execution of cell salvage relies on everyone involved in the process understanding their role
and responsibilities. The quality of the collected blood, the correct processing of that blood and the
safe reinfusion of the washed red cells can be influenced by all those involved. It is imperative to provide
adequate and appropriate training, including updates, to support all staff involved in the cell salvage
process.

SHOT has not identified any mortality related to cell salvage in the years this reporting category has
been active. This year, there were 3 cases where hypotension following infusion of salvaged red cells
via a LDF contributed to the need for postoperative high-dependency care. This underlines the need for
continued vigilance when using cell salvage. The adverse events relating to human errors or inexperience
were preventable and again emphasise the importance of all staff within the process having sufficient
knowledge and skills to perform their role safely. A few of this year’s incidents relate to poor communication
among staff and with laboratories. The correct labelling and prescription of autologous blood, with clear
instructions to those caring for patients is vital in these situations. Consideration of any requirement
for anti-D Ig is also vital in patients undergoing cell salvage especially when ICS has been used during
caesarean section in D-negative, previously non-sensitised individuals and where cord blood group is
confirmed as D-positive (or unknown).

Cell salvage is a valuable blood conservation method which is often under-utilised. All cell salvage
operators must undertake initial and regular update training and be assessed as competent with
documented training records. All hospitals where ICS and PCS are undertaken should report adverse
events to SHOT. Staff should be aware that monitoring of patients is as important for the reinfusion
of red cells collected by ICS or PCS as it is for allogeneic red cells and practitioners need to revisit
previous Annual SHOT Reports particularly related to autologous transfusion to optimise learning from
haemovigilance reports.

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Recommended resources
SHOT Video: Haemovigilance in cell salvage
https://www.shotuk.org/resources/current-resources/videos/

UK Cell Salvage Action Group: Technical factsheets and Frequently asked questions
https://www.transfusionguidelines.org/transfusion-practice/uk-cell-salvage-action-group/technical-
factsheets-and-frequently-asked-questions-faq

UK Cell Salvage Action Group

https://www.transfusionguidelines.org/transfusion-practice/uk-cell-salvage-action-group

Intraoperative cell salvage: a survey of UK practice

https://doi.org/10.1016/j.bja.2024.01.042

References
Klein, A. A. et al., 2018. Association of Anaesthetists guidelines: cell salvage for peri-operative blood conservation 2018.
Anaesthesia, 73(9), pp. 1141-1150. doi: https://doi.org/10.1111/anae.14331.

Medicines and Healthcare products Regulatory Agency , 2011. One Liners issue 82 - January 2011. [Online] Available
at: https://webarchive.nationalarchives.gov.uk/ukgwa/20110504182728/http://www.mhra.gov.uk/Publications/
Safetyguidance/OneLiners/CON105973 (Accessed 10 April 2024).

National Institute for Health and Care Excellence (NICE), 2005. Intraoperative blood cell salvage in obstetrics.
Interventional procedures guidance [IPG144]. [Online] Available at: https://www.nice.org.uk/Guidance/IPG144 (Accessed
09 April 2024).

UK Cell Salvage Action Group (UKCSAG), 2015. Intra-operative Cell Salvage: 2014. A Survey of Equipment and Practice
across the UK, s.l.: Joint UK Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee.
Available at: https://www.transfusionguidelines.org/document-library/documents/2014-ukcsag-survey-published-
april-2015/download-file/2014%20UKCSAG%20survey%20-%20April%202015.pdf (Accessed 10 April 2024).

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24 Paediatric Cases n=169

Authors: Anne Kelly and Helen New

Definition:
Paediatric cases comprise all reports for patients under 18 years of age, including all paediatric
cases from the other chapters in this report. Paediatric reports have been subdivided by recipient
age group: neonates ≤28 days; infants >28 days and <1 year; children ≥1 year to <16 years and
young people aged 16 to <18 years.

Abbreviations used in this chapter

ADU Avoidable, delayed and under/overtransfusion IUT Intrauterine transfusion
BSH British Society for Haematology LIMS Laboratory information management system
CS Cell salvage NEC Necrotising enterocolitis
DAT Direct antiglobulin test NM Near miss
ENT Ear, nose and throat PICU Paediatric intensive care unit
FAHR Febrile, allergic and hypotensive reactions RBRP Right blood right patient
FFP Fresh frozen plasma SCD Sickle cell disease
Hb Haemoglobin SRNM Specific requirements not met
HSCT Haemopoeitic stem cell transplant TACO Transfusion-associated circulatory overload
HSE Handling and storage errors TAD Transfusion-associated dyspnoea
HTR Haemolytic transfusion reactions TANEC Transfusion-associated NEC
HTT Hospital transfusion team TRALI Transfusion-related acute lung injury
IBCT Incorrect blood component transfused TTI Transfusion-transmitted infection
Ig Immunoglobulin UCT Uncommon complications of transfusion
ITP Immune thrombocytopenic purpura WCT Wrong component transfused

Key SHOT messages

• Failure of concessionary, rapid laboratory release of components in an emergency e.g., non-
neonatal specification for a child <1 year or best-matched red cells for a patient with antibodies
can result in significant transfusion delays

• Inappropriate administration of adult O D-negative red cells to neonates in emergency continues

to be reported

• Clear communication within teams and between clinical and laboratory areas regarding the
patient’s transfusion requirements is essential to ensure the timely and appropriate issue of blood
components

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Recommendations
• Laboratories should have clear policies for rapid, concessionary release of blood components,
including roles/responsibilities

• Neonatal/infant specification emergency components should be clearly distinguished from adult

components when stored together in satellite refrigerators, with staff training on correct selection
in emergency

• Management of paediatric FAHR should be timely and appropriate

Action: Hospital transfusion teams

Introduction
The total number of paediatric cases reported to SHOT in 2023 has increased slightly compared to
2022 (169 vs 151, Figure 24.1). Paediatric cases account for 169/2154 (7.8%) of total reports if NM
and RBRP are excluded and 274/3833 (7.1%) if NM and RBRP are included. Neonates and infants
represent 1/3 of paediatric cases, 56/169 (33.1%).

Overrepresentation of paediatric reports is seen once again in FAHR, ADU (delay and overtransfusion)
and IBCT-WCT. However, this year, paediatric reports are also overrepresented in HSE and in UCT
(Figure 24.2).

Clinical errors remain slightly more common than laboratory errors with 63/120 clinical (52.5%) versus
57/120 (47.5%). Overall, laboratory errors have increased in paediatric as well as in adult reports, likely
reflecting pressure on laboratory working. The prominence of clinical errors in ADU and HSE reflects the
additional complexities of prescribing and transfusing in neonates and children.

Figure 24.1:
Trends in paediatric
reports 2014-2023
162 169
159 151
14 18
15 10
139 136
136
132
17 15
122 17 123 13
5
19
79
79 85
95

69
69 69 83
74

65

28
18
40
23 28
20
17 28
11 19

41 38
27 28 30 29 28
22 25 19

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

≤28 days >28 days to <1 year 1 to <16 years 16 to <18 years

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Figure 24.2:
Percentages of FAHR 336
36
paediatric and total
235
IBCT-SRNM 22
reports in each
HSE 342
category in 2023 32

(n=169) Delayed 212

23

IBCT-WCT 121
23

Under or overtransfusion 20
9

Avoidable 127
8
% of total reports (2154)
TAD 2
33
% of paediatric reports (169)
HTR 53
2

TACO 172
2

UCT 24
6

Anti-D 425
1
4
TTI 1

CS 26
2

0% 5% 10% 15% 20% 25%

Percentage of reports

CS=cell salvage; FAHR=febrile, allergic and hypotensive reactions; HSE=handling and storage errors; HTR=haemolytic transfusion reactions;
IBCT-SRNM=incorrect blood component transfused-specific requirements not met; IBCT-WCT=IBCT-wrong component transfused;
TACO=transfusion-associated circulatory overload; TAD=transfusion-associated dyspnoea; TRALI=transfusion-related acute lung injury;
TTI=transfusion-transmitted infection; UCT=uncommon complications of transfusion

Figure 24.3:
Summary of
paediatric cases by Incorrect blood component transfused (IBCT) 11 11 18 5 45

category and age in

Febrile, allergic and hypotensive reactions (FAHR) 1 32 3 36
2023 (n=169)
Handling and storage errors (HSE) 11 5 14 2 32

Delayed transfusion 4 3 14 2 23

Under or overtransfusion 1 3 5 9

Avoidable transfusion 11 4 2 8

Uncommon complications of transfusion (UCT) 1 5 6

Haemolytic transfusion reactions (HTR) 11 2 ≤28 days

>28 days to <1 year
Non-TACO pulmonary complications 11 2
1 to <16 years
Transfusion-associated circulatory overload (TACO) 2 2 16 to <18 years
Cell salvage (CS) 11 2

Anti-D immunoglobulin errors (Anti-D Ig) 1 1

Transfusion-transmitted infections (TTI) 1 1

Deaths related to transfusion n=1

There was one death possibly related to transfusion (imputability 1) reported in 2023. This was a case
of possible TANEC, summarised in Case 24.1 and discussed in Chapter 20, Uncommon Complications
of Transfusion (UCT).

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Case 24.1: Death due to bowel perforation within 24 hours of red cell transfusion

An extreme preterm neonate (a month old) received a red cell transfusion for anaemia. Eight hours
later the neonate developed significant deterioration including a distended abdomen and required
reintubation. Abdominal X-ray was suggestive of NEC. The neonate subsequently developed bowel
perforation and metabolic acidosis and died.

Major morbidity n=27

There were 27 cases of major morbidity. FAHR remains the largest category with 21/27 cases. The
remaining cases were 2 delayed transfusions, 1 overtransfusion, 1 pulmonary non-TACO, 1 TTI and 1
HTR.

Error-related reports n=120

There was a significant increase in paediatric error reports in 2023 (120 versus 101 in 2022, 83 in 2021).

Incorrect blood component transfused (IBCT) n=45

The total number of IBCT reports increased in 2023, particularly for laboratory errors (n=33), in both
IBCT subcategories (IBCT-WCT and IBCT-SRNM).

IBCT-wrong component transfused (WCT) n=23

IBCT-WCT clinical errors n=8

Adult specification component to infant or neonate n=3

There continue to be reports of neonates receiving adult emergency O D-negative red cells.

Case 24.2: Adult O D-negative red cells given to a neonate in error when neonatal red cells
were available

A bleeding neonate required an emergency red cell transfusion. The laboratory instructed the clinical
team use the ‘emergency paedipack’ from the satellite refrigerator. An adult pack was accidentally
selected and transfused to the neonate.

Learning point
• SHOT receives recurring reports of incorrect administration of adult specification red cells to
neonates in an emergency. Hospitals should ensure that red cells suitable for neonates are clearly
distinguished from adult components when stored in the same refrigerator and that clinical staff
collecting blood understand the different component types

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Figure 24.4:
Example of how
to distinguish
neonatal from adult
components in a
satellite refrigerator

With permission from Rachel Moss, transfusion practitioner at Great Ormond Street Hospital

Incorrect component to HSCT recipient n=4

In 4 cases, a HSCT patient received red cells of the incorrect ABO blood group due to failure of
communication between the clinical and laboratory teams or to follow policy.

Other n=1

D-positive red cells were transfused to young female child in trauma/major haemorrhage pre-hospital setting.

IBCT-WCT laboratory errors n=15

Adult specification component to infant or neonate n=4

All 4 were infants who received standard adult red cells rather than neonatal/infant specification large
volume red cells. One was transfused during surgery with aliquots from a standard adult unit. The error
was discovered postoperatively when the parent found the remains of the unit amongst the child’s bag
of washing.

Incorrect component to HSCT recipient n=4

The incorrect ABO group component was issued for 4 post-HSCT patients despite clear LIMS instructions.

D-positive red cells to D-negative recipient n=4

A female neonate received a D-positive red cell unit because the theatre refrigerator had been incorrectly
stocked with D-positive neonatal emergency blood. Errors in D grouping impacting transfusions occurred
in 2 cases.

The final case was a male teenager with major haemorrhage who received eight units of group O
D-positive red cells pre-hospital. This was not in line with current BSH guidelines (Milkins, et al., 2013;
New, et al., 2016; New, et al., 2020).

Other n=3

Case 24.3: Preterm neonate erroneously assigned as blood group O

The laboratory assigned a preterm neonate as group O and issued group O FFP. It was subsequently
determined that the neonate had been grouped as A at birth in a different hospital where they were
transfused with emergency blood group O red cells. Of note, the laboratory should have issued
group AB FFP as only one group result was on record.

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Learning point
• If a neonate is transferred between hospitals, any history of prior transfusion must be communicated
to the receiving transfusion laboratory. Caution is required when interpreting neonatal groups, as
prior transfusion may result in mixed field or group misinterpretation

Another neonate received inappropriate transfusion of group O cryoprecipitate with only one grouping
sample in the laboratory. The final case was a laboratory mix-up between two packs of apheresis platelets.

IBCT-specific requirements not met (SRNM) n=22

There were 18 laboratory and 4 clinical errors where specific transfusion requirements were not met in
paediatric patients. These are detailed in Table 24.1.
Table 24.1:
Type of SRNM error Number of cases Detail of errors
Paediatric SRNM
Inappropriate electronic 6 One teenager with SCD (previous antibodies). Three
errors in 2023
issue neonates: 1 with positive antibody screen, 1 without
maternal antibody screen results and 1 with a positive DAT. (n=22)
Two children were post HSCT
Failure to request irradiated 5 4 clinical errors: 1 neonate with prior IUT, 1 young child
components with DiGeorge syndrome, 1 pre HSCT, 1 had received
fludarabine
1 laboratory error due to due to failure to check maternal
transfusion history for a neonate with a prior IUT
Incomplete testing 5 Two neonates with incomplete testing where maternal
antibody status was unknown; 3 infants over 4 months
with no antibody screen performed
Failure to provide 5 One neonate with a maternal antibody and 4 children with
phenotyped components SCD
Failure to provide HLA- 1 Routine HLA-matched platelets not provided
matched components

Avoidable, delayed, under or overtransfusion n=40

Avoidable transfusions n=8

There were 2 reports of non-bleeding older children with ITP being transfused with platelets.

Case 24.4: Platelet transfusion given to a non-bleeding teenager with acute ITP

A teenager presented with acute ITP. The platelet count was 14x109/L, on repeat 10x109/L. A platelet
transfusion was requested by the ENT team and administered. The patient had no bleeding.

