121
National Haemovigilance Office Annual Report 2004

National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

  • Upload
    voliem

  • View
    216

  • Download
    0

Embed Size (px)

Citation preview

Page 1: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office

Annual Report 2004

Page 2: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

1Annual Report

Contents

List of abbreviations 2

Foreword 4

Haemovigilance 6

An Overview: The First Five Years of the National Haemovigilance Scheme 10

Incorrect Blood Component Transfused 17

Incorrect Blood Component Transfused: Incidents involving Anti-D Immunoglobulin 49

Severe Acute Anaphylactoid or Anaphylactic Transfusion Reaction 59

Transfusion Associated Circulatory Overload 71

Delayed Haemolytic Transfusion Reaction 78

Acute Haemolytic and Other Severe Acute Transfusion Reaction: 82

Transfusion Related Acute Lung Injury 91

Suspected Transfusion Transmitted Infection 93

Pre- Deposit Autologous Donor Incidents 96

Paediatric Incidents 102

The Near Miss Project: The First Full Year of Reporting 109

Acknowledgements 115

Contacts 116

References 117

Appendix 1 120

Page 3: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office2

AA Severe Acute Anaphylactoid/Anaphylactic Reaction

AAA Abdominal Aortic Aneurysm

AABB American Association of Blood Banks

ACE Angiotensin-Converting Enzyme

A&E Accident and Emergency

AHOSTR Acute Haemolytic or Other Severe Acute Transfusion

Reaction

ARDS Adult Respiratory Distress Syndrome

BCSH British Committee for Standards in Haematology

CCU Coronary Care Unit

CJD Creutzfeldt Jacob Disease

CMV Cytomegalovirus

COAD Chronic Obstructive Airways Disease

CVA Cerebro Vascular Accident

CXR Chest X-ray

CPDA1 Citrate-Phosphate-Dextrose-Adenine

DAT Direct Antiglobulin Test

DHTR Delayed Haemolytic Transfusion Reaction

DIC Disseminated Intravascular Coagulation

DM Diabetes Mellitus

DOB Date of Birth

DVT Deep Venous Thrombosis

ECG Electrocardiograph

EPO Erythropoietin

EU European Union

FBC Full Blood Count

FDA Food and Drug Authority

FFP Fresh Frozen Plasma

GI Gastrointestinal

GP General Practitioner

GTN Glyceryl Trinitrite

Hb Haemoglobin

HBV Hepatitis B Virus

HCV Hepatitis C Virus

HDN Haemolytic Disease of the Newborn

HIV Human Immunodeficiency Virus

HLA Human Leucocyte Antigen

HVO Haemovigiliance Officers

IBCT Incorrect Blood Component Transfused

IBTS Irish Blood Transfusion Service

ICU Intensive Care Unit

ID band Identity band

IgA Immunoglobulin A

IgG Immunoglobulin G

IgM Immunoglobulin M

IM Intramuscular

IMB Irish Medicines Board

INR International Normalised Ratio

ITP Immune Thrombocytopaenic purpura

ITU Intensive Therapy Unit

List of Abbreviations

Page 4: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

IV Intravenous

JVP Jugular Venous Pressure

LDH Lactate Dehydrogenase

LOC Loss of Consciousness

LVF Left Ventricular Failure

MERS-TM Medical Event Reporting System for Transfusion

Medicine.

MRN Medical Record Number

MSBOS Maximum Surgical Blood Ordering Schedule

NAT Nucleic Acid Amplification testing

NCHCD National Centre for Hereditary Coagulation Disorders

NEQAS National External Quality Assurance Scheme

NHO National Haemovigilance Office

OPD Out Patient Department

PAD Pre-deposit Autologous Donation

PAS Patient Administration System

PBSC Peripheral Blood Stem Cell

PCC Prothrombin Complex Concentrate

PCR Polymerase Chain Reaction

PNH Paroxysmal Nocturnal Haemoglobinuria

PTP Post Transfusion Purpura

QA/QC Quality Assurance/Quality Control

RCA Root Cause Analysis

Rh Rhesus

RTA Road Traffic Accident

SD Solvent Detergent

SHOT Serious Hazards of Transfusion

SOP Standard Operating Procedure

STTI Suspected Transfusion Transmitted Infection

TACO Transfusion Associated Circulatory Overload

TA-GvHD Transfusion Associated Graft-versus-Host Disease

THR Total Hip Replacement

TRALI Transfusion Related Acute Lung Injury

TSO Transfusion Surveillance Officer

TTP Thrombotic Thrombocytopaenic Purpura

vCJD variant Creutzfeldt Jacob Disease

3Annual Report

Page 5: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office4

Foreword

The 2004 Annual Report from the National

Haemovigilance Office (NHO) completes five full

years of reporting of serious adverse reactions and

events relating to blood transfusion in Ireland. In

these five years, numerous recommendations and

findings have been issued, based on analysis of the

incidents reported to the NHO. This has assisted a

growing awareness of the extent and type of adverse

events/reactions associated with transfusion practice

in Irish hospitals and the measures available to

address these.

Confidence in the scheme continues and is reflected

in increasing reporting rates. As in 2003, 100% of

transfusing hospitals in the Republic of Ireland

participated in this scheme.

Findings and recommendations for 2004 are detailed

in the relevant chapters. Of great concern are the

preventable incidents in the categories of Incorrect

Blood Component Transfused and the potentially

preventable incidences of Transfusion Associated

Circulatory Overload. These incidents, combined

with events reported to the Near Miss project,

highlight errors and areas of high-risk in the

transfusion work processes, and provide an important

opportunity to improve practice and the quality of care

for patients in the context of a no/low blame culture.

The findings and recommendations also provide a

benchmarking tool for Hospital Transfusion

Committees when reviewing practice in their own

hospitals. These committees should be in place in all

hospitals that transfuse blood and they provide an

environment within which any errors identified,

together with their root causes, can be effectively

evaluated. Appropriate actions to improve future

performance and ultimately the safety and care of

patients can also be initiated.

Hospital-based Haemovigilance Officers (HVO) are a

vital part of the haemovigilance network in Ireland.

The NHO is very grateful to HVOs for their continued

efforts in heightening awareness and in developing

mechanisms to increase transfusion vigilance and

staff consciousness in hospitals to reporting such

incidents. The input of Transfusion Medical Scientists

and Consultant Haematologists is also a central

aspect of haemovigilance.

The NHO also acknowledges the continued support

of the Medical Director and staff of the Irish

Medicines Board (IMB). In particular, the expertise

and support of the staff of the IMB’s

Pharmacovigilance Department is especially

acknowledged.

The EU Blood Directive 2002/98/EC which comes

into effect on 8th November, 2005 governs the

activities of Blood Transfusion Services and Hospital

Blood Banks and has far reaching consequences for

Page 6: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

the regulation and management of blood transfusion

services in all EU member states. Two articles in

particular are relevant to haemovigilance in that they

provide a firm legislative basis for haemovigilance and

remove discretionary elements currently present in

relation to reporting of serious adverse reactions.

Article 14 contains specific provisions in relation to

the traceability of blood and blood components as far

as the patient and Article 15 requires that all serious

adverse reactions attributable to the quality and

safety of blood and blood components transfused are

captured and reported to the competent authority.

A number of cases in this report concern

inappropriate use of blood components. While the

risks of transmission of the known viruses HIV, HCV

and HBV are now extremely small, the emergence of

other infectious diseases such as variant Crutzfeldt-

Jakob Disease (vCJD) and West Nile Virus (WNV) as

new transfusion risks, emphasises the need to use

blood appropriately. In June 2005 an Irish blood

donor was subsequently diagnosed with vCJD,

indicating that vCJD is potentially in the blood supply.

Dr. Stefan Laspina who took over as Acting Director

of the NHO from the final quarter of 2004 to July

2005, joins with me in acknowledging the ongoing

support and efforts of the IBTS Chief Executive Mr.

Andy Kelly, National Medical Director, Dr. Willy

Murphy and the staff of the IBTS. Their efforts in the

continued recruitment of blood donors, who

consistently and voluntarily give blood donations and

in the processing and distribution of blood and blood

components to the highest safety standards are the

basic foundations of the national haemovigilance

scheme. Sincere thanks also to all those outside of

the NHO who contributed to the writing of this report.

Finally, the ongoing enthusiasm of the staff of the

NHO in their daily efforts to promote best transfusion

practice and also their patience and support in

compiling, drafting and writing this report is

personally acknowledged.

Dr. Emer Lawlor

Director,

National Haemovigilance Office

Dr. Stefan Laspina,

Acting Director,

National Haemovigilance Office

5Annual Report

Page 7: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

The national haemovigilance scheme is a confidential

anonymised system, co-ordinated by the National

Haemovigilance Office (NHO) and dedicated to the

achievement of a national standard in practice and

quality of care for all patients, before, during and

following completion of transfusion, has similarities to

pharmacovigilance, the system for monitoring drug

safety. It is the professional responsibility of all

healthcare professionals to support the concept of

haemovigilance, which is achieved through

adherence to issued best practice guidelines and

reporting of transfusion incidents/events.

From 8th November, 2005, reporting of serious

reactions which may be attributed to the quality and

safety of blood components will be mandatory as will

serious adverse events relating to the testing, storage

and distribution of blood and blood components.

European Communities (Quality and Safety of Blood

and Blood Components) Regulations 2005 SI

360/2005.

Definition of Terms used in Haemovigilance Serious Adverse Event:Definition:

Any untoward occurrence associated with the

collecting, testing, processing, storage and

distribution of blood and blood components that

might lead to

• Death

• Life-threatening

• Disabling or incapacitating conditions for patients

which results in, or prolongs, hospitalisation or

morbidity

Serious Adverse Reaction:Definition:

An unintended response in the patient associated

with the collection or transfusion of blood and blood

component that is

• Fatal

• Life-threatening

• Disabling

• Incapacitating which results in, or prolongs

hospitalisation or morbidity

National Haemovigilance Office6

Haemovigilance

“A set of surveillance procedures,from the collection of blood and itscomponents to the follow-up ofrecipients, to collect and assessinformation on unexpected orundesirable effects resulting fromthe therapeutic use of labile blood

products, and to prevent theiroccurrence or recurrence” (FrenchLaw regulation no. 93-5, January4th 1993)

Page 8: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

NHO Remit

The remit of the NHO is to: • Receive, collate and follow up reports from

hospitals and general practitioners of adverse

reactions/events connected with transfusion of

blood components/products and provide

feedback information to those making the report

as appropriate.

• Advise on the follow-up action necessary,

particularly with regard to suspected hazards.

• Report adverse reactions to the Irish Medicines

Board (IMB) according to an agreed procedure.

• Provide ongoing support to hospital-based TSO

and as appropriate to medical, nursing and

technical staff.

• Provide medical, scientific and nursing analyses of

reports of adverse reactions.

• Advise on improvements in safe transfusion

practice based on the data supplied by hospitals.

• Support development of clinical guidelines for

hospitals in relation to the use of blood

components/products.

• Support the audit function of hospitals in relation

to transfusion practice.

• Promote the development of fully traceable

transfusion records at hospital level.

• Report to the National Blood User’s Group on a

periodic basis with a view to developing national

best transfusion practice.

A major part of the remit of the office is education and

support in relation to best transfusion practice at

hospital level.

The NHO is located at the National Blood Centre,

(NBC) James’s St., Dublin 8 and functions under the

directorship of a Consultant Haematologist with two

and a half fulltime equivalent HVO, a Programme

Administrator and Assistant Administrator. A fulltime

HVO coordinates the ‘Near Miss Project’.

Hospital Transfusion CommitteesThe NHO actively encourages the development of

adequately resourced, multi-disciplinary Hospital

Transfusion Committees, and this is also a

recommendation of the National Blood Strategy

Implementation Group, highlighted in their report to

the Minister for Health and Children in 2004. (O’Reilly

2004) The Hospital Transfusion Committee acts as a

forum where local transfusion issues can be

discussed in a no-blame, non-punitive environment.

This multi-disciplinary approach to transfusion

supports the development of best practice. Smaller

centres may share a committee with their supplying

hospital.

Irish Medicines BoardRepresentatives of the IMB and the NHO had regular

meetings during 2004 to review reported incidents,

particularly where there was a question about the role

of concomitant medication. In addition, the IMB’s

Pharmacovigilance Unit provides a valuable resource

to the NHO, advising in relation to the overall

development of the programme.

National Blood Users GroupThe National Blood Users Group, established by the

Minister for Health and Children for the purpose of

preparing and disseminating guidelines for the use of

blood components/products in Ireland has a

membership drawn from a wide range of hospital

based transfusion disciplines, including

haematologists, medical laboratory technologists,

perfusionists, anaesthetists, surgeons and nurses,

representing a wide knowledge of transfusion

practice.

Guidelines published to date are:

• A Guideline for Transfusion of Red Blood Cells in

Surgical Patients (2000)

• A Guideline for the Use of Blood and Blood

Components in the Management of Massive

7Annual Report

Page 9: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Haemorrhage (2002)

• Guidelines for the Administration of Blood and

Blood Components (2004)

A number of further guidelines will be published

shortly.

Near Miss Research ProjectA three-year pilot project to capture “near miss”

events, funded by the IBTS, is currently operating,

with ten hospitals participating. Details of the results

are featured in the Near Miss Events chapter of this

report.

Education, Promotion and DevelopmentsThe NHO continues to support the development of

hospital in-service training programmes by working

closely with hospital based HVO. The office also

encourages the development of audit functions at

hospital level in an effort to promote best transfusion

practice. Support is also provided in transfusion

education for nursing and laboratory medical science

students.

All newly appointed hospital based HVO attend an

induction training programme at the NBC including

an introduction to Good Manufacturing Practice

(GMP) and an overview of the IBTS manufacturing

processes at the NBC. Smaller centres benefit from

the NHO developed ‘in-service’ education

programmes as HVO appointments are primarily in

centres with a sizeable blood usage. Nationwide

networking among HVO is also promoted by regular

correspondence through telephone/e-mail

communication and personal visits.

The NHO hosted the annual conference in Naas

entitled “Haemovigilance-from Concept to Reality” in

October 2004. Dr. Emer Lawlor, Director of the

NHO, presented a summary of the incidents reported

to the NHO in 2003. The keynote speaker was Dr.

Paul Ness, Director of Transfusion Medicine Division,

Johns Hopkins Hospital, Maryland, USA, who

presented on their haemovigilance programme, with

reference to delayed haemolytic transfusion reactions

(DHTR) incorrectly labelled samples and septic

platelet transfusion reactions. Other presentations

included:

• The Operation of the BARS System and the SATO

wristbands at Addenbrookes. by Claire Sidaway,

Specialist Practitioner of Transfusion,

Addenbrookes NHS Trust Hospital

• Safe Track by Deirdre Gough, HVO, St. James’s

Hospital

• Appropriate Blood Usage (In Neonates) by Dr.

Joan O’Riordan Consultant Haematologist, IBTS

• Review of Laboratory Implicated Errors 2003 by

Ken Gregg, Monaghan General Hospital

• A Web-based Approach to Improving Blood

Transfusion Safety by Paul O’Brien, St. Vincent’s

Hospital

• Clinical Experience with Octaplas in Ireland by Dr.

Volha Chekrizova, Medical Researcher,IBTS.

The NHO again hosted a poster competition which

was judged by Dr. Paul Ness and Ms Claire Sidaway.

The winning poster displayed details of Pre and Post

Red Cell Transfusion Haemoglobin Audit in General

and Vascular Surgery Patients and was compiled by

the haemovigilance group in St. James’s Hospital,

Dublin.

NHO AuditsTwo audits were carried out during the year to

evaluate the effectiveness of the Irish Haemovigilance

scheme. The first measured the level of satisfaction

amongst hospital based HVOs with the support

offered by the NHO. The findings were presented at

the HVO workshop in October 2004, together with

the NHO response and proposed action plan.

Staffing levels in the NHO have been improved and

National Haemovigilance Office8

Page 10: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

the action plan will be further addressed in the

coming year.

The second audit aimed to obtain a clear picture of

requirements at hospital level for effective

haemovigilance. The findings of this audit were

presented at a workshop for HVOs in November

2004 and circulated in early 2005. Some will be

incorporated into comprehensive guidelines for

standard delivery of haemovigilance.

The NHO News, an information newsletter circulated

to all HVO, provides an informal forum for the

reporting of work carried out within the NHO and

individual hospitals, and includes local education and

training initiatives and social events which may be of

interest to other HVO. Details of events of national

and international interest are also reported. During

2004, three editions of this newsletter were

published.

Information on haemovigilance can be directly

accessed on the IBTS website @ www.ibts.org.

Reports‘Did Not Progress’

A total of 244 transfusion reactions/events were

reported. Of these, 30 did not fulfil the criteria for a

haemovigilance event, as on further investigation it

was revealed that either the patient’s underlying

condition was attributed to symptom development, or

that a serious reaction to transfusion had not

occurred. In total 214 incidents were reviewed for

this report.

‘Nil to Report’For the second successive year, 100% (81) of

hospitals participated in the scheme by returning a

‘Nil to Report Form’ in 2004. 48 of those hospitals

(59%) reported a transfusion reaction or event

compared to 47 hospitals (58%) in 2003.

9Annual Report

Table 1 NHO-Confirmed Reports by Category

Total IBCT A/A TACO AHOSTR PAD TRALI TTI DHTR Incidents

214 126 35 15 24 7 0 3 4

100% 60% 16% 7% 11% 3% 0 1% 2%

0

30

60

90

120

150

IBCT

126

TACO

15

AHOSTR

24

PAD

7

TRALI

0

TTI

3

DHTR

4

AA

35

Figure 1. Haemovigilance Incidents 2004

IBCT Incorrect Blood Component/Product Transfused.

A/A Severe Acute Anaphylactoid or Anaphylactic Transfusion

Reaction.

TACO Transfusion Associated Circulatory Overload

AHOSTR Acute Haemolytic or Other Severe Transfusion Reaction.

TRALI Transfusion Related Acute Lung Injury

TTI Suspected Transfusion Transmitted Infection.

DHTR Delayed Haemolytic Transfusion Reaction

PAD Pre-deposit Autologous Donor incident

Page 11: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office10

An Overview:

The First FIVE YEARS of the NationalHaemovigilance Scheme

Findings: 2000-2004 The NHO scheme has been fully operational since

January 2000, and has published annual reports for

2000, 2001, 2002 and 2003. This year represents

the fifth year of reporting and presents an opportunity

to review the findings for the previous five years.

Approximately 875,841 blood components were

issued during the five-year period and a total of 778

adverse transfusion reactions/events were reported

to the NHO. During 2000, the first full year of

reporting, there were 85 incidents which fulfilled the

criteria for a reportable event (NHO Annual Report,

2000). By 2004, the number of events has increased

to 214 incidents fulfilling the criteria for a

haemovigilance event.

Incorrect Blood Component Transfused (IBCT) This category captured 428 of the 778 incidents and

in keeping with other haemovigilance schemes that

collect similar data, it is the largest category reported.

It also includes errors and omissions relating to blood

products such as anti–D and factor concentrates as

these also allow evaluation of the quality of systems in

place for transfusion practice. However suspected

adverse drug reactions associated with use of these

licensed medicinal products continue to be reported

to the Irish Medicines Board (IMB) as the competent

authority for licensing of medicinal products.

In 2001, in response to feedback, the IBCT incidents

were divided into levels of severity (NHO Annual

Report, 2001)

• Level 1 incidents are defined as those with the

potential for permanent injury or are life

threatening, and include wrong blood for wrong

patient and the transfusion of blood

components/products, which were not required.

• Level 2 incidents were classified as unlikely to

cause permanent harm. Between 2001- 2004,

139 (32%) of all IBCT were captured in this

group.

• Level 3 incidents have no realistic potential for

harm: During the four year period 65 incidents

(15%) were reported.

Page 12: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Table 2 Breakdown of NHO incidents (2000-2004) (n=778)

YEAR IBCT AA TACO DHTR AHOSTR TRALI TTI PAD Unusual TOTAL

2000 31 22 8 2 14 - 7 - 1 85

2001 69 35 16 1 12 3 2 3 3 144

2002 87 31 10 9 8 2 3 5 - 155

2003 115 23 14 9 8 1 4 6 - 180

2004 126 35 15 4 24 - 3 7 - 214

TOTAL 428 146 63 25 66 6 19 21 4 778

55% 19% 8% 3% 8% 1% 2% 3% 1% 100%

Wrong ABO Transfusion During the five-year period 2000- 2004, 20 reports

were received of incorrect ABO group red cells

transfused. In 13 of these cases, the red cells were

ABO incompatible. The total number of red cells and

whole blood issued for this period was 639,198.

Therefore, the risk of receiving a wrong ABO red cell

transfusion is about 1:31,959 units issued and of

receiving an ABO incompatible red cell transfusion is

of the order of 1:49,169 units issued. Seven of the

thirteen patients who received an ABO incompatible

red cell transfusion had symptoms of an acute

transfusion reaction. However, all recovered and no

fatalities were reported from the reaction.

11Annual Report

Table 3 Wrong ABO red cell transfusions 2000-2004

Year

20002001200220032004Total

TotalIBCT

316987115126428

IBCT Involvingincorrect ABOred cells

3645220

IBCTInvolving ABOincompatiblered cells

2415113

Units of redcells & wholeblood issued

124,797120,482127,601130,088 136,230639,198

Number per units 1:31959 1:49169issued

IBCT55%

AA19%

TTI2%

AHOSTR8%

TRALI1%

TACO8%

PAD3%

Unusual1%

DHTR3%

Figure 2 Breakdown of NHO incidents (2000-2004) (n = 778)

Page 13: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Prescription and Request In 152 cases (36%) the error was the first stage of

the transfusion process i.e. at prescription and

request indicating the importance of continuing

education for medical and nursing staff involved in

prescribing and ordering blood components.

Pre transfusion samplingPre transfusion sampling has been identified as the

site of first error in 32 (7 %) cases. Three of these

events were associated with the transfusion of ABO

incompatible red cells. This highlights the importance

of secure procedures for positive patient identification

and emphasises the necessity for each patient to

wear a secure ID band at the time of sampling. In one

case the transfusion was delayed because of sample

labelling problems. It is likely this delay contributed to

mortality. The introduction of automated solutions,

sample bar coding (Turner et al, 2003), extended/24

hours phlebotomy services, as well as the provision of

an ongoing transfusion education programme are key

recommendations.

Laboratory Procedures In 125 cases (29%) the first error occurred in the

laboratory. In many cases the error occurred on call

and often involved staff from other laboratory

disciplines covering the transfusion laboratories

indicating the importance of regular training of on call

staff. The use of automated grouping and automated

transmission of results would help reduce human

error through transcription and reading errors.

Site of Collection In 25 cases (6%) the first error was at the site of

collection. These resulted from absence or

inadequacy of checking procedures at the time of

collecting the component. Adequate checking

systems must be in place at the site of collection of

blood components/products from either the hospital

transfusion laboratory or the satellite fridge.

Bedside administration In 59 (14%) cases, the site of first error involved the

final bedside checking procedure with a failure to

accurately identify the patient or the

component/product pre transfusion. This resulted in

an incorrect component/product being administered.

The reasons for such errors are varied but as the final

bedside check provides the opportunity to detect and

prevent earlier errors its importance is highlighted.

The checking procedure must be performed at the

bedside and the patient should be asked to verify

their identification details. In addition, the patient must

be positively identified and an identity (ID) band must

be worn at the time of the pre-transfusion sampling

and must be in place at the time of transfusion.

The site of first error in the remaining IBCT cases

involved incidents occurring at the initial clerking

stage or at the supply centre or were unclear.

Wrong haematology values resulting inunnecessary transfusions. In 26 (6%) cases, transfusion was based on

inaccurate or absent haematology results or

inadequacy of the checking procedure. In 19 (4%) of

National Haemovigilance Office12

Laboratory(125) 29%

Prescription/Request(152) 36%

Clerking(7) 2%

Unclear(8) 2%

Collection(25) 6%

Supply Centre(19) 4%

Administration(59) 14%

Sampling(32) 7%

Figure 3 Site of first error 2000-2004 (n=427)

2006- One Anti D case not allocated a site of first error

Page 14: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

these cases, the transfusion of red cells was involved.

Errors in communication can be minimised by using

automated transfer of laboratory information to

hospital patient identification systems. All clinical

areas should have easy access to these systems and

staff should be trained in their use so that transfusion

decisions are based on the most up-to-date and

correct results.

Inappropriate transfusionsInappropriate transfusions were reported in 48 (11%)

cases. Nineteen (4%) of these cases resulted in an

unnecessary transfusion of either SD plasma or FFP.

In addition, ten reactions captured within the A/A

category were as a result of the inappropriate use of

plasma. Adherence to national guidelines is important

to avoid inappropriate use of blood components and

unnecessary donor exposure.

All clinical staff involved in transfusion must be familiar

with guidelines for administration of components

which will help avoid unnecessary transfusions. SD

plasma or FFP is only required for reversal of over

anticoagulation in the presence of major bleeding or

emergency surgery.

BLOOD PRODUCT ADMINISTRATION (Anti D andFactor concentrates) Seventy–five of these IBCT reports related to errors

in the administration of blood products, 59 (79 %) of

which involved the administration of Anti-D. Each

hospital should have clear policies and procedures

for the prescription and administration of Anti-D and

the management of Rh D negative women during

pregnancy. Procedures for the identification of the

patient prior to Anti-D or factor concentrate

administration should be as stringent as those

performed for transfusion.

REACTIONS Severe Acute Anaphylactoid or AnaphylacticTransfusion Reactions (A/A) Severe acute anaphylactoid or anaphylactic

transfusion reactions were the largest category of

serious adverse reactions with 146 incidents (19%)

reported. In 2004 there was an increase of 52% in

these incidents compared to the 2003 figures.

Between 2000 and 2003 twenty-two cases involved

the use of fresh frozen plasma (FFP), six of which

were for warfarin reversal as a result of over

anticoagulation, which were not in compliance with

current guidelines. The numbers of reactions

associated with plasma have fallen consistently since

the first year of reporting and the introduction of SD

plasma, which is associated with a low risk of allergic

type reactions. In 2004 there were two

anaphylactoid/anaphylactic transfusion reactions

associated with the use of SD plasma. However, this

has been offset by an increase in the number of these

reactions associated with platelets. Of the 87

reactions (60%) associated with platelets, the vast

majority, 67 (77%) were associated with the

transfusion of pooled platelet concentrates. In most

cases the patients responded rapidly to treatment.

Some of these transfusions were however considered

to be inappropriate.

Acute Haemolytic or Other Severe AcuteTransfusion Reaction. (AHOSTR) There were 66 incidents (8%) reported in this

category. In 2004 there was a three fold increase in

these incidents compared to the 2003 figures. Red

cell transfusion was involved in 56 (85%). Where

there was documentation of the investigations carried

out evidence of bacterial contamination was

excluded. Only 2 cases were associated with the

detection of red cell antibodies. However, seven of

the 13 incidents involving ABO incompatible red cell

transfusions, reported in the IBCT category were

accompanied by symptoms of an acute transfusion

13Annual Report

Page 15: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

reaction. In total therefore, of 63 red cell transfusion

reactions reported to the NHO during this period,

seven (11%) were due to ABO incompatibility. This

confirms the need to fully investigate all reactions

associated with the transfusion of red cells.

Transfusion Associated Circulatory Overload(TACO)

Transfusion associated circulatory overload (TACO)

was reported in 63 (8%) transfusions, of which 10

(15%) were associated with the use of plasma. In at

least six of these 10 (60%), the transfusion was

considered inappropriate and in two cases may have

contributed to mortality. In light of these findings, the

NHO issued an information leaflet on the use of FFP.

This leaflet outlined the firm indications for the

transfusion of FFP and highlighted the risks

associated with its use. This was updated to reflect

changes following the introduction of solvent

detergent (SD) treated pooled plasma in March

2002.

Forty-eight (76%) TACO incidents related to the

transfusion of red cells. Thirty-eight cases (60%)

involved patients aged 70 years or over. In one case

where the patient was already critically ill the

transfusion may have contributed to mortality. All

patients should be assessed pre- transfusion to

assess their likelihood to develop TACO. Particular

attention should be paid to the identification and

management of “high-risk “ patients such as the

elderly, infants and children, patients with a low body

weight and physiologically compromised patients

with a history of cardiac, respiratory or renal

insufficiency or chronic anaemia. Monitoring of the

patient’s fluid balance, transfusing as slowly as

possible and observing closely for signs and

symptoms of volume overload during and soon after

transfusion is recommended to minimise the risks.

The use of prophylactic diuretics is also

recommended.

Suspected Transfusion Transmitted Infection (TTI) There were 19 (2%) reports of suspected transfusion

transmitted infections (TTI). Investigation of these

reports confirmed one case of bacterial

contamination, which involved a pooled unit of

National Haemovigilance Office14

2000

3

1

-

3

1

8

2004

14

-

1

-

-

15

Total

48

1

1

10

3

63

2003

12

-

-

1

1

14

2002

10

-

-

-

-

10

2001

9

-

-

6

1

16

Table 4 Numbers of reports of TACO by component and reporting year

Component transfused

Red cells

Pooled Platelets

Apheresis Platelets

FFP or SD Plasma

Multi components

Total

Page 16: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

platelets from which coagulase negative

staphylococcus was cultured from both the patient

and the unit. The patient recovered without

complications.

Eighteen reports of possible viral transmission were

investigated: six Hepatitis C virus (HCV), seven

Hepatitis B virus (HBV), four Human

immunodeficiency virus (HIV) and one case of co-

infection with both HBV and HCV. Transfusion has

been excluded as the source of infection in 16 of the

18 patients by re-testing of donors or the archived

samples from the time of donation. In one case, one

donor could not be traced and so HBV transmission

by transfusion could not be excluded. In the second,

also a case of HBV, investigations are ongoing,

however in both cases the patients had other risk

factors.

This low incidence of confirmed TTI is in keeping with

the estimated risk of transfusion transmitted viral

infection which since the introduction by IBTS of

Nucleic Acid Amplification Testing (NAT) has been

estimated at 1 in 4 million units transfused for HIV, 1

in 4 million units transfused for HCV and 1 in

200,000 units transfused for HBV (O’Riordan J.,

Personal Communication).

Delayed Haemolytic Transfusion Reaction (DHTR) There were 25 (3%) reports received which were

categorised as DHTRs during 2000-2004. There

were no fatalities. These reactions, which are largely

unavoidable, are likely to increase as our patient

population, particularly the elderly, receive more

transfusions. In 15 (60%) of the 25 cases the

patients were aged over 70 years.

Transfusion Related Lung Injury (TRALI) Six cases (1%) suggestive of transfusion related

acute lung injury (TRALI) were reported. Three cases

involved red cells , one was associated with

apheresis platelets, one with fresh frozen plasma and

one case involved multiple blood products. TRALI

was confirmed in one case and considered highly

probable in three cases, one of which was associated

with fatality. It was considered possible in one case

and unlikely in a final case. There were no incidents

which met the criteria for TRALI reported in 2004.

Post-Transfusion Purpura (PTP) and Transfusion-Associated Graft-versus Host Disease (TA-GvHD) There were no incidents reported in these categories

during the first five years.

Pre-deposit Autologous Donor Incident (PAD) In 2001 the NHO began to collect reports relating to

pre-deposit autologous donor incidents. Twenty-one

(3%) incidents were reported and one of the adverse

events involved hospitalization of the patient but none

involved rescheduling of surgery. Seven, or one third

of the incidents involved children. In a number of

cases the donated blood was not required

suggesting the importance of careful donor selection

for PAD.

CURRENT PARTICIPATION The number of incidents submitted to the NHO has

continued to rise. Because of the anonymity of the

scheme, it is difficult to determine if the increase is as

a result of an improved detection rate in hospitals that

have always participated and/or a general increase in

participation as further hospitals report to the

programme. The success of the scheme to date can

be directly attributed to the work and enthusiasm of

the hospital based TSO’s, and the support they

receive from transfusion medical scientists and

consultant haematologists. However, in order to

encourage reporting and ensure the

recommendations from the reports are adopted

further work is required.

In November 2005, the EU Blood Directive

2002/98/EC will come into effect. This directive

governs the activities of Blood Transfusion Services

and Hospital Blood Banks. Article 14 of the Directive

contains specific provisions in relation to traceability

of blood and blood components in regard to the

patient. Article 15 requires all serious adverse

reactions attributable to the quality and safety of

blood and blood components transfused are

15Annual Report

Page 17: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

captured and reported to the competent authority.