Learning point
• Platelet transfusion in ITP is only indicated for serious bleeding or prior to a procedure when other
treatment has failed or if urgent (Estcourt, et al., 2017). The requirement for transfusion should be
discussed with a haematologist prior to administering platelets

In 2 cases, unnecessary platelet transfusions were given due to inaccurate results (platelet clumping).
One case of failure of communication led to repeat transfusion, 2 were avoidable use of group O

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D-negative red cells, and 1 child inappropriately received two units of platelets rather than one prior to
central line removal.

Delayed transfusion n=23

Delays in transfusion were again prominent within paediatrics; 15 cases were primarily due to laboratory
errors and 8 were clinical.

Laboratory errors n=15

Of the 15 laboratory cases, most appeared unrelated to being paediatric. There were 8 cases which
included delays in ordering from/provision by Blood Services; 1 case involved a failure to scan platelets
out of an agitator causing confusion and transfusion delay, and 2 cases resulted from grouping issues.

There was failure to communicate the timescale for crossmatch in the presence of red cell alloantibodies
in a child with a severe dermatological disorder, resulting in delay due to loss of venous access. In another
case, a teenager with leukaemia had a two-unit red cell transfusion requested but only a single unit issued.

Finally, there were delays in decision to issue components under concessionary release in urgent
situations for 2 patients, discussed in Cases 24.5 and 24.6.

Case 24.5: Delay in concessionary release of adult specification platelets for a neonate with
significant bleeding

Emergency platelet transfusion was requested for a severely thrombocytopenic neonate with liver
failure and both rectal and intracranial bleeding. Neonatal/infant specification platelets were not
available on site. The clinical team asked for standard adult specification platelets but there was a
2-hour delay in authorising their release due to difficulty in contacting the haematology medical team
and the laboratory’s inability to authorise emergency release.

Case 24.6: Delay in red cell transfusion for critically unwell teenager with SCD due to failure
to issue red cells urgently under concessionary release

A teenager with SCD and multiple red cell antibodies was on the point of cardiac arrest due to rapidly
progressive anaemia (from 97g/L to 45g/L), hypoxia, and acidosis. Whilst awaiting frozen thawed
red cells, the Blood Service consultant on call advised transfusing ABO, Rh matched, K-negative
red cells given the urgency. There was a 3-hour delay in issuing red cells. The pre-transfusion Hb
was 26g/L immediately prior to transfusion. The delay contributed to major morbidity in this patient.

Learning points
• For concessionary release of standard adult components to neonates and infants, laboratories
are recommended to have pre-agreed hierarchies in place (New, et al., 2016; New, et al., 2020)

• Clear communication between clinicians and laboratory staff is required in urgent situations to
ensure timely issue of blood components under concessionary release

• Transfusion laboratories require access to adequate senior support at all times

Clinical errors n=8

In one case, there was a request for a neonate where the maternal antibody was recorded as an anti-‘e’
but was actually anti-‘E’. In another case, an infant received a red cell transfusion with no confirmatory
group or consent. Three cases involved failure to order the blood component, to send a group and
screen sample pre-surgery, or to communicate with portering staff. Others involved expired staff training,
and communication problems in a major haemorrhage.

A teenager with SCD and positive antibody screen had an emergency red cell exchange delayed by
24-hours and is discussed in Case 24.7.

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Case 24.7: Delay in provision of appropriate red cells for a teenager with SCD and red cell
antibodies

A teenager with sickle chest syndrome required emergency red cell exchange transfusion. There
was a 24-hour delay due to poor communication between laboratory and clinical staff regarding
degree of urgency, and to failure to send crossmatch samples of sufficient volume to allow required
antibody testing. The patient recovered fully with no adverse impact from the delay.

Learning point
• Red cell antibodies can cause delay in obtaining compatible red cell units; additional samples are
often required, and good communication is vital to ensure timely provision of blood components

Undertransfusion n=1
A child was issued with a neonatal split red cell pack but required a larger volume.

Overtransfusion n=8
All 8 cases were clinical errors, 6 related to prescribing. In 1, a neonate was prescribed 30mL/kg of
red cells in error. Another involved failure to use the prescribing formula. For 1 child with a haematinic
deficiency, an inappropriately high Hb target was chosen resulting in a >30mL/kg transfusion (and
furosemide requirement). A lower threshold, smaller volume transfusion followed by haematinic
replacement would have been appropriate. Two cases involved prescription of a full adult unit to a
small recipient, 1 was an adult-sized platelet unit to a 6.5kg infant (40mL/kg) and the other was a full
adult red cell unit to a young child.

A significant overtransfusion occurred in a vulnerable preterm neonate described in Case 24.8.

Case 24.8: Overtransfusion in a preterm neonate due to illegible prescription

An extremely pre-term infant (birth weight 0.5kg) with NEC was prescribed platelets. The prescription
should have been 7.5mL but was misread as 75mL. The neonate received 43mL (83mL/kg) before
this was noticed and subsequently was hypertensive. The reporter commented that electronic
prescribing had not been implemented in paediatrics due to complexities.

There were 2 administration errors: a full unit and a part of a second were administered to a child; an
infant received excess platelets due to confusion around a pump attached to a three-way tap.

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Cell salvage n=2

Both cases were in older children (1 a teenager). One was a leak in a cell salvage set, the 2nd was the
presence of dark ‘spots’ in the red cells.

Handling and storage errors (HSE) n=32

There was a striking increase in 2023 (22 in 2022). Again, there were more clinical (26) than laboratory
(6) errors.
Table 24.2:
Type of HSE error Number of cases Detail of errors
Paediatric HSE
Pump-related errors 15 12 pump programming errors
errors in 2023 3 were due to a faulty pump
(n=32)
Giving set or infusion errors 5 4 errors involved giving sets
1 involved incompatible fluids
Cold chain errors 4 In 2 cases, neonates were transferred between hospitals
with accompanying red cell units. These were transported
under suboptimal conditions and without the awareness of
transfusion laboratory staff
Inappropriate return to 3
stock/reservation period
exceeded
Excessive time to transfuse 2 These transfusions took place over 5 hours and 40-45
minutes (an infant and a teenager)
Other 3 2 unusual cases of contamination of red cells for neonatal/
infant transfusions via needlestick injuries to the nurses
drawing up blood from the units using a needle rather than
a conventional giving set.

Anti-D immunoglobulin (Ig) n=1

There was an accidental late administration of anti-D Ig for a teenage patient following delivery of a
D-positive baby.

Transfusion-related reactions n=49

Febrile, allergic, and hypotensive reactions (FAHR) n=36

The number and proportion of paediatric platelet FAHR were lower this year than in previous years,
19/36 (52.8%). In the preceding 5 years (2018-22) they comprised 66% of paediatric FAHR (Figure
24.5 and 24.6).

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Figure 24.5:
Summary of
Multiple components 54 paediatric FAHR
Granulocytes 2 reports by
Plasma component type
Platelets from 2014-2023
43
Red cells 42
2
7 38
36 3 36
2 35
1 2 3
2 1
38
30 5
1
26 2
21 1
2 22 26 19
21 23
1

21 24
18 15

15 14 14
12 11 11
5 6 6 5

2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

Figure 24.6:
Paediatric febrile,
Red cells (192) Platelets (99) Plasma/cryo (29) Granulocytes (2) Multiple components (14)
allergic, and
hypotensive reports
100% (FAHR) in 2023
14
2 3
26
(n=36)
90%
a: Comparison of
80% proportions of adult
80 and paediatric
70%
19
60%

50%

40%

30% 178

20% 14

10%

0%
Adults Paediatric

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Figure 24.6:
Paediatric febrile, 100%

allergic, and
hypotensive reports 90% 3 4 7

(FAHR) in 2023
80%
(n=36)

b: Percentages of 70%
reaction types by 2
4
paediatric FAHR 60%
Mixed allergic/febrile
15
related to different 9 Anaphylactic/severe
allergic
component types 50%
1 Moderate allergic
for paediatric
reports 40% Febrile

30%
8

20% 6

6 1

10%
6

0%
Red cells Platelets Plasma/cryo Total

Figure 24.6b shows that 23/36 (63.9%) FAHR were allergic, 6/36 (16.7%) febrile and 7/36 (19.4%) mixed.

Of note, 2 red cell FAHR cases reported in 2023 were part of a cluster of 5 unusual reactions from a single
hospital (see example discussed in Case 24.9), the other 3 are discussed in Chapter 20, Uncommon
Complications of Transfusion (UCT).

Case 24.9: Allergic reaction to red cell component in multiply transfused patient

A child receiving regular red cell transfusions for a haemoglobinopathy, developed coughing followed
by drowsiness after only 4mL of red cells. There was increased work of breathing and prolonged
expiratory phase, with a drop in blood pressure. The child received intravenous antihistamine and
adrenaline, then further adrenaline with hydrocortisone was administered when the reaction was
prolonged. The child recovered and was subsequently given washed red cells.

Learning points
• The management of FAHR is summarised in the BSH guidelines (Soutar, et al., 2023)

• The UK Resuscitation Council guideline 2021, emphasised use of intramuscular adrenaline to

treat anaphylaxis, repeated after 5 minutes if required (Working Group of Resuscitation Council
UK, 2021)

Haemolytic transfusion reactions (HTR) n=2

One case was a delayed HTR in a teenager transfused for sickle chest crisis, subsequently found to
have developed an anti-U.

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The second case involved hyperhaemolysis which resulted in PICU admission in a child with SCD. No
new alloantibodies were detected.

Pulmonary complications of transfusion in neonates and children

n=4

Transfusion-associated circulatory overload (TACO) n=2

Both cases were in preterm infants less than 4 months old with chronic lung disease. One had low
albumin and developed an increased respiratory rate and oxygen requirement 1 hour after the transfusion
commenced (received approximately 6mL/kg). They responded to furosemide. The second had a patent
ductus arteriosus and developed signs of fluid overload post transfusion (15mL/kg).

A separate TACO risk assessment does not exist for paediatrics, however many of the same risk factors
apply. Caution is needed for prescribing transfusions in young children to ensure correct volume is
administered. As in these 2 cases, TACO can still occur in at-risk infants when transfused with standard
accepted volumes. Commonly used neonatal red cell top-up transfusion volumes (15mL/kg, (New, et
al., 2016; New, et al., 2020)) are significantly higher in relation to body weight than the one red cell unit
recommended for adults (NICE, 2015).

Non-TACO n=2
Following HSCT transplant, a teenager with SCD developed significant respiratory distress within 2 hours
after a platelet transfusion, requiring intensive care admission. Investigations for TRALI were negative.

In the second case an infant with a congenital diaphragmatic hernia and pulmonary hypertension
desaturated during a red cell transfusion. The child had been unwell since delivery and had developed
sepsis. The infant fully recovered from this event.

Transfusion-transmitted infections (TTI) n=1

There was 1 confirmed case of transfusion-transmitted malaria in a young child with thalassaemia in
2023. This is described in Chapter 21, Transfusion-Transmitted Infections (TTI), Case 21.5.

Uncommon complications of transfusion (UCT) n=6

There was 1 case of possible TANEC, resulting in the death of the neonate (discussed in Case 24.1 and
in Chapter 20, Uncommon Complications of Transfusion (UCT)).

One case involved hypertension following transfusion in a sick young child with acute leukaemia.

In another case there was a report of possible transfusion-associated hyperkalaemia (6.7mmol/L) in a

young child (10.4kg) undergoing cardiac surgery on bypass. The red cell unit was 35 days old. There are
no recommendations restricting age of red cells for children in this situation other than for large volume
infant transfusions. However, it is recommended that potassium concentrations should be checked in
the bypass fluid before connecting to the patient (New, et al., 2016; New, et al., 2020).

The other 3 cases were part of an unusual cluster of 5 in multiply transfused patients; 2 met FAHR criteria
and are discussed earlier in the chapter, but the other 3 were atypical. The 5 reactions had common
features including rapid onset of coughing, chest tightness, drowsiness (4/5) wheeze (2/5) after small
red cell volumes were transfused. Four received adrenaline. Despite detailed review and investigation,

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no common cause for the reactions were identified. These cases highlight the importance of local review
of transfusion reactions: the co-location of cases with similar features would not have been detected
by SHOT.

Learning point
• Detection of this cluster of reports highlights the key role of transfusion practitioners and other
members of the HTT in reviewing and trending their local transfusion errors and adverse reactions.
There is an EU directive stating that data must be routinely analysed ‘to identify quality problems
that may require corrective action or to identify unfavourable trends that may require preventive
action’ (European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), 2023)

Paediatric error reports with no harm n=105

The numbers of cases of no harm/near miss are summarised below. See individual chapters for details.

RBRP n=11

Near miss cases n=27

Near miss-WBIT n=67

Conclusions
Key themes emerging from the paediatric reports submitted to SHOT in recent years, and actions needed
to improve transfusion safety are summarised below:

• Paediatric teams should have access to local paediatric transfusion policies which must be aligned
with national guidelines

• Induction training of paediatric staff should include specific requirements and weight-based
prescribing to prevent errors in calculation of blood transfusion volumes and prescribing specific
requirements for transfusion

• Gaps in staff knowledge regarding significance of test results and interpretation should be addressed
and staff should be aware when to seek specialist advice

• Effective, timely and clear communication between clinical teams and transfusion laboratories is
vital, especially for children undergoing HSCT and patients with haemoglobinopathies as transfusion
requirements can be complex

• When transferring patients between hospitals, careful coordination and communication between
clinical and laboratory teams is essential to ensure safe transfusions

• Paediatricians and neonatologists should be able to recognise transfusion reactions that can occur
in various clinical settings and initiate appropriate management

• Members of the HTT should review and trend their local transfusion errors and adverse reactions in
order to promptly detect any clustering of cases and investigate appropriately

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Recommended resources
SHOT Bite No 4: Lessons in Paediatrics (including neonates)
SHOT Bite No. 5: FAHR (2021)
https://www.shotuk.org/resources/current-resources/shot-bites/

Webinar on accurate and complete patient identification for safe transfusion in paediatrics
https://www.shotuk.org/resources/current-resources/webinars/

Paediatric SHOT
https://www.shotuk.org/resources/current-resources/videos/

Paediatric Cases Cumulative Data

https://www.shotuk.org/resources/current-resources/data-drawers/paediatric-cases-cumulative-
data/

References
Estcourt, L. J. et al., 2017. Guidelines for the use of platelet transfusions. British Journal of Haematology, 176(3), pp.
365-394. doi: https://doi.org/10.1111/bjh.14423.