This removes the previous discretionary element in

relation to reporting of serious adverse reactions and

gives haemovigilance a firm legislative basis.

A number of strategies are currently being examined

to improve the reporting rates, such as changes to the

“Nil to Report” form, to allow feedback to hospitals of

their reporting rates in comparison to hospitals with

similar transfusion requirements. It is hoped to

address this issue in the future.

National Haemovigilance Office16

2000

37%

31%

68%

2004

59%

41%

100%

2003

60%

40%

100%

2002

49%

44%

93%

2001

50%

27%

77%

Table 5 Hospital Participation (2000–2004)

Year

Submitted incident

Nil to Report

Participation

Page 18: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

This category account for 60% of incidents reported(126 of 214)

There were no fatalities or major morbidity associatedwith the transfusions and all patients recoveredwithout complications. It is likely that in one casewhere transfusion was delayed because of samplelabelling problems that this contributed to mortality(Case 18).

The Site of First Error indicates the stage in thetransfusion chain where the IBCT first occurred.

Figure 4 Site of first error - IBCT Cases including Anti-D(n=125*)

17Annual Report

Incorrect Blood Component Transfused

Definition: Incorrect blood componenttransfused (IBCT) is thetransfusion of a bloodcomponent/product which did notmeet appropriate requirementsand/or was intended for anotherpatient (SHOT 1996).

Laboratory(36) 29%

Prescription/Request(48) 38%

Clerking(4) 3%

Collection(4) 3%

Supply(4) 3%

Administration(24) 20%

Sampling(5) 4%

*One Anti-D case (case 79) has not been allocated a site of

first error

Page 19: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Introduction

In 2001 the NHO introduced stratification ofincidents by level of severity in the IBCT category.The following classification system is used:

· Level 1 Events with the real potential for permanentinjury or to be life threatening.

· Level 2 Events that are very unlikely to causepermanent harm or have the potential forminimal or transient harm.

· Level 3 Events with no realistic potential for harm.

Level 1The transfusion of a unit of blood or blood componentor product to the wrong recipient has been taken asa major or level 1 incident, irrespective of whether theblood was by chance ABO compatible or whether ornot there were complications. This is due to thepotentially disastrous effects of the transfusion of thewrong blood to the wrong patient and the level ofsystem failure involved. Similarly, mistakes whereeither Rh D positive blood components were given toa Rh D negative female of child bearing age, or Anti-D prophylaxis was omitted in error or giveninappropriately have also been classified as level 1incidents. Inappropriate transfusions or events wherepatients who did not require a transfusion of a bloodcomponent/product but who received oneinadvertently on the basis of incorrect haematologyresults were also classified as level 1 incidents.

In 2004 there were 52 cases (42%) reported whichwere classified as Level 1 incidents.

Level 2Incidents such as failure to give cytomegalovirus(CMV) negative or irradiated cellular bloodcomponents have been classified as level 2 incidents.Although the effects of such a mistake are potentiallyvery serious, they are in fact extremely rare becauseleucodepletion of all blood components has verylargely abrogated the risks. Incidents whereguidelines were not adhered to or discrepancies inpatient identification or errors in handling bloodcomponents not meeting the criteria for a level 1incident have also been classified as level 2.

In 2004 there were 53 cases (42%) reported whichwere classified as Level 2 incidents.

Level 3Level 3 incidents on the other hand, do not pose anyrisk to patients. However, they do indicate defects inthe quality of the service delivered. Where multipleerrors have been reported in the same patient, wehave reclassified Level 3 incidents as Level 2because of the possible cumulative effects on thequality of service delivery. Those that are collectedunder the programme can be instructive and usefulfor education purposes as they are indicative of abreakdown in procedures. The National Blood UsersGroup (2002) recommends that any such breakdownshould be investigated and corrected even if therecipient of the transfusion is unharmed.

In 2004 there were 20 cases (16%) reported whichwere classified as Level 3 incidents.

*One Anti-D case (case 79) has not been levelled.

Summary of the key IBCT Findings andRecommendationsTables of all cases, selected detailed case historiesand the detailed findings and recommendations areincluded in the relevant subsections. Anti-D IBCTincidents are presented in a separate section at theend of this chapter.

National Haemovigilance Office18

Page 20: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Errors involving wrong ABO/Rh group,wrong blood or wrong blood to patient

Findings• There were 16 Level 1 incidents where the patient

received blood components of the wrongABO/Rh group or where the wrong blood orblood component was given. A number of theseinvolved components given to the wrong patient.

• An ABO incompatible red cell transfusion wasgiven to the wrong patient who did not require ablood transfusion (Case 116). This occurred in anA&E department where remote checking of theunit and failure to check the identity of the patientwho was not wearing an ID band wereresponsible for the error. The patient who wasGroup O, suffered a reaction after 100mls ofGroup A red cells had been transfused, by whichtime the error was discovered. The patientrecovered fully.

• A further patient (Case 76), who also did notrequire transfusion, received blood which wasfortunately ABO compatible. This error occurredbecause the wrong patient’s compatibility reportwas used to collect blood from the laboratory. Thewrong blood was therefore collected for thewrong patient. The unit was checked remotelyfrom the patient’s bedside. The nurse thenbrought the unit to the wrong patient’s bedsideand administered it without checking the patient’swristband.

• Two patients (Cases 27, 82) received red cells ofthe incorrect Rh group due to a laboratory error inrecording the results of testing.

• One patient (Case 1) was transfused with redcells crossmatched with a sample from a differentpatient of the same name because incompletedetails were taken when a telephone order wasmade. A further patient (Case 87) was transfusedwith red cells crossmatched using a frozen serum

sample from the wrong patient due to a sampletransposition. Fortunately in the two cases, bothpatients were the same ABO Rh group.

• One case (Case 57) involved the use of ABOcompatible ‘walk in’ donors to provide fresh wholeblood in a massive transfusion setting.

• Three patients (Cases 20, 23, 46) received Oplasma instead of their correct group which wasA. One case (Case 20) involved the collection,thawing and administration of unlabelled plasma inerror by nursing staff. In two cases (Cases 23, 46)the units were incorrectly issued by the laboratory.

• Two patients (Cases 53 and 78) received Oplatelets instead of their correct ABO group whichwas B and A respectively. One of these (Case 78)was an infant.

Recommendations • Staff administering transfusions must adhere

strictly to the policies and procedures fortransfusing blood.

• The checking procedure must be performed at thebedside. Remote checking is unacceptable anddangerous practice.

• The patient should be asked to verify theiridentification details and be involved in theidentification and checking process wherepossible.

• The patient identification details must always bechecked against the wristband during the bedsidecheck. The medical record alone must not beused to check patient identity.

• A check must be performed on the componentand on the identification documentation to ensurethat the correct component is selected at the siteof collection.

19Annual Report

Page 21: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

• Electronic forms of patient and bloodcomponent/product identification are nowavailable and are recommended as they providethe highest degree of security. Where thesesystems are not in place, manual bedsideidentification procedures at sampling andadministration remain the gold standard and mustbe strictly adhered to (NBUG, 2004).

• An uninterrupted working environment should bemaintained during the crossmatch and issue ofunits, to avoid distraction and/or transposition.

• When possible written or electronic blood/bloodcomponent transfusion requests are preferred. Inthe event of telephone orders hospitals shouldhave a SOP or policy regarding the informationrequired (NBUG, 2004).

• There is no place in the current management ofmassive haemorrhage for the use of ‘walk in’donors (NBUG, 2002).

• Hospitals should have a massive transfusionprotocol in place specifically designed for theirhospital taking into account local factors such asready availability of blood and blood components.This is particularly important in obstetrichaemorrhage. This protocol should be activatedperiodically to ensure that flaws are identified andstaff are familiar with it (NBUG, 2002).

Inappropriate Transfusions

Findings

There were 17 cases reported in this category. Thesewere of two types, transfusions based on incorrectlaboratory values and transfusions based on error inclinical judgement.

Incorrect Hb result There were two cases reported (Case 31, 93) wheretransfusion was based on the wrong Hb result. One

(Case 93) arose because of a communication errorbetween the clinical area and the laboratory and in thesecond (Case 31), the sample was unsuitable due tohaemolysis and should not have been processed.

Errors in clinical judgement There were 15 cases reported where the transfusionwas based on error in clinical judgement. Seveninvolved red cells and eight involved plasma.

Red Cells• Seven cases (Cases 4, 15, 33, 64, 70, 99, and

122) were reported where transfusion wasconsidered inappropriate because the Hb was notchecked between transfusions and the patientreceived more units than necessary. All sevenpatients were elderly and six were female.

• In two cases (Case 122 and 33), the Hb resultswere known. In Case 122, the Hb result of12.0g/dl was known, but the transfusion wasprescribed regardless.

• In the other case (Case 33), the Hb results werealso available but not checked and an elderlyfemale was over transfused. The Hb posttransfusion was 16.8 g/dl.

• In one case (Case 99), two units were prescribedand subsequently transfused where the patientwas stable and the clinical picture did not warranttransfusion.

PlasmaSeven Level 1 cases involved the inappropriate use ofplasma.

• In one case (Case 22), plasma was given tocorrect a low serum protein.

• In five cases (Cases 38, 62, 67, 71 and 120),plasma was given to reverse anticoagulants inpatients who were not bleeding. In Case 38, thepatient was scheduled for elective surgery.

National Haemovigilance Office20

Page 22: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

• In case 119, plasma was administered to manageintra-operative bleeding, which had stopped.Coagulation studies were not performed.

Recommendations• Red cell transfusion must be administered on a

unit by unit basis in the non-emergency setting.

• Plasma is not indicated for the correction of a lowserum albumin.

• Plasma is not indicated for elective anticoagulantreversal. Plasma should only be given whereemergency reversal of anticoagulant therapy isindicated and where prothrombin complexconcentrates which are now licensed for thisindication are unavailable.

Failure to give Antigen Negative Blood

FindingsIn two cases (Case 63 and 110), antigen negativeblood was not supplied when requested. In one ofthese cases (Case 63), the patient had a pre-existingRh antibody documented, but this information wasnot clearly available from either the poorly organisedmanual records or the incomplete computer recordsin the laboratory. In the second case (Case 110),incorrectly antigen typed blood was issued in error inan emergency.

Recommendations• Consideration should be given to issuing antibody

cards to all patients with clinically significantantibodies (NBUG, 2002).

• The possibility of a national patient antibodyregister for patients with red cell antibodies shouldalso be evaluated.

• Once a clinically significant red cell antibody hasbeen detected in the past, the patient shouldalways receive antigen negative blood, eventhough the antibody is no longer detectable,except in an emergency situation where antigennegative blood is not available.

Failure to supply special requirements inCMV negative and/or irradiatedcomponents

Findings• Fifteen cases involved failure to administer CMV

negative and/ or irradiated components topatients requiring them.

• Fourteen cases involved failure to prescribe thecorrect component and as in all but one case(Case 88), clinical details were not entered on therequest form, the laboratory was not alerted to theerror.

• Three cases (Cases 51, 89 and 91) involvedtransfusion in an emergency but in one case(Case 51) although the patient had stabilised andthe need for specialised requirements wasrecognised, two of the remaining units were notwithdrawn but were transfused on subsequentdays.

• In two cases (Cases 107, 108) the patient wasreceiving shared care between centres but thepatient had not been transfused in that centrebefore. In three cases (Cases 89, 91 and 17), thepatient was admitted to a different facility and thenecessity for specialised components was notrecognised.

• In three cases (Cases 50, 88 and 123), the errorinvolved the laboratory. In one case (Case 88),the requirements on the request form wereoverlooked. In two cases (Cases 50 and 123), thelaboratory system alert was not noticed on oneoccasion (Case 123) and had not been activatedin the other (Case 50), although previoustransfusions had been CMV negative andirradiated.

• One case (Case 98) involved failure to prescribeCMV components to a pregnant woman.

• The final bedside check did not detect any of theerrors.

21Annual Report

Page 23: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Recommendations • The importance of providing clinical details to

laboratories is re-emphasised. In all but one case,clinical details which would have alerted thelaboratory were not supplied.

• Blood transfusion request forms should be fullyread at processing with particular attention to anyspecial requirements.

• Blood transfusion laboratory computer systemalerts which draw attention to the need forspecialised components should be used whereverpossible.

• Hospitals must put in place systems to ensure thatpatients who require specialised products receivethe correct component wherever possible.

• These systems should include labelling of thepatient’s medical record. As some of the incidentsinvolved shared care or admission to differenthospitals, issuing of a patient card should beconsidered.

• There are situations where CMV negativecomponents cannot be supplied, as in the case ofspecialised components such as HLA matched orHPA 1a negative apheresis platelets where onlysmall suitable numbers of donors are available, orin cases of blood shortage. In these cases, theuse of non CMV negative product is appropriateand as the product is leucodepleted, the risk ofCMV infection is very small and is outweighed bythe risks of failure to transfuse.

Patient/sample identification problems

Findings• In a number of cases, samples were not properly

labelled with the correct patient details. In onecase (Case 18), an elderly patient with severeanaemia had an unidentified antibody which led todelay in obtaining the correct blood. The patientdied before transfusion and this delay probably

contributed to mortality.

• There were two cases where an incompletetelephone order to the laboratory led to problemsin patient identity where there were two patientswith the same names in the hospital. In one casealready described, (Case 1), the blood wascrossmatched against a sample from the wrongpatient.

• In Case 28, although the correct blood was issuedon the crossmatch sample from this patient, thepatient’s identity was incorrectly assigned in thelaboratory because the incorrect patient with thesame name was selected from the computerdatabase.

• In one case (Case 35), the patient who had beentransfused earlier expressed concern when henoticed he had an incorrect ID band. However thecorrect blood was transfused as the correct IDband had been on at sampling and the ID bandwas not checked prior to transfusion.

Recommendations

• A secure patient identification procedure shouldbe in place in all hospitals and the ID wristbandshould be worn from the taking of the crossmatchsample right through the transfusion. This IDwristband should contain three unique identifiers,which include the patient’s full name, date of birthand unique identification number (NBUG, 2004).

• It is the professional responsibility of the personwho removes the ID wristband to replace it.

• Sample tubes should be handwritten correctly andlegibly immediately after sampling at the patientsside. Until automated systems are available,identification procedures must be strictly adheredto at the bedside to reduce sample errors. Wherepossible the patient should be involved.

• Hospital laboratories should have SOP or policies

National Haemovigilance Office22

Page 24: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

for the acceptance or rejection criteria forincorrectly labelled samples. Such policies shouldcover amendments, which are acceptable, andthose, which are unacceptable and require a freshsample to be taken.

• In an emergency where there is insufficient time toobtain results from a fresh sample, the policyshould include the use of emergency Group O Rhnegative blood until the patient has beenregrouped.

• It is important that existing policies are fullyunderstood and regularly updated. It is critical toensure that on going education highlights to allmedical, nursing and laboratory staff, especiallythose not regularly working in transfusion orreturning from leave, the importance of strictcompliance.

Errors surrounding the Collection,Storage and Handling of BloodComponents

Findings• There were four cases (Cases 109,114, 121 and

127) where units were not correctly stored beforetransfusion, three involving red cells and oneinvolving SD plasma.

• These cases were Level 2 and Level 3 incidentsand are described in the appropriate tables.

• Case 121 involved a paedipack aliquot and isdescribed in the paediatric chapter.

Recommendations

• Documentation including the prescription shouldbe completed prior to collection of components inthe non-emergency setting.

• Should an unforeseen delay in thecommencement of the transfusion occur, it is

necessary to return the unit to controlled storagewithin 30 minutes and inform the laboratory toensure the unit is being returned to theappropriate fridge.

IBCT due to problems with infusion

FindingsThere were eight cases involving problems withinfusions.

• One case (Case 126), involved the transfusion ofantibiotics into the same line as a red celltransfusion via a three way tap. The patient whowas septic developed a fever and hypertensionpost transfusion. It is likely that this was relatedto his underlying condition rather than thetransfusion.

• In one case (Case 111), the second of two unitsof blood prescribed over three hours wasadministered in 50 minutes. The patient, a youngpost partum female, showed an increase in pulserate and blood pressure and chest tightnesssuggestive of fluid overload but recovered quicklywithout therapy.

• Four cases involved the use of a fluid giving setwithout an integral filter instead of a blood givingset (Cases 42, 58, 66 and 113). In two cases(Case 42, 113), the incident involved a newmember of staff. In one of these, the staff memberthought all fluids in theatre were administeredthrough a blood giving set as in the hospitals shehad previously worked in and presumed she wasusing a filtered set. In the second case, theperson was unfamiliar with the different packagingof the sets.

• One case (Case 66) arose because the fluidgiving sets and the blood administration sets werestored together and the wrong set was selected.

23Annual Report

Page 25: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Recommendations• No fluids other than normal saline should be

added to blood due to risk of haemolysis orclotting.

• It is recommended that blood administration setsbe stored separately to fluid administration sets.

• In the non-bleeding patient, infusion rates dependon the clinical context, age and cardiac status ofthe patient. Except for patients in the massivetransfusion setting, transfusion rates for bloodshould not exceed 2-4 mls/kg/hr (NBUG, 2004).

• The use of calibrated infusion pumps to ensurecorrect infusion rates should be evaluated.

Unit labelling Errors

Findings• There were three incidents (Cases 6, 24 and

105), where red cell units issued for transfusionwere mislabelled. In one of these cases (Case24), blood for two patients was labelled at thesame time and the unit labels were transposedbetween patients. Both were fortunately Group ORh negative and the patients suffered no harm.

Recommendations • There should be a dedicated area in the laboratory

for labelling products. At the time a unit is issued,there shall be a final check of transfusion recordsand each unit of blood or component (Brecher etal, 2003).

• Processing should be performed on samples fromthe beginning of the process to the endindividually and by one person, wherever possible.

• Where possible, two people should read andinterpret results in the laboratory.

• Wherever possible, only the units from one

crossmatch should be labelled and issued at anygiven time to avoid errors.

Blood Centre Supply problems Findings• Three incidents involved the supply centre, (Cases

25, 77, 110), where there was difficulty insupplying the correct component or where theincorrect component was issued in error.

• In one case (Case 77) there were no in-date Rhnegative platelets available to treat emergencyobstetric haemorrhage. A clinical decision wasmade to use Rh D negative platelets which hadexpired a few hours earlier in preference to Rh Dpositive platelets with Anti D.

• In Case 25, the product of choice for plasmaexchange was group B Octaplas. Due, however,to a shortage of group B Octaplas, Uniplas wasused.

• In another case (Case 110), an incompletelyantigen typed unit of red cells was selected andlabelled manually as antigen negative and issuedin error in an emergency, when in fact it wassantigen positive.

MiscellaneousFindings• There were a number of incidents where errors

occurred during issuing and administration ofblood where the possibility of patient harm waslow but which reflected failure to adhere to bestpractice.

• These included incidents where units had expiredpre-transfusion (Cases 39, 77), where more than72 hours had elapsed between the crossmatchsample being taken and the transfusion beingadministered (Case 5, 9, 54, 69, 80 and 117) orthe units were given too slowly (Case 13, 59, 100and 101).

National Haemovigilance Office24

Page 26: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Recommendations• While blood stock management to avoid wastage

due to outdating of units is an important aspect oflaboratory practice, laboratories should try toensure that blood close to expiry is not releasedfor patients who are unlikely to be able tocomplete the transfusion within the expiry period.

• Where blood isused near to expiry date the AABB2002 recommends that transfusion should becompleted prior to component expiration. Inindividual cases, a medical decision may be madeto continue the transfusion. The risk of stopping anecessary transfusion particularly when suppliesare short, coupled with the risk of exposing thepatient to another donor, must be balancedagainst the remote risks of completing atransfusion shortly beyond the expiry time.

• From starting the infusion to completion, infusionof the pack should take a maximum of four hours(NBUG, 2004).

• A repeat crossmatch sample is required if morethan 72 hours have elapsed since the time oftaking the pre-transfusion sample or betweentransfusions.

Incorrect Factor ConcentrateadministeredThe risk of errors when administering factorconcentrate therapy to patients is a constant hazard,particularly if staff are unfamiliar with the differentproducts. To minimise this, secure systems need tobe put in place to ensure the administration of thecorrect product to the correct patient. The NationalCentre for Hereditary Coagulation Disorders(NCHCD) has produced a standard protocol for staffadministering factor concentrates. This is availablefrom the NCHCD, located at St James Hospital,Dublin 8.

FindingsSix adverse events were reported involving factorconcentrates.

• In one case (Case 73), where recombinant factorVIII concentrate was given to the wrong patientwho was not a haemophilia patient, theprescription and drug were checked away fromthe bedside. When the patient’s first name wascalled, another patient with the same first namereplied and the patient’s ID wristband was notchecked.

• One patient (Case 112) who did not normallyrequire factor concentrate for control of his VonWillibrand’s disease received plasma derivedfactor concentrate in error through communicationfailure.

• Inadequate dosage was reported in two cases(Cases 19, 81).

• The wrong make of factor VIII concentrate wasadministered in one case (Case 21), and inanother (Case 115), the patient who requiredtreatment received the correct dose ofprothrombin complex which however had beenissued for a different patient.

Recommendations• The same precautions and identification proce-

dures need to be followed for factor concentratesas are for blood components.

• The importance of the bedside check is reiterated.

• Clear communication between treating centres isparamount in preventing error, as Case 112demonstrates.

• Except in the emergency situation, transfusion offactor concentrate products should only beadministered on the basis of a written prescription.

25Annual Report

Page 27: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office26

Leve

l

1 1 1 1 1 1 1 2

Case

Num

ber

IBCT

Case

116*

IBCT

Case

76*

I BCT

Case

87*

IBCT

Case

1*

IBCT

Case

27*

IBCT

Case

57

IBCT

Case

82*

IBCT

Case

49

ABO

and

RhD

Grou

pof

Patie

ntGr

oup

ORh

Dpo

sitive

Grou

pA

RhD

posit

ive

Grou

pO

RhD

nega

tive

Grou

pO

RhPo

sitive

Grou

pA

RhD

nega

tive

Grou

pA

RhD

posit

ive

Grou

pO

RhD

posit

ive

Grou

pO

RhD

nega

tive

ABO

and

RhD

Grou

pof

IBCT

Grou

pA

RhD

posit

ive

Grou

pO

RhD

posit

ive

Grou

pO

RhD

nega

tive

Grou

pO

Rhpo

sitive

Grou

pA

RhD

posit

ive

Two

units

ARh

Dpo

sitive

One

unit

ORh

Dpo

sitive

Grou

pO

RhD

nega

tive

Grou

pO

RhD

posit

ive

Volum

eof

IBCT

10m

lsof

red

cells

70m

lsof

red

cells

Thre

eun

itsof

red

cells

One

unit

ofre

dce

lls

Two

units

ofre

dce

lls

Thre

eun

itsof

red

cells

Two

units

ofre

dce

lls

One

unit

ofre

dce

lls

Sym

ptom

sand

Outc

ome

Hype

rtens

ion,t

achy

card

ia,dy

spno

ea,w

heez

e,re

stles

snes

sand

anxie

ty.

Noco

mpli

catio

nsas

are

sult

ofth

istra

nsfu

sion.

Noco

mpli

catio

nsas

are

sult

ofth

istra

nsfu

sion.

Noco

mpli

catio

nsas

are

sult

ofth

istra

nsfu

sion.

Noco

mpli

catio

nsas

are

sult

ofth

istra

nsfu

sion.

Dono

rssu

bseq

uent

lyte

sted

nega

tive

forv

iralm

arke

rs.No

com

plica

tions

asa

resu

ltof

this

trans

fusio

n.

Noco

mpli

catio

nsas

are

sult

ofth

istra

nsfu

sion.

Noco

mpli

catio

nsas

are

sult

ofth

istra

nsfu

sion.

Caus

eof

Erro

r

ABO

incom

patib

leblo

odad

mini

stere

dto

the

wron

gpa

tient

due

tore

mot

ech

eckin

gat

the

nurse

ssta

tion

and

failu

reto

chec

kpa

tient

’sID

atth

ebe

dside

.Pa

tient

wasn

otwe

aring

awr

istba

nd.

Com

patib

ility

form

from

the

wron

gpa

tient

sent

toth

elab

orat

ory

and

aun

itof

red

cells

wasc

ollec

ted.

The

unit

wasr

emot

elych

ecke

din

the

treat

men

tro

om.

The

patie

nt’s

IDwa

snot

chec

ked

atth

ebe

dside

prior

totra

nsfu

sion.

Seru

msa

mple

incor

rect

lylab

elled

.W

rong

patie

nts’

seru

mcr

ossm

atch

ed.

Thre

eun

itsof

the

wron

gblo

odtra

nsfu

sed

which

happ

ened

tobe

Grou

pO

RhD

nega

tive.

Telep

hone

requ

estt

olab

orat

ory

forb

lood

forp

atien

t.Th

eon

lyde

tail

requ

este

dby

the

labor

ator

ywa

sthe

patie

nt’s

nam

e.Th

ere

were

two

patie

nts

with

simila

rnam

esin

the

hosp

itala

ndblo

odwa

scro

ssm

atch

edan

diss

ued

onth

ewr

ong

patie

nt’s

sam

ple.

This

wasn

otde

tect

edat

the

beds

idech

eck

asth

eun

itwa

snot

chec

ked

again

stth

ewr

istba

nd.

RhD

grou

pre

cord

edinc

orre

ctly

byon

call

med

icals

cient

istdu

ring

chan

geov

erof

shift

.

Thre

eun

itsof

whole

blood

take

nfro

m“w

alkin

dono

rs”an

dtra

nsfu

sed

durin

ga

mas

sive

haem

orrh

age.

Patie

ntinc

orre

ctly

grou

ped

asRh

Dne

gativ

e,dis

cove

red

onre

chec

king

asRh

Dpo

sitive

.

RhD

posit

iveun

itgiv

ento

RhD

nega

tive

patie

ntbe

caus

ean

incor

rect

com

men

twas

atta

ched

toth

eun

itwh

ichre

ad“U

nitgr

oup

diffe

rent

from

patie

ntbu

tOK

totra

nsfu

se”i

nste

adof

“Use

only

inEm

erge

ncy”.

TABL

E:6:

Erro

rsin

volvi

ngW

rong

ABO/

RhGr

oup,

Wro

ngBl

ood

orBl

ood

toW

rong

Patie

nt(R

edCe

lls)(

N=11

)

*Inc

luded

asfu

llca

sehis

tory

Page 28: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

27Annual Report

Leve

l

2 2 2

Case

Num

ber

IBCT

Case

94*P IB

CTCa

se96

*P IBCT

Case

97*P

ABO

and

RhD

Grou

pof

Patie

ntGr

oup

ORh

Dpo

sitive

Grou

pO

RhD

posit

ive

Grou

pO

RhD

posit

ive

ABO

and

RhD

Grou

pof

IBCT

Grou

pO

RhD

posit

ive

Grou

pO

RhD

posit

ive

Grou

pO

RhD

posit

ive

Volum

eof

IBCT

One

aliqu

otof

paed

ipack

red

cells

One

aliqu

otof

pead

ipack

red

cells

One

aliqu

otof

paed

ipack

red

cells

Sym

ptom

sand

Outc

ome

Noco

mpli

catio

nsas

are

sult

ofth

istra

nsfu

sion.

Noco

mpli

catio

nsas

are

sult

ofth

istra

nsfu

sion.

Noco

mpli

catio

nsas

are

sult

ofth

istra

nsfu

sion.

Caus

eof

Erro

r

Thre

eali

quot

sofr

edce

llswe

reinc

orre

ctly

cros

smat

ched

and

trans

fuse

dfro

ma

paed

ipack

which

wasc

ross

mat

ched

and

alloc

ated

fora

noth

erba

byof

the

sam

ena

me.

Thre

eali

quot

sofr

edce

llswe

reinc

orre

ctly

cros

smat

ched

and

trans

fuse

dfro

ma

paed

ipack

which

wasc

ross

mat

ched

and

alloc

ated

fora

noth

erba

byof

the

sam

ena

me.

Thre

eali

quot

sofr

edce

llswe

reinc

orre

ctly

cros

smat

ched

and

trans

fuse

dfro

ma

paed

ipack

which

wasc

ross

mat

ched

and

alloc

ated

fora

noth

erba

byof

the

sam

ena

me.

TABL

E:6:

Erro

rsin

volvi

ngW

rong

ABO/

RhGr

oup,

Wro

ngBl

ood

orBl

ood

toW

rong

Patie

nt(R

edCe

lls)(

N=11

)(Co

nt)

*PInc

luded

asfu

llca

sehis

tory

inPa

ediat

ricCh

apte

r

Page 29: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Errors involving wrong ABO/Rh group orblood to wrong patient

A number of these cases are discussed in detail.

ERRORS INVOLVING BLOOD TO WRONGPATIENT: Case Histories (Red Cells)

Level 1 IBCT Case 116This elderly patient was being assessed in the A&Edepartment and was not prescribed for blood. Twostaff members checked a unit of Group A positive redcells, which was intended for another patient,remotely at the nurse’s station against thecompatibility label. One staff member then went tothis patient who was not wearing a wristband. Thestaff member did not ask the patient to identify herselfor check that she had a wristband. The transfusionwas commenced and following administration of 10mls of blood the patient developed symptoms ofhypertension, tachycardia, dyspnoea, wheeze,restlessness and anxiety. The staff member was stillat the bedside and realised that the wrong patienthad been selected. The unit was discontinued andchlorpheniramine, hydrocortisone IV, salbutamolnebuliser and oxygen at 4 L/min were administered.Intravenous NaCL was also commenced. The patientsettled shortly after the medication had beenadministered with resolution of symptoms within 24hours. The laboratory investigations showed that thepatient was Group O positive. The post transfusionDAT was positive but Hb, LFT’s , renal function testsand coagulation screen were normal and the patientrecovered fully.

Level 1 IBCT Case 76This incident involved the transfusion of 70 mls ofGroup O Rh D negative red cells to a group A Rh Dpositive patient who was not scheduled fortransfusion. The error occurred because a compatibility form foranother patient was sent to the laboratory requestingone unit of red cells. The laboratory provided acrossmatched unit for this request and it was

collected and brought to the clinical area. Twopeople checked the unit in the treatment room againstthe patient’s medical record. The nurse then went tothe wrong patient’s bedside. The patient was notasked to identify themselves and the details on thepatient’s wristband were not checked against the unitbefore the transfusion was commenced. The nursediscovered the error after 70 mls had been transfusedwhen it was noted that the compatibility form, whichwas now in the medical record, contained a differentname to that on the patient’s medical record. The unitwas immediately discontinued and the patientsuffered no complications as a result of thistransfusion.

Level 1 IBCT Case 87This female patient required a transfusion of threeunits of red cells for a perioperative bleed. A phonerequest for blood was made on-call to the laboratory.This patient had already been group and screenedand the medical scientist regularly working in bloodtransfusion thawed the specimen for crossmatch. Inerror, another patients frozen serum sample was usedfor this crossmatch. This occurred because thesample tube was incompletely labelled and while itcontained a similar unique number to that of thepatient, there were no other patient details. Also thesample tubes were normally stored in numerical orderbut on this occasion were out of sequence. Thepatient grouped as O Rh D negative. Three units ofgroup specific crossmatched red cells were issuedfor the patient. All three units were transfuseduneventfully. The error was discovered during aroutine check of all on-call work. The ward staff wereimmediately alerted and a sample was taken whichconfirmed the patient group as O Rh D negative.Laboratory investigations showed no evidence ofhaemolysis as the sample processed was the samegroup as the patient. As a result of this incident allserum samples are now bar-coded and must bescanned electronically prior to crossmatch.

Level 1 IBCT Case 1This elderly ITU patient, Patient X, with multi organ

National Haemovigilance Office28

Page 30: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

failure required a transfusion. A telephone call wasmade to the laboratory asking if a group and hold hadbeen performed on this patient and this wasconfirmed. Later, a further telephone call was maderequesting red cells for this patient. The telephonelog was not filled in, and no other details other thanthe patients name were requested by the laboratory.There were two patients with the same name in thehospital and the blood was crossmatched and issuedfor the wrong patient, Patient Y. When the blood wascollected from the fridge, only name details werechecked. During the bedside check, the compatibilitylabel was checked against Patient Y’s details on thecompatibility form. Patient’s X ID wristband waschecked against his medical records. However theunit of blood, labelled with Patient Y details, was notchecked against Patient X’s wristband. Onretrospective crossmatch it was found by fortunatecoincidence that the unit was the same group as therecipient.

Errors involving blood of wrong Rh group:Case histories (Red Cells)

Level 1 IBCT Case 27This elderly male patient, admitted for investigation ofsymptomatic anaemia, required a transfusion of twounits of red cells. The patient had no historical recordof transfusion in this hospital. The group andcrossmatch were done during the on call period. Twomedical scientists were covering the session from17.00 hrs to midnight and one of these had startedthe procedure. The other medical scientist, whowould not normally work in blood transfusion,completed the procedure. The blood group wasdone using gel cards and the result was recorded asgroup A Rh D positive. The actual result was Group ARh D negative. Two A Rh D positvie units were issuedand transfused uneventfully when the error wasdiscovered the following day, during a routine audit ofon call work. This incident highlighted that as far aspossible the person starting the group andcrossmatch should also complete the procedure.

Level 1 IBCT Case 82This group O Rh D positive female required atransfusion of two units of red cells for anaemia Hb6.3g/dl. A medical scientist not normally working intransfusion did the crossmatch during the on callperiod over a weekend. No historical group wasavailable for the patient. The patient’s group wasidentified and recorded as O Rh D negative. Twounits of compatible red cells were issued andtransfused. Three days later when a furthertransfusion was required the patient grouped asgroup O Rh D positive which was confirmed ontesting a second sample. Retrospective testing of theoriginal pre transfusion sample also confirmed thepatient as O Rh D positive. Investigation of theincident has shown that an error occurred whenrecording the results of the grouping procedure. Asecond medical scientist reviewing on call work thenext day failed to identify the error. As a result of thisincident it is now recommended that a second groupmust be processed to confirm all on call work if ahistorical group is not available.

Errors involving wrong ABO/Rh group:Case histories (Plasma)

Level 1 IBCT Case 20This male patient on warfarin therapy, required anemergency transfusion of solvent detergent (SD)plasma following a fall. The pre-transfusion samplewas processed on call and the patient grouped as ARh D positive. In error four units of Group O SDplasma instead of Group A SD plasma were collectedfrom the storage fridge by nursing staff and signedout of the central plasma log, thawed by the nursingstaff and brought unlabelled to the ITU for this patient.There was no compatibility form and the nursing staffthought this was the product of choice. The errorwent unnoticed during the bedside checkingprocedure. The patient suffered no complications asa result of this transfusion. The error was identifiedduring routine retrospective audit by the HVO. Thisincident has highlighted the necessity for a medicalscientist to be involved in the issue of bloodcomponents.

29Annual Report

Page 31: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Level 1 IBCT Case 23This elderly male patient with multiple medicalproblems on warfarin had suffered an internalhaemorrhage. Three units of SD Plasma wereprescribed for emergency anticoagulant reversal. Thepatient was Group A Rh D negative. A medicalscientist who normally works in this area issued threeunits of Group O SD Plasma in error. Two membersof staff checked the units at the bedside but the errorremained undetected. The error was discovered on aroutine check of the issued plasma several days later.A software change on the laboratory computer hasbeen requested to include a warning if SD Plasmawhich is not the same ABO blood group of thepatient is requested for issue.

National Haemovigilance Office30

Page 32: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

31Annual Report

Level

1

1

1

CaseNumber

IBCT Case 20*

IBCT Case 46

IBCT Case 23*

ABO and RhD Group ofPatient

Group A Rh Dpositive

Group A Rh Dpositive

Group A Rh Dnegative

ABO and Rh DGroup of IBCT

Group O SD Plasma

Group O SD Plasma

Group OSD Plasma

Volume ofIBCT

4 units of SD Plasma

Two units of SDPlasma

Three units of SDPlasma

Symptoms andOutcome

No complications as a resultof this transfusion.

No complications as a resultof this transfusion.

No complications as a resultof this transfusion.

Cause of Error

Group O SD Plasma was issued bynursing staff in error instead ofgroup A Octaplas.

Group O SD Plasma issued by thelaboratory to a group A patient.

Incorrect group SD Plasma issuedin laboratory in error for a group Apatient.

Table 7: Errors involving wrong ABO/Rh group Plasma (N=3)

Level

1

1

CaseNumber

IBCTCase 53

IBCT Case 78*P

ABO and RhD Group ofPatient

Group B Rh Dnegative withimmune anti D

Group A Rh Dpositive

ABO and Rh DGroup of IBCT

Group O Rh Dpositive

Group O Rh Dpositive

Volume ofIBCT

One unit of pooledplatelets

15mls of apheresisplatelets x 2

Symptoms andOutcome

No complications as a resultof this transfusion.

No complications as a resultof this transfusion.

Cause of Error

Group O Rh D positive plateletsissued to a Group B Rh D negativepatient due to incorrect groupselection in laboratory.

Group O platelets issued from thelaboratory for a Group A infant.

Table 8: Errors involving wrong ABO/Rh group platelets (N=2)

* Included as full case history

*P Included as full case history in Paediatric Chapter

Page 33: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office32

Level

1

1

1

1

1

1

1

CaseNumber

IBCT Case 4*

IBCT Case 15

IBCT Case 33*

IBCT Case 64*

IBCT Case 70*

IBCT Case 99

IBCT Case122*

Volume ofIBCT

At least one unitof red cells

One unit of redcells

Two units of redcells

One unit of redcells

Three units of redcells

Two units of redcells

Two units of redcells

Symptoms and Outcome

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

Cause of Error

The patient received four units of red cells over atwo-day period but the Hb was not checkedbetween transfusions. Post transfusion Hb was13.4g/dl.

Hb prior to transfusion was 7.9 g/dl. Followingtransfusion of second unit of red cells Hb was9.7.g/dl. Third unit of red cells was inappropriatelytransfused. The post transfusion Hb was 13.5g/dl.

Two units of red cells prescribed although the Hbwas 12.8g/dl. Post transfusion Hb was 16.8g/dl.

Inappropriate transfusion of red cells. Posttransfusion Hb 14.4g/dl.

Three units of red cells transfused to a patient onweekly erythropoietin therapy without checking theHb between units. Post transfusion Hb 13.3g/dl.

Inappropriate transfusion. Patient had frankhaematuria but was haemodynamically stable. Hb12.4g/dl pre transfusion.

Communication error regarding updated Hb result.Two units of red cells transfused with a Hb of12.0g/dl.

INAPPROPRIATE TRANSFUSIONS (N=17)Table 10: Transfusion based on error in clinical judgement (Red cells) (N=7)

Level

1

1

CaseNumber

IBCT Case 31

IBCT Case 93

Volume ofIBCT

One unit of redcells

Two units of redcells

Symptoms and Outcome

No complications as a result of thistransfusion.

No complications as a result of thistransfusion

Cause of Error

Patient admitted with breathlessness. Phone resultmisheard as Hb 8.2g/dl, actual result 10.8g/dl.Post transfusion Hb 13.9g/dl.

Pre transfusion FBC specimen haemolysed.Haemolysis of the U/E specimen identified whichshould have prompted inspection of the FBCspecimen.

INAPPROPRIATE TRANSFUSIONS (N=17)Table 9: Transfusion based on incorrect result (Red Cells) (N=2)

* Included as full case history

Page 34: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Inappropriate Transfusion: Red Cells

Transfusion based on incorrect result: Casehistories

Level 1 IBCT Case 31This elderly male patient with malignancy wasadmitted for investigations for shortness of breath.The patient had been discharged from hospital twoweeks earlier when the Hb was 10.8g/dl. On thisoccasion following admission to the ward, a phonedHb result from the A&E department was misheard as8.2g/dl. Two unit of red cells were prescribed and thefirst was administered uneventfully. A repeat Hb priorto the second unit was 10.8g/dl and therefore thisunit was not transfused. Subsequent investigationsshowed that the shortness of breath was actuallycaused by a chest infection.

Level 1 IBCT Case 93 This elderly female patient with a history ofcardiovascular disease received a perioperativetransfusion of two units of red cells for a reported Hb6.5g/dl. The medical scientist processed the urea,electrolytes and the FBC samples on call. The U/Eresult showed serum potassium of 10mmols/L as thespecimen was haemolysed. While this should haveraised the suspicion of a problem with the FBCspecimen, this was not repeated. Two units of redcells were crossmatched and transfused uneventfullywith no Hb measurement on a unit by unit basis. Thepost transfusion Hb was 13.9g/dl which wasdiscovered during a routine audit by thehaemovigilance officer.

Transfusion based on error in clinical judgement: -Case histories

Level 1 IBCT Case 4 This elderly female patient with a history of gastricbleeding was transfused for anaemia, Hb. 6.7 g/dl.The patient received a total of four units of red cellson consecutive days - two units on the first day andtwo on the following day. During this two day period

there had been no further evidence of active bleeding.The Hb was not checked between transfusions. Onthe next day, the patient’s Hb was 13.4 g/dl,therefore, at least one unit of red cells wasinappropriately transfused. The patient suffered nocomplications as a result of this transfusion. Theincident was picked up by the HVO on retrospectiveaudit.

Level 1 IBCT Case 33 This elderly female patient with chronic medicalproblems including malignancy and generalisedweakness was prescribed a transfusion of four unitsof red cells. The pre transfusion Hb. was 9.5 g/dl. Twounits were transfused and the repeat Hb was 12.8g/dl. Despite this, two further units were transfused.On the day following transfusion the Hb was 16.8g/dl. The laboratory staff detected the error when theHb results were being issued.

Level 1 IBCT Case 64 This elderly female patient with underlying ischaemicheart disease and severe rheumatoid arthritis wastransfused with three units of red cells. The unitswere prescribed for a Hb of 9.5g/dl. The patient’shaemoglobin post transfusion of two units was11.9g/dl and following the third unit was 14.4g/dl.Subsequent investigation into the cause of thedyspnoea revealed pulmonary fibrosis with asuspected respiratory tract infection and thetransfusion of these units was consideredinappropriate. While the guideline in the hospitalstates the need to assess transfusion on a unit by unitbasis, this was not done.

Level 1 IBCT Case 70 This female patient with chronic renal failure,hypertension and underlying malignancy wasreceiving weekly erythropoietin therapy for chronicanaemia. On this admission the Hb was 5.8g/dl andthree units of red cells were prescribed. Thetransfusion took place over a weekend perioduneventfully but the Hb was not checked on a unit byunit basis. On routine audit the HVO discovered the

33Annual Report

Page 35: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

patient’s post transfusion Hb was in fact 13.3g/dl.The patient suffered no complications as a result ofthis transfusion. It is likely that there was a problemwith the pre transfusion Hb sample although itappeared to be from the correct patient.

Level 1 IBCT Case 122 This patient with an underlying cardiac disease andother medical problems was awaiting surgery. Thesurgical procedure had been cancelled on a previousoccasion due to anaemia Hb 10.2 g/dl. The GPcontacted the consultant and requested that thepatient be admitted for transfusion prior to surgery inorder to avoid a further cancellation. The consultantthought this was the current Hb result but in fact itwas from a month before. On admission theconsultant left instructions that the patient was fortransfusion of three units of red cells. The patient hada FBC drawn on admission and the result was Hb12.0 g/dl. The medical officer did not convey thisresult to the consultant and the transfusionproceeded as directed. The patient received twounits of red cells but the third was cancelled when thepre-transfusion result was reviewed. This error wasdiscovered during routine audit by the HVO.

National Haemovigilance Office34

Page 36: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Inappropriate transfusion: Plasma

Transfusion based on error in clinical judgement:Case histories

Level 1 IBCT Case 38 This elderly patient was admitted in the afternoon foran elective procedure the following morning. Thepatient had taken 3mg warfarin in the morning prior toadmission. There was no documentation regarding

stopping warfarin prior to the procedure in thepatient’s medical record. The target range for INRprior to the procedure was 1.2 to 1.7. Vitamin K 2mgIV was administered in order to reverse theanticoagulation. The INR following this was 2.2. Oneunit of SD treated plasma was transfused and threehours later a further 2mg of Vitamin K wasadministered. The INR prior to the procedure was1.6.

35Annual Report

Level

1

1

1

1

1

1

1

2

CaseNumber

IBCT Case 22

IBCT Case 38*

IBCT Case 62*

IBCT Case 67*

IBCT Case 71*

IBCT Case 119*

IBCT Case120*

IBCT Case 52

Volume ofIBCT

One unit of SDplasma

One unit of SDplasma

Four units of SDplasma

Six units of SDplasma

Two units of SDplasma

Two units of SDplasma

Two units of SDplasma

Two units of SDplasma

Symptoms and Outcome

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

Cause of Error

Prescribed to treat hypoalbuminemia, contrary toguidelines for use of plasma.

SD plasma given to reverse anticoagulation due towarfarin prior to procedure.

SD plasma given to an elderly patient over 30minutes when vitamin K had already corrected theINR.

SD plasma given for warfarin reversal to a nonbleeding patient awaiting surgical review for kneeinjury INR 2.9.

SD plasma given for reversal of overanticoagulation with warfarin in non bleedingpatient.

Inappropriate transfusion of SD plasmapostoperatively to correct intraoperative bleeding,which had stopped. No coagulation studies hadbeen carried out.

SD plasma used to correct anticoagulation in nonbleeding patient.

SD plasma administered without a prescription.

INAPPROPRIATE TRANSFUSIONS (N=17)Table 11: Transfusion based on error in clinical judgement (Plasma) (N = 8)

* Included as full case history

Page 37: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Level 1 IBCT Case 62This elderly female patient on warfarin therapy, INR4.4, was admitted and was due to have an invasiveprocedure. Vitamin K 10mgs was given IV onadmission. A repeat INR ten hours later was 1.37.Two units of SD plasma were then prescribed statwith a further two units prescribed over 13 minuteseach for the reversal of oral anticoagulation. Inaddition to the unnecessary transfusion, the entirefour unit transfusion was completed within 30minutes which was against hospital policy whichstates that each individual unit should be transfusedover 30 minutes. The patient suffered nocomplications as a result of this transfusion. Theincident was discovered during a routine audit.

Level 1 IBCT Case 67 This patient with a history of cardiovascular diseaseand pulmonary embolus following previous surgery,was admitted for investigation of a knee injury. Thepatient was taking oral anticoagulants and the INRwas 2.8 with no associated bleeding. Six units of SDplasma were administered and the transfusion wascompleted prior to surgical review when it wasdecided that surgical intervention was not required. Atrial of Vitamin K was not considered. The patientsuffered no complications as a result of thisunnecessary transfusion.

Level 1 IBCT Case 71This elderly patient on warfarin therapy who was oneweek post surgery when the INR was found to be 7.4.There was no associated bleeding. A clinicaldecision was taken to administer two units of SDplasma to reverse this instead of administeringVitamin K despite being aware of current nationalguidelines regarding the use of SD plasma. Thefollowing day the INR was recorded at 5.7. Thepatient suffered no complications as a result of thisunnecessary transfusion.

Level 1 IBCT Case 119Two units of SD plasma were prescribed postoperatively for a patient following an elective surgical

procedure. No coagulation studies requested on thispatient. During a routine audit, the haemovigilanceofficer could not find a documented reason for thistransfusion as no other products were prescribed.When the prescription was questioned, theprescribing clinician felt that the patient bledexcessively during surgery although this appears tohave settled when the patient returned to the ward.The patient suffered no sequelae as a result of thisunnecessary transfusion.

Level 1 IBCT Case 120This patient admitted for medical investigations with ahistory of cardiac, respiratory and vascular disease,required treatment for raised INR of 17. The patientwas on warfarin therapy but there were no signs ofactive bleeding. One mg of vitamin K wasadministered and two units of SD plasma wereordered. The medical scientist queried the requestbut the two units were transfused overnight. The INRthe following day was 5.8. This transfusion did notcomply with national and local recommendations formanagement of excessive anticoagulation. The HTChas recommended that a consultant approve allrequests for plasma in future.

National Haemovigilance Office36

Page 38: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Failure to give antigen negative red cells:Case History

Level 1 IBCT Case 63This elderly patient with underlying malignancy andcardiac disease required a transfusion for anaemia5.5 g/dl. The patient had an anti C antibody presenton a previous occasion but the current antibodyscreen was negative. Manual and computer recordswere checked prior to transfusion but failed to detectthis history. On the manual records, two cards werestuck together, on the computer records twoepisodes were present but only one contained a fullhistory, so this information was missed. Three units ofred cells were transfused uneventfully. The error wasdiscovered during a training session. Post transfusionthe units were screened and one of the units wasfound to be C antigen positive. Post transfusiontesting showed the patient to be antibody screennegative, DAT negative.

37Annual Report

Level

1

1

CaseNumber

IBCT Case 63*

IBCT Case 110 This case isalso included inthe supplycentreproblemssection.

Antibodyspecificity

Anti-C

Possible anti Jka-detectedpreviously

Volume of redcells transfused

Three units of redcells

One unit of red cells

Symptoms andOutcome

No complications as aresult of this transfusion.

No complications as aresult of this transfusion.

Cause of Error

Antigen positive blood transfused to anantigen negative patient.Details missed during manual andcomputer record checking.

Patient with previous history of anti Jkaantibodies. Unit of red cells issued as anemergency from the supply centre wasincorrectly selected and labelled as antigennegative when in fact it was antigenpositive.

Table 12: Failure to give antigen negative red cells (N = 2)

* Included as full case history

Page 39: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office38

Level

2

2

2

2

2

2

2

2

2

2

CaseNumber

IBCT Case 2

IBCT Case 17

IBCT Case 50*P

IBCT Case 51

IBCT Case 55

IBCT Case 85

IBCT Case 86

IBCT Case 88

IBCT Case 89

IBCT Case 91

Volume ofIBCT

Two units of redcells.Two units of plateletconcentrate

Two units of redcells

One unit of red cells

Five units of redcells

Four units of redcells Two units of platelet concentrate

Four units of redcells

Three units of redcells, one unit ofapheresed platelets,one unit of plateletconcentrate

Two units of redcells

Two units of redcells

Two units of redcells

Symptoms and Outcome

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

Cause of Error

CMV negative and irradiated blood not requested.

Failure to request CMV antibody negative andirradiated red cells for post solid organ transplantpatient in a different facility.

CMV negative and irradiated red cells not orderedand error not detected on processing in laboratoryas this requirement had not been flagged on aprevious transfusion.

CMV negative and irradiated red cells notprescribed in emergency setting.

Patient on list for solid organ transplant. CMVnegative and irradiated products not ordered.

CMV negative and irradiated red cells required butnot prescribed.

CMV negative and irradiated components requiredbut not prescribed. No clinical details included onthe request form, which could have alertedlaboratory staff.

CMV negative and irradiated units were prescribedbut not issued from the laboratory and the unitswere subsequently transfused without specialrequirements being noticed.

During an emergency admission CMV negative andirradiated units were not requested and with notransfusion history, the units were issued andtransfused without special requirements being metin this different facility.

Failure to prescribe CMV negative or irradiated redcells for an emergency transfusion for anaemiafollowing a solid organ transplant in a differentfacility.

Table 13: Error in CMV negative and irradiated component administration (N=15)

*P Included as full case history in paediatric chapter

Page 40: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Error in CMV negative and irradiatedcomponent administration: Case History

Level 2 IBCT Case 98 This young female patient required a transfusion oftwo units of red cells Hb 6.4g/dl for an ante partumhaemorrhage at 21 weeks gestation. Theprescription did not specify that CMV negative bloodwould be required and the request form did notindicate that this was an antenatal patient thus thelaboratory were not prompted to issue according tohospital policy. Two units of red cells were issuedand transfused uneventfully and the error was notdiscovered until a further request was made to thelaboratory specifying that this was an antenatal

patient. Of the two units that had been transfusedone was CMV positive. The patient has suffered nosequelae to date as a result of this transfusion.

39Annual Report

Level

2

2

2

2

2

CaseNumber

IBCT Case 98*

IBCT Case 102

IBCT Case 107*P

IBCT Case 108

IBCT Case 123

Volume ofIBCT

Two units of redcells

One unit of redcells

One unit of redcells

60 mls of red cells

One unit of redcells

Symptoms and Outcome

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

Cause of Error

Failure to prescribe CMV negative red cells for antenatal patient.

Patient with haematological malignancy, onchemotherapy, was not prescribed CMV negative orirradiated red cells.

Failure to prescribe CMV negative or irradiated redcells for a patient with a malignant haematologicaldisorder. Patient was receiving shared carebetween two different centres.

Failure to request and prescribe irradiated bloodproducts for a patient with a malignanthaematological disorder. Patient was receivingshared care between two different centres.

Failure to prescribe CMV negative or irradiated redcells for a potential solid organ transplant patient.Requirement for special needs flagged in computerfrom previous transfusions but not noted.

Table 13: Error in CMV negative and irradiated component administration (N=15) (cont)

* Included as full case history*P Included as full case history in paediatric chapter

Page 41: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Level

1

1

2

2

3

3

3

3

3

3

3

CaseNumber

IBCT Case 18*

IBCT Case 35*

IBCT Case 28*

IBCT Case 43

IBCT Case 14

IBCT Case 16

IBCT Case 29

IBCT Case 45

IBCT Case 47

IBCT Case 74

IBCT Case 75

Volume ofIBCT

Units nottransfused

Three units of redcells over two days

Three units of redcells

One paedi-pack

One unit of redcells

Two units of redcells

One unit of redcells

One unit of redcells

Three units of redcells

Eight units of redcells

One unit of redcells

Symptoms and Outcome

Failure to transfuse.Possible contribution to mortality.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

Cause of Error

Patient’s name, date of birth, and hospital numberincorrect on sample referred to reference centre.Patient had an unidentified antibody. Delay inproviding compatible red cells.

Patient expressed concern that he had received thewrong blood as he was wearing a wristbandbelonging to another patient. However he hadreceived the right blood as the ID band was correctduring sampling. Incorrect ID band not checked attime of transfusion.

Patient selection error during laboratory processingresulted in an incorrect compatibility label beinggenerated. The name and date of birth wereidentical but the hospital number and address wereincorrect.

Incorrect date of birth was transcribed from notesonto request form and sample tube.

Crossmatch sample without MRN number sent infrom GP. Transfused in hospital but the patient’sMRN number did not appear on either the sampletube, the crossmatch form, the compatibility label,the issue voucher or the wristband.

Surname incorrectly spelled on both request formand sample tube, leading to the issue andtransfusion of two units with surname incorrectlyspelled on both units and the collection slip.

One digit error in date of birth on pre transfusionsample request form and on unit transfused.

Incorrect date of birth inadvertently entered on thepatient’s ID wristband and sample tube.

Incorrect date of birth given by patient whenextremely unwell. Correct date of birth in previousrecords. Computer system in laboratory andhospital information system not linked.

Units transfused with incorrect DOB not confirmedduring bedside checking procedure.

Mother of patient stated patient’s date of birthincorrectly, i.e month, day, year instead of day,month, year.

Table 14: Patient/sample identification problems (N=11)

National Haemovigilance Office40

* Included as full case history

Page 42: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Patient/sample identification problems:Case Histories

Level 1 IBCT Case 18This elderly male patient with a symptomatic anaemia,Hb 3.1g/dl, was admitted from a care facility forevaluation and treatment. The patient had a history ofa CVA. The pre-transfusion sample was taken duringroutine working hours. A positive antibody screen wasdiscovered and a further sample was taken and sentto a reference laboratory for confirmation andcompatibility testing. The sample was incorrectlylabelled with respect to name and date of birth and arepeat sample was requested. A transfusion historywas not recorded on the request form and the carefacility was contacted but there was a delay in gettingthe information. A Chido antibody was identified inthe reference centre and compatible red cells wereissued. The patient became extremely unwell,suffered a cardiac arrest and died before receivingthe blood. The post mortem result revealed a severechest infection with bilateral pleural effusions,however, the delay in providing compatible red cellsmay have contributed to the patient’s death.

Level 1 IBCT Case 35 This male patient with a history of malignancyrequired a transfusion of three units of red cells forpostoperative anaemia. He had a previous transfusionhistory on file in this hospital. Two days following thetransfusion a relative approached the clinical staffconcerned that the wrong blood may have beenadministered as the patient was wearing an identitywristband that belonged to a different patient.Subsequent investigation has revealed that thepatient actually received the correct units intended fortransfusion. During pre transfusion sampling thepatient was wearing the correct identity wristband butthis was removed in theatre and replaced by a handwritten identity band. Following transfer to the ward itwas noted that the identity band was hand writtenand this was replaced with a printed identitywristband from the patient’s medical record, takenfrom the wrong record. The final bedside checkingprocedure pretransfusion involved verbal confirmation

of identity with the patient but did not include the stepto confirm the identity wristband. The patient sufferedno complications as a result of this incident.

Level 2 IBCT Case 28 This patient was prescribed a transfusion of threeunits of red cells for anaemia and a sample was sentto the laboratory for group and crossmatch. Thelaboratory computer system does not require thepatient details for processing. The user was given achoice of two patients on the system with the samename and the same date of birth; one was not an in-patient. The user selected the wrong patient and therequest was processed using the incorrect addressand hospital number. Thus the compatibility form andcompatibility labels were generated with incorrectdetails. Each unit was collected as requiredseparately and on each occasion the error was notdetected during collection of the units from thelaboratory. Two members of staff carried out thepretransfusion check at the bedside but failed todetect the error as each unit was checked against theblood compatibility form only and the patient’s identityband had been removed to gain IV access and notreplaced. When the last unit was collected a memberof the staff noticed the incorrect details on the unit.

41Annual Report

Page 43: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office42

Level

1

1

2

2

2

2

2

2

2

2

CaseNumber

IBCT Case 111*

IBCT Case126*

IBCT Case 30

IBCTCase 40

IBCT Case 42*

IBCT Case 58

IBCT Case 66

IBCT Case 113

IBCT Case 124

IBCT Case 125

Volume ofIBCT

One unit of redcells

One unit of redcells with ivantibiotics

One unit of CMVantibody negativeand irradiated redcells

One unit ofapheresed platelets

Four units of redcells

Two units of redcells

One unit of redcells

Half a unit of redcells

90 mls of red cells

100 mls of red cells

Symptoms and Outcome

Chest tightness 40 minutesfollowing transfusion.

Pyrexia >1.5°C Hypertension.Chlorpheniramine andhydrocortisone administered.Recovered within 24 hours.Reaction probably related topatient’s underlying condition.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

Cause of Error

One unit of red cells prescribed over 3 hoursinfused in error within 50 minutes.

Antibiotics administered through a three-way tapinto the same line as the blood transfusion.

Unit of red cells transfused using an IVadministration set that had been used for aprevious platelet transfusion.

Platelets infused via an unsuitable pump.

Four units of red cells administered through a nonfiltered giving set because the staff memberpresumed that all fluids in the operating theatrewere transfused through blood administration sets.

Two units of red cells inadvertently administeredthrough a non filtered giving set.

Unit of red cells administered through a nonfiltered administration set. Blood administrationsets and regular administration sets are storedtogether.

Incorrect administration set used inadvertently bynew staff member.

Incorrect administration set inadvertently used.

Transfusion not checked against writtenprescription, blood warmer not used as indicated.

Table 15: IBCT due to problems with infusion (N=10)

* Included as full case history

Page 44: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

43Annual Report

IBCT due to problems with infusion:Case histories

Level 1 IBCT Case 111 This young female patient required a transfusion ofred cells for postnatal anaemia -Hb 6.1g/dl. Two unitswere prescribed, each over a three hour period. Thefirst unit was given uneventfully however the secondunit had been infused in error within 50 minutes.Forty minutes following transfusion the patientcomplained of chest tightness and the heart rate andblood pressure were elevated from the baseline andthe patient required medical review. The examinationwas unremarkable and no specific medication wasprescribed. The patient recovered from this incidentwithin four hours. The incident was discovered whenthe HVO was asked in the ward about the need forinfusion pumps to avoid transfusion beingadministered too quickly and the incident of theinadvertent transfusion was described. As a result ofthis incident a report is currently being prepared intothe use of infusion pumps for transfusion.

Level 1 IBCT Case 126 This elderly male patient with underlying sepsis wasreceiving a transfusion of red cells for anaemia. Thepatient was prescribed IV antibiotics, which werechecked by two members of staff. The antibioticswere administered through a three-way tap into thesame line as the blood transfusion. Later anothermember of staff noticed the empty antibiotic bag insitu. The antibiotics were completed and theremainder of the transfusion was completed.Immediately following completion the patientdeveloped a rise in temperature of 1.2°C and a rise inblood pressure. Two and half-hours post transfusionthe temperature had further increased by 2.7°Cabove base line. Chlorpheniramine andhydrocortisone IV were administered. Posttransfusion the DAT and antibody screen wasnegative. The patient recovered fully within 24 hours.

Level 2 IBCT Case 42 This patient with a malignancy required a transfusionof four units of red cells for an intra-operative bloodloss. All four units were administered through a givingset without an integral filter. A new member of thestaff thought that all fluids in the operating theatrewere transfused through a blood giving set, as wasthe practice in other hospitals and she had worked inand presumed she was using a filtered set. Anotherstaff member detected the error. The patient sufferedno complications as a result of this transfusion

Page 45: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Unit Labelling Errors: Case histories

Level 1 IBCT Case 24 This female patient with a history of cardiac diseasewas prescribed a unit of red cells for anemia. In thelaboratory, the crossmatch was conductedsimultaneously with a crossmatch for another patientwho was prescribed two units of red cells. Bothpatients typed as Group O Rh D negative and hadnegative antibody screens. The unit numbers for eachpatient were transposed and subsequently incorrectlyentered on the computer system. One of the unitswas issued from the laboratory and the transfusioncommenced. One hour after the product had beencollected, laboratory staff detected the error duringroutine audit. The transfusion was discontinued. Onretrospective crossmatch the unit was confirmedcompatible with the recipient.

Level 2 IBCT Case 105 This female patient with an underlying malignancywas admitted via A&E and required a transfusion ofred cells for symptomatic anaemia Hb 5.8g/dl. Thepatient regularly attended the day ward fortransfusion. On this occasion, three units of red cellswere prescribed during the on call period. Duringissue of the units, however, a problem was

encountered with the computer printer and only twoissue labels were printed. These two labels werereversed and then fixed to crossmatch compatible butincorrect units. The third unit was returned to stockat that time. During the collection of the first unit,which was labelled with the details for the unit putback into stock, the incorrect label went unnoticed.The unit was checked at the bedside but the unitnumber was not checked. The unit was transfuseduneventfully. The ward phoned the laboratory for thesecond and third units and at this point, the error wasdiscovered. A new label was generated for thesecond unit which was correct. However, during thecollection process the unit was signed out of thelaboratory against the wrong unit. The unit wastransfused uneventfully and the third unit, nowcorrectly labelled was also administered. The errorrelating to the transfusion of the second unit wasdiscovered when the medical scientist on call wascarrying out an audit of units remaining in the fridgeand discovered that one unit signed out actuallyremained in the fridge. The patient suffered nocomplications as a result of this transfusion but theincident has highlighted the importance of checkingboth the unit number and the compatibility label onthe back of the pack.

National Haemovigilance Office44

Level

1

2

2

3

CaseNumber

IBCT Case 24*

IBCT Case 105*

IBCT Case 6

IBCT Case 41

Volume ofIBCT

One unit of redcells

Two units of redcells

One unit of redcells

24 units of SDPlasma

Symptoms and Outcome

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

Cause of Error

Unit numbers for two different crossmatchedpatients transposed on compatibility slip.

Unit labels for crossmatched units attached to theincorrect units. Undetected during the final bedsidechecking procedure.

The medical scientist crossmatched three units forthis patient. The labels for two of the intendedunits were transposed.

Incorrect batch number and group on SD Plasmaon label in error in emergency due to incorrectselection of batch number from computer.

Table 16: Unit labelling errors (N=4)

* Included as full case history

Page 46: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

45Annual Report

Level

1

1

2

CaseNumber

IBCT Case 77

IBCT Case 110IBCT

Case 25*P

ABO and RhD Group ofPatientGroup A Rh Dnegative

Group O Rh Dpositive

Group B Rh Dnegative

ABO and RhD Group ofIBCT

Rh D negative

Group O Rh Dpositive

Uniplas - SDPlasma

Volume ofIBCT

Two units ofplatelet concentrate

One unit of redcells

Plasma exchangedon four occasionswith 12 units ofUniplas

Symptoms andOutcome

No complications as aresult of this transfusion.

Significant rise in BPduring transfusion, whichresolved on cessation oftransfusion and withoutmedication. Unlikely tobe related to thetransfusion.

Positive DAT.No other complications asa result of thistransfusion.Subsequently transfusedwith group B FFP.

Cause of Error

No in-date Rh negativeproduct available. Expiredunits issued and transfused inemergency obstetrichaemology.