European Committee (Partial Agreement) on Blood Transfusion (CD-P-TS), 21st Edition, 2023. Good Practice
Guidelines, paragraph 9.4.2. Directive 2005/62/EC, Annex 9.4.2. In: Guide to the preparation, use and quality assurance
of blood components. s.l.:European Directorate for the Quality of Medicines and Healthcare (EDQM). Available at:
https://freepub.edqm.eu/publications/AUTOPUB_48/detail (Accessed 13 May 2024).

Milkins, C. et al., 2013. Guidelines for pre-transfusion compatibility procedures in blood transfusion laboratories.
Transfusion Medicine, 23(1), pp. 3-35. doi: https://doi.org/10.1111/j.1365-3148.2012.01199.x.

National Institute for Health and Care Excellence (NICE), 2015. Blood transfusion. NICE guideline [NG24]. [Online]
Available at: https://www.nice.org.uk/guidance/ng24 (Accessed 07 March 2024).

New, H. V. et al., 2016. Guidelines on transfusion for fetuses, neonates and older children. British Journal of
Haematology, 175(5), pp. 784-828. doi: https://doi.org/10.1111/bjh.14233.

New, H. V. et al., 2020. British Society for Haematology Guidelines on transfusion for fetuses, neonates and older
children (Br J Haematol. 2016;175:784–828). Addendum August 2020. British Journal of Haematology, 191(5), pp. 725-
727. doi: https://doi.org/10.1111/bjh.17109.

Soutar, R. et al., 2023. Guideline on the investigation and management of acute transfusion reactions. British Journal of
Haematology, 201(5), pp. 832-844. doi: https://doi.org/10.1111/bjh.18789.

Working Group of Resuscitation Council UK, 2021. Emergency treatment of anaphylaxis. Guidelines for healthcare
providers, UK: Resuscitation Council UK. Available at: https://www.resus.org.uk/library/additional-guidance/guidance-
anaphylaxis/emergency-treatment (Accessed 10 April 2024).

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25 Haemoglobin Disorders n=88

Authors: Asha Aggarwal and Joseph Sharif

Abbreviations used in this chapter

ADU Avoidable, delayed and under/overtransfusion IVIg Intravenous immunoglobulin
APPG All Party Parliamentary Group NHR National Haemoglobinopathy Registry
CMV Cytomegalovirus NHSE National Health Service England
DHTR Delayed haemolytic transfusion reaction NHSBT NHS Blood and Transplant
ED Emergency department NTDT Non-transfusion dependant thalassaemia
FAHR Febrile, allergic and hypotensive reaction RCI Red Cell Immunohaematology
G&S Group and screen SaBTO Advisory Committee on the Safety of Blood,
Hb Haemoglobin Tissues and Organs
HCP Healthcare professional SCD Sickle cell disease
HSCT Haematopoietic stem cell transplant SCTAPPG All-Party Parliamentary Group on Sickle Cell and
HSSIB Health Services Safety Investigations Body Thalassaemia
HSE Handling and storage error Sp-ICE Specialist Services Integrated
HTR Haemolytic transfusion reaction Clinical Environment
IBCT Incorrect blood component transfused SRNM Specific requirements not met
ICU Intensive care unit WCT Wrong component transfused

Key SHOT messages

• 2023 saw the highest number of HTR and hyperhaemolysis in SCD, leading to 2 deaths

• Alloimmunisation and HTR are a significant risk of transfusion in haemoglobinopathy patients and
in particular SCD. The importance of weighing up the risks and benefits of transfusion and the
need to provide blood components that meet the requirements for these patients may not be
appreciated by healthcare professionals without specific expertise

Recommendations
• Haematology teams must be involved in the management of haemoglobinopathy patients
presenting to secondary care and be consulted regarding transfusion decisions

• It is important to gain a full transfusion history from the patient and inform the transfusion laboratory
when patients present to an unfamiliar hospital. The national database (Sp-ICE or equivalent)
should be checked, and the patient’s base hospital transfusion laboratory asked for previous
transfusion records

• All haemoglobinopathy patients should have a baseline extended red cell phenotype or genotype
prior to transfusion (Trompeter, et al., 2020)

Action: Hospital transfusion teams, clinical teams looking after patients with haemoglobin
disorders, laboratory management

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Introduction
Red cell transfusion is a cornerstone of treatment of SCD and thalassaemia. Transfusions can be given
both electively and as an emergency during physiological stress (Davis, et al., 2017).

The number of incidents reported to SHOT in this patient group has been steadily increasing year-on-year.
This year has seen the highest number yet, with 88 cases in total. There were 25 cases of major morbidity
and 2 transfusion-related deaths reported. Figure 25.1 shows cumulative data for adverse transfusion
events in patients with haemoglobin disorders since 2010 when SHOT started collating these reports.

a. Sickle cell disease (n=484) b. Thalassaemia (n=143) Figure 25.1:

Cumulative data for
2.5% 2.3% 2.1%
adverse transfusion
3.3% 3.5% events in patients
4.2%
with haemoglobin
5.2% 4.2%
disorders 2010 to
4.9% 30.1% 2023
10.7% 34.3%
a. Sickle cell
HTR & 7.7% FAHR disease (n=484)
SRNM 30.1% b. Thalassaemia
10.7% 63.6% (n=143)
9.8%

17.5%
12.6%
29.3%

(166) HTR (25) NM (43) FAHR (11) RBRP (5) HTR

(142) IBCT-SRNM (16) IBCT-WCT (25) IBCT-SRNM (7) NM (3) ALLO
(52) FAHR (12) RBRP (18) HSE (6) IBCT-WCT
(52) ADU (11) HSE (14) ADU (6) UCT

ADU=avoidable, delayed or under or overtransfusion; ALLO=alloimmunisation; FAHR=febrile, allergic or hypotensive reactions;

HTR=haemolytic transfusion reactions; IBCT-SRNM=incorrect blood component transfused-specific requirements not met; IBCT-WCT=IBCT-
wrong component transfused; NM=near miss; TACO=transfusion-associated circulatory overload; TAD=transfusion-associated dyspnoea;
TTI=transfusion-transmitted infection; UCT=uncommon complications of transfusion
Categories with 2 or fewer reports are not included in the figures

Deaths related to transfusion n=2

There were 2 deaths related to transfusion (imputability 2, probable) reported in 2023 in haemoglobinopathy
patients. Both were patients with SCD that died from haemolytic complications following elective
transfusions (one had hyperhaemolysis, one had a DHTR). Further details can be found in Chapter 19,
Haemolytic Transfusion Reactions (HTR).

Major morbidity n=25

There were 25 reports associated with major morbidity, including 16 HTR, 6 FAHR, 2 delayed transfusions
and 1 TTI.

Haemolytic transfusion reactions n=25

There were 25 reports of HTR in haemoglobinopathy patients, all in the context of SCD. This included
13 reports of hyperhaemolysis.

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Figure 25.2: Types

of HTR reported
in patients with
haemoglobin
disorders in 2023 1

(n=25)

Acute HTR
13 11 Delayed HTR
Hyperhaemolysis

HTR=haemolytic transfusion reactions

Case 25.1: DHTR despite best practice

A patient with SCD sustained an ankle fracture and required surgery. They were known to have
anti-S and anti-M antibodies. They received two compatible red cell units preoperatively and were
discharged with appropriate safety-netting. The patient presented the following week to ED with
sickle pain and anaemia. Their blood results showed evidence of significant haemolysis and they
were treated with IVIg, steroids, rituximab and eculizumab. The patient received one unit of red
cells during this treatment when her Hb dropped to 35g/L and spent 2 days on ICU before making
a full recovery.

Case 25.2: Hyperhaemolysis recurrence after miscommunication

A patient with SCD presented to the ED with pain. It was noted that they had a Hb of 49g/L
(baseline 50-55g/L). One unit of red cells was transfused overnight, after discussion with the on-call
consultant haematologist. The next day, the haematologist noted that the patient had a history of
hyperhaemolysis which had not been relayed on the phone overnight. The patient was subsequently
started on steroids and was monitored as an inpatient for 2 days. They returned 3 days after discharge
with pain and evidence of haemolysis. The patient remained in the hospital for 6 weeks, including
5 days on ICU.

Case 25.3: The importance of informed consent

A patient with SCD was admitted with a painful crisis. Two units of red cells were transfused,
despite the Hb being at baseline for this patient. The indication for this transfusion was not clear.
Six days later, they had an acute deterioration with hyperhaemolysis. The patient was admitted to
ICU for 7 days, treated with IVIg, steroids and tocilizumab and subsequently made a full recovery.
On discharge, the patient expressed concern that the rationale for the initial transfusion was not
explained to them. There was no documentation of consent for the transfusion.

Another case involving DHTR and death after an exchange transfusion has been described in detail in
Chapter 19, Haemolytic Transfusion Reactions (HTR), Case 19.1. It demonstrates the importance of
communication and coordination between medical teams in this complex patient group.

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Learning points
• Hyperhaemolysis is a serious complication of transfusion in SCD patients and can lead to death
and serious morbidity. It can occur despite giving extended phenotype-matched red cells and
without laboratory evidence of new alloimmunisation. Alloimmunisation and HTR can have serious
implications on future transfusion provision in a cohort who may often need transfusion across
their lifespan. Patients should be fully informed about the specific risks of alloimmunisation and
HTR during the consent process, and unnecessary transfusions must be avoided

• Timely and effective communication between clinical and laboratory staff, between hospitals and
between teams is vital for safe transfusions

• Patient education and understanding of the reasoning behind interventions is fundamental to

ensure safety. This may empower them to challenge when things are incorrect. Staff should also
question and check whether interventions are required

• A detailed and accurate transfusion history is essential, particularly when patients present to a
new hospital

Febrile, allergic and hypotensive reactions n=13

There were 13 reports of FAHR, 7 of which were in patients with SCD, and 6 occurred in patients with
thalassaemia. All patients made a full recovery.

IBCT-specific requirements not met n=16

There were 16 cases of SRNM.

Case 25.4: Avoidable alloimmunisation in a patient with thalassaemia

A patient with NTDT required a red cell transfusion during pregnancy. The laboratory was not
informed that the patient had thalassaemia on the first ‘booking’ G&S, so Rh and K typing were not
performed. The second G&S sample did include the relevant clinical information, but the required
testing was not performed. Three red cell units were issued to the patient without being Rh/K-
matched. The patient made an anti-c and anti-E antibody as a result.

Case 25.5: SRNM in SCD

A patient with SCD presented to hospital with a Hb of 49g/L. The LIMS had a flag to say that the
patient had SCD, but this was not noted. Rh and K typing were not performed. The patient was O
D-positive, but O D-negative red cells were provided for stock management reasons, though the
transfusion was not an emergency. No pre-administration checklist was in use in the hospital, so
specific requirements were not checked at the bedside. The case was picked up on a subsequent
audit of O D-negative red cell use.

Case 25.6: Confusion about red cell matching post HSCT

A patient with SCD required a red cell transfusion after an allograft. Laboratory staff were unclear
whether the Rh phenotype would be maintained post transplant, and this was not made clear on the
local protocol. This has since been clarified and the post-HSCT protocol updated.

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There were 3 reported cases of CMV-unselected red cells being given to pregnant haemoglobinopathy
patients on regular transfusion programmes in 2023.

Learning points
• Laboratory staff must be informed when patients have a haemoglobinopathy, particularly when
patients are new to a hospital. This will help ensure specific transfusion requirements are met and
previous alloimmunisation is not overlooked for this patient cohort

• There may be additional specific transfusion requirements for some patients which must be taken
into consideration when issuing blood components, e.g., irradiation post HSCT or CMV-negative
components when pregnant (SaBTO, 2012)

• As HSCT for haemoglobinopathy patients becomes more common, protocols for blood provision
need to be updated

• A joint statement from NHS Blood and Transplant, National Blood Transfusion Committee, United
Kingdom Thalassaemia Society and Sickle Cell Society issued in November 2023 confirms
removal of maximum age requirements for red cells transfusion to patients, including those
with haemoglobinopathies, and can be accessed at this link: nhsbt-removal-of-maximum-age-
requirements-for-red-cells-transfusion-to-patients-including-those-with-haemoglobinopathies.pdf
(b-s-h.org.uk). It has been agreed that the BSH guidelines on red cell transfusion in sickle cell
disease and on pre-transfusion compatibility procedures in blood transfusion laboratories will be
updated in this respect. The SRNM definition and reporting criterial will also be updated in due
course to reflect these changes

IBCT-wrong component transfused n=4

There were no reports of ABO-incompatible blood transfusions in patients with haemoglobin disorders
in 2023.

Avoidable, delayed or under/overtransfusion n=12

There were 12 cases of avoidable or delayed transfusions, of which 2 led to major morbidity.

Case 25.7: Delayed exchange transfusion

A teenage patient with SCD required an emergency exchange transfusion due to acute chest
syndrome. The patient had a new positive antibody screen. The blood had been sent in a paediatric
tube, so there was insufficient serum for RCI testing. Two further samples were sent, but one sample
tube had expired and the other was both insufficient and incorrectly labelled. Further samples then
had to be collected. In the end, provision of appropriate red cell units took 22 hours.

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Learning points
• Acute chest syndrome can result in rapid deterioration and respiratory failure. Multiple guidelines
and consensus statements support the use of early transfusion in this condition (Howard, et al.,
2015)

• Effective inventory management should be in place to avoid using expired sample tubes. Reminders
for upcoming expiry dates, clear labelling and minimising overstocking can mitigate the risk of
using expired items

Handling and storage errors n=8

There were 8 cases of handling and storage errors when transfusing patients with haemoglobinopathies
in 2023. Most of these involved issues with infusion pump settings including staff being unfamiliar with
equipment. None of these incidents led to major morbidity.

Transfusion-transmitted infections n=1

There was 1 confirmed case of transfusion-transmitted malaria in a young child with thalassaemia in
2023. This is described in Chapter 21, Transfusion-Transmitted Infections (TTI), Case 21.5.