Unit of red cells issued as anemergency from the supplycentre was incorrectlyselected and labelled asantigen negative when in factit was antigen positive.

Inability of supply centre tosupply group B SD plasma forlarge volume exchange.

Table 17: Blood supply centre problems (N=3 )

*P Included as full case history in paediatric chapter

Level

2

2

3

3

CaseNumber

IBCT Case 114

IBCT Case 121*P

IBCT Case 109

IBCT Case 127

Volume ofIBCT

Two units of SDplasma

One aliquot of redcells

One unit of redcells

One unit of redcells

Symptoms and Outcome

No complications as a result of thistransfusion

No complications as a result of thistransfusion

No complications as a result of thistransfusion

No complications as a result of thistransfusion

Cause of Error

SD Plasma transfused 12 hours after it wasthawed.

Last aliquot of paedipack red cells removed fromfridge in error and wasted. Stock neonatal red cellsused.

Blood out of controlled storage for 1 hour and 25minutes, then returned to fridge. Later transfused.

Unit recalled by blood issue centre as thetemperature of the blood storage area on thevehicle during delivery was not within specificationon one probe, although van temperature chart waswithin specification.

Table 18: Errors surrounding collection, storage or improper handling of components (N=4)

*P Included as full case history in paediatric chapter

Page 47: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office46

Level

3

CaseNumber

IBCT Case 39

Volume ofIBCT

Two units of redcells

Symptoms and Outcome

No complications as a result of thistransfusion.

Cause of Error

Two units transfused which had expired. Due to abank holiday the day before ward staff checkingthe unit had mixed up the date and thought it wascorrect. It is not clear why short-dated blood wasissued from the laboratory.

Table 20: Expired units transfused (N=1)

Volume ofIBCT

One unit of redcells

One unit of redcells

One unit of redcells

One unit of redcells

One unit of redcells

Two units of redcells

Cause of Error

Crossmatch sample should have been repeated asmore than 72 hours had elapsed since the originalcrossmatch had been taken The patient had beentransfused within that time.

Patient needed three units of red cells. Third unitgiven outside 72 hours from the collection of thecrossmatch sample. A new sample would havebeen required.

A unit of red cells was collected from the issuefridge more than 48 hours after the first unit wastransfused outside hospital policy.

Unit issued using a crossmatch specimen whichwas 58 hours old when the patient had beentransfused within this period outside hospital policy.

Transfusion >72 hours from time of sample.Failure by laboratory to remove blood from thefridge.

An on call medical scientist crossmatched 2 unitsof red cells outside the 48 hour period required byhospital policy.

Miscellaneous (n=14) Included in this category are reports of:• Expired pre-transfusion sample/units (6)• Expired units transfused (1)• Transfusion time exceded (5) • Unit inappropriately checked (1)• Failure to prescribe transfusion (1)

Table 19: Expired pre-transfusion sample/units (N=6)

Symptoms and Outcome

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

CaseNumber

IBCT Case 5

IBCT Case 9

IBCT Case 117

IBCT Case 69

IBCT Case 54

IBCT Case 80

Level

2

2

2

2

3

3

Page 48: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

47Annual Report

Level

2

CaseNumber

IBCT Case 90

Volume ofIBCT

Half a unit of redcells

Symptoms and Outcome

No complications as a result of thistransfusion.

Cause of Error

In a busy, short staffed ward, collection slip usedto cross check unit instead of compatibility reportform.

Table 22: Unit inappropriately checked prior to transfusion (N=1)

Level

3

CaseNumber

IBCT Case 118

Volume ofIBCT

One unit of redcells

Symptoms and Outcome

No complications as a result of thistransfusion.

Cause of Error

Red cells documented in patients notes but nottranscribed into the transfusion prescription chart.

Table 23: Failure to prescribe transfusion (N=1)

Level

3

3

2

3

3

CaseNumber

IBCT Case 13

IBCT Case 59

IBCT Case 83

IBCT Case 100

IBCT Case 101

Volume ofIBCT

One unit of redcells

One unit of redcells

One unit of redcells

One unit of redcells

One unit of redcells

Symptoms and Outcome

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

Cause of Error

Transfusion time exceeded four hours and resultedin some of the product being transfused aftermidnight on the date of expiry.

One unit of red cells transfused over 5 hours and10 mins following removal from fridge.

One unit of red cells transfused over 6 hours.

.

Unit transfused over 6 hours.

Unit transfused over 5 hours and 10 minutes.

Table 21: Transfusion time exceeded (N=5)

Page 49: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Wrong component transfused - Factorconcentrate: Case history

Level 1 IBCT Case 73 This patient with an underlying malignancy receivedrecombinant factor VIII in error. The product hadbeen prescribed for a patient with factor VIIIdeficiency. The patient was sharing a room with threeother patients and the product was checked againstthe prescription by two people in the clinic room,away from the patient’s bedside. When the patient’sfirst name was called in the ward, the incorrect patientanswered and the ID band or the mandatory three

identifiers were not confirmed. The product was givento this patient. The error was discovered followingadministration when the patient was again called bythe first name and replied that was not his name. Thecorrect patient was then identified and factor VII wasthen given to the correct patient.

National Haemovigilance Office48

Level

1

1

1

2

2

2

Volume ofIBCT

RecombinantFactor IX

RecombinantFactor VIII given towrong patient

Plasma derivedFactor VIIIConcentrate

One vial of theincorrect type ofrecombinant factorVIII

Recombinant factorVIII

One vial ofprothrombincomplexconcentrate

Cause of Error

An error was made in calculating the dose ofFactor IX required and an inadequate dose wasgiven.

Lack of communication between the primary carefacility and the prescribing hospital led to thisincident.

Remote checking and patient not formallyidentified. Factor VIII given to the wrong patient.

Only one person checked the register. The wrongpatient was selected when checking the registerand incorrect information passed on to theprescriber.

Patient with severe factor FVIII deficiency requiredrecombinant Factor VIII. The correct product but anincorrect dose was prescribed and administered.

Vial labelled for another patient was collected fromthe blood bank.

Table 24: – Wrong component transfused - Factor concentrate (N=6)

Symptoms and Outcome

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

Unnecessary exposure to bloodproduct.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

No complications as a result of thistransfusion.

CaseNumber

IBCT Case 19

IBCT Case 73*

IBCT Case 112

IBCT Case 21

IBCT Case 81

IBCT Case 115

* Included as full case history

Page 50: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Findings There were 25 incidents involving Anti-D. Thirteen(54%) were classified as serious or level 1 incidents.Nine (38%) were classified as level 2 and 2 (8%)were classified as level 3. One case was not levelledas it occurred outside the control of the hospital.

Errors in administration (N=7) • Six level 1 incidents involved the administration of

Anti-D in error (Cases 37, 48, 60, 92, 95 and106). Three involved administration of Anti-D toRh positive women.

• Two of these cases involved administration to thewrong patient (Cases 37 and 106), one of whomwas Rh D positive, because of failure to followcorrect identification procedures.

• In two further cases, patients were given Anti-Dbecause of a transcription error in the patient’schart in one case (Case 60), and a faxed report ofan incomplete laboratory investigation enteredonto the computer in the second case (Case 95).

Both patients were Rh D positive.

• In two cases (Case 48 and 92) the patient wasalready alloimmunised and therefore did notrequire Anti-D immunoglobulin prophylaxis.

Omission/Delay (N=12)Anti-D was omitted in six cases (Cases 3, 10, 26, 56,103 and104).

The reasons for failure to give Anti-D include:

• In one case, due to a laboratory transcription error,a test result was recorded incorrectly (Case 103).

• In another case (Case 3), there was an incorrectphoned result from the laboratory and the correctreport was only received five days post discharge.

• In a further case (Case 56), the patient hadsuffered a fall and a due to failure to review theKleihauer result prior to discharge, administrationof Anti-D was omitted. Subsequently the patient

Incorrect Blood Component TransfusedIncidents involving Anti–D Immunoglobulin

Incidents involving errors or omissions relating to Anti-D are collected by the NHO as they also relate totransfusion practice. Adverse reactions to theadministration of Anti-D are reportable directly to theIMB under the Pharmacovigilance Scheme, and ifreceived by the NHO are forwarded to them. Therefore,these are not covered in this report.

Page 51: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

was readmitted to the hospital five weeks later forbleeding and received Anti-D on that admission.

• In another case (Case 104), Anti-D was not givenfor a large vaginal bleed at 35 weeks by the GP orat a routine hospital visit one week later. Thepatient was found to be alloimmunised at delivery.

In six cases Anti-D administration was delayed frombetween four to 11 days (Cases 7, 8, 12, 36, 84, and79).

The causes of the delay include:

• Failure to take a cord blood sample and thesubsequent transfer of the mother to anotherhospital (Case 8).

• Failure to prescribe Anti-D at time of receipt of thecord blood result and subsequently the result wasincorrectly transcribed into the chart (Case 84).

• In one case (Case 7), the result was only availableafter discharge. The patient was booked to returnfor a procedure which would have been within 72hours of delivery. A decision was made toadminister the Anti-D at this visit and while it wasissued it was not administered at that time.

• In three cases (Cases 12, 26, and 79), the patientcould not be contacted/failed to return to receiveAnti-D. However in one of these cases (Case 26)the delay was originally caused by the fact that theinitial blood group sample was incorrectly labelledand had therefore not been processed.

Recommendations• Procedures for the identification of the patient

prior to Anti-D administration should be asstringent as those performed for transfusion, i.e.checking of the records at the bedside andcorrect patient identification as per nationalguidelines (NBUG 2004).

• There should be easy access to current laboratoryresults, either in written or electronic format. Boththe prescriber and the person administering Anti-D should always check the most recent report ofthe patient’s RhD and antibody screen to assessthe need for the product prior to administration.Transcribed RhD results must not be accepted;the original reports must always be consulted.Wherever possible, these written results ratherthan telephone results should be used toprescribe and administer Anti-D.

• Anti–D results should not be entered into thecomputer/released before the result has beenconfirmed.

• Effective communication between clinical andlaboratory staff relating to antibody screening andthe issuing of Anti-D, both in the ante and postnatal period is vital in preventing errors. This isparticularly important where patients are receivingshared care between their GP and Obstetrician.

• Where mothers or babies are being nursedoutside the normal clinical areas or in a differenthospital, it should be the responsibility of thereferring unit to follow up these patients andensure that clinical staffs are aware of specificrequirements.

• Medical and Nursing staff working in all clinicalareas where RhD negative women are beingtreated should be familiar with Anti-D guidelines inorder to avoid errors or delay in the administrationof Anti-D.

• Where Anti-D has not been administered withinthe 72 hour period every effort should still bemade to administer the Anti-D within nine to tendays of the sensitising event as this may affordsome protection (BCSH,1999).

National Haemovigilance Office50

Page 52: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Problems with weak RhD groups ormisinterpretation of RhD status (n =4)

There were four cases in this category (Cases 11, 34,61 and 65)

• It is debatable whether some of these should beregarded as true errors as appropriatereagents/techniques were used and thedifficulties in identification of weak D types reflectthe limitations of the technology.

• In one case (Case 11), Anti-D was administeredon the basis of historical records and thesignificance of the weak D type (RhDu) was notrecognised by the laboratory or the administeringstaff.

• In two reports (Case 61 and 65), Anti-D wasissued and administered while awaiting aconfirmatory result from a reference centre whichshowed the patient to be RhD positive (weak Didentified). The administration of Anti-D in thesecases was in fact appropriate as the practice is inline with BCSH guidelines (2004).

• In one case (Case 34), a patient who had beenpreviously been classified as Rh D negative andhad received Anti-D, was now reclassified as RhDpositive (weak D) using different technology. Thisnew result was misfiled resulting in unnecessaryadministration of Anti-D.

Recommendations for weak RhD typing• The use of Du terminology is no longer

recommended. The phrase Du was originally usedfor D antigens detected by only some Anti-Dreagents. High grade Du cells are those that aredirectly agglutinated by some Anti-D reagents andlow grade Du refers to D antigens only detectedusing the indirect antiglobulin technique (IAT). TheBCSH Guidelines (2004) for compatibility testingrecommend that the IAT should not be used for D

typing of patients to reduce the potential formistyping partial D variants as Rh D positive.

• RhD variants may be divided into those that reflecta quantitative change or a qualitative change in theRhD antigen.

• Partial RhD variants are qualitatively different. TheRhD antigen is a mosaic of epitopes and partialRhD variants lack a proportion of these epitopes.People whose red cells lack part of the RhDmosaic can then form antibodies to the missingepitope which behave like Anti–D when testedagainst normal RhD types. The most commonpartial D type associated with risk ofalloimmunization to RhD is DVI.

• Weak D variants are considered to have all the Depitopes present but expressed weakly i.e. fewerD antigen sites per cell.

• Partial weak D cells have some epitopes missing,the remainder being expressed weakly.

• Most examples of weak D can be easily detectedby selecting high affinity monoclonal reagents forroutine RhD typing. The reagents/techniques usedshould not detect partial DVI types.

• Patients should not be regarded as RhD positivewhere a weak positive result has been obtainedusing only a single Anti-D reagent (or a pool ofmore than one reagent). It is safer to regard thepatient as RhD negative until confirmatorygrouping has been performed by a referencelaboratory

• Where verification checks against historicalresults reveal a discrepancy of an RhD group(previous RhD negative – now RhD positive) itshould not be assumed that this was due to failureof previous technology to identify a weak RhDphenotype. Confirmatory typing should be

51Annual Report

Page 53: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

performed on a new sample to exclude a sampleidentification error.

• Investigation of discrepancies may require involvereferral to a reference serology laboratory. As Anti-D should be given as soon as possible after thesensitizing event and always within 72 hours,administration should not be delayed pendingavailability of results.

• The BCSH guidelines on compatibility testing(BCSH 2004) which includes RhD typing advisethat where uncertainty arises regarding a patient’sRhD status that the patient is treated as RhDnegative pending further investigation, as in Case61 and 65.

• Because it may be difficult or impossible todistinguish between passive Anti-D resulting froma previous Anti-D injection during pregnancy andweak Anti-D resulting from early immunisation,Anti D immunoglobulin should be given to anyeligible woman with weak Anti-D antibody atdelivery unless it has been clearly confirmed thatshe is already immunised (BBTS/RCOG 1999).

• Patients identified as having a partial D antigenshould be regarded as RhD negative and thesignificance should be explained to the patientand her clinician.

• Patients who are confirmed as weak RhD positiveshould be regarded as RhD positive fortransfusion and Anti-D prophylaxis purposes. If thepatient was treated as RhD negative in the pastthen the findings should be explained to both thepatient and the clinician and the patient’s fileclearly marked to indicate the change in status sothat confusion does not arise when sensitizingevents occur.

National Haemovigilance Office52

Page 54: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

53Annual Report

Level

1

1

1

1

1

1

3

Volume of IncorrectBlood Component orProduct Transfused

One dose of Anti-D

One dose of Anti-D

One dose of Anti-D

One dose of Anti-D

One dose of Anti-D

One dose of Anti-D

One dose of Anti-D

Cause of Error

Anti-D given in error to a RhD positive motherbecause of remote checking and failure toconfirm positive patient identification prior toadministration.

Two group RhD negative patients with the samename and same address delivered babies within48 hours. One baby was RhD positive and theother RhD negative. Anti-D was given to thewrong mother.

Patient’s blood group incorrectly transcribed asO RhD negative on to the inside front cover ofthe patient’s record based on a report from adifferent hospital.

Blood group report faxed to ward, fromcomputer results which had been enteredbefore testing was complete on sample.

Anti-D detected in mother’s blood from previoussensitising incident, unknown cause.Laboratory instruction not to administer Anti-D.During medical follow up Anti-D ordered andadministered in error.

One unit of Anti-D given to an alreadysensitised mother following delivery.

PV bleeding during the first trimester, hospitalpolicy specifies half the normal dose to begiven in this case i.e. 626 iu. Full dose wasgiven.

Table 25: Administration of Anti-D in error (N=7)

Symptomsand Outcome

No complicationsreported to date.Unnecessaryexposure to bloodproduct

No complicationsreported to date.Unnecessaryexposure to bloodproduct.

No complicationsreported to date.Unnecessaryexposure to bloodproduct

No complicationsreported to date. Unnecessaryexposure to bloodproduct

No complicationsreported to dateUnnecessaryexposure to bloodproduct

No complicationsreported to date.Unnecessaryexposure to bloodproduct

No complicationsreported to date.

RhD Group of Patient

RhD positive

RhDnegative

RhD positive

RhD positive

RhDnegative

RhDnegative

RhDnegative

CaseNumber

IBCTAnti-D Case 106

IBCT Anti-D Case 37*

IBCTAnti-D Case 60*

IBCTAnti-D Case 95*

IBCTAnti-DCase 92*

IBCT Anti-D Case 48

IBCT Anti-D Case 32

WRONG IDENTITY

TRANSCRIPTION/RECORDING ERROR

ALLOIMMUNISED

INCORRECT DOSAGE

* Included as full case history

Page 55: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office54

Level

1

1

1

1

2

2

Volume of IncorrectBlood Component orProduct TransfusedAnti-D omitted

Anti-D omitted

Anti-D omitted

Anti-D omitted

Anti-D omitted

Anti-D omitted

Cause of Error

An incorrect phone result was given by thelaboratory to the ward, stating that baby wasRhD negative. Baby was in fact RhD positive.Mother did not receive Anti-D. The official resultwas only received after discharge of the motherand was not acted on.

Administration delayed pending Kleihauer result.Kleihauer test showed occasional cells but notreviewed and Anti-D not administered.

Patient miscarried; the blood group testing wasperformed correctly but recorded incorrectly.Patient should have received Anti-D at thattime. Error detected on subsequent pregnancy.

Ante natal patient with a PV bleed at 35 weeksattended GP. Anti-D was not given. Routine antenatal visit one week later Anti-D notadministered. At delivery it was noted thatAnti-D antibodies had developed.

Failure to administer Anti-D following bleed in13th week of pregnancy. Previousgroup/records not checked

Patient presented post trauma at 36 weeksgestation. Specimen incorrectly labelled, repeatsample requested. Patient contacted and didnot return for 10 days. Patient refused Anti-D.

Table 26: Omission in administration of Anti-D (N= 6)

Symptomsand Outcome

No complicationsreported to date.

No complicationsreported to date.

No complicationsreported to date.

Anti-D antibodydeveloped

No complicationsreported to date.

No complicationsreported to date.

RhD Group of Patient

RhD Negative

RhD Negative

RhD Negative

RhD Negative

RhD Negative

RhD Negative

CaseNumber

IBCT Anti-D Case 3

IBCT Anti-D Case 56

IBCTAnti-D Case 103

IBCT Anti-D Case 104

IBCTAnti-D Case 10

IBCT Anti-D Case 26

Page 56: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

55Annual Report

Level

1

1

1

2

n/a

2

Volume of IncorrectBlood Component orProduct TransfusedOne dose of Anti-Dadministered four days afterthreatened miscarriage.

One dose of Anti-Dadministered eight days postdelivery

Anti-D given >100 hoursfollowing delivery

One dose of Anti-D 5 days after bleed

Anti-D givenat 96 hours

Anti-D given 11 days post firstbleed

Cause of Error

Patient had a threatened miscarriage, 17 weeksgestation. Sample processed the following dayby which time the patient had been discharged.Patient scheduled to return for a procedurewithin the 72 hours Anti-D was issued foradministration at this visit but it was notadministered at this time.

Cord blood not taken from baby prior tomothers transfer to another hospital followingcaesarean section. The need for Anti-D for themother not identified.

Cord blood incorrectly transcribed into medicalnotes as RhD negative. Patient had beendischarged when the error was noted

Delay in administering Anti-D post sampletaking as the patient had been discharged andhad given an incorrect telephone number.

Patient discharged herself early. Did not returnfor Anti-D until >72 hours in spite of fourtelephone calls

Attended emergency room on two occasionswith heavy bleeding prior to 12th week ofpregnancy. Previous group records not checked.

Table 27: Delay in administration of Anti-D (N=6)

Symptomsand Outcome

No complicationsreported to date.

No complicationsreported to date.

No complicationsreported to date.

No complicationsreported to date.

No complicationsreported to date.

Unknown

RhD Group of Patient

RhD Negative

RhD Negative

RhD Negative

RhD Negative

RhD Negative

RhD Negative

CaseNumber

IBCTAnti-D Case 7

IBCTAnti-D Case 8*

IBCTAnti-D Case 84

IBCT Anti-D Case 12

IBCT Anti-D Case 79

IBCT Anti-D Case 36

* Included as full case history

Page 57: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office56

Level

2

2

2

2

Volume of IncorrectBlood Component orProduct TransfusedOne dose of Anti-D

One dose of Anti-D

One dose of Anti-DReviewed and Anti-Dregarded as appropriate

One dose of Anti-D Reviewed and Anti-Dregarded as appropriate

Cause of Error

Anti-D was administered on the basis issued ofan historical records (A Rh negative, Dupositive) Most recent sample was not testeduntil the next working day and was reported asRh D positive. Both the laboratory and theadministering staff were unaware of thesignificance of Du positivity.

Patient previously grouped as A RhD negativeand received Anti-D in previous pregnancies.Although initial sample in current pregnancytested in reference laboratory suggested shemay have a partial D antigen, further testing ona new sample confirmed she was RhD positive(weak D). The new result was misfiledresulting in unnecessary Anti-D administration.

Patient grouped RhD negative, however,confirmation RhD status from reference centreshowed the patient was RhD weak D positive.

Patient grouped RhD negative by on callmedical scientist not normally working intransfusion. Scientist unaware of confirmatorytesting required for weak D group patients.

Table 28: Failure to identify weak RhD groups or misinterperation of RhD status (N=4)

Symptomsand Outcome

No complicationsreported to date.

No complicationsreported to date.

No complicationsreported to date.

No complicationsreported to date.

RhD Group of Patient

RhDpositive(weak Dpositive)

RhD positive (weak Dpositive)

RhD positive(weak Dpositive)

RhD positive (weak Dpositive)

CaseNumber

IBCT Anti-D Case 11

IBCT Anti-DCase 34

IBCT Anti-DCase 61

IBCTAnti-D Case 65

Level

3

2

Volume of IncorrectBlood Component orProduct TransfusedOne dose of Anti-D

One dose of Anti-D

Cause of Error

Incorrect batch number on the issue label andbox label of Anti-D as the batch numberselected was that of the next batch which wasin stock but not in use.

Vial of Anti-D labelled for one patient given to adifferent patient who also needed Anti-D.

Table 29: Anti-D batch number/labelling incorrect (N=2)

Symptomsand Outcome

No complicationsreported to date.

No complicationsreported to date.

RhD Group of Patient

RhDnegative

RhDnegative

CaseNumber

IBCT Anti-DCase 44

IBCTAnti-DCase 72

Page 58: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

A number of case histories are described in moredetail

Wrong Patient

Level 1 IBCT Anti-D Case 37 Two RhD negative mothers with the same first namesurname and same address gave birth within 48hours. One baby grouped as RhD positive and theother as RhD negative. Anti-D was prescribed andrequested correctly for the RhD negative mother whohad delivered the RhD positive infant. Two healthcare professionals checked the documentation,which included the mother and infant’s RhD status,prescription and product, at the nurse’s station. TheAnti-D was administered at the bedside using themothers name as confirmation only and wasadministered to the incorrect patient. Followingadministration a midwife highlighted the presence oftwo patients with the same name and address to theperson who had administered the Anti-D and the errorwas realised. The correct patient received Anti-Dsubsequently.

Recording Errors

Level 1 IBCT Anti-D Case 60 This young group RhD positive patient delivered aRhD positive baby. An old report which originatedfrom another hospital was filed in the patient’s chart,where the result was recorded as RhD negative. Thisresult was transcribed on the inside front cover of thepatients current chart and Anti-D was prescribed,issued and administered to the patient based on thisresult. There were in fact more recent resultsavailable from the admitting hospital which showedthe patient to be Rh D positive. The error remainedundetected prior to issue from the laboratory whichdid not check their own Anti-D typing results. Theerror was discovered while checking the medicalnotes for other information.

Level 1 IBCT Anti-D Case 95 This antenatal patient presented to hospital at 11weeks gestation with a PV bleed and bloods weresent for routine antenatal screening to a laboratoryoff- site. The patient was aware that her blood groupwas RhD positive and she was discharged later thatevening. The patient’s blood group result was faxedto the ward later that weekend and the report showedthe group was O RhD negative. The patient wascontacted and requested to attend for administrationof Anti-D. When she presented she again repeatedthat in fact she was RhD positive and refused Anti-D.At this point the midwife contacted the laboratory andexplained the lady’s concern. The medical scientistchecked the computer records and said that thecorrect result had been faxed to the clinical area andAnti-D was administered by the midwife. Thelaboratory telephoned the ward some time later andstated that the result, which had been faxed to theward, was in fact incomplete and incorrect and thepatient’s blood group was O RhD positive. On postevent analysis it appears that a result had beenentered on the laboratory computer system prior tothe complete result being available and confirmed.

Alloimmunised

Level 1 IBCT Anti-D Case 92This RhD negative primigravida delivered a RhDpositive baby. Anti-D was detected in the mother’sblood. The reason for this sensitisation was unclear.The laboratory requested a further sample of bloodfrom the mother for Anti-D quantitation. Followingreview the laboratory result forms and the nursingnotes clearly stated that the mother was not for Anti-D immunoglobulin administration. The patient wasdischarged home. The mother attended a follow upmedical appointment and in error was referred backto the maternity hospital for Anti-D administration.The product was prescribed and administered asordered.

57Annual Report

Page 59: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Omission/delay in administration of Anti-D: Case history

Level 1 IBCT Anti-D Case 8 This lady was transferred to another hospital followinga caesarean section delivery. The baby did not havecord blood taken immediately post delivery althoughthe baby was subsequently grouped as RhD positive.On transfer of the mother back to the maternityhospital medical staff realised that the mother wasgroup RhD negative and the baby was group RhDpositive. Anti-D had not been administered to themother. Anti-D was administered eight days postdelivery.

National Haemovigilance Office58

Page 60: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

This category captures acute allergic andanaphylactic reactions. All allergic type reactionsexcept for mild rashes and localised urticaria arecollected by the NHO as are such reactionsoccurring despite premedication cover.

As allergists are moving away from the term‘anaphylactoid‘, the European HaemovigilanceNetwork are proposing that the term ‘anaphylacticreaction’ which covers both anaphylactoid reactionsand anaphylactic shock should replace it. The NHOproposes to change the title of this category in 2006to Acute Allergic and Anaphylactic Reactions.

The cause of these allergic type reactions is not fullyelucidated (Gilstead, 2003). Severe IgA deficiency ispresent in about 1:700 blood donors and a smallnumber of individuals who are IgA deficient developanti IgA antibodies which can be associated withsevere and occasionally fatal reactions. In theJapanese population, where haptoglobin deficiency ismuch more common than IgA deficiency, anti-haptoglobin antibodies have been associated withallergic/anaphylactoid reactions. (Koda et al 2000)

In the majority of patients, however, no underlyingcause is found in the patient to explain the reactions.Reactions may not be triggered by the bloodproducts per se but rather by other concurrentaspects of patient treatment or parallel drugadministration. It is now appreciated thatangiotensin–converting enzyme (ACE) inhibitorsblock kininase II allowing accumulation of plasmakinins and increasing the risk of an anaphylactoidreaction (Unsworth 2005).

Plasma constituents in the product may beresponsible. Since the replacement of FFP by SDplasma which is associated with a low risk of allergictype reactions, increasing numbers of these reactionshave been reported to the NHO associated withplatelets. The majority are associated with pooledplatelets but cases have also been reported withapheresis platelets. Release of cytokines/chemokines in stored platelets such as C3a and C5a,have been suggested as a cause (Boehlen 2001)(Gilstad 2003) . In a small series of patients, removalof plasma from platelet concentrates andreplacement by platelet storage medium reduced the

Severe Acute Anaphylactoid orAnaphylactic Transfusion Reaction

DefinitionAllergic, anaphylactoid and anaphylactic transfusion reactions span a range ofsymptoms of varying severity. The symptoms encompass simple allergic-typereactions such as urticaria/pruritis associated with or without gastrointestinaldiscomfort, to more severe reactions such as stridor, wheeze, bronchospasm,laryngeal oedema and hypotension. The onset of intractable hypotension or shockwith loss of consciousness is commonly designated as an anaphylactic reaction. Inits severest form anaphylaxis can be fatal. (Vamvakas, 2001)

59

Page 61: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

incidence of allergic type reactions, although it didnot have a significant effect on the incidence of febrilenon haemolytic type reactions. (Heddle 2002).

Serum tryptase is a marker of anaphylaxis whichpeaks in one to two hours and may return to normal inthree to four hours, but it can remain elevated for upto 48 hours. It has been suggested serum tryptasedeserves further study as a potential marker forsevere allergic transfusion reactions, with or withoutanaphylaxis. (Domen, and Hoeltge, 2003)

Findings

This category accounted for 16% (35 of 214) of theincidents reported during the reporting year. Thisrepresents an increase of 50% of submitted reportsbased on the 2003 figures due to increased reactionsassociated with platelets.

• The incidence of A/A was 1:651 units of plateletsissued,.1:22705 units of red cells/whole bloodissued and 1:12424 units of SD plasma issued.

• As in previous years, the majority of A/A reactionsinvolved platelets. Twenty one involved pooledplatelets and six involved apheresis platelets.

• Six (17 %) of the reports were associated with redcell transfusions.

• Two reports (6%) involved SD plasma (Cases 16and 31). In one case (Case 16), it appears thatthe transfusion was inappropriate as SD plasmainstead of vitamin K was used for warfarin reversal.

• Paediatric patients (under 18 years old) wereinvolved in seven reports (20%). The samepaediatric patient, however, was involved in threeof the reports (Cases 21, 22, and 23).

• As three patients were involved in more than onereport, a total of 31 patients were involved. Of the31 patients, 26 had an underlying malignantcondition.

• In eight reports, the patient had had a previoustransfusion reaction. In five cases, the patient hadreceived premedication prior to transfusion butwent on to develop a reaction nonetheless. Theseverity of the reaction however may havelessened. In one further report (Case 35), thepatient had a previous reaction to medication andwas receiving regular chlorpheniramine but did notreceive premedication before the transfusion.

• In 27 reports, recommendations were made tomanage future transfusions. In 12 reportspremedication cover prior to future transfusionswas recommended. In nine reports apheresisplatelets were recommended associated withpremedication. Washed components wererecommended in six cases.

• The majority of cases responded well to treatmentwith chlorpheniramine or a combination ofchlorpheniramine and hydrocortisone, within twohours. However in ten reports further treatmentwas required. One case (Case 34) associatedwith red cells required glyceryl trinitrate (GTN)spray, oxygen and IV fluids and transfer to atertiary centre for further management, althoughfuture transfusions have been uneventful.

• In the majority of reports there were cutaneousmanifestations, but in seven, these were notpresent. In one of these cases (Case 8), overloadwas also present and it is unclear if the reactionwas actually A/A. In one report (Case 30) the mainsymptoms were nausea and vomiting.

National Haemovigilance Office60

Page 62: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Recommendations

• Even mild allergic reactions should be reported tothe hospital blood bank and haemovigilanceofficer as subsequent reactions may be moresevere.

• Most allergic/anaphylactic transfusion reactionsrespond to chlorpheniramine. Steroids should bereserved for the more severe reactions.

• Prophylaxis with antihistamine should be given ifthere is a previous history of allergy or repeatedreactions.

• Protocols and training for the management ofsevere A/A reactions should be in place in eachhospital and all staff involved in transfusion shouldbe familiar with them. The National Blood UsersGroup (NBUG) has produced recommendationsfor the Management of an Acute TransfusionReaction (NBUG 2004) (See Appendix 1)

• Patients who have experienced an anaphylactoidreaction during a blood component transfusionshould have a label placed on their chart alertingclinical staff to their history of transfusionreactions and to ensure that appropriatepremedication is given prior to future transfusions.

• Where patient are receiving shared care, systemsmust be in place so that all relevant details relatingto transfusion such as history of reaction/allergyand/or premedication requirements can becommunicated between centres effectively.

• IgA deficiency (<0.05mg/dl) with anti IgAantibodies can cause severe anaphylactoidreactions and anaphylaxis.

• Patients with severe or repeated reactions shouldhave IgA levels performed.

• Since the transfused product may contain

appreciable quantities of IgA, where possible,samples taken pre-transfusion should be used tocheck for IgA levels.