NHR-NHSBT data linkage

The National Haemoglobinopathy Registry (NHR) is a register of people in the UK with all types of
inherited red cell disorders. The register is held by NHSE and is intended to support direct clinical care,
and for commissioning services within England. The NHR-NHSBT data linkage went live on Tuesday
12th March 2024. NHSBT red cell antibody data held on NHSBT systems is now available in the NHR
on the transfusion tab and will be clearly marked as NHSBT red cell antibody records. This is a significant
improvement in transfusion safety for patients who may need blood transfusion either as part of routine
care or as an emergency. The data transfer will happen routinely every night to ensure new results move
into the NHR, so the data is as up to date as possible.

This is a key milestone for NHSBT and NHSE in ensuring that critical results important for safe transfusion
practice are available to clinical teams who need the information. All hospitals will continue to communicate
with the patient’s normal haemoglobinopathy centre transfusion laboratory to ensure that any results
that may not be part of the NHSBT antibody record are also included in any decision-making regarding
transfusion.

Conclusion
This year saw the highest number of SHOT reports in patients with haemoglobinopathies. Most major
morbidity came from HTR, particularly hyperhaemolysis. Patients must be adequately informed and
consented for these risks when a transfusion decision is being considered. This should be clearly
documented in the patient’s notes in line with SaBTO guidance. Consent should be reviewed frequently
for those on regular transfusion treatment (SaBTO, 2020).

To reduce the risk of HTR and alloimmunisation, all haemoglobinopathy patients are eligible for full
red cell genotyping as part of the ‘Haem Match’ project, which should help to more accurately match
appropriate donors to patients (Gleadall, et al., 2020).

25. Haemoglobin Disorders 233

 ANNUAL SHOT REPORT 2023 SPECIAL CLINICAL GROUPS

A common theme in the case studies above is the lack of adequate communication. Effective
communication between hospitals, within hospital teams and between clinicians and the laboratory is
vital to ensure that transfusion errors do not occur. In addition, good communication with patients to
explain interventions and to take a thorough transfusion history is also crucial, particularly when patients
present to unfamiliar hospitals. The antibody history for haemoglobinopathy patients is available to
laboratory staff on Sp-ICE or other similar national databases. This has recently been added to the NHR.

The lack of experience in managing SCD patients in areas outside of haematology was highlighted in the
APPG ‘No One’s Listening’ report (SCTAPPG, 2021). The HSSIB recommended that NHS England review
whether there should be a minimum training requirement for all HCP about SCD after an investigation in
2023 (HSSIB, 2023). The case studies above demonstrate that this is an ongoing problem. The message
that haemoglobinopathy patients outside of haematology wards should have haematologists closely
involved in their care and their transfusion decisions needs emphasising further.

A recent Lancet article summarised strategies to improve outcomes for SCD patients worldwide (Piel, et
al., 2023). Transfusion availability and safety were key aspects of this. While the UK has a relatively robust
and safe blood supply, as demonstrated above, improvements must be made to enhance transfusion
safety for this patient group.

Recommended resources
SHOT Bite No. 14: Transfusion errors and reactions in patients with Haemoglobinopathies
SHOT Bite No. 15: Hyperhaemolysis
https://www.shotuk.org/resources/current-resources/shot-bites/

SHOT Video: Haemolytic Transfusion Reactions in patients with Haemoglobinopathies

https://www.shotuk.org/resources/current-resources/videos/

SHOT Safety Notice 02: SRNM 2022

https://www.shotuk.org/resources/current-resources/safety-notices/

References
All-Party Parliamentary Group on Sickle Cell and Thalassaemia (SCTAPPG), 2021. No One’s Listening – A Report
[Online] Available at: https://www.sicklecellsociety.org/no-ones-listening/ (Accessed 10 April 2024).

Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO), 2012. SaBTO report of the Cytomegalovirus
Steering Group. [Online] Available at: https://www.gov.uk/government/publications/sabto-report-of-the-cytomegalovirus-
steering-group (Accessed 10 April 2024).

Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO), 2020. Guidelines from the expert advisory
committee on the Safety of Blood, Tissues and Organs (SaBTO) on patient consent for blood transfusion. [Online]
Available at: https://www.gov.uk/government/publications/blood-transfusion-patient-consent/guidelines-from-the-
expert-advisory-committee-on-the-safety-of-blood-tissues-and-organs-sabto-on-patient-consent-for-blood-transfusion
(Accessed 10 April 2024).

Davis, B. A. et al., 2017. Guidelines on red cell transfusion in sickle cell disease Part II: indications for transfusion. British
Journal of Haematology, 176(2), pp. 192-209. doi: https://doi.org/10.1111/bjh.14383.

234 25. Haemoglobin Disorders

SPECIAL CLINICAL GROUPS ANNUAL SHOT REPORT 2023

Gleadall, N. S. et al., 2020. Development and validation of a universal blood donor genotyping platform: a multinational
prospective study. Blood Advances, 4(15), pp. 3495-3506. doi: https://doi.org/10.1182/bloodadvances.2020001894.

Health Services Safety Investigations Body (HSSIB), 2023. Management of sickle cell crisis. [Online] Available at: https://
www.hssib.org.uk/patient-safety-investigations/management-of-sickle-cell-crisis/ (Accessed 29 April 2024).

Howard, J. et al., 2015. Guideline on the management of acute chest syndrome in sickle cell disease. British Journal of
Haematology, 169(4), pp. 492-505. doi: https://doi.org/10.1111/bjh.13348.

Piel, F. B. et al., 2023. Defining global strategies to improve outcomes in sickle cell disease: a Lancet Haematology
Commission. The Lancet, 10(8), pp. E633-E686. doi: https://doi.org/10.1016/S2352-3026(23)00096-0.

Trompeter, S., Massey, E. & Robinson, S., 2020. Position paper on International Collaboration for Transfusion Medicine
(ICTM) Guideline ‘Red blood cell specifications for patients with hemoglobinopathies: a systematic review and guideline’.
British Journal of Haematology, 189(3), pp. 424-427. doi: https://doi.org/10.1111/bjh.16405.

25. Haemoglobin Disorders 235

 ANNUAL SHOT REPORT 2023 SPECIAL CLINICAL GROUPS

Transfusion Errors in Transplant Cases

26 n=97

Authors: Jennifer Davies, Vera Rosa and Shruthi Narayan

Abbreviations used in this chapter

ABOi ABO-incompatible NBTC National Blood Transfusion Committee
BMS Biomedical scientist NM Near miss
BSBMTCT British Society of Blood and Marrow PLS Passenger lymphocyte syndrome
Transplantation and Cellular Therapy RCPath The Royal College of Pathologists
EBMT European Group for Blood and Marrow SCRIPT The SHOT United Kingdom Collaborative
Transplantation Reviewing and reforming IT Processes in
EI Electronic issue Transfusion
HSCT Haematopoietic stem cell transplant SOT Solid organ transplant
IBCT Incorrect blood component transfused SRNM Specific requirements not met
ID Identification TA-GvHD Transfusion-associated graft-versus-host disease
IT Information technology WBIT Wrong blood in tube
LIMS Laboratory information management system WCT Wrong component transfused

Key SHOT messages

• Flags and notes in the LIMS are not effective in preventing selection and release of ABOi components
if staff do not pick these up and follow up with appropriate actions

• Communication is critical for the management of transfusion in transplant patients, particularly

where there is shared care across multiple organisations

• Recommendations from the 2022 Annual SHOT Report continue to be relevant this year

Recommendations
• Processes should be in place to ensure effective communication of transplant timetables to all
clinical and laboratory teams involved in patient care

• Laboratories should have a process that ensures information relating to appropriate component
selection is recorded or updated in the LIMS in a timely manner, and not depend on one individual

• Laboratories should review the functionality of the LIMS with the supplier to ensure all currently
available functionality is optimised for safe component selection. Where deficiencies are noted a
roadmap for further development should be agreed, with timeframes, to include algorithms that
support safe selection and are not dependent on flags and notes

• Where LIMS are dependent on alerts or notes for safe selection of blood components, these must
be clear, unambiguous, not easily overridden and account for all component types. It should be
recognised that these may not prevent ABOi events and so risk assessments must address the
current situation and future plans for improvement

236 26. Transfusion Errors in Transplant Cases

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• Pre-transfusion checklists for transplant patients should include confirmation that components
received have the correct specific requirements and ABO/D type in accordance with the transplant
protocol

Action: Laboratory management, IT departments, clinical teams with responsibility for

transplant patients

Introduction
For transplant recipients, decisions on which ABO/D group of components for transfusion must take
account of the ABO and D types of both the recipient and the donor. Approximately 40-50% of HSCT
are ABOi, this incompatibility may be major or minor. Major and minor incompatibility each occur in
approximately 20-25% of transplants, and bidirectional incompatibility in 5% (Worel & Kalhs, 2008).
The ABO and D group transfusion requirements of these patients change over time during the clinical
course of the transplant. Bidirectional incompatibility includes both major and minor mismatch, with the
presence of antibodies in both the recipient and donor plasma which can react with donor and recipient
red cells respectively.

Guidance is available on the irradiation requirements for cellular component transfusion in patients at
risk of developing TA-GvHD (Foukaneli, et al., 2020). The EBMT Handbook provides information on
transfusion support for HSCT patients (Schrezenmeier, et al., 2019).

The ‘Safe transfusions in haemopoietic stem cell transplant recipients’ document has been developed
by SHOT in collaboration with RCPath, NBTC and BSBMTCT. This supports safe transfusion decisions
in HSCT recipients and can be incorporated into local procedures and policies.

A national guidance document for transfusions in SOT recipients is being developed by British Society
for Haematology. PLS is a complication of both solid-organ and stem cell transplant, caused by donor
B lymphocytes producing antibodies that can result in destruction of recipient red cells (Moosavi, et al.,
2020; Yazer & Triulzi, 2007).

Summary of cases from 2023

A total of 97 cases were reported to SHOT in 2023, an increase from 58 in 2022. Cases included SOT
(n=19) and HSCT (n=78) recipients. Table 26.1 shows the distribution of all the cases reported. There
were no deaths reported that were directly attributed to the transfusion error. Many cases, 37/97 (38.1%)
were instances where the specific requirements for transfusion were not met. The majority of these (21/37)
were failure to provide irradiated components, inappropriate use of electronic issue accounted for 6/37
cases. Of the 40 cases of IBCT-WCT, 37 cases involved transfusion of the wrong ABO/D group to the
recipient. One case of suspected PLS was reported in a group O patient post transplant with a group
A liver. In addition to the 77 transfused errors, there were 20 near miss reports.

26. Transfusion Errors in Transplant Cases 237

 ANNUAL SHOT REPORT 2023 SPECIAL CLINICAL GROUPS

Table 26.1: Total

IBCT-WCT and IBCT-
cases of IBCT-WCT, Type of error NM cases Total cases
SRNM cases
IBCT-SRNM and Wrong ABO and/or D group 37 2 39
NM transfusion
Not irradiated 21 6 27
errors in SOT and
HSCT recipients Wrong blood in tube - 9 9

reported to SHOT Inappropriate electronic 6 - 6

in 2023 (n=97) issue
Incomplete testing 5 - 5

Not antigen-negative 3 - 3

Wrong patient 1 2 3

Wrong component type 2 - 2

Not HLA-matched 2 - 2

Not high-titre negative - 1 1

Total 77 20 97

The most commonly implicated blood component in the WCT and SRNM errors reported were red cells.
Figure 26.1 shows the distribution of blood components involved in these cases. In 1 case, multiple
blood components were implicated.

Figure 26.1:
Blood component 58

implicated in the
IBCT-WCT and
IBCT-SRNM errors
reported in 2023
(n=77)

15

3
1

Red cells Platelets FFP Multiple components

Component type

FFP=fresh frozen plasma

As shown in Figure 26.2, the number of IBCT-WCT and IBCT-SRNM cases have been increasing with
the highest number of incidents for both categories reported in 2023.

238 26. Transfusion Errors in Transplant Cases

SPECIAL CLINICAL GROUPS ANNUAL SHOT REPORT 2023

Figure 26.2:
Number of
IBCT-WCT IBCT-SRNM Near miss transplant-related
reports (HSCT and
20 SOT) from 2019 to
2023

37
8
13
16
17

28
25 14
17
40
26 22
20 20

2019 2020 2021 2022 2023

IBCT-SRNM=incorrect blood component transfused-specific requirements not met; IBCT-WCT=IBCT-wrong component transfused

IT-related transplant cases n=72

There were 72/97 (74.2%) cases that had an IT element involved in the error. These themes are
demonstrated in Figure 26.3.

Figure 26.3:
23 Themes related
to IT in transplant
21
error cases
reported in 2023
(n=72)

10

5 5
4

2
1 1

LIMS not Failure to Lack of Not IT recognised Transcription Not used Downtime Printing
updated heed functionality configured as solution error correctly error
in timely alerts correctly
manner
IT theme

IT=information technology; LIMS=laboratory information management system

26. Transfusion Errors in Transplant Cases 239

 ANNUAL SHOT REPORT 2023 SPECIAL CLINICAL GROUPS

Case 26.1: ABO-incompatible red cell transfusion

A HSCT patient (patient group A and donor group O) was transfused group A red cells. The
information related to appropriate selection of ABO group for blood components was available in
the notes in the LIMS but was not read by the BMS.

Reliance on notes and alerts in the LIMS that can be missed or easily overridden do not provide effective
IT barriers to preventing error.

Case 26.2: Specific transfusion requirements not met: information not added to LIMS in timely
manner

A notification of irradiated blood components requirement for a patient pre HSCT was sent to the
laboratory manager by email. The patient was admitted to the ward and required a transfusion before
the laboratory manager had acknowledged the email and updated the LIMS. The patient was transfused
with red cells that were not irradiated.

Processes for notification of transplant information relating to appropriate selection of blood components
should not be reliant on a single point of failure. In this case, notifications were sent to an individual rather
than a team email, hence dependent on a single individual being able to act in a timely manner.

Case 26.3: Incorrect red cells selected for patient with suspected passenger lymphocyte syndrome

A group A patient received a liver transplant from a group O donor. Post transplant, the patient was
noted to have a positive direct antiglobulin test, and group A red cells were noted to be incompatible
in serological crossmatch. A sample was referred for further testing and anti-A1 eluted from the
patient red cells. A requirement for group O red cells was added to the LIMS for future transfusion.
However, two units of group A red cells were transfused to the patient at a later date. The units
were serologically crossmatch-compatible and there was no evidence of haemolysis in the patient.