• If anti IgA antibodies are present these patientswill require special transfusion managementincluding the use of saline washed cellularcomponents for future transfusions.

• Washed components for the management of A/Areactions are only appropriate for patients with ahistory of anaphylactic or severe anaphylactoidtransfusion reactions uncontrolled bypremedication. A poorly justified requirement forwashed components may cause undue delayswhen transfusions are needed in the future. Inaddition, washing of platelets can affect plateletyields with loss of platelet numbers and viabilityfrom the washing process and poor in vivoincremental rises.

• Before prescribing washed platelets for patientswith a history of transfusion reactions to pooledproducts, a trial of apheresis platelets should beundertaken as patients who react to pooledplatelets may often tolerate apheresis platelets.

• Classical allergic or anaphylactoid reactions donot routinely require culture of the unit or pack orserological investigations. However, whereatypical symptoms such as fever are present in asuspected A/A reaction or where skinmanifestations are absent, it is important to culturethe implicated unit/s and the patient, to rule outunderlying sepsis and/or bacterial infection in theunit and in the case of red cells to undertakeserological tests to exclude incompatibility.

61Annual Report

Page 63: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office62

Case

No.

AA Case

1 AA Case

2 AA Case

3 AA Case

4 AA Case

5 * AA Case

7

Age

yrs

Gend

er

52 F 46 M 43 F 22 F 51 M 68 M

Com

pone

nt

One

unit

poole

dpla

telet

conc

entra

te

T wo

units

HLA

mat

ched

plate

letco

ncen

trate

One

unit

poole

dpla

telet

conc

entra

te

One

unit

poole

dpla

telet

conc

entra

te

One

unit

ofpo

oled

plate

letco

ncen

trate

One

unit

ofpo

oled

plate

letco

ncen

trate

Reas

onfo

rTra

nsfu

sion

Plat

eletc

ount

15x1

09/L

Malig

nanc

y.

Plat

eletc

ount

14x1

09/L

Haem

atolo

gical

Malig

nanc

y.

Plat

eletc

ount

34x1

09/L

Haem

atolo

gical

mali

gnan

cy,

activ

eble

eding

.

Plat

eletc

ount

17x1

09/L

Malig

nanc

y.

Plat

eletc

ount

76x1

09/L

Malig

nanc

y,ac

tive

bleed

ing.

Plat

eletc

ount

28x1

09/L

Malig

nanc

y.

Sym

ptom

s

Urtic

aria,

GIsy

mpt

oms

includ

ingcr

amps

.

Bilat

eral

perio

rbita

loe

dem

a.

Dysp

noea

,fall

ingO 2

satu

ratio

nsch

ills.

Dysp

noea

,sub

-ste

rnal

disco

mfo

rt,ta

chyc

ardia

(170b

pm),

fallin

gO 2

satu

ratio

ns,c

hills.

Urtic

aria,

dysp

noea

,GI

sym

ptom

s,ta

chyc

ardia

,fall

ingO 2

satu

ratio

ns.

Flush

ing,ur

ticar

ia.

Inves

tigat

ions

Unit

cultu

red

nogr

owth

.IgA

levels

notc

heck

ed.

Unit

cultu

red,

nogr

owth

.IgA

levels

notc

heck

ed.

IgAlev

elsno

rmal.

Cultu

reof

unit

and

patie

ntno

grow

th.

Patie

ntcu

lture

d,no

grow

th,u

nitno

tcult

ured

.IgA

levels

notc

heck

ed

Cultu

reof

both

unit

and

patie

nt,n

ogr

owth

.IgA

levels

notc

heck

ed.

None

Stag

eTra

nsfu

sion

Reac

tion

Deve

loped

Follo

wing

com

pletio

nof

trans

fusio

n.

Follo

wing

com

pletio

nof

trans

fusio

n.

Follo

wing

com

pletio

nof

trans

fusio

n.

Follo

wing

com

pletio

nof

trans

fusio

n.

Follo

wing

com

pletio

nof

trans

fusio

n.

Follo

wing

com

pletio

nof

trans

fusio

n.

Treat

men

t

Hydr

ocor

tison

ean

dch

lorph

enira

mine

IV.

Hydr

ocor

tison

ean

dch

lorph

enira

mine

IV.

Chlor

phen

iram

ineIV.

Hydr

ocor

tison

ean

dch

lorph

enira

mine

IVan

dsa

lbuta

mol

nebu

lizer

.

Hydr

ocor

tison

ean

dch

lorph

enira

mine

IV.

Hydr

ocor

tison

ean

dch

lorph

enira

mine

IV

Sequ

elae/

Reco

mm

enda

tions

forf

utur

etra

nsfu

sions

Reco

very

with

inon

eho

ur.

Subs

eque

nttra

nsfu

sions

have

been

unev

entfu

l.

Reco

very

with

inm

inute

s.No

reco

mm

enda

tions

docu

men

ted.

Reco

very

with

in30

minu

tes.

Aphe

resis

plate

letsh

ave

been

reco

mm

ende

dfo

rfu

ture

trans

fusio

ns.

Reco

very

with

in20

minu

tes.

Aphe

resis

plate

letsh

ave

been

reco

mm

ende

dfo

rfu

ture

trans

fusio

ns.

Reco

very

with

in45

minu

tes.

Patie

ntsu

bseq

uent

lyha

da

mild

urtic

arial

reac

tion

follo

wing

aphe

resis

plate

lets

and

isno

wbe

ingtra

nsfu

sed

with

wash

edpla

telet

s.

Reco

very

with

inon

eho

ur.

Prem

edica

tion

ofch

lorph

enira

mine

and

para

ceta

mol

have

been

reco

mm

ende

dfo

rfut

ure

trans

fusio

ns.

Tabl

e30

:AA

Case

sAs

soci

ated

with

Plat

elet

s(n

=27)

*Inc

luded

asa

full

case

histo

ry*P

Includ

edas

afu

llca

sehis

tory

inpa

ediat

ricch

apte

r

Page 64: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

63Annual Report

Case

No.

AA Case

8 AA Case

9 AA Case

10 AA Case

11 AA Case

12 AA Case

13 *

Age

yrs

Gend

er

82 M 20 F 12 F 11 F 45 F 58 M

Com

pone

nt

One

unit

ofpo

oled

plate

letco

ncen

trate

One

unit

ofap

here

sispla

telet

conc

entra

te

One

unit

Poole

dpla

telet

conc

entra

te

One

unit

poole

dpla

telet

conc

entra

te

One

unit

poole

dpla

telet

conc

entra

te

One

unit

ofap

here

sispla

telet

conc

entra

te

Reas

onfo

rTra

nsfu

sion

Plat

eletc

ount

6x1

09/L

Haem

atolo

gical

mali

gnan

cy.

Plat

eletc

ount

<10x

109 /L

Malig

nanc

y.

Plat

eletc

ount

54x

109 /L

Haem

atolo

gical

mali

gnan

cy,

seps

is.

Plat

eletc

ount

18X1

09/L

Haem

atolo

gical

mali

gnan

cy.

Plat

eletc

ount

18x1

09/L

Haem

atolo

gical

mali

gnan

cy.

Plat

eletc

ount

<10x

109 /L

Haem

atolo

gical

mali

gnan

cy.

Sym

ptom

s

Hype

rtens

ion,

tach

ycar

dia,c

hills

rigor

s,fa

llin

O 2sa

tura

tion

and

rise

inPC

O 2,E

CGch

ange

s.

Dysp

noea

,sub

stern

aldis

com

fort,

fallin

gO 2

satu

ratio

ns,

restl

essn

essa

ndan

xiety

.

Urtic

aria

desp

itepr

emed

icatio

nwi

thhy

droc

ortis

one

and

chlor

phen

iram

ineIV.

Urtic

aria,

itch

and

disco

mfo

rtde

spite

prem

edica

tion

with

hydr

ocor

tison

ean

dch

lorph

enira

mine

IV.

Urtic

aria,

chills

rigor

s,vo

mitin

g,co

ugh

and

tight

ness

inth

roat

.

Urtic

aria,

dysp

noea

,str

idor,

whee

ze,a

ndfa

lling

O 2sa

tura

tions

.

Inves

tigat

ions

Cultu

reof

pack

and

patie

nt,n

ogr

owth

.

IgAlev

elno

rmal.

Cultu

reof

the

patie

ntan

dun

it,no

grow

th.

None

None

ABO

incom

patib

ility

exclu

ded.

IgAlev

elsno

rmal.

None

Stag

eTra

nsfu

sion

Reac

tion

Deve

loped

Follo

wing

trans

fusio

nof

50m

ls.

45m

inute

sint

oth

etra

nsfu

sion

when

190

mls

had

been

trans

fuse

d.

Follo

wing

com

pletio

nof

trans

fusio

n

45m

inute

safte

rco

mm

encin

gtra

nsfu

sion.

One

hour

follo

wing

com

pletio

nof

trans

fusio

n.

Twen

tym

inute

sint

oth

etra

nsfu

sion

when

160

mls

had

been

trans

fuse

d.

Treat

men

t

Hydr

ocor

tison

e,ch

lorph

enira

mine

,ad

rena

line

IV,sa

lbuta

mol

nebu

lizer

.Tran

sfusio

ndis

cont

inued

Hydr

ocor

tison

ean

dch

lorph

enira

mine

IV.Tra

nsfu

sion

disco

ntinu

ed.

None

Hydr

ocor

tison

eIV.

Hydr

ocor

tison

ean

dch

lorph

enira

mine

IV.

Hydr

ocor

tison

ean

dch

lorph

enira

mine

IVox

ygen

and

salbu

tam

olne

buliz

er.

Sequ

elae/

Reco

mm

enda

tions

forf

utur

etra

nsfu

sions

Died

unre

lated

totra

nsfu

sion.

Reco

very

with

intw

enty

minu

tes

Aphe

resis

plate

letsa

ndpr

emed

icatio

nha

vebe

enre

com

men

ded

forf

utur

etra

nsfu

sions

.

Reco

very

with

inth

irty

minu

tes.

Was

hed

com

pone

ntsh

ave

been

reco

mm

ende

dfo

rfut

ure

trans

fusio

ns.

Reco

very

with

inth

irty

minu

tes.

Was

hed

com

pone

ntsh

ave

been

reco

mm

ende

dfo

rfut

ure

trans

fusio

ns.

Reco

very

with

info

urho

urs.

Reco

mm

enda

tions

notd

ocum

ente

d.

Reco

very

with

in10

minu

tes.

Subs

eque

nttra

nsfu

sions

with

prem

edica

tion

ofch

lorph

enira

mine

have

been

unev

entfu

l.

Tabl

e30

:AA

Case

sAs

soci

ated

with

Plat

elet

s(n

=27)

(con

t)

*Inc

luded

asa

full

case

histo

ry*P

Includ

edas

afu

llca

sehis

tory

inpa

ediat

ricch

apte

r

Page 65: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office64

Case

No.

AA Case

14 * AA Case

19 AA Case

20,2

4Sa

me

patie

nt

AACa

se21

,22&

23Sa

me

patie

nt*P

Age

yrs

Gend

er

26 F 20 M 62 F 6 M

Com

pone

nt

One

unit

ofap

here

sispla

telet

conc

entra

te

One

unit

ofpo

oled

plate

letco

ncen

trate

Two

units

ofap

here

sispla

telet

conc

entra

te(1

sttra

nsfu

sion)

Two

units

aphe

resis

plate

letco

ncen

trate

(2nd

trans

fusio

n)

One

unit

ofpo

oled

plate

letco

ncen

trate

(1st

trans

fusio

n)

Reas

onfo

rTra

nsfu

sion

Plat

eletc

ount

67x1

09/L

Haem

atolo

gical

mali

gnan

cy,

activ

eble

eding

.

Plat

eletc

ount

15x1

09/L

Haem

atolo

gical

mali

gnan

cy.

Plat

eletc

ount

<10x

109 /L

Haem

atolo

gical

mali

gnan

cy.

Plat

eletc

ount

<10x

109 /L

.Ha

emat

ologic

alm

align

ancy

.

Plat

eletc

ount

10x1

09/L.

Malig

nanc

y.

Sym

ptom

s

Hype

rtens

ion,d

yspn

oea,

subs

tern

aldis

com

fort

desp

itepr

emed

icatio

nof

chlor

phen

aram

ine.

Exte

nsive

rash

onall

limbs

.Dy

spno

eastr

idor,

whee

ze,

tach

ycar

dia,

hype

rtens

ion,

anxie

tyan

dpe

riorb

italo

edem

a.

Feeli

ngof

sunb

urn

onbo

thleg

sand

naus

ea.

Diar

rhoe

afo

llowi

ngda

y.

Rash

onan

terio

rasp

ect

offo

otan

dsw

ollen

foot

.

Urtic

aria

Inves

tigat

ions

IgAlev

elno

rmal,

HLA

antib

ody

scre

enne

gativ

e.

IgAlev

elspo

sttra

nsfu

sion

norm

al.

HLA

antib

ody

scre

enne

gativ

e.

IgAlev

elsno

rmal.

None

Stag

eTra

nsfu

sion

Reac

tion

Deve

loped

Two

hour

sFoll

owing

com

pletio

nof

trans

fusio

n.

Post

trans

fusio

n

Post

trans

fusio

nfo

llowi

ngda

yat

hom

e.

Post

trans

fusio

nat

hom

e.

Post

trans

fusio

n

Treat

men

t

Chlor

phen

iram

ine.

Hydr

ocor

tison

ean

dch

lorph

enira

mine

IV

None

,pat

ientw

asat

hom

e.

None

Sequ

elae/

Reco

mm

enda

tions

forf

utur

etra

nsfu

sions

Reco

very

with

infiv

em

inute

s.Pr

emed

icatio

nwi

thch

lorph

enira

mine

and

aphe

resis

plann

ed.

Ifun

succ

essfu

lsa

line

wash

edpla

telet

sto

beus

ed.

Reco

very

with

info

urho

urs.

Subs

eque

nttra

nsfu

sions

using

aphe

resis

plate

letsh

ave

been

unev

entfu

l.

Reco

very

time

uncle

ar.

Subs

eque

nttra

nsfu

sions

with

aphe

resis

plate

letsa

ndpr

emed

icatio

nof

chlor

phen

iram

ineha

vebe

enun

even

tful.

Reco

very

with

inon

eho

ur.

Tabl

e30

:AA

Case

sAs

soci

ated

with

Plat

elet

s(n

=27)

(con

t)

*Inc

luded

asa

full

case

histo

ry*P

Includ

edas

afu

llca

sehis

tory

inpa

ediat

ricch

apte

r

Page 66: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

65Annual Report

Case

No.

AACa

se25 AA

Case

26,2

7Sa

me

patie

nt

AAca

se28

Age

yrs

Gend

er

46 M 68 F 49 F

Com

pone

nt

One

unit

ofpo

oled

plate

letco

ncen

trate

(2nd

trans

fusio

n)

One

unit

ofpo

oled

plate

letco

ncen

trate

(3rd

trans

fusio

n)

Two

units

poole

dpla

telet

conc

entra

te

One

unit

poole

dpla

telet

conc

entra

te(1

sttra

nsfu

sion)

One

unit

poole

dpla

telet

conc

entra

te(2

ndtra

nsfu

sion)

One

unit

poole

dpla

telet

conc

entra

te

Reas

onfo

rTra

nsfu

sion

Plat

eletc

ount

14x1

09/L.

Malig

nanc

y.

Plat

eletc

ount

19x1

09/L.

Malig

nanc

y.

Plat

eletc

ount

27x1

09/L.

Haem

atolo

gical

mali

gnan

cy.

Plat

eletc

ount

16x1

09/L.

Haem

atolo

gical

mali

gnan

cy.

Plat

eletc

ount

6x10

9 /L.

Haem

atolo

gical

mali

gnan

cy

Plat

eletc

ount

11x1

09/L.

Haem

atolo

gical

mali

gnan

cy.

Sym

ptom

s

Urtic

aria,

coug

han

dlum

pin

thro

at.

Whe

eze,

coug

h,lum

pin

thro

atan

ditc

hde

spite

prem

edica

tion

with

hydr

ocor

tison

ean

dch

lorph

enira

mine

IV.

Perio

rbita

loed

ema,

redn

essa

ndex

trem

eitc

hing

ofbo

thpa

lms.

Urtic

aria,

rise

inte

mpe

ratu

reof

1°C.

Urtic

aria,

dysp

noea

,wh

eeze

,che

sttig

htne

ssan

dco

ugh

desp

itepr

e-m

edwi

thhy

droc

ortis

one

and

chlor

phen

iram

ineIV.

Urtic

aria,

tach

ycar

dia,

dysp

noea

.

Inves

tigat

ions

None

None

None

None

None

Cultu

reof

patie

ntan

dpa

ck,n

ogr

owth

.

Stag

eTra

nsfu

sion

Reac

tion

Deve

loped

Post

trans

fusio

n.55

minu

tesa

fter

com

men

cing

trans

fusio

n

Post

trans

fusio

n.30

minu

tesa

fter

com

men

cing

trans

fusio

n

45m

insaf

ter

com

men

cing

first

unit

and

10m

insint

oth

ese

cond

unit.

16m

lsha

dbe

entra

nsfu

sed

140

mls

had

been

trans

fuse

d

Follo

wing

com

pletio

nof

trans

fusio

n

Treat

men

t

None

Salbu

tam

olne

buliz

er.

Hydr

ocor

tison

ean

dch

lorph

enira

mine

IV.

Hydr

ocor

tison

ean

dch

lorph

enar

mine

IV.Tra

nsfu

sion

disco

ntinu

ed.

Hydr

ocor

tison

eO 2

adm

iniste

red.

Hydr

ocor

tison

ean

dch

lorph

enira

mine

IV.

Sequ

elae/

Reco

mm

enda

tions

forf

utur

etra

nsfu

sions

Reco

very

with

inon

eho

ur.

Prem

edica

tion

prior

tofu

ture

trans

fusio

nsre

com

men

ded.

Reco

very

with

inon

eho

ur.S

ubse

quen

ttra

nsfu

sions

with

wash

edpla

telet

shav

ebe

enun

even

tful.

Reco

very

with

ineig

htho

urs.

Prev

ious

reac

tion

topla

telet

s.W

ashe

dpla

telet

san

dpr

emed

icatio

nwi

thhy

droc

ortis

one

and

chlor

phen

iram

inefo

rfut

ure

trans

fusio

nsha

vebe

enre

com

men

ded.

Reco

vere

dwi

thin

seve

nho

urs.

Pre-

med

with

hydr

ocor

tison

ean

dch

lorph

enira

mine

reco

mm

ende

d.

Reco

very

with

intw

oho

urs.

Prem

edica

tion

with

chlor

phen

iram

inean

dap

here

sispla

telet

shav

ebe

enre

com

men

ded

forf

utur

etra

nsfu

sions

.

Reco

vere

dwi

thin

two

hour

s.Pr

emed

icatio

nof

antih

istam

inepr

iorto

plate

lettra

nsfu

sion

hasb

een

reco

mm

ende

dfo

rfut

ure

trans

fusio

ns.

Tabl

e30

:AA

Case

sAs

soci

ated

with

Plat

elet

s(n

=27)

(con

t)

*Inc

luded

asa

full

case

histo

ry*P

Includ

edas

afu

llca

sehis

tory

inpa

ediat

ricch

apte

r

Page 67: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office66

Case

No.

AAca

se29 AA Ca

se30 AA Ca

se33

AA Case

35

Age

yrs

Gend

er

54 F 73 M 55 M 30 M

Com

pone

nt

One

unit

poole

dpla

telet

conc

entra

te

One

unit

ofA

poole

dpla

telet

conc

entra

tePa

tient

O

One

unit

ofpo

oled

plate

letco

ncen

trate

One

unit

poole

dpla

telet

conc

entra

te

Reas

onfo

rTra

nsfu

sion

Plat

eletc

ount

16x1

09/L.

Haem

atolo

gical

mali

gnan

cy,p

ost

BMT.

Plat

eletc

ount

2x10

9 /L.

Haem

atolo

gical

mali

gnan

cy.

Plat

eletc

ount

57x1

09/L.

Liver

biops

y.

Plat

eletc

ount

10x1

09/L.

Haem

atolo

gical

mali

gnan

cy,

post

BMT.

Sym

ptom

s

Dysp

noea

,whe

eze,

thro

atsw

elling

,fall

inO 2

satu

ratio

ns.

Naus

eaan

dvo

mitin

g

. Urtic

aria,

dysp

noea

,GI

sym

ptom

sand

perio

rbita

loed

ema.

Ches

ttigh

tnes

s,na

usea

,vom

iting,

feeli

ngof

appr

ehen

sion

and

doom

,fac

ialsw

elling

.

Inves

tigat

ions

None

Cultu

reof

the

patie

nt,n

ogr

owth

.Pac

kcu

lture

,Co

agula

sene

gativ

esta

phylo

cocc

us,p

roba

bleco

ntam

inatio

n.

Cultu

reof

the

patie

ntan

dun

itno

grow

th.

IgAlev

elsno

rmal.

Stag

eTra

nsfu

sion

Reac

tion

Deve

loped

With

in15

minu

teso

fco

mm

encin

gtra

nsfu

sion

when

150

mls

had

been

trans

fuse

d.

Afte

rfou

rminu

teso

ftra

nsfu

sion

Follo

wing

com

pletio

nof

trans

fusio

n

Afte

r20

minu

teso

ftra

nsfu

sion.

150

mls

trans

fuse

d.

Treat

men

t

Hydr

ocor

tison

e,ch

lorph

enira

mine

IVan

dO 2

adm

iniste

red.

None

None

Hydr

ocor

tison

ean

dch

lorph

enira

mine

IV.

Sequ

elae/

Reco

mm

enda

tions

forf

utur

etra

nsfu

sions

Reco

vere

dwi

thin

30m

inute

s.Pr

emed

icatio

nan

dpla

telet

aphe

resis

have

been

reco

mm

ende

dfo

rfut

ure

trans

fusio

ns.

Reco

vere

dwi

thin

minu

tes.

Subs

eque

ntpla

telet

trans

fusio

nswi

thch

lorph

enira

mine

prem

edica

tion

have

been

unev

entfu

l.

Reco

vere

dwi

thin

one

hour

.Pr

emed

icatio

nof

chlor

phen

iram

ineha

sbe

enre

com

men

ded.

Reco

vere

dwi

thin

20m

inute

s.Pr

emed

icatio

nof

hydr

ocor

tison

e,ch

lorph

enira

mine

and

wash

edpla

telet

sha

vebe

enre

com

men

ded

forf

utur

etra

nsfu

sions

.

Tabl

e30

:AA

Case

sAs

soci

ated

with

Plat

elet

s(n

=27)

(con

t)

Page 68: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

67Annual Report

Case

No.

AA Case

6 AA Case

15 P* AA Case

17 AA Case

18 AA Case

32 AA Case

34 *

Age

yrs

Gend

er

19 M 5 M 83 M 11 M 50 F 62 F

Com

pone

nt

One

unit

red

cells

One

unit

red

cells

One

unit

red

cells

One

unit

red

cells

One

unit

red

cells

One

unit

red

cells

Reas

onfo

rTra

nsfu

sion

Anae

mia

Hb7.7

g/dl

Haem

atolo

gical

mali

gnan

cy.

Anae

mia

Hb7.6

g/dl

Haem

atolo

gical

mali

gnan

cy,

activ

eble

eding

.

Anae

mia

Hb7.4

g/dl

Card

iacdis

ease

,m

ultipl

em

edica

lpr

oblem

s.

Anae

mia

Hb8.1

g/dl

Haem

atolo

gical

mali

gnan

cy.

Anae

mia

Hb8.1

g/dl

Vasc

ulard

iseas

e,ac

tive

bleed

ing.

Anae

mia

Hb8.6

g/dl

Malig

nanc

y.

Sym

ptom

s

Dysp

noea

,itch

ing,

naus

ea,g

ener

alise

djoi

ntpa

in.

Urtic

aria,

pero

rbita

loe

dem

a.

Oede

ma

ofup

perl

ip

Urtic

aria,

feve

rrise

of1.9

°C,c

hills,

rigor

s,ta

chyc

ardia

.

Urtic

aria

and

puffy

eyes

.

Urtic

aria,

tach

ycar

dia,

strido

r,wh

eeze

,fa

lling

O 2sa

tura

tion,

flush

ing,s

ubste

rnal

disco

mfo

rtan

da

rise

inte

mpe

ratu

reof

1.3°C

.

Inves

tigat

ions

ABO

incom

patib

ility

exclu

ded.

Post

trans

fusio

nan

tibod

ysc

reen

nega

tive.

Cultu

reof

patie

ntan

dun

it,no

grow

th.

None

ABO

incom

patib

ility

exclu

ded,

IgAlev

elno

rmal.

ABO

incom

patib

ility

exclu

ded.

Cultu

reof

patie

ntan

dun

it,no

grow

th.

ABO

incom

patib

ility

exclu

ded.

Cultu

reof

the

unit,

nogr

owth

.

Stag

eTra

nsfu

sion

Reac

tion

Deve

loped

Afte

r10

minu

teso

ftra

nsfu

sion.

50m

lstra

nsfu

sed.

Follo

wing

com

pletio

nof

trans

fusio

n.

With

intw

oho

urso

fco

mm

encin

gtra

nsfu

sion.

With

inth

ree

hour

sof

com

men

cing

trans

fusio

n.24

0mls

had

been

trans

fuse

d.

Afte

rone

hour

and

20m

inute

soft

rans

fusio

n.10

0m

lstra

nsfu

sed.

One

hour

forty

minu

tes

afte

rcom

men

cing

trans

fusio

n.24

0m

lstra

nsfu

sed.

Treat

men

t

Antie

met

icgiv

enfo

rna

usea

.Tra

nsfu

sion

disco

ntinu

ed.

Chlor

phen

iram

ine

Trans

fusio

ndis

cont

inued

.No

treat

men

tgive

n.

Hydr

ocor

tison

eIV,

para

ceta

mol.

Trans

fusio

ndis

cont

inued

.

Hydr

ocor

tison

ean

dch

lorph

enira

mine

IV.

Trans

fusio

ndis

cont

inued

.Hy

droc

ortis

one

chlor

phen

iram

ineIV,

adre

nalin

e,GT

Nsp

ray

oxyg

enan

dIV

fluids

.Tra

nsfe

rred

tote

rtiar

yce

ntre

foro

bser

vatio

n.

Sequ

elae/

Reco

mm

enda

tions

forf

utur

etra

nsfu

sions

Reco

very

with

in30

minu

teso

fre

ceivi

ngtre

atm

ent.

Furth

ertra

nsfu

sions

have

been

unev

entfu

l.

Reco

vere

dwi

thin

two

and

aha

lfho

urs

Subs

eque

nttra

nsfu

sions

with

prem

edica

tion

ofch

lorph

enira

mine

have

been

unev

entfu

l.

Reco

very

with

in30

minu

tes.

Prem

edica

tion

ofan

tihist

amine

has

been

reco

mm

ende

dfo

rfut

ure

trans

fusio

n.

Reco

very

with

in4-

5ho

urs.

Prem

edica

tion

ofan

tihist

amine

has

been

reco

mm

ende

dfo

rfut

ure

trans

fusio

n.

Reco

very

time

notd

ocum

ente

d.Su

bseq

uent

trans

fusio

nswi

thpr

emed

icatio

nof

chlor

phen

iram

ineha

vebe

enun

even

tful.

Unkn

own

reco

very

time.

Care

ful

obse

rvat

iondu

ring

subs

eque

nttra

nsfu

sions

which

were

unev

entfu

l.

Tabl

e31

:AA

Case

sAs

soci

ated

With

Red

Cells

(n=6

)

*Inc

luded

asa

full

case

histo

ry*P

Includ

edas

afu

llca

sehis

tory

inpa

ediat

ricch

apte

r

Page 69: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office68

Case

No.

AA Case

16 * AA Case

31

Age

yrs

Gend

er

83 M 22 F

Com

pone

nt

Two

units

SDpla

sma

Thre

eun

itsSD

plasm

a

Reas

onfo

rTra

nsfu

sion

INR

3.8Ha

emat

oma

seco

ndar

yto

traum

a,ca

rdiac

disea

se.

INR

1.6Ma

jortra

uma.

Sym

ptom

s

Dysp

noea

,ras

hon

arm

san

dsto

mac

h,py

rexia

,ris

eof

2°C

inte

mpe

ratu

re.I

gAlev

elsno

tche

cked

.

Urtic

aria,

mar

ked

hypo

tens

ion,

bron

chos

pasm

.

Inves

tigat

ions

Cultu

reof

both

pack

s,no

grow

th.P

atien

tnot

cultu

red.

None

Stag

eTra

nsfu

sion

Reac

tion

Deve

loped

With

in30

minu

tes

follo

wing

com

pletio

nof

trans

fusio

n.

Follo

wing

com

pletio

nof

thre

eun

itsof

SDpla

sma.

Treat

men

t

Hydr

ocor

tison

e,ch

lorph

enira

mine

IVan

dox

ygen

ther

apy.

Hydr

ocor

tison

e,ch

lorph

enira

mine

IV,no

radr

enali

nean

dge

lofus

in.

Sequ

elae/

Reco

mm

enda

tions

forf

utur

etra

nsfu

sions

Reco

vere

dwi

thin

two

hour

s.Su

bseq

uent

trans

fusio

nsof

SDpla

sma

with

hydr

ocor

tison

ean

dch

lorph

enira

mine

prem

edica

tion

have

been

unev

entfu

l.

Patie

ntdie

dfiv

eda

yslat

erun

relat

edto

trans

fusio

n.

Tabl

e32

:AA

Case

sAs

soci

ated

With

Plas

ma

(n=2

)

*Inc

luded

asa

full

case

histo

ry*P

Includ

edas

afu

llca

sehis

tory

inpa

ediat

ricch

apte

r

Page 70: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Severe Acute Anaphylactoid orAnaphylactic Transfusion Reaction. CaseHistories:The following stories are described in detail as theyshow the problems encountered. (Cases 15, 21, 22and 23 are discussed in the Paediatric Chapter)

AA Case 5 This male patient with a newly diagnosed malignanthaematological disorder was actively bleeding. Hewas prescribed a transfusion of one unit of CMVantibody negative and irradiated pooled platelets for aplatelet count of 76x109/L. The patient’s primary careteam had indicated that the platelet count should bemaintained above 70x109/L. On completion of theunit the patient developed symptoms of urticaria,dyspnoea, tachycardia and falling oxygen saturations.Chlorpheniramine and hydrocortisone wereadministered intravenously and the patient recoveredwithin 45 minutes. Bacteriological investigations ofboth the patient and the unit isolated no microorganism, IgA levels were not done. One subsequenttransfusion with apheresis platelets resulted in a mildurticarial reaction and as a result, future needs havebeen managed with saline washed plateletsuneventfully.

AA Case 13 This male patient with a malignant haematologicaldisorder required a transfusion of one unit of plateletsfor a low platelet count. The patient had receivedprevious transfusions of pooled and apheresisplatelets uneventfully. On this occasion, following160 mls of apheresis platelets, the patient developedurticaria, dyspnoea, stridor, wheeze and falling oxygensaturations. The transfusion was initially continued ata slower rate and then discontinued completely andchlorpheniramine, hydrocortisone and salbutamolnebulizers were administered. The patient recoveredwithin ten minutes without complications.Subsequently the patient has had severaltransfusions of apheresis platelets with premedication of chlorpheniramine withoutcomplications.

AA Case 14 This young female patient with a newly diagnosedmalignant haematological disorder was administereda transfusion of one unit of platelets for a plateletcount of 67X109/L as she was actively bleeding. Thepatient had received a previous transfusion of pooledplatelets and developed a mild urticarial reaction andas a result, had been subsequently transfused withpooled platelets with pre medication ofchlorpheniramine. On this occasion following premedication and 180 mls of platelet apheresis, thepatient developed hypertension, dyspnoea andsubsternal discomfort. The transfusion wasdiscontinued and chlorpheniramine and oxygenadministered. The patient recovered within fiveminutes without complications. The HLA antibodyscreen was negative and IgA level pre transfusionwas within normal limits. Future transfusions willinclude a further attempt at pre medication andapheresis platelets and should the patient reactagain, saline washed platelets will be recommended.