PLS is an uncommon condition. This case illustrates the importance of effective flags and algorithms
in the LIMS to support safe selection of appropriate red cells. In this case, a serological crossmatch
was performed, however, SHOT data continue to demonstrate that inappropriate EI occurs with this
patient cohort.

Near miss errors n=20

In 2023, 11 near miss cases related to IBCT-SRNM (7/11) and IBCT-WCT (4/11) were reported, and 9
cases related to NM-WBIT. In all but 1 of the IBCT-WCT and IBCT-SRNM cases the error was detected
at the pre-administration check. A formal pre-transfusion checklist was used in only 5/11 cases. In a
single case, the laboratory team became aware of the transplant only when the clinical team called to
discuss specific transfusion requirements.

Of the NM-WBIT cases, 6/9 were due to failure to identify the patient correctly at the time of phlebotomy,
2 due to failures to label the sample at the patient side and 1 sample was not labelled by the person
taking the sample. Samples were handwritten in 8/9 cases. In 1 case the sample was labelled using an
electronic system, investigation showed that the wrong ID band had been printed for the patient and
positive patient identification was not performed at the time of phlebotomy.

In 2 NM-WBIT cases the reporting organisation stated that the laboratory did not employ the confirmatory
sample policy (Milkins, et al., 2013). In the remaining cases 5/7 stated that the error was detected as a
result of the confirmatory sample policy.

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Commentary
Most transfusion-related errors in HSCT and SOT patients are either transfusion of ABO/D-mismatched
blood components, or failure to administer irradiated components putting the patient at risk of TA-GvHD.
Poor communication of vital information between teams involved in patient care (clinical and laboratory)
resulting in failure to update the LIMS and failure to heed alerts in IT systems continue to be the most
common errors noted. Users are often dependent on alerts or notes in the LIMS to make decisions
about component selection rather than functionality in the LIMS that confirms the correct selection.
A SHOT SCRIPT LIMS user survey in 2019 noted deficiencies in compatibility algorithms for post-
transplant patients. This was explored in a LIMS supplier survey in 2020 (see ‘Recommended resources’
section) where these were noted as improvements in future releases by some suppliers. Where LIMS
are dependent on alerts or notes for guidance on safe selection, these must be clear, unambiguous and
take into account appropriate selection for red cells, plasma and platelet components. Alerts should
prompt appropriate actions and not be easily overridden by the user. LIMS functionality in terms of
assigning blood groups to patients where testing results are indeterminate has also been implicated in
flawed decision-making.

Errors in clinical communication are further compounded by the shared care of patients between
transplant centres and the patient’s local hospital, which necessitates the need for effective transfer
of information between multiple centres and laboratories. Where notifications are made by email,
laboratories should ensure that these are accessed regularly, accessible to a team, not an individual
and are not a single point of failure. Notification processes should include fail-safes, including laboratory
feedback to the clinical team that the information has been added to the LIMS, incorporation of specific
requirements (irradiated) into component orders and inclusion of expected component ABO types and
specific requirements in pre-administration checklists.

SHOT data show that transfusion of the wrong ABO or D group in ABO- or D-mismatched transplants,
and failure to provide irradiated components continues to be a problem. Although improved functionality
in LIMS could reduce risk of error, this does not negate the need for staff knowledge and skills. Training,
educational activities and competency-assessments should include transfusion in transplant patients, for
both clinical and laboratory staff. Decision-making aids, such as the SHOT resource (Safe transfusions
in haemopoietic stem cell transplant recipients; see ‘Recommended resources’ below) should be
easily accessible and incorporated into local procedures and guidance. The impact of human factors
and ergonomics on provision of safe transfusions must not be underestimated. The key to eradicating
transfusion errors and advancing patient safety is to create systems for reliable healthcare delivery and
systems should be designed with human factors and ergonomics at the forefront (Narayan, et al., 2023).

Recommended resources
Safe transfusions in haemopoietic stem cell transplant recipients - 2021
https://www.shotuk.org/resources/current-resources/

SHOT Bite No. 18: Transplant Patients (2021)

SHOT Bite No. 20: IBCT-SRNM (2022)
SHOT Bite No. 27: Solid Organ Transplant (SOT) 2023
https://www.shotuk.org/resources/current-resources/shot-bites/

SCRIPT survey reports

https://www.shotuk.org/resources/current-resources/script/

26. Transfusion Errors in Transplant Cases 241

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References
Foukaneli, T. et al., 2020. Guidelines on the use of irradiated blood components. British Journal of Haematology, 191(5),
pp. 704-724. doi: https://doi.org/10.1111/bjh.17015.

Milkins, C. et al., 2013. Guidelines for pre-transfusion compatibility procedures in blood transfusion laboratories.
Transfusion Medicine, 23(1), pp. 3-35. doi: https://doi.org/10.1111/j.1365-3148.2012.01199.x.

Moosavi, M. M. et al., 2020. Passenger Lymphocyte Syndrome; a Review of the Diagnosis, Treatment, and Proposed
Detection Protocol. Transfusion Medicine Reviews, 34(3), pp. 178-187. doi: https://doi.org/10.1016/j.tmrv.2020.06.004.

Narayan, S. et al., 2023. The 2022 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. doi: https://doi.org/10.57911/WZ85-3885.

Schrezenmeier, H., Körper, S., Höchsmann, B. & Weinstock, C., 2019. Chapter 23 Transfusion Support [Online]. In: The
EBMT Handbook: Hematopoietic Stem Cell Transplantation and Cellular Therapies 7th ed. s.l.:Springer, pp. 163-170.
doi: https://doi.org/10.1007/978-3-030-02278-5.

Worel, N. & Kalhs, P., 2008. AB0-incompatible allogeneic hematopoietic stem cell transplantation. Haematologica,
93(11), pp. 1605-1607. doi: https://doi.org/10.3324/haematol.2008.001057.

Yazer, M. H. & Triulzi, D. J., 2007. Immune hemolysis following ABO-mismatched stem cell or solid organ transplantation.
Current Opinion in Hematology, 14(6), pp. 664-670. doi: https://doi.org/10.1097/moh.0b013e3282e9a576.

242 26. Transfusion Errors in Transplant Cases

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Immune Anti-D in Pregnancy n=42 27

Authors: Vera Rosa and Susan Robinson

Definition:
Cases of D-negative pregnant women who become sensitised and are found to have developed
immune anti-D, which is detected during pregnancy, either at booking or later in the index
pregnancy.

Abbreviations used in this chapter

APH Antepartum haemorrhage IUD Intrauterine death
BMI Body mass index IV Intravenous
BSH British Society for Haematology NICE National Institute for Health and Care Excellence
cffDNA Cell-free fetal deoxyribonucleic acid NPP No previous pregnancies
FMH Fetomaternal haemorrhage PP Previous pregnancies
HDFN Haemolytic disease of the fetus and newborn PSE Potentially sensitising event
IAT Indirect antiglobulin test PVB Per vaginal bleeding
Ig Immunoglobulin RAADP Routine antenatal anti-D Ig prophylaxis

Key SHOT messages

• There are ongoing missed opportunities where pregnancy management is not ideal

• Obesity, delivery beyond 40 weeks and high FMH are potential risk factors for D sensitisation

• Cases of D sensitisation are still occurring even when best practice is followed

• Lack of long-term follow-up of patients following significant FMH impacts management of future
pregnancies as immune anti-D may not be detected promptly

• In cases where immune anti-D resulted from an error related to anti-D Ig administration, SHOT
reports should be submitted for both categories

Recommendations
• Healthcare organisations must ensure that local policies reflect national guidance to allow best
practice

• Healthcare organisations must embed a reviewing process of local policies against current versions
of national guidance

Action: Healthcare organisations, transfusion service managers, maternity teams

• Hospital transfusion teams should perform a comprehensive investigation with a system-focused

approach when pregnancy management is not ideal

27. Immune Anti-D in Pregnancy 243

 ANNUAL SHOT REPORT 2023 SPECIAL CLINICAL GROUPS

Action: Healthcare organisations, hospital transfusion teams, maternity teams

• Training, education resources and competency-assessments relating to anti-D Ig administration

and management of D-negative pregnancies must be extended to non-maternity services e.g.,
non-gynaecology wards and emergency departments

Action: Training leads

• Cases of immune anti-D found for the first time in pregnancy should be reported to SHOT, aiming
to provide a complete data set after delivery

Action: Transfusion teams

Introduction
To improve understanding of the causes of continuing anti-D immunisations, SHOT has been reviewing
cases where immune anti-D has been detected for the first time in the current (index) pregnancy
since 2012. The reporters are requested to provide data on booking weight and BMI, management of
sensitising events during pregnancy and the administration of RAADP, both in the index pregnancy and
the pregnancy immediately before the index pregnancy (if applicable). In cases where patients had been
previously pregnant, details of delivery including anti-D Ig administration should be reported.

Results
In 2023 a total of 42 cases were reported, 7 cases occurred in women with NPP, and 35 in women
with PP. Reporting is fairly consistent, however, the available data would suggest that D sensitisation in
pregnancy remains under-reported (see the assumptions and calculation provided in the 2018 Annual
SHOT Report (Narayan, et al., 2019)).

Cumulatively SHOT now has useful data on 139 women with NPP and 388 women with PP.

244 27. Immune Anti-D in Pregnancy

SPECIAL CLINICAL GROUPS ANNUAL SHOT REPORT 2023

Figure 27.1:
Number of
Previous pregnancy reports of anti-D
No previous pregnancy immunisation in
50 pregnancy by year,
2012-2023
45

39
37 36
34 35
32 31 31

22

17 16 17 16
14
11
9 9 8 7
4 5
2

2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

No previous pregnancy (NPP) n=7

For a detailed discussion of the NPP cases, and tables containing similar details to those published
in previous Annual SHOT Reports, please see the supplementary information on the SHOT website
(https://www.shotuk.org/shot-reports/report-summary-and-supplement-2023/).

When anti-D Outcome of Figure 27.2:

RAADP PSE
detected pregnancy Summary of the
2023 NPP data
2 APH/PVB (n=7)
(7 and 9 weeks)
1 fall
or abdominal 3 live births
trauma (25 weeks) All phototherapy
2
before 12 week 1 exchange
3 received RAADP transfusion
gestation (1st
trimester)
2 1 live birth
before 28 weeks 1 delayed RAADP
phototherapy
gestation, but after
7 NPP
12 weeks
gestation 1 live birth
1* no RAADP received required no
2 treatment
at or after 28
weeks gestation 2 live births
2** ineligible 1 phototherapy
1 1 required no
for RAADP
at delivery treatment

APH=antepartum haemorrhage; NPP=no previous pregnancy; PSE=potentially sensitising event; PVB=per vaginal bleeding; RAADP=routine
antenatal anti-D Ig prophylaxis
*RAADP appointment was not arranged. Anti-D detected at 38 weeks gestation
**Immune anti-D detected before 28 weeks gestation (at 11 weeks and 9 weeks gestation)

27. Immune Anti-D in Pregnancy 245

 ANNUAL SHOT REPORT 2023 SPECIAL CLINICAL GROUPS

Illustrative cases
Case 27.1: Incorrect management of pregnancy results in development of clinically significant
antibodies

A woman delivered at 38+6 weeks gestation and suffered post-partum major haemorrhage. Anti-D
and anti-C were detected in this sample for the first time. This could have led to a delay in issuing
crossmatched units while further testing was performed, but fortunately there was no delay in
providing appropriate blood. During pregnancy, the woman had not received RAADP and was not
offered cffDNA testing to enable correct management of pregnancy and prevent development of
clinically significant antibodies.

The initial anti-D Ig error in this case has been described in Chapter 9, Adverse Events Related to Anti-D
Immunoglobulin (Ig) in the major morbidity section.

The presence of maternal alloantibodies not only affects blood supply at delivery but also future
transfusions and subsequent pregnancies. The requirement for antigen-negative red cells and IAT
crossmatch can cause delays with potential adverse consequences for the patient including unavailability
of suitable red cells. In emergency situations, the benefit versus risk of haemolytic transfusion reaction
needs to be assessed by the clinical team on a case-by-case basis. In Case 27.1, emergency O
D-negative red cells should be suitable for transfusion as the phenotype selected for these units are
C- and E- (rr). It is important to note that emergency group O red cells may not always be suitable for
patients with alloimmunisation to other antigens from different blood group systems.

Case 27.2: High anti-D level contributed to premature induction of labour

A woman attended the early pregnancy assessment unit with pain and bleeding at 9+5 weeks
gestation. Pregnancy booking had been completed and the blood group was available. Anti-D Ig
was not administered as per organisational guidelines. Immune anti-D was detected at 28 weeks.
At 34+5 weeks the anti-D quantification was 170.6IU/mL. Labour was induced at 34+5 weeks. After
delivery the baby required double volume exchange transfusion and phototherapy due to HDFN
and recovered.

In this pregnancy, the management following PSE was not ideal and was likely the cause of the D
sensitisation. According to the current BSH guideline, PSE in pregnancies occurring at <12 weeks
gestation where uterine bleeding is associated with abdominal pain require administration of a minimum
250IU anti-D Ig (Qureshi, et al., 2014). Healthcare organisations must ensure that local policies reflect
national guidance for best practice. In this case the presence of immune anti-D resulted in premature
induction of labour, and consequently the baby required phototherapy as well as double volume exchange
transfusion as part of the treatment for HDFN.

Learning points
• The presence of alloantibodies has an impact in blood provision for mother and baby with potential
to cause delays due to blood unavailability and serological crossmatch requirement

• Local policies must reflect national guidelines for best practice to avoid maternal alloimmunisation

Previous pregnancies (PP) n=35

The index pregnancy in these cases refers to the current pregnancy – the pregnancy in which alloimmune
anti-D was first detected.

For a detailed discussion of the PP cases, and tables containing similar details to those published in
previous Annual SHOT Reports, please see the supplementary information on the SHOT website (https://
www.shotuk.org/shot-reports/report-summary-and-supplement-2023/).

246 27. Immune Anti-D in Pregnancy

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When anti-D Outcome of

Figure 27.3:
RAADP PSE
detected index pregnancy Summary of the
2023 PP data
RAADP in preceding
pregnancy (n=35)
1 miscarriage
6 live births
1 phototherapy
7 received RAADP 1 IUD at 40 weeks 5 required no treatment

1 received 1 APH/PVB 1 live birth

delayed RAADP (26 weeks)
1 phototherapy

1 miscarriage
16* 4 live births
before first 5 received RAADP but
trimester 1 phototherapy;
gestation unknown 1 with IV fluids
1 with IVIg
2 required no treatment

1 miscarriage 3 live births

(6 weeks)
1 required phototherapy,
3 ineligible IV fluids, IV antibiotics
for RAADP and IVIg
1 required phototherapy
2** terminations and IVIg
35 PP
(6 weeks) 1 no information given

10 live births
1 required phototherapy
1 required phototherapy
and top-up transfusion
1 required multiple
transfusions
10 received 1 required phototherapy,
5 RAADP 1 fall or
before 28 week exchange transfusion
abdominal and IVIg
gestation, but after trauma
12 week gestation 6 required no treatment
(17 weeks)

11 1*** did not 1 live birth

receive RAADP
at or after 28 required no treatment
weeks gestation
1 unknown****
3 7 live births
at delivery 8 not eligible for
RAADP 3 required phototherapy
1 required phototherapy
and top-up transfusion
1 required phototherapy,
top-up transfusion and
folic acid
2 required no treatment

APH=antepartum haemorrhage; IUD=intrauterine death; IV=intravenous; IVIg=intravenous immunoglobulin; PP=previous pregnancy;

PSE=potentially sensitising event; PVB=per vaginal bleeding; RAADP=routine antenatal anti-D Ig prophylaxis
*In 1 case, the anti-D was detected at delivery in previous pregnancy but regarded as prophylactic. Detected at booking in the index
pregnancy
**No information provided of the gestation when pregnancy was terminated
***D-variant, patient regarded as D-positive throughout pregnancy
****Patient moved to India

Illustrative cases
Case 27.3: Two-dose RAADP regime and no group and screen sample at delivery
Immune anti-D was detected for the first time at booking (11+2 weeks) during the 4th pregnancy.
No red cell antibodies were detected in the previous pregnancy up to 1 month prior to delivery (no
group and screen sample taken at delivery). The Kleihauer test performed after delivery at 36 weeks

27. Immune Anti-D in Pregnancy 247

 ANNUAL SHOT REPORT 2023 SPECIAL CLINICAL GROUPS

gestation estimated <2mL fetal bleed and 500IU anti-D Ig was given within 72 hours. The RAADP
regime followed in the preceding pregnancy was two 500IU doses.

In this case, D sensitisation was not confirmed as to have occurred prior to or after delivery as a group and
screen sample was not taken post delivery. From the information provided, the postnatal management
appeared to be correct considering the estimated FMH, dose of anti-D Ig administered and the time
frame of administration (within 72 hours). In 2023, cases of D sensitisation continue to be reported to
SHOT where the management of pregnancy was deemed to be appropriate.

Current guidelines recommend either a two-dose regime (2x500IU) or one-dose regime (1x1500IU) (NICE,
2008). The one-dose regime has been associated with higher compliance as the patient only needs to
attend one appointment (MacKenzie, et al., 2011). However, the two-dose regime can provide a higher
protection to D sensitisation. A study conducted in Australia showed that a higher proportion of women
who had received a two-dose RAADP regime had detectable anti-D Ig levels at delivery compared to
those who had received a one-dose regime (White, et al., 2019).

Case 27.4: Immune anti-D detected for the first time in a patient with multiple risk factors for
D sensitisation and previous IUD

Immune anti-D was detected for the first time in the index pregnancy at 12+1 weeks gestation. The
patient had a high BMI >30 in both the previous and index pregnancies. This was the fifth pregnancy,
with two previous live births, one miscarriage and one IUD.

The preceding pregnancy resulted in an IUD at 40+4 weeks gestation. The FMH volume was 56mL
and 5600IU anti-D Ig was administered IV. In the follow-up sample, taken 48 hours after anti-D Ig
administration and after delivery of the stillbirth at 40+5 weeks, a repeat FMH sample detected a fetal
bleed volume of 4mL and further 500IU of anti-D Ig was administered. No follow-up sample was
taken after the repeat 500IU dose. It is unclear if the decision to not take further follow-up samples
for FMH testing was discussed with the haematology consultant.

In this case, there were multiple risk factors for D sensitisation; delivery beyond 40 weeks gestation, high
BMI, and previous high volume FMH. In cases where multiple risk factors are present, it may be beneficial
to consider a follow-up after 6 months for assessment of D sensitisation. Current BSH guidelines for FMH
considers long term follow-up following significant FMH (Austin, et al., 2009) but it might be of benefit
to extend this consideration to other risk factors. In addition, it is recommended that follow-up samples
should be taken every 72 hours post anti-D Ig administration until fetal cells are no longer identified in
the FMH test (Austin, et al., 2009).

Good practice was noted in this case as the treating team administered anti-D Ig IV appropriately in
view of the high volume of fetal bleed and a follow-up sample was taken within the correct time frame
considering the route of administration (48 hours when anti-D Ig administered IV).

Learning points
• When fetal cells are detected on follow-up samples, repeat FMH testing should be continued until
clearance of fetal cells is confirmed

• The benefit of a long-term D sensitisation follow-up should be considered on a case-by-case basis

Conclusion
The 2023 data demonstrate that issues continue to occur in the management of D-negative pregnant
patients. This is not only reflected in this chapter but also in Chapter 9, Adverse Events Related to Anti-D
Immunoglobulin (Ig). The cases reported in both categories highlight missed opportunities for correct
management relating to anti-D Ig administration following PSE and RAADP.

In 2 cases, the immune anti-D was assumed to be prophylactic where there were no records of anti-D
Ig administration in the index pregnancy. In 1 case, the patient did not receive anti-D Ig following a PSE
(>20 weeks gestation) nor as part of RAADP.

248 27. Immune Anti-D in Pregnancy

SPECIAL CLINICAL GROUPS ANNUAL SHOT REPORT 2023

When considering risk factors for immune anti-D, it is important to evaluate not only the physical factors
such as high BMI, large FMH and delivery beyond 40 weeks gestation, but also social and mental health
factors that may impact patient’s access to receive optimal treatment. These are contributory factors
for non-compliance or non-reporting PSE during pregnancy and can result in incomplete, insufficient or
absence of management throughout pregnancy.

When reporting these cases to SHOT, it is important to provide the BMI as well as the weight at booking
because the BMI can provide a more accurate estimation of the risk obesity poses to D sensitisation.

SHOT appreciate that the information relating to previous pregnancies is not always easily accessible.
However, to identify and understand the possible causes for D sensitisation, especially in those cases where
the anti-D is detected at booking in the index pregnancy, the report should be completed as fully as possible.

Recommended resource
SHOT Bite No.29: Differences of reporting errors related to anti-D Ig and immune anti-D
https://www.shotuk.org/resources/current-resources/shot-bites/

References
Austin, E. et al., 2009. Guidelines for the Estimation of Fetomaternal Haemorrhage. British Committee for Standards in
Haematology (BCSH), pp. 1-23. Available at: https://b-s-h.org.uk/guidelines/guidelines/the-estimation-of-fetomaternal-
haemorrhage (Accessed 20 February 2024).

MacKenzie, I. Z., Dutton, S. & Roseman, F., 2011. Evidence to support the single-dose over the two-dose protocol for
routine antenatal anti-D Rhesus prophylaxis: a prospective observational study. European Journal of Obstetrics and
Gynecology and Reproductive Biology, 158(1), pp. 42-46. doi: https://doi.org/10.1016/j.ejogrb.2011.04.033.

Narayan, S. et al., 2019. The 2018 Annual SHOT Report, Manchester: Serious Hazards of Transfusion (SHOT) Steering
Group. doi: https://doi.org/10.57911/4ENZ-ET89.

National Institute for Health and Care Excellence (NICE), 2008. Routine antenatal anti-D prophylaxis for women who are
rhesus D negative TA156. [Online] Available at: https://www.nice.org.uk/guidance/ta156
(Accessed 12 February 2024).

Qureshi, H. et al., 2014. BCSH guideline for the use of anti-D immunoglobulin for the prevention of haemolytic disease of
the fetus and newborn. Transfusion Medicine, 24(1), pp. 1-66. doi: https://doi.org/10.1111/tme.12091.

White, S. W. et al., 2019. Single dose v two-dose antenatal anti-D prophylaxis: a randomised controlled trial. The
Medical Journal of Australia, 211(6), pp. 261-265. doi: https://doi.org/10.5694/mja2.50266.

27. Immune Anti-D in Pregnancy 249

 ANNUAL SHOT REPORT 2023

Acknowledgements

The Steering Group take this opportunity to thank the following individuals and organisations for their
contributions without which the publication of this 27th Annual SHOT Report would not have been
possible:

• The Blood Services of the United Kingdom for funding and support

• The Royal College of Pathologists to which SHOT is affiliated

• The Blood Services of the United Kingdom for the provision of data relating to the issue of blood
components:

– Central Planning Team, NHSBT

– Mr James Smith, Senior Information Analyst, SNBTS

– Mrs Lee Wong, Head of the Blood Health Team, WBS

– Mrs Martina McCalmont, Senior Biomedical Scientist, Hospital Services Department, NIBTS

– Mrs Emma Haworth, Marketing Manager, Octapharma Ltd for data relating to SD-FFP (Octaplas®)

• The expert group who reviewed TRALI cases:

– Dr Tom Latham, NHSBT Bristol

– Dr Peter Davis, Bristol University Hospitals NHS Foundation Trust

– Dr Jill Clarkson, NHSBT Newcastle

– Dr Andrew Charlton, NHSBT Newcastle

– Dr Andrew Bentley, Manchester University NHS Foundation Trust

– Dr Puneet Malhotra, St Helens and Knowsley Teaching Hospitals NHS Trust

– Dr Margarita Gonzales, SNBTS

• Clinical and scientific staff, in hospitals and reference laboratories, who have contributed to the
clinical and laboratory investigation of cases

• Toast Design Consultancy Ltd for maintenance of the SHOT website

• Dendrite Clinical Systems for the maintenance of the online reporting system

• Raquel Lopez, SHOT Office Administrator

• Jenny Leonard for the illustrations

• ARC-UK Technologies for design and production of the report

• Hospital transfusion teams for submitting case reports to the scheme

All collaborators who have contributed to this Annual SHOT Report.

250 Acknowledgements
WEBSITE ONLY ANNUAL SHOT REPORT 2023

Medicines and Healthcare products

Regulatory Agency (MHRA) Report 28
Authors: Chris Robbie, Mike Dawe, Shirley Stagg

Abbreviations used in this chapter

BCR Blood compliance report IAG Inspection action group
BE Blood Establishment IBCA Incorrect blood component accepted
BMS Biomedical Scientist IBCI Incorrect blood component issued
BSQR Blood Safety and Quality Regulations 2005 IBCO Incorrect blood component ordered
(as amended) LIMS Laboratory information management system
CAPA Corrective and preventive action NBTC National blood transfusion committee
CATPD Component available for transfusion PSIRF Patient safety incident response framework
past de-reservation PTTE Pre-transfusion testing error
CCE Component collection error QMS Quality management system
CLE Component labelling error RC Root cause
DEE Data entry error RCA Root cause analysis
ECAT Expired component available for transfusion SABRE Serious Adverse Blood Reactions and Events
EDQM European Directorate for the Quality of SAE Serious adverse event
Medicines & Healthcare SAR Serious adverse reaction
FR Failed recall SOP Standard operating procedure
GPG Good Practice Guide SPE Sample processing error
HBB Hospital blood bank UNSPEC Unspecified
HD Handling damage

Key MHRA messages

• The MHRA haemovigilance team continues to work hard to improve the depth of investigations
and improve the identification of root causes and corrective measures with reporters

• There has been another increase in the number of investigation reports that have identified system
errors or weak processes

• Staffing and workload issues remain a factor in the errors reported. It is the third most common
‘system error’ after inadequate processes and ineffective training

• Hospital transfusion teams should implement an effective tracking and trending system of root
cause to identify emerging trends so effective CAPA can be implemented

• Attention should be made to the SAE and root causes highlighted in this chapter to ensure these
are being reported consistently and that QMS are reviewed for robustness and effectiveness

Summary
There has been an increase in the total number of reports received during 2023. The increase is seen
to be as a result of more SAE reports being received. While the increase in the number of reports looks
sharp compared to last year, it must be remembered that the reports for the previous few years have
been influenced by the effects of COVID-19. When viewed in the context of the last 10 years the increase
in numbers of reports demonstrates a steadier increase. While this might demonstrate an increase in

28. Medicines and Healthcare products Regulatory Agency (MHRA) Report 251
 ANNUAL SHOT REPORT 2023 WEBSITE ONLY

potential risk of harm to patients, it could also be a natural increase in reporting due to greater awareness
of the types of SAE reportable under the BSQR.

The proportion of SAE reported to be due to process and system deficiencies has risen to 70% and the
proportion due to human error dropped to 30%. These figures should be seen as encouraging rather
than discouraging as it represents a greater proportion of reporters are identifying one or more system
improvements rather than holding individual staff members responsible for ‘human errors’.

SABRE report data

Table 28.1 and Figure 28.1 show the total numbers of reports and the numbers of reports submitted as
SAE and SAR for the previous 10 years. There has been a 19% increase in the total number of reports
submitted in 2023. Most of these are in the SAE categories. Overall, the number of reports received
show an upward trend over ten years.

Table 28.1:
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023
Submitted
SAE 762 764 1027 1076 1198 1197 1093 1143 1118 1325
confirmation
reports 2014–2023 SAR 346 262 464 508 408 497 590 526 710 731

Total 1108 1026 1491 1584 1606 1694 1683 1669 1828 2056

Figure 28.1:
2500
Submitted
confirmation
reports 2014-2023 2000

1500

1000

500

0
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023

SAE SAR Total

Serious adverse events n=1325 (+207)

Definition: (Department of Health, 2005) Any untoward occurrence associated with the collection,
testing, processing, storage and distribution, of blood or blood components that might lead to
death or life-threatening, disabling or incapacitating conditions for patients or which results in,
or prolongs, hospitalisation or morbidity

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Event category Number of reports Table 28.2: Total

number of SAE
Materials 0
reports by event
Apheresis collection 2
category
Whole blood collection 6
Testing of donations 8
Processing 10
Distribution 16
Donor selection 83
Storage 326
Other 874

Grand total 1325

Table 28.2 shows the total number of SAE reports received by event category. Proportions of reports
received remain similar to previous years, but there has been a 15% increase in ‘other’ SAE and a 33%
increase in the number of storage SAE following a reduction last year.