AA Case 16This elderly patient with underlying cardiac diseasewas on multiple medication including warfarin andantibiotic therapy. The patient was transfused withtwo units of SD plasma over a three-hour period for ahaematoma secondary to trauma, INR 3.8. Warfarintherapy had been discontinued the day prior totransfusion but vitamin K was not given. Thirtyminutes following the transfusion the patientdeveloped symptoms of dyspnoea, a rash on botharms and abdomen and a rise in temperature of 2°Cto 38.2°C. Oxygen was given and IV hydrocortisoneand chlorpheniramine were administered. Symptomsresolved within two hours. Both packs were culturedand found to be negative. The patient was notcultured. IgA level not checked. The patient receivedsubsequent transfusions of SD treated plasma totreat further bleeding with antihistamine and steroidcover which were uneventful. Vitamin K was notadministered.

69Annual Report

Page 71: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

AA Case 34 This female patient required a transfusion of one unitof red cells for symptomatic anaemia of malignancyHb 8.6g/dl. One hour and 40 minutes into thetransfusion when 240 mls had been transfused thepatient became flushed and developed symptoms ofurticaria, tachycardia, stridor/wheeze, falling oxygensaturation and substernal discomfort. The transfusionwas discontinued and IV chlorpheniramine,hydrocortisone, epinephrine and glycerine trinitratespray (GTN) was given. Bacteriological culture of theunit showed no growth. The patient required transferto a tertiary centre for further observation andmanagement. Investigations of the reaction wereinconclusive and the IgA level was not checked.Further transfusions were required following transferto the tertiary facility and were uneventful.

National Haemovigilance Office70

Page 72: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

IntroductionTransfusion–associated circulatory overload (TACO)occurs when the transfusion rate or volume exceedsthe capacity of a compromised cardiovascular system(Zhou et al, 2005). Pulmonary complications (eitherTACO or TRALI) are now among the most frequentlynoted life threatening hazards of transfusion. TACOis often under-recognised (Popovsky, 2004,Andrzejewski and Popovsky 2005) and consequentlycan be under-reported. The incidence for thisreporting year in the NHO is 0.01% (1: 9730 units ofred cells issued) and TACO accounts for 7% of theincidents reported. Popovsky (2004) suggests thatthe incidence of TACO occurring in a patientundergoing transfusion is more likely to be in theregion of 1-8% (Popovsky, 2004).

TACO can result from over-transfusion to individualsat risk, often the elderly or the very young, in whomfluid infusion engulfs the capacity of the left ventricle,causing congestive cardiac failure and ultimatelypulmonary oedema (Bux, 2005). However whilethese patient populations are particularly susceptible,no recipient of blood is resistent (Stack et al, 1996).

Patients with severe chronic anaemia are also at riskof TACO resulting from rapid changes in circulatingvolume. Such patients should be transfused slowly toavoid acute changes in blood volume which mayprecipitate heart failure (Stack et al, 1996).Transfusion should not be required in the vast majorityof patients with chronic anaemia due to underlyinghaematinic deficiencies of iron, B12 or folate. Thesepatients respond quickly to specific replacementtherapy (Saxena et al1993). Where compliance ispoor, parenteral iron should be used to treat irondeficiency. Iron sucrose preparations are associatedwith less side effects than iron dextran preparations(Bailie et al 2005).

Anaemia in the context of cardiac disease presentsparticular problems. It is found to be present in 25-50% of this patient group and its presence in heartfailure is associated with a poorer prognosis (Anandet al, 2005). The causes of the anaemia appear to bemulti-factorial and include decreased erythropoiesis,hemodilution and inhibition of erythropoietin synthesisby ACE inhibitors. Iron deficiency due to nutritional

Transfusion Associated CirculatoryOverload (TACO)

DefinitionTransfusion Associated CirculatoryOverload (TACO) is characterised by thedevelopment of acute pulmonaryoedema secondary to congestive cardiacfailure. Signs and symptoms canmanifest during, or within some hours of

transfusion and can include any or all ofthe following: dyspnoea, orthopnoea,cyanosis, tachycardia, hypertension andpulmonary and/or pedal oedema. Chestauscultation reveals the presence ofrales (Popovsky, 2001).

71

Page 73: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

anaemia, malabsorption and gastrointestinal bleedingmay also be important. (Anand 2005). There isencouraging evidence that the anaemia of heartfailure, not due to other causes, may be improved bytreatment with erythropoieitin and iron therapy. Thistreatment may improve symptoms and reduce the riskof hospitalisation for worsening heart failure (NHS,Clinical Guideline 5, Silverberg et al, 2001, Manciniet al 2003). Transfusion in patients with acutecoronary syndromes who develop bleeding oranaemia during their hospitalisation, may beassociated with higher mortality rates (Rao et al,2004).

TACO can manifest itself during or within hours of thetransfusion. Non-specific symptoms frequentlyreported include chest tightness, headache and drycough.TACO in patients can often be readily identified.Occasionally, however, symptoms associated withother transfusion reactions or medical conditions canoverlap making it difficult to diagnose. Zhou et al(2005) suggest that measurement of B-natriureticpeptide (BNP), which is secreted from the cardiacventricles in response to volume expansion andoverload, is useful in evaluation of patients withsuspected transfusion related respiratory distress. Itmay be considered as a useful adjunct marker indiagnosing overload.

Findings• The cases included in this chapter illustrate the

difficulty of managing anaemia in patients with pre-existing cardiac disease.

• 14 out of 15 cases (93%) of TACO casesreported involved the transfusion of red cells.

• One case, (Case 15) was difficult to categorise asdefinitely TACO and was initially reported as anAA. It is not possible to be sure whether thesymptoms and signs in the patient who had pre-existing cardiac disease were due to the

transfusion or were coincidental. However thedevelopment of cardiac arrhythmias andsubsequent myocardial infarction is suggestive ofa cardiac cause for the symptoms and the incidenthas been captured as a TACO.

• One case, (Case12) was associated with atransfusion of apheresis platelets. Although thevolume of apheresis platelets is only 220-250 mls,the transfusion was given over 15-20 minutes.

• All but one of the patients were aged between 60-88 years and all were at risk of TACO, due to theirunderlying medical conditions.

• In six out of 15 cases, TACO occurred on the firstunit, and in two cases the patient received 100mlsor less of the transfusion before developingsymptoms.

• In a number of cases, the patient was either inpositive fluid balance or had evidence ofperipheral oedema prior to transfusion.

• In seven cases, records show that a fluid balancechart was either not kept, or was inaccurate due toincontinence. In two cases other fluids wereinfusing simultaneously with the red cells. In bothof these cases the fluid balance chart was notedto be inaccurate due to incontinence.

• Most patients responded quickly to diuretictherapy, but in one case (Case 11), where thepatient was already critically ill with underlyingmalignancy, the transfusion may have contributedto mortality.

• In nine cases, the patients were on regular diuretictherapy. In one case, (Case 13) this was stoppedthree days earlier due to dehydration. In three ofthese cases, additional diuretics were givenbefore transfusion or between units.

• In four cases, pre-transfusion diuretics were

National Haemovigilance Office72

Page 74: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

administered but proved insufficient in preventingTACO.

• In one case (Case 6), two units prescribed overtwo days were inadvertently given on the sameday resulting in TACO. However in two furthercases (Cases 3 & 7), where the transfusion wasgiven over two days, the patients still developedTACO.

• In one of these two cases (Case 3), furthertransfusions were administered uneventfully withdiuretic cover.

Recommendations• As no patient is immune, all patients should be

reviewed pre-transfusion to assess their risk ofdeveloping TACO. Particular attention should bepaid to the identification and management of‘high-risk’ patients which include:

• Patients of low body weight,

• Elderly

• Infants and children,

• Physiologically compromised patients,especially with a history of cardiac, respiratoryor renal insufficiency or chronic anaemia.

• At risk patients should be transfused slowly at arate of 1 ml/kg/hour (Popovsky 1985) and closeattention, where possible, should be paid to thepatient’s fluid balance status not only during thetransfusion but also in the 24 hour period prior totransfusion. Single unit transfusions can result inTACO and therefore should be monitored asclosely as multiple unit transfusions (Andrzejewskiand Popovsky, 2005).

• Transfusion should be on a unit-by-unit basis, with

a medical assessment of the patient prior tocommencing transfusion and before administeringany further component. This assessment shouldinclude:

• A careful estimation of the patient’s hydrationstatus prior to transfusion.

• Thorough review of the patient’s fluid balanceduring transfusion of any blood component.

• The possible need for ‘prophylactic’ diuretictherapy.

• The risk of TACO can be reduced by theadministration of pre-transfusion diuretics. Thismay also be necessary for those on regulardiuretic therapy.

• In very low weight/ at-risk patients, it may beadvisable to transfuse units with 24 hoursbetween each unit in combination with pretransfusion diuretics. Some subjects take as longas 24 hours to readjust blood volume particularlyin those patients whose venous pressure is raisedpre-transfusion (Mollison et al 1998).

• Where possible, simultaneous infusion of otherfluids during transfusion should be avoided inpatients at risk of TACO.

• In cases of iron-deficiency anaemia, transfusionshould only be considered when the anaemia issymptomatic. (Saxena et al, 1993). Where oraliron is not tolerated or compliance is poor,parenteral iron therapy should be considered.

73Annual Report

Page 75: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office74

Case

No.

TACO

Case

1

TACO

Case

2

TACO

Case

3*

TACO

Case

4

TACO

Case

5

Age

yrs

Gend

er

63 M 88 M 56 F 64 F 63 M

Weig

htkg 68 Un

k

55 Ukn

Ukn

Volum

eTra

nsfu

sed

One

com

plete

unit

and

>100

mls

ofth

ese

cond

unit

ofre

dce

lls

>10

0mls

red

cells

over

two

hour

s

Two

units

ofre

dce

lls

One

unit

red

cell

conc

entra

te

One

unit

ofre

dce

lls

Rate

ofTra

nsfu

sion

90m

lspe

rhou

r

Two

units

over

four

hour

seac

h

Thre

eun

itsov

erfo

urho

urse

ach

over

two

days

One

unit

over

four

hour

s

Over

four

hour

s

Pre-

exist

ingPr

oblem

s

Myoc

ardia

linf

arct

ionan

dlef

tve

ntric

ularf

ailur

e.Hb

7.2g/

dlPo

sitive

fluid

balan

ceof

1512

mls

Seve

reco

nges

tive

card

iacfa

ilure

,isc

haem

iche

artd

iseas

e,re

nal

impa

irmen

t.Hb

7.7g/

dlPo

sitive

fluid

balan

ceof

122m

ls

Carc

inom

aof

the

lung.

Histo

ryof

myo

card

ialinf

arct

ion,

hype

rtens

ion,p

eriph

eral

vasc

ular

disea

sean

dep

ileps

y.Hb

6.5g/

dl

Haem

atolo

gical

mali

gnan

cyRe

curre

ntpn

eum

onia

Perip

hera

loed

ema

Hb8.6

g/dl

Sym

ptom

s&Ou

tcom

e

Deve

loped

dysp

noea

and

pulm

onar

yoe

dem

adu

ring

the

seco

ndun

it.Tre

atm

ent:

Frus

emide

IVad

mini

stere

dan

dsy

mpt

oms

reso

lved.

Noco

mpli

catio

ns.

Dysp

noea

,tac

hyca

rdia,

expir

ator

ywh

eeze

,dec

reas

edair

entry

both

base

s,ra

ised

JVP

Treat

men

t:hy

droc

ortis

one,

fruse

mide

,neb

ulise

rsy

mpt

omsr

esolv

ed.

Noco

mpli

catio

ns

Tach

ypno

ea,c

ough

ingan

dvo

mitin

g.Tre

atm

ent:

oral

diure

ticsg

iven

with

good

resp

onse

.Dy

spno

eaan

dsy

mpt

omsr

esolv

ed.

Noco

mpli

catio

ns

Dysp

noea

,tac

hyca

rdia,

bilat

eral

crep

sand

whee

ze,l

ower

edO 2

satu

ratio

nsan

dch

estt

ightn

ess.

Treat

men

t:fru

sem

ide,g

lycer

yltrin

itrat

e–fu

llre

cove

ryNo

com

plica

tions

Dysp

noea

,clam

my,

pale,

swea

ty.

Ches

tx-ra

ysh

owed

exte

nsive

alveo

larsh

adow

ingTre

atm

ent:

hydr

ocor

tison

e,fru

sem

ide,O

2ne

bulis

ers

Died

days

later

unre

lated

totra

nsfu

sion

Com

men

ts

Nodiu

retic

prior

totra

nsfu

sion

Regu

lardiu

retic

ther

apy

and

diure

ticpr

iorto

trans

fusio

n.

Eject

ionfra

ction

10%

-pat

ient

susc

eptib

leto

over

load.

First

unit

given

over

4ho

urs,

seco

ndgiv

enne

xtda

yov

er3

hour

sand

40m

inute

s.Flu

idba

lance

wasn

otre

cord

edpr

iorto

ordu

ring

the

trans

fusio

n.Di

uret

icgiv

enpr

iorto

3rd

unit

–tra

nsfu

sed

unev

entfu

lly

Haem

acel

infus

ingsim

ultan

eous

ly.No

regu

laror

prop

hylac

ticdiu

retic

.Flu

idba

lance

char

tina

ccur

ate.

Reac

tion

occu

rred

when

only

60-8

0mls

had

trans

fuse

d90

minu

tesa

fter

com

men

cem

ento

ftra

nsfu

sion.

Onre

gular

diure

tics.

Fluid

balan

ceina

ccur

ate

prior

toth

etra

nsfu

sion

Tabl

e33

:TAC

OCa

ses

(n=1

5)

*Inc

luded

asa

full

case

histo

ry

Page 76: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

75Annual Report

Case

No.

TACO

Case

6*

TACO

Case

7

TACO

Case

8

TACO

Case

9

TACO

Case

10

Age

yrs

Gend

er

74 F 74 F 60 F 80 F 76 M

Weig

htkg 37 Uk

n

46 <70

Unk

Volum

eTra

nsfu

sed

One

unit

and

150

mls

red

cells

Two

units

and

300m

lsof

third

unit

ofRe

dCe

lls

220m

lsof

red

cells

One

unit

and

200m

lsof

red

cells

60m

lsof

first

unit

ofre

dce

lls

Rate

ofTra

nsfu

sion

Two

units

over

four

hour

seac

hov

ertw

oda

ys.

Thre

eun

itsov

ertw

oda

ys

Over

four

hour

s

Over

four

hour

seac

h

Four

units

over

4ho

urs

each

Pre-

exist

ingPr

oblem

s

Malig

nanc

y.Lo

werl

imb

oede

ma.

Hb8g

/dl

Malig

nanc

ywi

thlun

gse

cond

aries

and

unde

rlying

infec

tion.

Rena

lfail

ure

Hb6.6

g/dl

Post

oper

ative

anae

mia,

hype

rtens

ionHb

6.3g/

dl

Card

iacco

nditio

n,pe

riphe

ral

vasc

ulard

iseas

ean

dan

aem

iaHb

7.4g/

dlPo

sitive

fluid

balan

ceof

1000

mls.

GIble

eding

,con

gesti

veca

rdiac

failu

reHb

4.3g

Sym

ptom

s&Ou

tcom

e

Dysp

noea

fallin

gox

ygen

satu

ratio

nTre

atm

ent:

Oxyg

en,d

iscon

tinue

dun

it–

full

reco

very

Noco

mpli

catio

ns.

Pyre

xia,t

achy

card

ia,hy

perte

nsion

,ba

ckpa

in,dy

spno

eaan

dwh

eeze

.Tre

atm

ent:

Frus

emide

,par

acet

amol

–re

cove

ryin

6ho

urs

Noco

mpli

catio

ns.

Hype

rtens

ion,t

achy

card

iaTre

atm

ent:

Disc

ontin

ued

trans

fusio

n,fru

sem

idean

dox

ygen

Noco

mpli

catio

ns

Atria

lfibr

illatio

n,hy

perte

nsion

tach

ycar

dia,d

yspn

oea

fallin

gox

ygen

satu

ratio

ns,u

rtica

ria,

Treat

men

t:fru

sem

ide40

mgs

given

with

anef

fect

ivediu

resis

of19

60m

lsNo

com

plica

tions

Brad

ycar

dia,d

yspn

oea,

and

fallin

gO 2

satu

ratio

nsTre

atm

ent:

Frus

emide

,cyc

lomor

ph,i

soso

rbide

dinitr

ate

infus

ion,o

xyge

nNo

com

plica

tions

Com

men

ts

Both

units

inadv

erte

ntly

given

onth

esa

me

day.

Onre

gular

diure

ticsa

ndals

obe

twee

nun

its

Pallia

tive

care

patie

nt.

Frus

emide

given

follo

wing

seco

ndun

it.Fo

llowi

ngfir

stun

itwa

sin

nega

tive

fluid

balan

ceof

200m

ls.

Nore

gular

diure

tics.

Noflu

idba

lance

reco

rded

prior

toth

etra

nsfu

sion.

Onre

gular

diure

tics.

First

unit

trans

fuse

dun

even

tfully

.No

pre-

trans

fusio

ndiu

retic

.

Onre

gular

diure

tics

OnNa

Clinf

usion

simult

aneo

usly.

Inacc

urat

eflu

idba

lance

prior

totra

nsfu

sion

Trans

fusio

nre

com

men

ced

and

othe

runit

sgiv

enwi

thfu

rther

fruse

mide

and

mor

phine

Tabl

e33

:TAC

OCa

ses

(n=1

5)(c

ont)

*Inc

luded

asa

full

case

histo

ry

Page 77: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office76

Case

No.

TACO

Case

11

TACO

Case

12

TACO

Case

13

TACO

Case

14

TACO

Case

15

Age

yrs

Gend

er

63 M 66 M 85 F 80 M 81 F

Weig

htkg 69 72 38 Un

k

Unk

Volum

eTra

nsfu

sed

Two

units

ofre

dce

lls

One

unit

ofap

here

sispla

telet

s

One

unit

ofre

dce

llsan

d20

0m

lsof

seco

ndun

it.(re

ceive

don

eun

itof

red

cells

the

prev

ious

day)

150

mls

ofre

dce

llsov

ertw

oho

ursa

nd20

minu

tes

One

unit

ofre

dce

lls

Rate

ofTra

nsfu

sion

Over

4ho

urse

ach

Over

30m

inute

s

Over

four

hour

seac

h

Over

sixho

urs

Give

nov

er40

minu

tes

Pre-

exist

ingPr

oblem

s

Card

iomyo

path

y,ca

rcino

ma

ofth

elun

gHb

8g/d

l

Haem

atolo

gical

disor

der,

anae

mia

Cong

estiv

eca

rdiac

failu

re,o

ther

med

icala

ndga

stroin

testi

nal

cond

itions

Hb6.5

g/dl

Chro

nicob

struc

tive

pulm

onar

ydis

ease

,car

diac

disea

se,d

iabet

es,

hype

rtens

ion.

Hb8.9

g/dl

Posit

iveflu

idba

lance

of37

0mls

prior

totra

nsfu

sion

Perip

hera

lvas

cular

disea

se,h

istor

yof

mali

gnan

cy,c

ereb

rali

nfar

ctan

dhy

perte

nsion

Hb9.9

g/dl

Sym

ptom

s&Ou

tcom

e

Hype

rtens

ion,f

alling

oxyg

ensa

tura

tions

.Tre

atm

ent:

Diur

etic

with

good

resp

onse

Patie

ntdie

d24

hour

spos

ttra

nsfu

sion

poss

ibly

relat

edto

trans

fusio

n,alt

houg

hth

epa

tient

wasv

ery

ill.

Incre

ased

hear

trat

e,dy

spno

eaTre

atm

ent:

Hydr

ocor

tison

e,ch

lorph

enam

ine–

reco

very

inon

eho

urNo

com

plica

tions

Dysp

noea

,fall

inO 2

satu

ratio

n,fa

lling

urina

ryou

tput

Treat

men

t:fru

sem

idean

dox

ygen

Noco

mpli

catio

ns

Dysp

noea

,hyp

erte

nsion

,fall

inur

inary

outp

utTre

atm

ent:

fruse

mide

,res

pons

eun

clear

Patie

ntdie

d2

mon

thsl

ater

unre

lated

totra

nsfu

sion.

Supe

rven

tricu

larta

chyc

ardia

,hyp

oten

sion

facia

lras

h,Tre

atm

ent:

gelof

usin,

chlor

phen

iram

ine,h

ydro

corti

sone

,ad

enos

ine,f

ruse

mide

and

oxyg

enPa

tient

died

10da

yslat

erun

relat

edto

the

trans

fusio

n

Com

men

ts

Onre

gular

diure

ticth

erap

yan

dpr

e-tra

nsfu

sion

diure

tic.

Plat

elets

given

over

15-2

0m

inute

s.No

regu

lardiu

retic

s.No

fluid

balan

ce

Stop

ped

regu

lardiu

retic

ther

apy

thre

eda

yspr

iorto

trans

fusio

n.Ina

ccur

ate

fluid

balan

ce.

Onre

gular

diure

tics

Myoc

ardia

linf

arct

ionfo

llowi

ngda

y

Tabl

e33

:TAC

OCa

ses

(n=1

5)(c

ont)

Page 78: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

TACO Case Histories

We describe 2 of the case reports in detail toillustrate some of the issues highlighted:

TACO Case 3 This low weight female patient (weight 55kg) with ahistory of malignant lung disease and a Hb of 7.6g/dlrequired a transfusion of three units of red cells. Oneunit was transfused without incident. The next day,immediately following the administration of thesecond unit over 3 hours and 40 minutes, the patientdeveloped symptoms of dyspnoea, increasedrespiratory rate (40/min), excessive coughing andvomiting. Oral diuretics were prescribed andadministered with a good diuretic response. Thesymptoms improved quickly with full resolution withinfour hours. Eight hours after the completion of thesecond unit, a third unit of red cells was prescribedand administered uneventfully. An oral diuretic wasadministered prior to this transfusion.

TACO Case 6 This elderly low weight female patient withmalignancy required a transfusion of two units of redcells. Her Hb level was 8g/dl. The patient had nodocumented underlying history of cardiac orrespiratory disease but was receiving regular diuretictherapy for limb oedema. The two units wereprescribed over four hours each and were to be givenon two separate days. Inadvertently both units wereadministered on the same day. The patient receivedher regular diuretic that morning and the first unitinfused uneventfully over three hours. Oral frusemide20 mgs was given between the first and second units.Within 30 minutes of commencing the second unit,following transfusion of approximately 150 mls, thepatient developed symptoms of dyspnoea and fallingoxygen saturations. The transfusion wasdiscontinued completely. Nasal oxygen therapy wascommenced and no further diuretics wereadministered. The patient recovered withoutsequelae and although the timeframe is unclear anote in the patients chart four hours after the eventsuggests she had recovered at that stage.

77Annual Report

Page 79: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

This category accounted for 2% of the incidentsreported (4 of 214), down from nine cases in thepreceding two years. This type of reaction is thoughtto occur at a frequency of 1:400-1:700 transfusions.It is therefore, likely that a number of these reactionsgo undiagnosed. This is possibly due to the fact thatmost of the patients receiving transfusions are alreadyvery ill and the symptoms are attributed to theirunderlying condition. Typically patients present withfalling haemoglobin and other signs of haemolysisincluding a raised bilirubin and possibly renalimpairment a few days (usually 4-10) aftertransfusion. On the vast majority of occasions theantibody screen prior to the transfusion is found to benegative for the antibody responsible. The antibodiesusually involved belong to the Rh and Kidd families.

Findings: • There were four cases reported this year, down

from nine in the previous two years.

• Grading: Group 1: Asymptomatic with ‘antibody only’ detected

(with or without a positive antiglobulin test(DAT)). Two cases; Case 2 and Case 4.

Group 2: Evidence of haemolysis measured by fallinghaemoglobin and positive DAT. None

Group 3: Falling Hb with jaundice with or without apositive DAT. Two cases; Case 1 and Case 3.

Group 4: As for Group 3, but with renal impairment.None.

• As in previous years, the antibodies implicatedbelong to the Rh, Kidd and Duffy families.

• There were no fatalities associated with thesereactions.

• In Case 1, the patient presented ten days after atransfusion with a rising bilirubin but this wasthought to be due to the underlying condition or to

Delayed Haemolytic Transfusion Reaction

DefinitionDelayed haemolytic transfusion reactionsare defined, for the purpose of thisreport, as those occurring more than 24hours following the transfusion of a bloodcomponent. A haemolytic transfusionreaction occurs when antigen-positive

red blood cells are transfused to apatient who develops an alloantibody tothat antigen. It results in the lysis oraccelerated clearance of red blood cellsdue to immunologic incompatibilitybetween the blood donor and therecipient (Boehlen & Clemeston, 2001)

78

Page 80: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

the patient's medication. It was only at asubsequent stage during DAT testing that thediagnosis was made.

• In Case 2, allo-absorption studies were not carriedout prior to transfusion with the result that some ofthe units of blood transfused were positive for anantigen to which the patient already had anantibody.

Recommendations• It is likely that there is under-diagnosis or under-

reporting of this condition. It is essential that anypatient presenting with any signs of haemolysis ora positive DAT, some days after a transfusionshould be investigated for a DHTR. Thesuccessful diagnosis depends also on accuratehistory taking and the elicitation of a history ofrecent transfusion.

• Use of red cell panels in sensitive antibodyscreening techniques, adequate training andproficiency testing of all staff involved in cross-matching and participation by all concerned inexternal quality assurance schemes shouldcontribute to the minimisation of this complication.

• Patients with Autoimmune Haemolytic Anaemiawith strong autoantibody reactions present aparticular problem. In non emergenciesabsorption studies should be carried out toexclude the presence of an underlying clinicallysignificant antibody prior to transfusion of thesepatients. If emergency transfusion is required thenRh phenotype compatible, K negative bloodshould be provided and the clinician advised ofthe potential incompatibility. Patients withtransfusion dependent autoimmune haemolyticanaemia should be monitored at regular intervalsso that transfusion requirements are anticipated,providing sufficient time for extended compatibilitytesting procedures to be performed prior totransfusion. Absorption studies should be carriedout prior to transfusion wherever possible.

However, urgent treatment should not be delayed.

• Undue delay in transfusion rather than the delayedreaction itself may lead to fatalities (SHOT 2002).Urgent transfusion should not be delayedunnecessarily and in the case of a DHTR,specialist advice should be sought for futuretransfusion management.

• There is a need for the on-call facility to performcomplex serological investigations such asabsorption studies in autoimmune haemolyticanaemia out of hours.

• Local policies/procedures should be in place forthe management of emergency transfusion whereunidentified antibody(ies) or difficulties inprovision of compatible blood occur.

• Consideration should be given to issuing antibodycards to patients with clinically significantantibodies (NBUG 2002) and the possibility of anational patient antibody register for patients withred cell antibodies should also be evaluated.(Lariat & Fisher 2005)

79Annual Report

Page 81: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office80

Case

No.

DHTR

Case

2*

DHTR

Case

4

Age

yrs

88yr

s

75yr

s

Gend

er

F F

Pre-

exist

ingco

nditio

n

Auto

imm

une

haem

olytic

anae

mia

with

mult

iple

med

icalp

roble

ms.

Sym

ptom

soff

alling

Hb,r

aised

biliru

bin,d

eter

iorat

ingre

nal

func

tion,

apo

sitive

DAT

and

evide

nce

ofsp

hero

cyto

sis

COAD

,CVA

,hyp

erte

nsion

,Ad

dison

’sdis

ease

with

unde

rlying

mali

gnan

cyan

dwi

desp

read

met

asta

sis

Inter

valb

etwe

entra

nsfu

sion

and

onse

tof

sym

ptom

s/sig

ns

Multip

letra

nsfu

sions

adm

iniste

red

over

thre

em

onth

s.

Anti

Ch/R

g18

days

afte

rtra

nsfu

sion

Treat

men

t

None

None

Findin

gs

Allo

anti-

Jka

dete

cted

afte

rem

erge

ncy

trans

fusio

nof

thre

eun

itsof

blood

that

were

later

foun

dto

beJk

apo

sitive

.

Bilir

ubin,

LDH,

GTT

allra

ised

pre

trans

fusio

n.Re

nalf

unct

ionte

stsab

norm

alpr

e-tra

nsfu

sion

Outc

ome

Patie

ntdie

dse

vent

een

days

later

unre

lated

totra

nsfu

sion.

Leas

tinc

ompa

tible

blood

wasi

ssue

dan

dtra

nsfu

sed

unev

entfu

lly.

Tabl

e34

:Del

ayed

Haem

olyt

icTr

ansf

usio

nRe

actio

n(D

HTR)

(n=4

)Gr

oup

1

Case

No.

DHTR

Case

1*

DHTR

Case

3

Age

yrs

51yr

s

79yr

s

Gend

er

F F

Pre-

exist

ingco

nditio

n

Post

majo

rGIs

urge

ryan

dre

nal

failu

re.

Anae

mia,

GIble

ed-H

aem

atem

esis

and

mela

ena

Treat

men

t

None

None

Findin

gs

Anem

ia,ra

ised

biliru

bin,D

ATpo

sitive

Anti

-E,-

c,-J

kade

tect

ed

Raise

dbil

irubin

Anti-

Jkb ,

and

poss

ibly

anti-

Ean

dan

ti-s

Outc

ome

Patie

ntdie

don

em

onth

afte

rtra

nsfu

sion

–de

ath

unre

lated

toth

ere

actio

n.

Trans

fuse

dwi

thco

mpa

tible

antig

enne

gativ

eblo

od.R

ecov

ered

with

intw

owe

eks.

Noco

mpli

catio

ns

Tabl

e35

:Del

ayed

Haem

olyt

icTr

ansf

usio

nRe

actio

n(D

HTR)

(n=4

)Gro

up3

Inter

valb

etwe

entra

nsfu

sion

and

onse

tof

sym

ptom

s/sig

ns

11da

ys.

8da

ys

*Inc

luded

asa

full

case

histo

ry

Page 82: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Delayed Haemolytic Transfusion Reaction(DHTR). Case Histories:

DHTR Case 1 This acutely ill patient required transfusion due tointraoperative bleeding. The patient had fivetransfusion episodes over a period of eleven days,totalling 15 units RCC, 16 units of plasma and threepacks of platelets. The antibody screen was negativeon two occasions. Despite continued transfusiontherapy her Hb remained consistently low. Ten daysafter the first transfusion episode it was noted that thepatient’s bilirubin level had raised but it was felt thatthis might be related to the patient’s condition andmedication. At the same time the DAT (previouslynegative) was found to be positive and subsequentantibody screening showed the patient haddeveloped anti-E, anti-c and anti-Jka. The patient dieda month later, although the death was deemedunrelated to the transfusion reaction.

DHTR Case 2 This elderly patient required a transfusion for longstanding warm AIHA. The Hb level at transfusion was5.4 g/dl. Previously the patient had been referred tothe IBTS and was shown to have an autoantibody aswell as an allo anti-Cw. On a previous admission overa weekend, the patient required an urgent transfusionfor a low Hb 5.8 g/dl, and three units of genotypedmatched blood were transfused withoutcomplications. A pre-transfusion sample confirmedthe continuing presence of the auto-antibody,however no allo anti-Cw was detected. The patientcontinued to have Cw negative blood. On the nextadmission, again on a weekend, the patient wassymptomatic with a Hb of 7.2g/dl and blood wasurgently needed. The transfusion went ahead withoutfull absorption studies. Although further sampleswere requested for full work up at the IBTS, thesewere not taken. The next admission occurred onemonth later, once again at a weekend. The Hb levelwas 5.4 g/dl and the patient received a transfusion offour units of red cells. No absorption studies werecarried out prior to the transfusion. These were

carried out on the next working day and they revealedan allo anti-Jka. All four packs transfused were testedand three units were found to be Jka positive. Sinceno absorption studies were performed on theprevious occasion, it is unclear when the allo anti Jka

developed. The patient died unrelated to thetransfusion seventeen days post transfusion.

81Annual Report

Page 83: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

This category accounted for 11% of incidentsreported (24 of 214). The differential diagnosis forthese reactions will always include red cellincompatibility and bacterial infection and an effortshould be made to exclude both these possibilities.As in reports in previous years, it has been noted thatit is not always possible to establish the cause of thereaction and that symptoms caused by the patient’sunderlying condition may have contributed to thepresentation.

Findings 2004

• There was a sharp rise in the number of reactionsin this category as compared to previous years.Apart from increased awareness and thereforeincreased reporting, no specific reason wasidentified to explain this increase.

• 20 out of the 24 cases occurred after transfusionof red cell units. 16 out of the 24 patients had anunderlying history of malignancy. Of the 18patients where information was available about

patient recovery, 11 recovered within four hoursand the remainder, except for one patient whoserecovery was delayed, recovered within 24 hours.Of the cases where treatment is recorded, 17patients received treatment that includedparacetamol, chlorpheniramine and hydro-cortisone. Five patients received no treatment andrecovered spontaneously.