Storage data n=326 (+81)

Storage remains the second largest individual error category (after ‘other’) and comprises of all BSQR
reportable storage SAE in both the laboratory and clinical areas. The MHRA Haemovigilance Team lead
has broken this category down further to try and identify specific storage error sub-types, Table 28.3.
For a description of the sub-categories used, see Appendix 1.

Storage sub-classification 2023 (+/- 2022) 2022 position Table 28.3: SAE
storage error sub-
Incorrect storage of component 156 (+38) 1
classifications
Component expiry 58 (+20) 2
Return to stock error 37 (+15) 4
Sample expiry 36 (+7) 3
Security 13 (-1) 5
Storage temperature deviation 9 (+2) 7=
Failure to action alarm 9 (+1) 6
Miscellaneous 7 (NC) 7
30- or 60-minute rule 1 (-1) 9

Total 326 (+81) X

Following a decrease in the number of storage errors last year, there has been a 33% increase in total in
2023. The top 4 storage sub-categories have all shown an increase with the largest increase in incorrect
storage of component.

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Figure 28.2
Root causes of
incorrect storage of
E RROR
components
M AN 1
sub-category U 1
(n=156) H
Human error

16 8 (16) Procedural steps omitted/

wrong procedure performed
31

System error
45
(45) Inadequate process
(16) Inadequate QMS - staffing
and workload

38 (38) Ineffective training

16 (31) Inadequate training
(1) Incorrect procedure
(8) Lapsed/no training
R
RO (1) Inadequate supervision
SYS TE M E R

QMS=quality management system

As the single largest sub-category of storage, Figure 28.2, shows the breakdown of incorrect storage
of component by root cause.

90% of all Incorrect storage of component errors are related to one or more deficiencies in the quality
system. Only 10% were related to human error where staff have knowingly followed the wrong procedure
or skipped steps in a process.

29% demonstrate either inadequate design of processes designed to maintain the quality and safety of
blood and blood components or involved multiple errors within the system in use.

49% are in some way related to training;

• 24% show the training to be ineffective

• 20% show the training to be inadequate

• 5% show staff have either not received training or their previous training has lapsed

Common themes from the narratives of incorrect storage of component reports shows;

• Processes and procedures are not clear on how blood should be stored safely and correctly

• Errors are made when staff do not handle blood regularly and have forgotten their training

• Training of staff in blood and blood component storage is not given a high enough priority during
staff induction training and continuous training thereafter

• Training material does not always cover all aspects of storage e.g., how to distinguish between
components and their different storage requirements

• Errors often occur because shifts are not staffed with adequate numbers of trained staff

• Agency/bank staff training is inadequate

• Agency/bank staff are expected to handle components without having been trained in the local
procedures

All storage errors are covered by the requirements of the BSQR. Most of these storage errors occur in
clinical areas. It is still a widely held belief that storage errors in clinical areas are clinical errors and that
investigation and reporting of these errors is not covered by the BSQR. This is incorrect. All storage

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errors that affect the quality and safety of blood and blood components must be fully investigated as
per the requirements of the BSQR and GPG.

Recommendation
• Hospital Trusts/Health Boards must improve all areas relating to the quality and safety of blood
and blood component storage and the investigation of such storage errors

Action: Hospital transfusion teams

Other n=874 (+118)

Table 28.4: ‘Other’
Other sub-category 2023 (+/- 2022) 2022 position
Incorrect blood component issued (IBCI) 194 (+58) 2
Pre-transfusion testing error (PTTE) 148 (+24) 4
Sample processing error (SPE) 146 (-1) 1
Component collection error (CCE) 127 (-9) 3
Component labelling error (CLE) 115 (NC) 5
Data entry error (DEE) 89 (+27) 6
Failed recall (FR) 24 (+9) 7
Component available for transfusion past de-reservation (CATPD) 10 (+6) 9=
Incorrect blood component ordered (IBCO) 7 (-2) 8
Expired component available for transfusion (ECAT) 6 (+3) 11
Incorrect blood component accepted (IBCA) 4 (+3) 12=
Handling damage (HD) 3 (+3) 14
Unspecified (UNSPEC) 1 (-3) 9=

Total 874 (+118) X

Table 28.4 shows the number of reports in the ‘other’ category of SAE. There has been a 15% increase
in events that fall into this category. The majority of the increases have been in the sub-categories;

• Incorrect blood component issued

• Data entry error

• Pre-transfusion testing error

Please see Appendix 2 for a description of the sub-categories.

Human and system error categories and human factors

The BSQR requires that ‘preventable causes’ of SAE are investigated and reported (Department of
Health, 2005). The GPG also states ‘Where human error is suspected or identified as the cause of the
deviation, this should be formally justified and care should be exercised so as to ensure that process,
procedural or system-based errors or problems are not overlooked, if present.’ (EDQM, 2023).

What this means is that for all SAE reported on SABRE, the root cause investigation must first identify
any system-based causes, or ‘human factors’. It must be stressed that the term ‘human factors’ is not
a fancy term now used to describe ‘human error’. Human factors are all the factors which influence
an individual’s behaviour. These can be factors associated with an organisation itself, the task or the
process being undertaken, including the environment and equipment used as well as factors associated
with an individual’s personality and actions. Therefore, human factors, or ergonomics, are exactly the
system-based factors reporters are required to investigate according to the requirements of the BSQR
and the GPG.

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MHRA assign a category on review of an SAE report to reflect the most prominent causative factor.
Assessment of these reports can distinguish between events caused by system errors and human errors
(slips/ lapses/ omissions). For a description of the categories used, see Appendix 3.

Table 28.5 shows the breakdown of reports in the human/system error sub-categories.

Table 28.5: Human/

Human error sub-category Total 2023 (+/- 2022) 2022 position
system error sub-
System error/ Inadequate process 396 (+121) 1
categories, 2023
Human error/ Procedure performed incorrectly 252 (+25) 2
Human error/ Procedural steps omitted/wrong procedure performed 195 (+70) 5
System error/ Inadequate QMS – staffing and workload 145 (+5) 4
System error/ Ineffective training 144 (-32) 3
System error/ Inadequate training 96 (+16) 6
System error/ Incorrect procedure 52 (+9) 7
System error/ Lapsed/no training 15 (-7) 8
System error/ Inadequate supervision 11 (+1) 9

Total 1306 (+208) X

Figure 28.3:
Human/system
error sub-
categories Human error
(n=1306) R 15
RO
(252) Procedural steps omitted/
11 52 wrong procedure performed
ER

252 96 (144) Procedure performed

AN

incorrectly
HUM

195
System error
144
OR

(396) Inadequate process

(145) Inadequate QMS - staffing
ERR

and workload
145 (195) Ineffective training
EM

(96) Inadequate training

(52) Incorrect procedure
ST

396
SY
(15) Lapsed/no training
(11) Inadequate supervision

QMS=quality management system

NOTE: These numbers should be used as guidance only. The quality of this data is limited by a number
of factors.

• The RC of incidents are usually the result of many contributory factors. The sub-category chosen
reflects the most likely reason for the main SAE category. If multiple factors are involved relating to
the QMS, then ‘Inadequate process’ has been chosen as the sub-category rather than choosing a
category that best fits the main SAE reported

• The sub-category chosen is based on the information in the report. A limited investigation or a report
which does not provide MHRA with enough information may not be sub-categorised appropriately

The MHRA haemovigilance team continues to work with reporters to improve the quality of SAE
investigations. 14 training sessions were undertaken either with individual hospital trusts or regional

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groups. These training sessions in investigation of events, RC and CAPA are available free of charge
on request. The team continues to be strict in terms of accepting confirmation reports and many have
been returned to encourage reporters to investigate and report to a much greater depth to encourage
them to identify the system-based problems and improve the quality of the CAPA.

Table 28.5 shows a 19% increase in the number of reports due to human factors. However, 70% of
these reports have identified one or more system improvements as a result of their investigations. This
demonstrates a continued improvement in the quality and depth of investigations, either initially or after
a request for more detail by the MHRA haemovigilance team. The remaining 30% are either genuine
slips or lapses by individuals, or examples of reports that may have benefitted from a more in-depth
investigation.

Common themes from the narrative of these investigation reports show;

• 30% of these reports either demonstrate a weak process or system design or involve multiple system
deficiencies

• Inadequate process errors may involve the poor identification and mitigation of distractions

• 11% of these reports are directly related to staffing, workload, or skill-mix issues and is the third
largest ‘system error’ sub-category. However, it must be noted that some of the 30% Inadequate
process reports, may also include some aspects of staffing and workload issues, since this category
may reflect multiple system or process deficiencies

• Many reports note errors are made when staff are ‘busy’. It may not always be possible to directly
link these to staffing and workload since improved prioritisation of workloads may have prevented
the error from occurring

• Many reports do not reflect the seriousness of the event as they only reflect actual harm and not
potential harm

• Many confirmation reports initially assign a RC as Human error without fully identifying process or
system deficiencies

• Many CAPA are initially proposed to be reminding staff to ‘be more vigilant’ and to ‘follow procedures’.
This is not an appropriate CAPA as it demonstrates a failure to identify genuine causes and the
implementation of effective CAPA

• RC are often identified as a failure to perform an adequate second check. Failure to perform second
checks are not RC as the error has already occurred by the time the second check was performed

• Many reports continue not to be reported ‘as soon as known’

• Many confirmation reports are delayed due lack of engagement from clinical areas or by reviews of
investigation reports

Recommendations
• All reporters must continue to thoroughly investigate all SAE, even those with no actual harm to
patients. It is through thorough investigations that improvements can be identified to reduce risks
to the quality and safety of blood and blood components and reduce the risk of harm to patients

• When investigating an incident, reporters must have taken care to ensure that process, procedural
or system-based errors or problems have not been overlooked. For example, if distractions have
been identified then these distractions must be addressed in the CAPA to avoid reoccurrence

• CAPA must correct the error made and not just rely of making error checking more robust

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 ANNUAL SHOT REPORT 2023 WEBSITE ONLY

• Engagement from staff in clinical areas must be improved. It is the responsibility of the Trust
or Health Board to ensure all SAE are investigated and reported in a timely manner as per the
requirements of the BSQR

• Reporters are reminded to report ‘as soon as known’. You are required only to submit a Confirmation
report with RC and ‘Proposed’ CAPA. Changes to CAPA following review can be added to SABRE
reports as Footnotes

Action: Hospital transfusion teams

Top 5 SAE
Presented below are the top 5 SAE that originate from the ‘other’ category. These have been broken
down into their specification or ‘human factors’ sub-categories.

Figure 28.4:
Incorrect blood
component issued
R
RO
Human error
- IBCI (n=194) 1
ER (22) Procedural steps omitted/
26 13 wrong procedure performed
AN

7
(26) Procedure performed
M

incorrectly
HU

19
22

System error
(73) Inadequate process
33 (33) Inadequate QMS - staffing
and workload
R

(19) Ineffective training

RO

(7) Inadequate training

ER

73 (13) Incorrect procedure

EM
(1) Inadequate supervision
T
SYS

QMS=quality management system

Nearly three quarters of Incorrect blood components issued (76%) are related to system errors and
the rest (24%) are due to slips lapses and omissions. The largest proportion are due to inadequately
designed processes or a combination of system errors. 17% are a direct result of staffing and workload
issues which affect the selection of the correct requirements for patients.

As the single most common SAE sub-category and following a 43% increase in the number of IBCI
reports it is imperative that reporters thoroughly investigate and address the RC and identify effective
CAPA. Reporters are reminded that CAPA must ensure that the correct component is selected in the
first place and not rely on ensuring that checks later in the process identify errors already made.

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Figure 28.5:
Pre-transfusion
R
R RO Human error
testing error
E (PTTE) (n=148)
N (21) Procedural steps omitted/
A
wrong procedure performed
M
HU

11 16 (11) Procedure performed

6 incorrectly
21

System error
32
(52) Inadequate process
(9 Inadequate QMS - staffing
and workload
52 9
(32) Ineffective training

R
RO
(6) Inadequate training
R (16) Incorrect procedure
E
M
TE
SYS

QMS=quality management system

1 equipment failure is not included in the figure

78% of PTTE are due to 1 or more weaknesses in the quality system. 21% appear to be due to slips
and lapses in concentration. The most commonly reported cause of PTTE are inadequate processes
(35%). While most of these would suggest that processes are not as robust as they could be, there is
significant evidence to suggest that other system factors are involved such as incorrect procedures (11%)
and training issues (26%). The data would therefore suggest that testing processes would be improved by;

• reviewing processes and training to ensure they are robust

• making full use of equipment capabilities
• producing effective documentation that directs staff to follow procedures correctly
• ensuring that training is thoroughly understood

Many reports that fell into the Ineffective training sub-category indicated that staff involved lacked
experience so support should be given to staff even after training to ensure that they fully understand
the process correctly.
Figure 28.6: Sample
processing error
(SPE) (n=146)
R 1
Human error
RO (3) Procedural steps omitted/
ER

5 wrong procedure performed

AN

10
(77) Procedure performed
incorrectly
H UM

32
System error
OR

77
(17) Inadequate process
ERR

(32) Inadequate QMS - staffing

and workload
17
(10) Ineffective training
EM

3
(5) Incorrect procedure
ST

SY
(1) Inadequate supervision

QMS=quality management system

1 equipment failure is not included in the figure

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SPE fall into similar human factor sub-categories as last year. The sample acceptance process is largely
manual and relies on many checks prone to slips and lapses of concentration. It is therefore no surprise
that 55% of these reports are reported to be due to human error. However, 22% are recorded to be due
to staffing and workload issues. Investigations into SPE, including the regular trending and monitoring of
these errors should therefore try to go further to attempt to determine if these errors are genuinely due
to slips or lapses only or whether further system improvements such as the elimination and reduction of
distractions and increase in available capacity to assist staff conducting these tasks.
Figure 28.7:
Component
collection error R Human error

(CCE) (n=127) RO (26) Procedural steps omitted/

R wrong procedure performed
E

4
AN

11 5 (11) Procedure performed

incorrectly
HU M

20
26
System error
(24) Inadequate process
(5) Inadequate QMS - staffing
30 and workload

R
24 (30) Ineffective training
5 RO (20) Inadequate training
ER
(4) Incorrect procedure

T EM (5) Lapsed/no training

S YS

QMS=quality management system

2 equipment failures is not included in the figure

As a largely manual process that relies on visual checks around 29% of CCE are reported to be a result
of human errors. However, where investigations have been conducted to an acceptable level of depth
71% of reports have been concluded to be a result of some form of system error. Training issues account
for 44% whether that is because people haven’t been trained at all or because training has been poorly
delivered or not clearly understood.

CCE must always be thoroughly investigated and RC and CAPA identified due to the possible knock-on
effects. Many undetected collection errors end up being detected at the bedside. Unfortunately, not all
do, and there are a small number of cases where blood has been transfused to the wrong patient as a
direct result of an initial CCE.
Figure 28.8:
Component
Human error
labelling error (CLE) 1
(9) Procedural steps omitted/
(n=115) wrong procedure performed
R

(38) Procedure performed

RO

4 4 incorrectly
5
HUMAN ER

38 9
System error
OR

(25) Inadequate process

20 (20) Inadequate QMS - staffing
ERR

and workload
9 (9) Ineffective training
EM

(5) Inadequate training

25
(4) Incorrect procedure
ST

SY
(1) Lapsed/no training
(4) Inadequate supervision

QMS=quality management system

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53% of CLE in the previous year’s report were determined to be due to slips and lapses. However, last
year this percentage dropped to 41% indicating improvements to investigations which identified process
and system deficiencies.

39% of reports were due to staffing and workload or weak processes identifying one or more system
or process deficiencies. It is important to fully define the process for labelling components that map out
all the required steps and checks and that that process is described in a comprehensive SOP. This will
ensure standardisation of practice and guard against individuals improvising and following non-standard
practices increasing the risk of error.

Recommendations
Review QMS to ensure the processes involved in the most frequently occurring SAE are robust.
Ensure that:

• the process is thoroughly defined

• that procedures are written giving full and clear instructions how to perform the task

• that training is planned, adequate, delivered and understood

• Where staffing and workload is determined to be a factor, these factors must be addressed with a
plan to increase staffing or to re-prioritise workloads, or both, to support safety for patients and staff

• Distractions must be designed out of processes and where they cannot be, mitigations must be
put in place to minimise their effect

Action: Hospital transfusion teams

Blood establishment reporting n=145 (+33)

Although reports from BE are included in the main analysis, the specific nature of the SAE reports from
BE are lost in the greater numbers of reported hospital transfusion laboratory SAE. Figure 28.10 displays
the reported BE SAE in 2023.

Figure 28.9: Blood

(4) Equipment failure (1) System error - inadequate supervision establishment SAE
(27) Human error - procedural steps (8) System error - inadequate training event category
omitted/wrong procedure performed (1) System error - incorrect procedure
Apheresis collection (50) Human error - procedure performed
by specification
11
(3) System error - inadequate QMS –
incorrectly (n=145)
staffing and workload
(1) Product defect
(22) System error - ineffective training
Storage/HSE 111 (28) System error - inadequate process

Testing of donations 3 11 2 1

Processing 1 4 12 1

Distribution/HSE 111

Whole blood collection 4 11

Other 5 1 15 11 8

Donor selection 19 43 4 11 3 12

0 10 20 30 40 50 60 70 80 90

QMS=quality management system; HSE=handling and storage errors

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The majority of the reports fall into the donor selection category and typically involve errors where a
donor is accepted despite requiring deferral for travel, medical or life-style reasons. Although the diagram
indicates that most of these reports are due to ‘human’ error, i.e., slips, lapses and omissions, this is
usually because the error is not spotted until after the donor’s next donation. This makes it difficult to
assess if the error is a ‘system’ error. However, all BE when reporting donor selection errors perform
recalls and assess the current donation for the deferral reason. Also, processes, procedures and training
are regularly reviewed so the risk to the patient is classed as low.

Figure 28.11 shows a breakdown of the 31 reports which fall into the ‘other’ category.

Figure 28.10:
BE reports in
'other' category (5) Human error - procedural steps (1) System error - inadequate QMS –
(n=31) omitted/wrong procedure performed staffing and workload
(1) Human error - procedure performed (1) System error - inadequate training
incorrectly
(15) System error - inadequate process (8) System error - ineffective training
IBCA 1

PTTE 1 3 1

IBCI 1 7 1 1

FR 3 1 4 1 6

0 2 4 6 8 10 12 14 16

See Appendix 2 for key to category abbreviations

QMS=quality management system

Serious adverse reactions (SAR)

Definition: (Department of Health, 2005) an unintended response in a donor or in a patient that
is associated with the collection, or transfusion of blood or blood components that is fatal, life-
threatening, disabling or incapacitating, or which results in or prolongs hospitalisation or morbidity…
blood establishments and the person responsible for the management of a hospital blood bank shall
notify the Secretary of State (Competent Authority) of any serious adverse reactions observed during
or after transfusion which may be attributable to the quality or safety of blood or blood components:

(i) Collected, tested, processed, stored or distributed by the blood establishment, or

(ii) Issued for transfusion by the hospital blood bank

Blood products
Adverse reactions involving blood products (i.e. licensed medicines such as anti-D Ig, Octaplas®
(Solvent-Detergent fresh frozen plasma), or coagulation factor concentrates should be reported to the
MHRA via the Yellow Card scheme (http://yellowcard.mhra.gov.uk).

Summary of SAR report data

To avoid any confusion the MHRA will only supply, in this Annual SHOT Report, total SAR figures that
qualify for reporting to MHRA under the BSQR, see Figure 28.12.

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Figure 28.11:
SAR reports,
by imputability,
298
reported to SABRE
in 2023
240

131

52

10

0-Excluded or 1-Possible 2-Probable 3-Definite Not assessable

unlikely

Imputability

Inspection report
The MHRA inspectorate have continued to verify blood compliance reports and have conducted 25
inspections since April 2023. A total of 289 BCR were submitted for review for the reporting period 01
April 2022 to 31 March 2023.

The BCR were scored and discussed at a meeting of the BCR Assessment Team (BAT) in August 2023.
The BAT meeting discusses the risk scores from the BCR submitted. In addition, risks raised due to
haemovigilance data from the SABRE reports received, major changes to blood banks and previous
inspection history are discussed.

An overview of the compliance management escalation processes used by the GMP inspectorate,
including information on the IAG and CMT referral processes, is available from the MHRA inspectorate
blog:

https://mhrainspectorate.blog.gov.uk/2017/02/06/overview-of-compliance-management-escalation-
processes-used-by-the-gmp-inspectorate/

There have been 2 referrals to IAG or CMT so far from this cycle of inspections. Summary of significant
issues identified at inspected sites include:

Management of change

The control of change continues to be a deficiency that is commonly raised at blood inspections. The
deficiencies raised include:

• The absence of a user requirement specification

• The lack of a validation master plan (VMP) to guide management through the validation and
qualification of the change.

• Inadequate risk assessment and actions to mitigate risks

• The lack of evidence of sign off of stages of the change control prior to implementation

• The lack of validation evidence to show that the system was fit for task before implementation

• Failure to carry out a post implementation effectiveness check

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Management of non-conformances

The management of non-conformances is regularly raised as a deficiency due to the following:

• Inadequate investigation for an appropriate root cause therefore the inadequate implementation of
an effective CAPA to avoid reoccurrence

• Failure to consider the potential for harm as well as actual harm especially Trusts using the Datix
system

• The lack of an adequate justification for human error being identified as a root cause

• The lack of justification for the late closure of deviations and performing impact risk assessments

• Tracking and trending systems employed not identifying recurring problems due to an emphasis on
consequence rather than root cause

• Inspections are also identifying a worrying trend that Trusts are not reporting incidents to the
competent authority as soon as known

The availability of trained and competent staff

Issues with adequate capacity within the laboratory is an ongoing problem and is often raised as
highlighted by:

• The absence of an effective capacity management plan or similar document to ensure adequate
management of blood transfusion operations and the quality management system

• The inadequate management of risk register entries such as reducing the risk score without an
appropriate justification

• Staff working significantly above their contracted hours to ensure staff rotas are adequately staffed

• Trusts failing to meet several quality metric targets

Blood collection and training

Blood collection and training was not being adequately managed in that:

• Blood collection training and competency audits showing that Trusts were not meeting their KPI for
staff blood collection training

• Inadequate systems in place to control infrequent users of the system and blocking staff who had
left the Trust

Recall

Although there were evidence that external and internal recalls had been regularly performed the systems
in place lacked sufficient detail regarding that actions were to be taken within pre-defined periods of time.

For further information on MHRA and the Regulation of Blood please refer to the MHRA website: https://
www.gov.uk/topic/medicines-medical-devices-blood/blood-regulation-safety

The MHRA Blood forum was launched in June 2016 as a tool to help those involved in blood
component collection, processing, testing and distribution to comply with the EU Blood Directives, UK
Statutory Instruments, and good practice requirements. It provides the ideal opportunity for extended
communication between peers and allows users to put forward their comments and get ‘real-life’
examples of ways in which they can manage robust quality procedures that ensure compliance and
which dovetail with their own business needs and resources. https://forums.mhra.gov.uk/forumdisplay.
php?60-Blood-Forum

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Comment from Julie Staves, NBTC, Transfusion Laboratory

Managers, Chair
This year’s MHRA report on the BSQR is somewhat concerning to me and I feel it reflects the issues
are being experienced across hospital transfusion laboratories.

The increase in the number of reports being made, remains a positive, it shows there is a continued
commitment to reporting and the increase in the acknowledgement that errors are frequently due to
process, or system deficiencies is pleasing.

70% of SAE are assigned to system errors as the causative factors which does mean that we should
be able to address them. More thorough investigation of the 30% of SAE related to human errors may
mean even more errors can be addressed with system improvements. This increase in errors such as
incorrect blood component issues, pre-transfusion testing errors and data entry errors is something we
should try and address in our own laboratories. The MHRA commentary flags the issues we are all facing
daily that of maintaining adequate staffing levels who are suitably trained, and competency assessed.

The 15% increase in the storage errors being report is of concern after a reduction in these in 2022, the
fact that many of these errors are related to one or more deficiencies in the quality system means that it is
imperative that all Trusts/Hospitals take the time to look at their own systems and consider what changes
we should be considering to prevent similar issues within our own departments, including clinical areas.

I would like to flag the recommendations with this report, they are something we should all review carefully
and ensure that if we find our systems are not compliant, then we act accordingly to address the issues.

MHRA haemovigilance team update 2023

The haemovigilance team continues to provide an education service. During 2023 there have been 14
online education events. The team also supports SHOT, UKTLC, NBTC and Regional HTT meetings
on request.

If you are interested in finding out more about how the haemovigilance team could support you, contact

E Mail: [email protected],
[email protected]

Other useful contacts

[email protected] – For matters regarding inspections and inspector advice

[email protected] – Any advice regarding Blood Facilities
[email protected] – For advice regarding the Blood Compliance Report

References
Department of Health, 2005. The Blood Safety and Quality Regulations 2005. [Online] Available at: https://www.
legislation.gov.uk/uksi/2005/50/introduction/made (Accessed 11 April 2024).

European Directorate for the Quality of Medicines & Healthcare (EDQM), 2023. Guide to the preparation, use and quality
assurance of blood components. [Online] Available at: https://www.edqm.eu/en/blood-guide (Accessed 29 April 2024).

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Appendices
Appendix 1:
A component has time expired and not been removed from the storage
Storage Component expiry
location according to laboratory procedures
subcategories Incorrect storage of component A component has not been stored in the correct location
A sample has expired and the component has not been removed from the
Sample expiry
supply chain for the original patient
A component has been returned to the supply chain in error instead of
Return to stock error
being quarantined or discarded
A storage location alarm has been activated but not actioned according to
Failure to action alarm
the procedure
The storage temperature has gone out of specification without an alarm
Storage temperature deviation
being activated
A storage location is accessible to staff or public who are not authorised
Security
to do so
Red cells are returned to a refrigerator after 30 or 60 minutes have
30- or 60-minute rule
elapsed contrary to local procedures for return of unused red cells
Any other storage event affecting the quality and safety of blood or blood
Miscellaneous
components

Appendix 2: Incorrect blood component

Blood issued which does not meet the patient’s specific requirements
Other issued (IBCI)
subcategories Sample incorrectly receipted into the laboratory that should have been
Sample processing error (SPE)
rejected
Component labelling error (CLE) Typically transposition of labels
Any error in the process of testing patient samples and the interpretation
Pre-transfusion testing error (PTTE)
of results
Any error in the collection of components from storage locations, or the
Component collection error (CCE)
handover of components on collection from the laboratory
Transcription errors of data, including both electronic and hand-written
Data entry error (DEE)
data
Failed recall (FR) Failure to recall components in a timely manner
Any error affecting the quality and safety of components not specified
Unspecified (UNSPEC)
elsewhere
Component available for transfusion Expired components which were incorrectly collected, prior to their
past de-reservation (CATPD) scheduled re-stock by the laboratory
Expired component available for Any component issued for a patient, where the component expires prior
transfusion (ECAT) to the planned transfusion
Incorrect blood component ordered Components ordered from a blood establishment that do not meet the
(IBCO) patient’s specific requirements
Handling damage (HD) Damage to a component affecting its quality and safety
Incorrect blood component Blood accepted into a laboratory for a specific patient where the special
accepted (IBCA) requirements have not been matched

Appendix 3: Procedure performed incorrectly Failure to carry out a step(s) correctly

Human error Procedural steps omitted/wrong
Missing a key step or not following the procedure
subcategories procedure performed
Inadequate process Inadequate design of a process. Also includes multiple causative factors
Incorrect procedure Process not properly described in the SOP
Ineffective training Training not understood by operator
Inadequate training Training process not fit for purpose
Lapsed or no training Carrying out a procedure without any formal training
Staffing levels below the minimum level, or unacceptably high workload
Inadequate QMS – staffing and
has resulted in staff making errors. It is also important to consider an
workload
appropriate skill-mix when deciding on minimum staffing levels
Errors have been made by trainees or inexperienced members of staff and
Inadequate supervision
should have been noticed by adequate supervision

266 Appendices
ANNUAL SHOT REPORT 2023

267
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