• The haemoglobin prior to transfusion ranged from5 g/dl to 8.8 g/dl. Most of these patients wereelderly and had multiple underlying problems.Only one patient was transfused at a Hb of 10g/dl.The patient had a history of multiple medicalproblems and was on antibiotics and had receivedtwo units of red cells on the previous day withoutproblems.

• In the majority of the 14 cases where atemperature rise of >1.5°C was documented,either the patient or the unit or both were cultured.However, only two out of the four cases involvinga platelet transfusion were cultured.

Acute Haemolytic and Other Severe AcuteTransfusion Reaction: (AHOSTR)

DefinitionAcute Transfusion Reactions are definedas those occurring within twenty fourhours of transfusion. The major concernin evaluating these reactions is toexclude bacterial contamination of theunit or haemolysis due to incompatiblered cells (Heddle & Kelton, 2001).

For the purpose of the NHO report,Acute Haemolytic Transfusion Reactionsoccurring due to incorrect bloodtransfused are captured in the ‘IncorrectBlood Component Transfused’ chapter.Anaphylaxis/Anaphylactoid transfusionreactions are also reported within aseparate chapter

82

Page 84: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Positive cultures were found in four cases – in threeof them, the patient sample cultured positive and inthe fourth, culture of the unit was positive. On furtherevaluation, however, these results were notconsidered to be associated with the transfusion butwere due to the patient’s underlying condition orcontamination.

• Red cell incompatibility was excluded in 13 cases.In one case (Case 1) associated with fever andrigors, anti-Fya antibody was detected 5 days afterthe transfusion and in another, (Case 26) wherethe patient showed evidence of haemolysis, ananti-Lua antibody was identified. However, an antiLua antibody is not usually of significance and wasnot considered to be the cause of the patient’sreaction, which remains unexplained. In the rest ofthe cases, no serology investigations werereported.

• In one case (Case 11), a reaction to platelets, thepatient had developed HLA antibodies whichwere probably responsible for the reaction.

Recommendations:

• Every patient should be carefully monitored duringtransfusion with special emphasis placed on thestart of each new unit. Individual units should becommenced slowly, and the patient observedclosely for the first 15 minutes/50 mls as severereactions are most likely to occur within this time.(BCSH 1999).

• Each hospital must have a policy in place for themanagement of an acute transfusion reaction.This should include the medical and nursingmanagement of the patient’s symptoms and theinvestigations necessary to complete thetransfusion reaction analysis. Following a severetransfusion reaction, the transfusion should bediscontinued completely and no further units fromthis crossmatch should be transfused until anABO incompatible transfusion has been excluded

and the blood has been re-crossmatched.

• Investigations should include: -

- Re-confirming the identification of the patientand the unit

- Re-confirming the ABO and Rh D group of thepatient and the unit

Blood samples for:- Repeat group, antibody screen and

crossmatch to exclude an ABO or red cellincompatible transfusion including a clottedsample for antibody identification using serum

- full blood count (FBC)- direct antiglobulin test (DAT)- coagulation screen- biochemistry analysis to include serum bilirubin

and LDH (NBUG 2000)- blood cultures

• Where antibody is detected in the post transfusionsample taken within 24 hours of the transfusionwhich was not detected in the pre-transfusionsample, the pre-transfusion sample should betested by a different technique and/or referred toa reference laboratory for investigation as it islikely that the antibody was present pre-transfusion but was not detected.

• It is essential to carry out adequate serologicalinvestigations in patients with multiple antibodieswho present with an acute reaction.

• If possible, further transfusions should be delayeduntil completion of the transfusion reaction work-up.

• In AHOSTR, particularly where there is fever andchills/rigors, both the patient and the transfusedunit(s) should be cultured to exclude bacterialcontamination of the unit. This is particularlyimportant when the reaction occurs in platelet

83Annual Report

Page 85: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

transfusion as platelet concentrates are stored at20°C and the incidence of bacterial contaminationis highest in platelet concentrates. To reduce thisrisk, the IBTS has undertaken bacteriologicalscreening of all platelet concentrates before issuesince the last quarter of 2004.

• A protocol for culturing of the blood component isavailable by writing to the QA/QC Department ofthe IBTS. This protocol outlines the procedure tobe followed when culturing a unit implicated in afebrile transfusion reaction.

• Specimens e.g. urine, sputum, necessary toexclude other possible sources of infection shouldalso be cultured.

National Haemovigilance Office84

Page 86: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

85Annual Report

Case

No.

AHOS

TRCa

se1*

AHOS

TRCa

se2

AHOS

TRCa

se3

AHOS

TRCa

se5

AHOS

TRCa

se6

AHOS

TRCa

se8*

AHOS

TRCa

se9

Com

pone

ntPr

escr

ibed

Two

units

ofre

dce

lls

Two

units

ofre

dce

lls

Two

units

ofre

dce

lls

Four

units

ofre

dce

lls

One

unit

ofre

dce

lls

One

unit

ofwa

shed

red

cells

One

unit

ofre

dce

lls

Age

Yrs

Gend

er

78 F 74 F 83 F 89 F 72 F 42 F 60 F

Unde

rlying

cond

ition

Seps

isse

cond

ary

toga

stric

surg

ery

Haem

atolo

gical

mali

gnan

cy

Ischa

emic

Hear

tDi

seas

e

Pulm

onar

yem

bolus

.Ch

ronic

anae

mia

Malig

nanc

ypo

stope

rativ

ean

aem

ia,se

psis

Paro

xysm

alNo

ctur

nal

Haem

oglob

inuria

Haem

atolo

gical

mali

gnan

cy

Volum

etra

nsfu

sed

onse

t

Follo

wing

trans

fusio

nof

150

mls

ofre

dce

lls.

Patie

ntha

dre

ceive

da

trans

fusio

n1

mon

thpr

eviou

sly.

150

mls

ofse

cond

unit

100m

lsre

dce

lls

100m

lsof

4th

unit.

One

unit

ofre

dce

lls

150

mls

ofre

dce

lls.

120

mls

ofre

dce

lls

Sym

ptom

s/sig

ns

Patie

ntco

mpla

ined

ofrig

orsa

ndfe

ver.

Risin

gbil

irubin

post

trans

fusio

nwi

thin

6ho

urs.

Urine

posit

ivefo

ruro

bilino

gen

Agita

tion,

feeli

ngof

impe

nding

doom

and

tach

ycar

dia.

Tem

pera

ture

rise

>1.5

°C,c

hills,

rigor

s,re

stles

snes

s,an

xiety

,ta

chyc

ardia

and

feeli

ngof

impe

nding

doom

Tem

pera

ture

>1.5

°C,c

hills

and

rigor

s

Hype

rtens

ion,

tach

ycar

dia.

Tem

pera

ture

rise

>1.5°

C

Tem

pera

ture

rise

of2.5

°C,

hype

rtens

ion,n

ause

aan

dge

nera

lac

hes.

Tem

pera

ture

rise

0.6°C

,chil

lsan

drig

ors,

rise

inblo

odpr

essu

rebu

tre

main

edno

rmot

ensiv

e

Inves

tigat

ions

The

DAT

wasp

ositiv

ein

IgGin

pre

and

post

trans

fusio

nsa

mple

s.An

tibod

ysc

reen

wasp

ositiv

e.Su

bseq

uent

inves

tigat

ions5

days

later

show

edan

ti-Fy

a .

Pack

cultu

red

–no

orga

nism

siso

lated

.Re

dce

llinc

ompa

tibilit

yex

clude

d.

Patie

ntno

tcult

ured

.Unit

cultu

red

-no

orga

nism

siso

lated

.Re

dce

llinc

ompa

tibilit

yex

clude

d.

Patie

ntcu

lture

dpo

sitive

for

staph

yloco

ccus

aure

us-p

roba

bleco

ntam

inant

.Un

itno

tcult

ured

.

Patie

ntan

dun

itcu

lture

d-n

oor

ganis

miso

lated

Bact

eriol

ogica

lscr

eenin

gof

the

unit

wasn

egat

ive.

Histo

ryof

prev

iousr

edce

llan

tibod

iesan

dhis

tory

ofpr

eviou

stra

nsfu

sion

reac

tion.

Red

cell

incom

patib

ility

exclu

ded.

Bact

eriol

ogica

lscr

eenin

gof

both

patie

ntan

dun

itwa

sneg

ative

Treat

men

t&Ou

tcom

e

Non

stero

idala

nti-i

nflam

mat

ory.

Patie

ntre

cove

red

with

noill

effe

cts

with

in6

hour

s.

Oxyg

enth

erap

y.Sp

onta

neou

srec

over

yaf

ter1

0to

15m

inute

s.

Trans

fusio

ndis

cont

inued

com

plete

ly.Hy

droc

ortis

one

given

.Re

cove

red

with

inon

eho

ur.

Unit

disco

ntinu

edco

mple

tely.

Para

ceto

mol

given

.Re

cove

red

fully

with

inon

eho

uran

dre

main

edap

yrex

ial.

Para

ceto

mol

given

.Obs

erve

dre

cove

rywi

thin

two

hour

s.

Para

ceta

mol

given

.Re

cove

red

with

out

com

plica

tions

.

Trans

fusio

ndis

cont

inued

com

plete

ly.Hy

droc

ortis

one

and

chlor

phen

iram

inegiv

en.

Patie

ntre

cove

red

with

inon

eho

ur

Tabl

e36

:AHO

STR

case

s(n

=24)

*Inc

luded

asa

full

case

histo

ry

Page 87: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office86

Case

No.

AHOS

TRCa

se10

AHOS

TRCa

se12

AHOS

TRCa

se13

AHOS

TRCa

se14

AHOS

TRCa

se15

AHOS

TRCa

se16

*

AHOS

TRCa

se26

*

Com

pone

ntPr

escr

ibed

One

unit

ofre

dce

lls

Red

cells

One

unit

ofre

dce

lls

One

unit

ofre

dce

lls

One

unit

ofre

dce

lls

One

unit

ofre

dce

lls

Thre

eun

itsof

red

cells

Age

Yrs

Gend

er

43 F 86 M 58 M 27 M 32 M 72 M 65 F

Unde

rlying

cond

ition

Haem

atolo

gical

mali

gnan

cy

Haem

atolo

gical

mali

gnan

cy

Malig

nanc

y

Multip

leinj

uries

follo

wing

RTA

Malig

nanc

y

Haem

atolo

gical

disor

der,

card

iacdis

ease

Intra

oper

ative

blood

loss

Volum

etra

nsfu

sed

onse

t

150

mls

ofre

dce

lls

150m

ls

Few

mls

With

in40

minu

teso

fco

mm

encin

gtra

nsfu

sion

With

in30

minu

teso

fco

mm

encin

gtra

nsfu

sion.

Sym

ptom

socc

urre

dth

ree

hour

safte

rtra

nsfu

sion.

Next

day.

Sym

ptom

s/sig

ns

Hype

rtens

ion,t

achy

card

ia,dy

spno

ea,r

estle

ssne

ss,a

nxiet

yan

da

feeli

ngof

impe

nding

doom

Tem

pera

ture

rise

of2.9

°C,

tach

ycar

dia,c

hills,

naus

ea,

vom

iting

Tem

pera

ture

rise

>1.5

°C.

Chills

and

rigor

s.Hy

perte

nsion

Tach

ycar

dia,c

hills,

rigor

s,ap

preh

ensio

n.

Hypo

tens

ion,

restl

essn

ess,

anxie

ty,f

eelin

gof

impe

nding

doom

,ting

ling

inbo

thar

ms

Tem

pera

ture

rise

>1.5°

C,ta

chyc

ardia

,rigo

rs,hy

perte

nsion

,dy

spno

eaan

dta

chyp

noea

,flus

hed

and

incon

tinen

t.

Haem

atur

ia,hy

pote

nsion

,fall

ingha

emog

lobin

sligh

tcya

nosis

,na

usea

.Ra

ised

biliru

binan

dLD

H

Inves

tigat

ions

Red

cell

incom

patib

ility

exclu

ded.

Cultu

reof

the

patie

ntan

dth

eun

itne

gativ

e

Red

cell

incom

patib

ility

exclu

ded.

Cultu

reof

unit

nega

tive,

patie

ntsh

owed

coag

ulase

nega

tive

staph

lococ

ci-co

incide

ntal

cont

amina

tion

Red

cell

incom

patib

ility

exclu

ded.

DAT

post

trans

fusio

nne

gativ

e

Red

cell

incom

patib

ility

exclu

ded

and

patie

ntan

dun

itcu

lture

dne

gativ

e.

Red

cell

incom

patib

ility

exclu

ded.

Post

trans

fusio

nIgA

level

norm

al.

Red

cell

incom

patib

ility

exclu

ded.

Patie

ntno

tcult

ured

.Un

itcu

lture

dne

gativ

e.

Pre

trans

fusio

nan

tibod

ysc

reen

had

ident

ified

anan

ti-Lu

a

antib

ody,

which

wasa

lsoide

ntifie

dpo

stop

erat

ively

and

conf

irmed

ata

refe

renc

ece

ntre

.No

tcon

sider

edca

use

ofre

actio

n.

Treat

men

t&Ou

tcom

e

Initia

llyth

eun

itwa

ssto

pped

tem

pora

rily

afte

r150

mls

had

been

infus

edan

dth

enco

ntinu

edat

aslo

werr

ate.

Subs

eque

ntly

disco

ntinu

edco

mple

tely.

Sym

ptom

sim

med

iately

reso

lved

with

outt

reat

men

t.

Hydr

ocor

tison

e20

0mg

IV,pa

race

tam

ol1g

,m

etoc

lopra

mide

IV.Re

cove

red

with

inon

eho

urwi

thno

illef

fect

s.

Trans

fusio

ndis

cont

inued

.Par

acet

omol

given

.Ri

gors

subs

ided

with

in20

minu

tes.

Tem

pera

ture

norm

alwi

thin

four

hour

s.

Trans

fusio

ndis

cont

inued

,par

acet

omol

given

.Re

cove

red

with

intw

oho

urs.

Trans

fusio

ndis

cont

inued

.No

spec

ifictre

atm

entg

iven.

Reco

vere

dwi

thin

one

hour

O 2,I

Vch

lorph

enira

mine

and

hydr

ocor

tison

e.Pa

tient

reco

vere

dwi

thin

48ho

urs

Subs

eque

nttra

nsfu

sions

with

prem

edica

tion

unev

entfu

l.

Futu

retra

nsfu

sion

will

bem

anag

edus

ingRh

phen

otyp

edKe

llne

gativ

ecr

ossm

atch

com

patib

lere

dce

lls.

Tabl

e36

:AHO

STR

case

s(n

=24)

(Con

t)

*Inc

luded

asa

full

case

histo

ry

Page 88: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

87Annual Report

Case

No.

AHOS

TRCa

se19

AHOS

TRCa

se20

*P AHOS

TRCa

se21

AHOS

TRCa

se22

AHOS

TRCa

se23

AHOS

TRCa

se24

Com

pone

ntPr

escr

ibed

One

unit

ofre

dce

lls

One

unit

ofJK

b

antig

enne

gativ

ere

dce

lls

One

unit

ofCM

Vne

gativ

ere

dce

lls

One

unit

ofre

dce

lls

Two

units

ofre

dce

lls

One

unit

ofre

dce

lls

Age

Yrs

Gend

er

82 M 3 M 50 F 83 F 38 F 85 M

Unde

rlying

cond

ition

Malig

nanc

y

Haem

atolo

gical

mali

gnan

cy

Auto

imm

une

haem

olytic

anem

ia

Multip

lem

edica

lpr

oblem

s

Treat

men

tfor

post

oper

ative

com

plica

tion

Malig

nanc

y

Volum

etra

nsfu

sed

onse

t

100

mls

ofre

dce

lls

. 93m

ls

300

mls

Appr

oxim

ately

80m

lsof

red

cells

.

Durin

gse

cond

unit

ofre

dce

lls.

Two

hour

sand

45m

insint

oth

etra

nsfu

sion.

(230

mls)

Sym

ptom

s/sig

ns

Tem

pera

ture

rise

>1.5°

C

Tem

pera

ture

rise

>1.5°

Cba

ckac

he,n

ause

a

Tem

pera

ture

rise

>1.5°

C,ha

emog

lobinu

riaan

dvo

mitin

g.

Pyre

xia,r

igors,

tach

ycar

dia,

naus

ea,v

omitin

gan

dre

spira

tory

prob

lems.

Tem

pera

ture

rise

>1.5°

C

Tem

pera

ture

rise

>1.5°

C,Hy

perte

nsion

,GI

sym

ptom

s,rig

ors

Inves

tigat

ions

Patie

ntan

dun

itcu

lture

dne

gativ

e.

Patie

ntcu

lture

d–

noor

ganis

ms

isolat

ed.

Noinv

estig

ation

sca

rried

outa

lthou

ghpa

tient

had

histo

ryof

Anti-

Jkb

antib

odies

.

Red

cell

alloa

ntibo

dyex

clude

d.Un

itcu

lture

d-n

ogr

owth

.Pat

ient

cultu

red

-Sta

phCi

treus

(not

cons

idere

dre

lated

totra

nsfu

sion)

Patie

nt,u

nitan

dse

gmen

tline

cultu

red

-no

grow

th.

Red

cell

incom

patib

ility

exclu

ded.

Patie

ntan

dun

itcu

lture

d-n

ogr

owth

.Red

cell

incom

patib

ility

exclu

ded.

Histo

ryof

tem

pera

ture

rise

onpr

eviou

stra

nsfu

sion

-not

inves

tigat

ed.

Red

cell

incom

patib

ility

exclu

ded.

Unit

cultu

red

-no

grow

th.

Patie

ntno

tcult

ured

.

Treat

men

t&Ou

tcom

e

Chlor

phen

iram

inean

dan

tipyr

etic

adm

iniste

red.

Patie

ntdie

dun

relat

edto

trans

fusio

nse

ven

days

later

.

Trans

fusio

nwa

sdisc

ontin

ued,

patie

ntre

cove

red

fully

with

outs

pecif

ictre

atm

ent

Para

ceto

mol

and

proc

hlorp

eraz

inegiv

en,

reco

vere

dwi

thno

illef

fect

s.

Chlor

phen

iram

ine,

hydr

ocor

tison

ean

dox

ygen

ther

apy.

Patie

ntha

dalr

eady

rece

ived

para

ceta

mol.

Nofu

rther

treat

men

tgive

n,re

cove

red

quick

ly.

P ara

ceto

mol

given

and

trans

fusio

nco

ntinu

edini

tially

.Tra

nsfu

sion

disco

ntinu

edwh

ensy

mpt

omsw

orse

ned.

Patie

ntre

cove

red

with

in12

hour

s.

Tabl

e36

:AHO

STR

case

s(n

=24)

(Con

t)

*PInc

luded

asa

full

case

histo

ryin

paed

iatric

chap

ter

Page 89: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office88

Case

No.

late

lets

AHOS

TRCa

se4

AHOS

TRCa

se11

*

AHOS

TRCa

se18

*

AHOS

TRCa

se25

Com

pone

ntPr

escr

ibed

One

unit

ofap

here

sispla

telet

s

One

unit

ofpo

oled

plate

lets

One

unit

ofap

here

sispla

telet

s

One

unit

ofpo

oled

plate

lets

Age

Yrs

Gend

er

79 M 51 F 62 F 75 F

Unde

rlying

cond

ition

Haem

atolo

gical

mali

gnan

cy

Haem

atolo

gical

mali

gnan

cy.

Malig

nant

haem

atolo

gical

disor

der.

Malig

nanc

y

Volum

etra

nsfu

sed

onse

t

150m

ls

45m

inute

sfoll

owing

trans

fusio

n

222m

ls(1

unit)

.Re

actio

noc

curre

don

eho

urpo

sttra

nsfu

sion

One

hour

post

trans

fusio

n

Sym

ptom

s/sig

ns

Hype

rtens

ion,

light

head

ed,n

ause

a,vo

mitin

gan

dtre

mor

Tem

pera

ture

rise

>1.5

°C.C

hills,

rigor

sand

tach

ycar

dia

Feve

r,ta

chyc

ardia

,dys

pnoe

a,fa

lling

oxyg

ensa

tura

tions

,chil

lsan

drig

ors,

naus

ea,v

omitin

gan

dbr

onch

ospa

sm

Hype

rtens

ion,t

achy

card

ia,dy

spno

ea,f

ever

,chil

lsan

drig

ors.

Inves

tigat

ions

Patie

ntcu

lture

d-n

oor

ganis

ms

isolat

ed.

Unit

cultu

red

posit

ivefo

rco

agula

sene

gativ

esta

phylo

cocc

iaf

ter3

1ho

urs.

(Dee

med

cont

amina

nt)

Posit

iveDA

Tpr

ean

dpo

sttra

nsfu

sion

Patie

ntfo

und

tobe

HLA

alloim

mun

ised.

Bloo

dcu

lture

san

dse

gmen

tline

cultu

res-

nega

tive.

Patie

ntcu

lture

dne

gativ

e.Re

actio

nno

tinv

estig

ated

due

toco

mm

unica

tion

prob

lem.T

RALI

exclu

ded.

Dono

rinv

estig

ation

sne

gativ

e.

Susp

ecte

dre

actio

nno

tinv

estig

ated

Treat

men

t&Ou

tcom

e

IVhy

droc

ortis

one

and

chlor

phen

iram

inegiv

en.

Reco

vere

dwi

thin

one

hour

and

disch

arge

dlat

erth

atda

y.

Hydr

ocor

tison

ean

dch

lorph

enira

mine

.Re

cove

red

with

inon

eho

ur

Oxyg

en,h

ydro

corti

sone

,chlo

rphe

niram

ine,

and

proc

hlorp

eroz

inead

mini

stere

d.Pa

tient

reco

vere

dfro

mth

ere

actio

nwi

thin

24ho

urs.

Subs

eque

nttra

nsfu

sions

have

been

unev

entfu

l.

Chlor

phen

iram

ine

Tabl

e36

:AHO

STR

case

s(n

=24)

(Con

t)

*Inc

luded

asa

full

case

histo

ry

Page 90: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Acute Haemolytic or Other SevereTransfusion Reaction (AHOSTR)

Detailed case histories (Red Cells)

AHOSTR Case 1This elderly patient, who was in ICU and on antibiotictherapy for sepsis, was prescribed two units of redcells for anaemia secondary to gastric surgery. Thepatient had received a number of transfusions themost recent of which was one month previously. Onthis occasion, having received one hundred and fiftymls of red cells, the patient developed fever andrigors. The patient was treated with a non-steroidalantiflammatory and the transfusion was discontinuedcompletely. She recovered with no ill effects withinsix hours. The DAT was positive in IgG pre and posttransfusion but the eluate was negative. The initialpost transfusion antibody screen was weakly positivebut no specificity was detected. A urine sampleshowed raised urobilinogen and she was found tohave a rising bilirubin. Subsequent investigations fivedays later at the reference centre showed thepresence of anti-Fya and HLA antibodies. Culture ofthe unit was negative .

AHOSTR Case 8This young female patient with Paroxysmal NocturnalHaemoglobinuria required a transfusion of red cellsfor Hb of 7.5 g/dl. She had suffered a severetransfusion reaction in 2001 in another hospital andsince then was to be transfused with washed redcells. In 2001 the serology on this patient hadrevealed anti-C, anti-S, anti-K. The patient hadreceived several washed red cell transfusions, whichwere compatible, without incident. During atransfusion of washed cells in 2002 the patientdeveloped symptoms of pyrexia, rigors andhypotension, the unit was discontinued andparacetamol was administered. A further unit wastransfused with no complications following thatincident. On this occasion 3hrs and 15 mins into thetransfusion, 150 mls of washed antigen negative redcells had been infused. Symptoms of a temperature

rise of 2.5°C, rigors, hypotension, tachycardia,nausea, and general aches developed. The unit wasdiscontinued, the patient received paracetamol andsymptoms resolved. The unit subsequently culturednegative.

AHOSTR Case 16 This elderly male patient with underlyingmyelodysplasia, cardiovascular disease andcongestive heart failure was prescribed one unit ofred cells for symptomatic anaemia -Hb 8.8g/dl. Thepatient had been transfused with three units of redcells over the previous month uneventfully. Thepatient received his regular diuretic medication thatmorning and the unit infused over four hours. Threehours following the transfusion, the patient becameextremely flushed and developed a pyrexia (39.2°C)and symptoms of dyspnoea, tachypnoea, tachycardia,hypertension, falling O2 saturations, rigors andagitation developed. Following medical reviewoxygen, hydrocortisone, and chlorpheniramine wereadministered. The patient’s symptoms improved buthe still remained short of breath with wheezing for 24hours which had completely resolved within 48 hours.The patient was reviewed for future transfusionmanagement by the consultant haematologist.Subsequent transfusions have been covered bypremedication with hydrocortisone, chlorpheniramineand have been uneventful. Investigations of thereaction excluded red cell incompatibility. The patientwas not cultured but culture of the unit was negative.

AHOSTR Case 26 This female patient required a transfusion of one unitof red cells intra operatively for a blood loss of about1 litre. Two days post operatively the patient had afurther blood loss of 1340 mls from surgical drains.The Hb was 6.1g/dl and an additional two units of redcells were administered. The following day her urinebecame dark, concentrated and was positive ++ forblood. The patient was very pale with a slightcyanosis and developed symptoms of hypotensionand nausea. At that time this was attributed to asuspected drug interaction. The patient’s Hb was

89Annual Report

Page 91: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

7.1g/dl and a further two units of red cells wereprescribed. Investigations for the cause of thehaematuria, revealed no abnormalities and the causeof the bleeding was not established. Duringtransfusion of the second unit when there was againfrank haematuria, the unit was discontinued andinvestigation of a suspected transfusion reaction wasinitiated.

Post transfusion investigations included re-grouping,cross match and antibody screen. The pre-transfusion antibody screen had identified an anti-Luaantibody, which was also identified post operativelyand confirmed at a reference centre. Crossmatchcompatible blood was provided but antigen negativeblood is not required for patients with anti-Lua. Thebilirubin was 32.2, the LDH was 6130 (Norm 230-460) the DAT was weakly positive. Both units fromthat transfusion were cultured negative. Tests forparoxysmal nocturnal haemoglobinuria (PNH) werenegative. Haemosiderin was negative immediatelypost transfusion but positive one week latersuggestive that haemolysis had occurred. Therecommendation from the reference centre was thatfuture transfusions should be managed with Rhphenotyped K negative compatible blood. Duringinvestigation of this reaction it emerged that thepatient had been transfused over 20 years ago withfour units of red cells. At that time she also developed“black urine” which was treated by her GP. Earlierthis year she was admitted to a different hospital withsymptomatic anaemia and received four units of redcells, which was followed by the occurrence of darkurine five days later. Investigations into the cause ofthe anaemia were inconclusive.

Detailed Case histories - Platelets

AHOSTR Case 11 This patient with a malignant haematological disorderrequired a transfusion of one unit of pooled plateletsfor a low platelet count. The patient had receivedthirty seven units of platelets and sixteen units of redcells over the previous two months and had a slight

reaction following the last transfusion of platelets, butrecovered without medication. On this occasion,forty-five minutes following transfusion, the patientdeveloped pyrexia 39.2°C, chills, rigors andtachycardia. Hydrocortisone and chlorpheniraminewere administered IV and the patient recovered withno ill effects within one hour. Patient blood cultureswere negative, the segment line cultures werenegative but as the pack and administration set wereopen to air these were not cultured. Investigationsshowed that the patient had developed HLAantibodies.

AHOSTR Case 18This patient with thrombocytopenia, secondary to amalignant haematological disorder, was prescribedone unit of apheresis platelets. The transfusion wascompleted uneventfully. However, one hour posttransfusion the patient developed fever with chills andrigors, tachycardia, dyspnoea, bronchospasm andfalling oxygen saturations. Oxygen, hydrocortisone,chlorpheniramine and prochlorperazine were givenand the patient recovered from the reaction within 24hours. The patient’s chest x-ray post reaction showeda mild cardiomegaly with prominence of the upperlobe veins but no evidence of an active process.Bacteriological culture of the patient isolated noorganisms, however due to a misunderstandingbetween clinical and laboratory staff, the implicatedunit was not cultured. The transfusion laboratory wasnot informed of the reaction and transfusion reactioninvestigations were not carried out. Futuretransfusions for this patient using pre medicationcover with chlorpheniramine have been uneventfulfollowing this regimen. This case was originallyreported as a possible case of TRALI but donorinvestigations carried out were negative.

National Haemovigilance Office90

Page 92: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

INTRODUCTION

Although a number of suspected cases werereported and investigated during this reportingperiod, there were no reported cases fulfilling thecriteria for TRALI. Two reports were originallyconsidered. One case was reported as a suspectedcase of TRALI but this was excluded on the basis ofclinical findings, and this case was re-categorised asAHOSTR. A second case, originally reported asTRALI, was subsequently outruled based on clinicaland autopsy findings.

It is very difficult to distinguish TRALI from othercauses of acute lung injury which also causedyspnoea, hypoxia, interstitial and alveolar infiltrateson chest X ray. Patients may also present withhypo/hypertension. Symptoms begin within six hoursof transfusion and in the majority of cases the patientoutcome is good. However, as systems are put inplace to tackle fatal outcomes from other adverseevents, TRALI is slowly coming to increasedprominence.

The true incidence is unknown and may range from1:5000 to 1:100,000 units of plasma containingblood components transfused. Underreporting andthe lack of prospective data complicate the issuefurther. However, it is important to recognise thatTACO is much more common than TRALI and wherethere is evidence of fluid overload or cardiac failure,the diagnosis is very unlikely to be TRALI (NHO2002).

The presence of white cell antibodies (including HLAclass I and II antibodies, granulocyte-specificantibodies and anti-monocytic antibodies) has beenreported to be associated in about 80% of cases andcorrespondence between the donor antibody andpatient antigen is found in up to 50% of these. Thereare, however, a number of cases where no antibody isfound. It has been proposed that non-immunologicmechanisms may play a part in causing TRALIwhereby two insults to the lung are necessary, thefirst one being a predisposing event such as traumaor sepsis and the second, transfusion of a biologicallyactive substance such as lipids found in storedcellular blood products.

Transfusion Related Acute LungInjury

DefinitionTransfusion Related Acute Lung Injury(TRALI) is a clinical combination of acuterespiratory distress, hypotension, feverand rigors associated with bilateralpulmonary oedema with no evidence ofcardiac failure or fluid overload.Symptoms typically begin within 1-2hours of transfusion and always within 6hours (Popovsky, 2001)

91

Page 93: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

It is important that the condition is recognisedpromptly and timely intervention with oxygen, ifnecessary, mechanical ventilation and other supportmeasures are fundamental to a successful outcome.

A great deal of consideration has been given to thedefinition of TRALI. A proposal put forward by theCanadian Consensus Conference suggests thatTRALI should be divided into TRALI and possibleTRALI based on the clinical symptoms/signs(adapted from Klienman et al, 2004)

Recommendations • To prevent TRALI, it is important to underline the

need for vigilance in the appropriate use of bloodand blood components, as transfusion relatedadverse events can be associated with fatalities.

• It is important that hospital staff be made moreaware of this complication of transfusion in orderfor it to be recognised and dealt with in anappropriate fashion. This would also facilitateprompt investigation and case review.

• The IBTS has put in place a number of measureswith a view to minimising the risk from TRALI.These include avoiding the use of plasma fromfemale donors both for suspension of pooledplatelets and as FFP and from early 2004,deferring new and lapsed female plateletpheresisdonors with a history of pregnancy. Moreover, aspart of the vCJD Policy, SD Plasma has becomethe standard plasma product. To date, SD treatedplasma has not been convincingly implicated inTRALI.

National Haemovigilance Office92

TRALI

Acute Lung Injury (ALI) is characterised by1. Acute onset2. Hypoxemia Sp02 <90% on room air or other

evidence of hypoxemia3. Bilateral infiltrates on frontal chest Xray4. No evidence of circulatory overload5. No pre-existing acute lung injury (ALI) before

transfusion or during or within six hours oftransfusion.

6. No alternate risk factors for Acute Lung Injurypresent

Possible TRALI

1. ALI as above2. No pre-existing ALI before transfusion or during or

within six hours of transfusion.3. Alternative risk factors for Acute Lung Injury

present (see table below)

Symptoms of dyspnoea, tachypnea, tachycardia, fever,hypotension or hypertension are present in somecases but are not sufficiently specific to be included inthe definition of TRALI or possible TRALI

Risk Factors for ALI

Direct Lung Injury Indirect Lung InjuryAspiration Severe sepisPneumonia ShockToxic inhalation Multiple traumaLung contusion Burn injuryNear drowning Acute pancreatitis

Cardiopulmonary bypassDrug overdose

The incidence of ALI varies considerably among theseconditions and may be as high as 40 percent forintensive care unit-related cases of septic shock andaspiration or as low as 2 percent for cases ofcardiopulmonary bypass and intensive care unit-related drug overdose.

Figure 5

Page 94: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

This category accounted for 1% of incidents reported(3 of 214) in 2003. The NHO collects andinvestigates reports of all suspected transfusion-transmitted viral infections relating to bloodcomponents which have been transfused after theintroduction of mandatory testing for that virus. Viralinfections which not covered by mandatory testing,e.g. Hepatitis A virus, CMV and Parvovirus, but arereported to the NHO and suspected to be associatedwith a blood transfusion during the current reportingyear will be recorded as an NHO incident andinvestigated appropriately. The NHO also collectsand investigates reports of transfusion-transmittedbacterial and parasitic infections.

The onset of symptoms related to a transfusion-transmitted viral infection may occur several weeks toyears after the date of transfusion. Bacterial orparasitic infections are usually associated with acutesymptoms and come to clinical attention soon aftertransfusion. Viral diseases however, may not beassociated with any symptoms until some years later.Therefore, reports received within this category arenot necessarily the result of components transfusedduring this reporting year.

Infections presenting weeks, months or years after atransfusion are termed post-transfusion infections.These may indeed be due to the transfusion of aninfected or contaminated unit, but equally, infectionmay have been acquired from another source.Investigation of markers of infection in an implicateddonation, or in subsequent samples from the donorsof implicated donations, can confirm transfusion asthe probable cause of infection, or identify the need toinvestigate other possible sources (SHOT, 1999).Such investigations may involve microbiologicaltesting of many donors and may take many months tocomplete.

A post transfusion infection is confirmed astransfusion-transmitted once investigations arecomplete and the following criteria are fulfilled:(SHOT, 1999)

The recipient had evidence of infection following thetransfusion, with no evidence of infection prior to thetransfusion

and, either

Suspected Transfusion TransmittedInfection

93

Page 95: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

A donor who had evidence of the same transmissibleinfection donated at least one component received bythe infected recipientor

At least one component received by the infectedrecipient was shown to have been contaminated withthe same infectious agent.

Much concern has been voiced in recent yearsregarding the risk of transfusion-transmitted infectionand much quality assurance effort has been directedtowards appropriate testing and handling of bloodafter collection. There is very good evidence that withcontinuous improvements in the donorselection/testing procedures and manufacturingprocesses used in Ireland, the risk of transfusion-transmitted infection is very small.

The current estimated risks for HIV and HCV are lessthan 1 per 4 million components transfused(O’Riordan J., personal communication). Theseresidual risk estimates are based on serologicaltesting and nucleic acid amplification testing (NAT)for HCV and HIV.

Even prior to the introduction of NAT testing, the riskfor Hepatitis C for screened blood was estimated tobe 1-500,000.

The risk for HBV has been estimated at approximately1:200,000 since the introduction of testing forantibody to Hepatitis B core in January 2002(O’Riordan J., personal communication).

Hepatitis B infection is not uncommon in thecommunity and in up to 40% of cases no risk such assexual exposure, intravenous drug abuse ortransfusion is present. Evidence of past clearedinfection in blood donors, a highly selectedpopulation was found in 0.17% i.e. 17 in 10,000donors in the first year of testing. In many of thesecases, nosocomial risks in the past may beresponsible. Such cleared infection does not pose a

risk to recipients and in a number of countries, suchindividuals are acceptable as donors. In Ireland, weintroduced core antibody testing in 2002 to reducethe possible risk of donors donating before HBVinfection was fully cleared i.e. in the second windowperiod when HbsAg is no longer detectable in bloodbut before an adequate (>100miu/l) antiHbs antibodyis found. Because hepatitis B core antibodies are amandatory test, donors with cleared infection foundreactive for the marker are also deferred.

Investigations into suspected transfusion transmittedinfections are difficult. They can involve considerableupset to donors who often have to be recalled andoffered testing and they are resource intensive.Where pre-transfusion samples are available, thesesamples can provide significant help in investigation.Patients such as haematology patients who willrequire ongoing transfusion should be offered testingbefore therapy and at regular intervals with storage ofsamples wherever possible for further testing ifnecessary.

The risk of receiving an incorrect blood component isin fact much greater than the risk of receiving atransfusion-transmitted infection. Over the seven yearperiod since the United Kingdom Serious Hazards ofTransfusion (SHOT) began reporting, confirmedreports of TTI accounted for 2.2% of incidents incomparison to reports in the IBCT category, whichaccounted for almost 63.9% (SHOT 2003)

Findings • Three incidents, which fit the criteria of suspected

transfusion-transmitted infection, were reported tothe NHO during this reporting year.

• There were two reports of suspected HIV infectionand one of HBV.

• In all cases, transfusion was excluded as the likelycause.

National Haemovigilance Office94

Page 96: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

95Annual Report

CaseNumber

TTI Case 1

TTI Case 2

TTI Case 3

Viral Marker

HIV

HIV

HBV

Outcome

Transfusion excluded

Transfusion excluded

Transfusion excluded

Table 37: Suspected Transfusion Transmitted Infection (n=3)

Number ofdonorsinvolved

53

3

16

Gender

F

F

M

Year ofTransfusion

2004

2004

2004

Adult orChild

Adult

Adult

Adult

Page 97: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Adverse incidents or reactions during the donationare reported in this section. Incidents occurringduring the transfusion of autologous blood arecaptured elsewhere in this report under the relevantcategory.

These adverse reactions accounted for 3% of thetotal incidents reported (7 of 214).

The majority of autologous donors tolerate thedonation procedure without incident, but adversereactions occur occasionally (Brecher et al, 2002).The most common reaction is vasovagal in nature(Yomtovian and Praprotnik, 2001). However, severereactions are up to 12 times more likely in autologousdonors than allogeneic donors. (Popovsky et al,1995) High risk autologous donors include thosewith coronary artery disease or congestive cardiacfailure or uncontrolled hypertension or on medicationwhich affects the haemodynamic response of thecardiovascular system (Vamvakas and Pineda, 2000).Haemodynamic monitoring in high risk patientsundergoing autologous blood donation has detected

a significant number of adverse changes in responseto blood donation not detectable by simpleobservation (Spiess et al, 1992).

Pre Autologous Donation (PAD) is an option forsuitable patients where transfusion is anticipatedduring surgery (BCSH, 1993). One application forPAD has been in the field of elective orthopaedicsurgery. Advances in anaesthesia and surgicaltechnique, however, combined with reducedtransfusion thresholds have diminished the need fortransfusion in such patients. Politis and Richardson(2004) undertook a survey to determine the incidenceof PAD throughout Europe and report almost onethird of autologous units donated are not used.

The technique became popular during the 1980’s asa result of public concern regarding transfusion safetybut has declined with the increasing safety of bloodtransfusion for the main transfusion transmittedviruses HIV, Hepatitis B & C. However othertransfusion transmitted infection agents are emergingincluding West Nile Virus and vCJD. A case of vCJD

Pre- Deposit Autologous DonorIncidents

Definition

An adverse or unforeseen event, which isexperienced by the donor during orfollowing a pre-deposit autologousdonation procedure. (SHOT, 2001)1

96

Page 98: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

in a transfusion recipient was reported in the UK inlate 2003 (Llewelyn et al, 2004) and the reportedfinding of abnormal prions at post mortem in thespleen of a second recipient who died of unrelatedcauses but who had received a unit of blood from adonor who developed vCJD supports thetransmission of vCJD through transfusion (Peden etal, 2004). In 2005, an Irish blood donor developedsymptoms considered to be due to vCJD. While anumber of precautionary measures have been put inplace to reduce the risk of transmitting vCJD by bloodtransfusion in Ireland, no universally effective measureexists to prevent its transmission and reducedexposure to transfusion and appropriate blood usageremain the most important measure.

The benefits to the patient of autologous transfusioninclude elimination of the risk of transmission ofinfectious diseases and alloimmunization and otherimmunological effects of allogeneic transfusion(Politis and Richardson, 2001).

Innerhofer et al (2005) in a prospective study reportthat despite universal white blood cell (WBC)filtration, recipients of allogeneic blood transfusionare still at greater risk of developing postoperativeinfections in comparison to autologous recipients.

However, Linden and Kruskall (1997) point out thatalthough autologous blood is considered safer thanallogeneic blood, it is not without risk. Bacterialcontamination, febrile non-haemolytic reactions andallergic reactions have all been reported followingautologous transfusion (Goldman et al, 2002). Otherdisadvantages associated with PAD are the necessityfor a definite date for surgery, increased likelihood ofreceiving a transfusion, bacterial contamination, riskof error, volume overload, and additional cost. Biliotte et al (2002) demonstrated that pre- operativeautologous donation increased the likelihood oftransfusion at the time of surgery.

According to Carless et al, (2004) in a systematicanalysis of autologous blood techniques the

advantages of autologous transfusions arecounteracted by lower pre-operative Hb levels andhigher overall transfusion rates, and they suggestusing other techniques such as antifibrinolytic drugsin conjunction with conservative transfusionthresholds to reduce the need for allogeneic blood.

Other forms of autologous transfusion in particularintraoperative cell salvage may reduce the need forallogeneic transfusion. (National Blood ConservationStrategy for NBTC and NBS Working Party Report,2004). An audit commissioned by the National BloodStrategy Implementation Group (NBSIG) in 2001found the use of autologous transfusion techniques inIreland is low and has recommended that cell salvageprogrammes be established in major hospitals as theyconsider this is the most effective alternative toallogeneic blood transfusion.

Regulatory aspects

Hospitals collecting pre-deposit autologous bloodwill now be considered blood establishments inrespect of the collection of autologous units and assuch subject to the same scrutiny as a bloodtransfusion service under Article 29 of the EuropeanDirective 2002/98/EC, which came into effect inNovember 2005.

Detailed requirements covering autologous donationsare detailed in Commission Directive 2004/33/ECwhich addresses technical requirements for blooddonors including autologous donors. It coversinformation to be given to donors, storage, andtransport and distribution requirements.

These directives can be downloaded fromhttp://europa.eu.int.

Findings:

• Six of the seven incidents involved PAD fororthopaedic surgery. The remaining incident wasassociated with PAD for urological surgery.

97Annual Report

Page 99: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Symptoms reported were generally vasovagal innature and ranged from feeling light-headed,nauseated and faint to actually fainting. Onset ofsymptoms ranged from during the procedure up totwenty-four hours post donation.

• One donor developed a generalized body rash 24hours after donating one unit and a severeurticaria on the torso, arms, legs and handsimmediately following the donation of a secondunit. This resolved with treatment the next day.The patient was on ACE inhibitors and it is notclear whether the reaction was related to the drugor the PAD although a sibling had had a similarreaction after blood donation.

• Six of the donors were discharged the same day.However, one donor required overnighthospitalisation. This patient was onantihypertensive medication.

• Three of the donors had each donated a unitpreviously, one of whom had felt nauseated andweak post donation but three of the donorsinvolved were donating blood for the first time.

• Four of the donors were under sixteen years ofage and three weighed less than 50 kgs. In one ofthese cases, although the donor completed apredonation questionnaire, she did not disclosethat she felt faint and weak at the sight of blood orneedles.

• Simultaneous volume replacement was notundertaken during the donations. However, two ofthe donors who experienced symptoms at the endof or following the donation were given fluids IV.

• All of the donors recovered without complicationsand one successfully donated a second unituneventfully seven days later.

• The blood collected was transfused in six of theseven cases. Two donors received allogeneic

blood in addition to the PAD blood. In one of thecases re-assessment post-transfusion after thefirst allogeneic unit might have obviated the needfor further transfusions.

Recommendations

• Paediatric patients and adult patients weighingless than 50 kg need special consideration, andcare should be taken to ensure the volume drawndoes not exceed 12% of the estimated bloodvolume. (BCSH, 1994)

• All PAD clinics should monitor the donations usinga digital scales. This would ensure that donationson children or lower weight adults could bestopped at < 450mls. Patients less than 16 yearsmay require to be bled into smaller bags assuggested by the BSCH guidelines (1994).

• Donors receiving antihypertensive medicationshould be carefully monitored. Volumereplacement should be considered for patients ontreatment with beta-blockers and/or angiotensinconverting enzyme (ACE) inhibitors as their abilityto respond to a reduction in blood volume may becompromised by their treatment.

• Careful selection of patients for PAD, such asyoung, fit adolescents may reduce the need forallogeneic transfusions in these patients anddecisions to transfuse additional allogeneic bloodpost-operatively should be based on carefulclinical assessment.

National Haemovigilance Office98

Page 100: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

99Annual Report

Case

No.

PAD

Case

1 PAD

Case

2 PAD

Case

3 *

Plan

ned

Proc

edur

e

Rem

oval

ofsp

inalr

ods

Ganz

oste

osto

my

Elect

iveor

thop

aedic

surg

ery

15 F 14 F 43 F

50 49 60

Hb g/dl

14.7

13.1

14.4

&12

.0

Curre

ntMe

dicat

ion

Oral

iron

Oral

analg

esia

ACE

inhibi

tor

/thiaz

idediu

retic

and

oral

analg

esics

.

Com

plica

tions

Naus

eaan

dhy

pote

nsion

post

dona

tion.

Light

-hea

ded

and

naus

eaat

end

ofdo

natio

n.

24ho

ursf

ollow

ing1s

tdo

natio

nur

ticar

iaov

erbo

dy.

Follo

wing

2nd

dona

tion

seve

rera

shov

erto

rso,

hand

s,an

dba

ck.

Reac

tion

Dona

tion

Histo

ry

On1s

t

On1s

t

On2n

d.1s

tun

even

tful.

Com

men

ts

Past

histo

ryof

naus

eaan

dfe

eling

weak

.50

0mls

ofIV

fluids

adm

iniste

red.

Reco

vere

dwi

thno

com

plica

tions

.Di

scha

rge

Hb10

.3.g/

dl.

Past

histo

ryof

need

leph

obia.

500m

lsof

IVflu

idsad

mini

stere

d.Re

cove

red

with

noco

mpli

catio

ns.

Disc

harg

eHb

8.9g/

dl.

Requ

ired

anti-

hista

mine

table

tsan

dcr

eam

toea

sera

sh.R

ecov

ered

with

noco

mpli

catio

ns.

Disc

harg

eHb

9.7g/

dl.

PAD

unit

(s)

trans

fuse

d

None

.

Auto

logou

sunit

trans

fuse

dan

d1u

nitof

allog

eneic

blood

adm

iniste

red.

Both

units

trans

fuse

d

Tabl

e38

:Pr

e-op

erat

iveAu

tolo

gous

Dono

rInc

iden

ts(N

=7)

Age YrsGender

Weight kg1 1 2No Planned

Donations

*Inc

luded

asa

full

case

histo

ry

Page 101: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office100

Case

No.

PAD

Case

4 PAD

Case

5 * PAD

Case

6 PAD

Case

7 *

Plan

ned

Proc

edur

e

Orth

opae

dicsu

rger

y

Orth

opae

dicsu

rger

y

Urolo

gical

surg

ery

Orth

opae

dicsu

rger

y

13 F 61 M 61 M 15 M

44 101

80 66

Hb g/dl

14.6

13.5

16.1

15.4

Curre

ntMe

dicat

ion

Oral

iron

Card

iosele

ctive

beta

-bloc

ker,

class

IIca

lcium

anta

gonis

t.Br

onch

odil

ator

sora

llyan

dvia

inhala

tion.

Oral

analg

esia

None

Bron

chod

ilato

rinh

aler

Com

plica

tions

Naus

eaan

dvo

mitin

g30

mins

post

dona

tion.

Brad

ycar

dia,

hypo

tens

ion,

losso

fcon

sciou

snes

sFa

inted

follo

wing

dona

tion

of50

0mls

Light

-hea

dedn

ess,

felt

faint

20m

inspo

stdo

natio

n.

Light

-hea

dedn

ess.

Faint

ed25

mins

post

dona

tion

Reac

tion

Dona

tion

Histo

ry

On1s

t.2n

dun

even

tful

On2n

d.1s

tun

even

tful.

On2n

d1s

tun

even

tful

On2n

d.1s

tun

even

tful.

Com

men

ts

Reco

vere

dwi

thno

com

plica

tions

.Di

scha

rge

Hb7.9

g/dl.

Requ

ired

over

night

adm

ission

.Re

cove

red

with

noco

mpli

catio

ns.

Disc

harg

eHb

10.6

g/dl.

Reco

vere

dwi

thno

com

plica

tions

.Di

scha

rge

Hb10

.9g/

dl.

Reco

vere

dwi

thno

com

plica

tions

.Po

st-tra

nsfu

sion

Hb7.4

g/dl.

Disc

harg

eHb

.10.4

g/dl.

PAD

unit

(s)

trans

fuse

d

One

unit

trans

fuse

d.

2un

itstra

nsfu

sed.

2un

itsof

trans

fuse

d.

2un

itsof

auto

loguo

usan

d2

units

ofall

ogen

eicblo

odad

mini

stere

d.

Tabl

e39

:(Co

ntin

ued)

Pre-

oper

ative

Auto

logo

usDo

norI

ncid

ents

(N=7

)

Age YrsGender

Weight kg3 2 2 3No Planned

Donations*

Includ

edas

afu

llca

sehis

tory

Page 102: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Pre-operative Autologous Donor (PAD)Incidents (n=7) Case Histories

PAD Case 3 This female patient was pre-donating two units ofblood for elective orthopaedic surgery. Assessmentof donor fitness was carried out and the patient’sweight was 60 kgs and Hb 14.4g/dl prior to the firstunit and 12.0 g/dl prior to donation of the secondunit. The patient had a history of hypertension, whichwas well controlled with the ACE inhibitor /thiazidediuretic, Capozide. The collection of the first unit wasuneventful. However, the following day the patientwent on holiday and developed a generalised bodyrash, which she attributed to a change in the sheetsin the hotel. Within one hour following donation of thesecond unit, however, the patient developed a virulenturticaria on torso arms legs and hands that requiredan antihistamine cream and tablets to alleviate theitch. This settled within 24 hours. The patient’s Hblevel prior to transfusion was 9.3g/dl. and the patientreceived the two pre-deposited units followingsurgery. No further allogeneic units were required ondischarge the Hb was 9.7g/dl. Further investigationof this incident revealed that a sibling had a similarreaction when donating blood. The patient denied anysimilar previous rash.

PAD Case 5 This male patient was scheduled to pre-donate twounits of blood prior to a total hip replacement forwhich the MSBOS recommended two units of blood.His pre-donation Hb was 13.5g/dl. The donor had ahistory of asthma and hypertension and his currentmedications included a cardioselective beta- blocker,a class II calcium antagonist, a bronchodilator,salbutamol inhaler and oral analgesics. Immediatelyfollowing the second donation of 500mls (includinganticoagulant) of whole blood, the donor felt faint hadsymptoms of bradycardia, hypotension and loss ofconsciousness. The donor was reviewed by themedical team and remained in hospital overnight andwas referred to a cardiologist for review, which wasnormal. The patient’s haemoglobin prior to transfusion

was 10.1 g/dl and the two units, which had beencollected, were administered based on theintraoperative blood loss. No extra allogeneic unitswere required. Prior to discharge home the patientsHb was 10.9g/dl.

PAD Case 7 This young boy was pre-donating his second unit ofblood for elective orthopaedic surgery. He haddonated one unit previously. Between 450-460 mlsof blood were collected uneventfully and the patientrested in the donation facility for 20 minutes. Shortlyafterwards he became lighted-headed and fainted.He returned to the donation facility and rested for afurther hour and had some fluids orally. He recoveredwithout incident from this event. A third unit was nottaken. Peri-operatively when the patient had reachedhis maximum allowable blood loss (MABL), bothautologous units were transfused. The patient’shaemoglobin post transfusion was 7.4 g/dl and hisvital signs were within normal limits. However, on daythree post-operatively the patient becamesymptomatic complaining of dizziness and feelinglight-headed on getting out of bed and two furtherunits of allogeneic red cells were administered. In thiscase, reassessment after the first allogeneic unitmight have obviated the need for a further transfusion.The patients discharge haemoglobin was 10.4g/dl.

101Annual Report

Page 103: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Paediatric patients form an important sub group oftransfusion patients. This chapter summarises thefindings on the 24 paediatric cases reported, whichaccount for 11% of the total reports received. Themajority of reports were in the IBCT category, seveninvolved acute reactions and four were reactionsassociated with PAD.For the purpose of this report, paediatric patients aredefined as age 18 years or under.

Findings IBCT• There were 12 reports in the IBCT category. The

majority of errors were similar to those found in theadult patients.

• In one case (Case 78) a group A baby receivedgroup O platelets due to a request error to thesupply centre by a medical scientist on call notnormally working in the transfusion laboratory.

• One patient was involved in three reports (Cases94, 96 & 97) where three paedipack aliquots wereincorrectly crossmatched and transfused from a

paedipack which was crossmatched and allocatedfor another baby of the same name.

• In three cases (Cases 50, 107 & 108) there wasa failure to prescribe CMV negative/irradiatedcomponents. Two of these (Cases 107 and 108)involved shared care between facilities and as noclinical details were provided, the laboratory wasnot aware of the requirements. In the third case,(Case 50) although the patient had receivedprevious CMV negative/irradiated components,the alert on the laboratory computer had not beenactivated so the error was not detected.

Findings Reactions There were 12 reports in the reaction category.

• The most common reaction reported was in theAA category with seven reports. Pooled plateletswere involved in five cases and red cells in two.

• Three of the AA cases occurred despite theadministration of premedication of

Paediatric Incidents

102

Page 104: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

chlorpheniramine and hydrocortisone.

• Further transfusion was managed usingpremedication alone in three cases and washedcomponent in three cases. One of these whorequired washed components was a patient whohad three separate reactions to pooled platelets(Case 21, 22, 23).

• Cutaneous manifestations were present in all ofthe AA reports.

• There was one report in the AHOSTR category.

• Four cases involved reactions associated with pre-deposit autologous donations and are discussedin the PAD chapter.

Recommendations.• On going training should be provided for medical

scientists providing on call cover who do notnormally work in transfusion to highlight specialrequirements for neonates.

• Each aliquot of a paedipack dedicated to aspecific infant should be individually labelled forthe intended infant to reduce the chance ofissuing it to another infant.

• Medical staff must be aware of guidelines forprescribing irradiated products in paediatricpatients.

• Alert stickers should be placed on charts wherepatients have special requirements e.g.irradiated/CMV negative components.

• Blood transfusion laboratory computer systemalerts which draw attention to the need forspecialised components should be used whereverpossible.

• As some of the incidents involved shared care oradmission to different hospitals, issuing of apatient card should be considered.

• A/A reactions are distressing for both the patientand the clinical team and washed componentsmay be indicated for serious repeated reactions.However, poorly justified requirements for washedcomponents may cause undue delays whentransfusions are needed in the future. In addition,washing of platelets can affect platelet yields withloss of platelet numbers and viability from thewashing process and poor in vivo incrementalrises.

• Before prescribing washed platelets for patientswith a history of transfusion reactions to pooledproducts, apheresis platelets (which areassociated with a lower rate of reactions) withpremedication cover should be tried first.

• It is important to ensure that the patient has apatent IV cannula and that all documentation iscorrect prior to collection of the unit. Should therebe a delay in the commencement of thetransfusion it is necessary to return the unit tocontrolled storage within thirty minutes and informthe laboratory to ensure the unit is being returnedto the appropriate fridge.

103Annual Report

Page 105: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office104

Level

1

2

2

2

2

2

2

2

3

3

Volume of IncorrectBlood Component orProduct Transfused15mls of apheresis plateletsx 2

Plasma exchanged on fouroccasions with 12 units ofUniplas.

One paedi-pack

One unit of red cells.

One aliquot of red cells

One aliquot of red cells

One aliquot of red cells

One unit of red cells

Discovered when 60 mls ofred cells transfused ,discontinued.

One aliquot of red cells

One unit of red cells

One unit of red cells

Cause of Error

Group O platelets requested and issued toGroup A baby.

Inability of supply centre to supply group B SDPlasma for large volume plasma exchanges.

Incorrect date of birth was transcribed fromnotes onto request form and sample tube.

CMV negative and irradiated red cells notordered as required and error not detected onprocessing as this requirement had not beenflagged on a previous transfusion.

Paedipack aliquot incorrectly crossmatchedand transfused from a paedipack which wascrossmatched and allocated for another babyof the same name.

Paedipack aliquot incorrectly crossmatchedand transfused from a paedipack which wascrossmatched and allocated for another babyof the same name.

Paedipack aliquot incorrectly crossmatchedand transfused from a paedipack which wascrossmatched and allocated for another babyof the same name.

Failure to prescribe CMV negative or irradiatedred cells for a patient with a malignanthaematological disorder.

Failure to request and prescribe irradiatedblood products for a patient with a malignanthaematological disorder.

In error last aliquot of paedipack removedfrom and left out of fridge too long andwasted.

One digit error in date of birth on pretransfusion sample request form and on unittransfused.

Mother of patient stated patient’s date of birthincorrectly, i.e. month, day, year instead ofday, month, year.

TABLE 40: IBCT Paediatric Incidents (N=12)

Symptoms andOutcome

No complications as a resultof this transfusion.

Positive DAT. Nocomplications as a result ofthis transfusion.Subsequent transfusionswith Group B FFP.

No complications as a resultof this transfusion.

No complications as a resultof this transfusion.

No complications as a resultof this transfusion

No complications as a resultof this transfusion

No complications as a resultof this transfusion

No complications as a resultof this transfusion.

No complications as a resultof this transfusion.

No complications as a resultof this transfusion

No complications as a resultof this transfusion.

No complications as a resultof this

Age

1 wk

1yr

39 days

18 months

5 wks

3 yrs

15 yrs

22 days

3 yrs

7 yrs

CaseNumber

IBCT Case 78*P

IBCTCase 25

IBCTCase 43

IBCT Case 50*P

IBCT Case 94,96, 97samepatient*P

IBCT Case 107*P

IBCT Case 108

IBCTCase 121*P

IBCT Case 29

IBCT Case 75

*P Included as a full case history in this chapter

Page 106: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Wrong Platelet ABO group

Level 1 IBCT Case 78 This premature neonate with sepsis required atransfusion of platelets for thrombocytopenia. Thepatient’s blood group was A Rh D positive. A Rh Dpositive platelets should have been requested. Inerror, group O Rh D positive platelets were requestedby an on-call medical scientist not normally working inblood transfusion. The supply centre did not detectthe error as the information about the patient’s bloodgroup was incorrect. The platelets were administeredin two doses of 15 mls uneventfully and bothtransfusions were checked at the bedside by twoclinical staff; however the group discrepancy wentunnoticed. A medical scientist normally working inblood transfusion discovered the error the followingday during a routine audit of on-call work. The patientsuffered no complications as a result of thistransfusion.

Problems with Paedipacks

Level 2 IBCT Case 94, 96, 97 This neonate required a top up transfusion foranaemia of prematurity. There were three infants withthe same surname being nursed in the ITU at thistime. On call a medical scientist not normally workingin transfusion issued an aliquot crossmatched for thisbaby, from a paedipack which had been allocated andcrossmatched for one of the other babies of the samename. Both babies were of the same blood group.The error occurred due to a failure to confirm correcthospital number and date of birth on the babyintended for transfusion. In the hospital, the unit,which is split into aliquots, is labelled with the baby’sdetails but each aliquot is not individually labelled.However the crossmatch form contains the donornumber, which is on each aliquot and used forconfirmation during the final bedside checkingprocedure. The error went unnoticed and wasrepeated on the same baby on two further occasions.All transfusions were uneventful and a senior medicalscientist discovered the error during a routine audit.

Both babies required further transfusions and newaliquots were assigned.

Level 2 IBCT Case 121 This premature neonate required a transfusion of redcells for anaemia. The baby had already receivedthree of the five neonatal aliquots available at thehospital. On this occasion the baby required onefurther aliquot but two units were removed from thefridge in error. One aliquot was transfused but theother one had to be discarded as it had been out ofcontrolled storage for too long. The following dayhaving reviewed the patient a decision was made totransfuse a further unit of red cells. A new paedipackof red cells was ordered but due to the baby’scondition a decision was made to transfuse the babyimmediately using the stock red cells for neonatal use.

CMV / Negative Irradiated componentsnot prescribed

Level 2 IBCT Case 107 This child with a malignant haematological disorderrequired a transfusion of two units of CMV negativeand irradiated red cells for anaemia. The child wasreceiving shared care between two facilities. Theprescription however did not state the need forspecial requirements and the first unit was issuedfrom the laboratory and transfused. When thelaboratory staff contacted the clinical area to see ifthe second unit was required they were informed ofthe shared care programme and it was then realisedthat CMV negative and irradiated components shouldhave been prescribed. As this was the firsttransfusion outside the primary care facility notransfusion history was available.

Level 2 IBCT Case 50 This young child with a malignant disorder required ared cell transfusion. The patient had receivedprevious transfusions of CMV negative and irradiatedblood products. On the previous transfusion, theappropriate product was issued but the alert which

105Annual Report

Page 107: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

would have indicated the special requirements forfuture transfusions was not activated on the laboratorysystem. On this occasion, one unit of red cells wasprescribed but the requirement for CMV negative andirradiation was not specified. The laboratory staff werenot alerted by the IT system as the alert had not beenactivated previously. One unit of red cells wastransfused. By chance the unit was CMV negative butwas not irradiated. The patient suffered nocomplications as a result of this incident. The error wasdetected on a subsequent transfusion. As a result ofthis incident all computer records of paediatriconcology patients have been flagged as requiring CMVnegative and irradiated products. All new cases withspecial transfusion requirements have a sticker placedon the front of the chart.

Transfusion Reactions

AA Case 15This five-year-old male patient with a malignanthaematological disorder required a red cell transfusionfor anaemia. The unit of red cells was administered asprescribed over three and half-hours. Two hours aftertransfusion the patient developed symptoms ofurticaria and periorbital oedema. Chlorpheniraminewas given and the patient recovered fully within twoand half-hours. The patient suffered no furthercomplications as a result of this transfusion. Noinvestigations were carried out. Pre-medication ofchlorpheniramine for future transfusions wasrecommended and the patient has had receivedsubsequent transfusions with no complications usingthis regime.

AA Case 21, 22 & 23 This young male child with a malignancy requiredseveral transfusions of platelets in the day care settingfollowing chemotherapy. Following transfusion of a unitof pooled platelets, the patient developed an urticarialrash which did not require treatment and whichsubsided within 30 minutes. During a subsequenttransfusion of pooled platelets one week later, thepatient developed urticaria, a cough and a lump in his

throat. No medication was prescribed. One unit of redcells was then transfused uneventfully and the childwas discharged. On the third occasion, one week later,premedication of chlorpheniramine and hydrocortisonewas given prior to a further transfusion of pooledplatelets. Following transfusion, the patient developeda cough, wheeze and itch which required treatmentwith a salbutamol nebulizer. The symptoms resolvedwithin one hour and future recommendations fortransfusion of this child include the administration ofwashed platelets. Subsequent transfusions using thisprotocol have been successful.

AHOSTR case 20This young male child with a malignant haematologicaldisorder required one unit of CMV negative red cellsfor anaemia. The patient grouped as O Rh D positive,the historical antibody screen was positive for Anti Jkb

which was not detected on this occasion. Antigennegative blood was crossmatched and issued. Duringtransfusion, when 93 mls had been transfused, thepatient developed symptoms of fever (>1.5°C) withbackache and nausea. The transfusion wasdiscontinued completely and no medication was given.A full recovery was made but the recovery timeframewas not specified in the case notes. The patient wascultured and no organisms were isolated. However thesuspected reaction was not investigated and the unitwas not cultured.

National Haemovigilance Office106

Page 108: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

107Annual Report

Case

No.

AACa

se10 AA

Case

11 AACa

se15 *P AA

Case

18 AACa

se21

,22

&23

*P

Com

pone

nt

One

unit

poole

dpla

telet

conc

entra

te

One

unit

poole

dpla

telet

conc

entra

te

One

unit

red

cells

One

unit

red

cells

One

unit

ofpo

oled

plate

letco

ncen

trate

(1st

trans

fusio

n)

One

unit

ofpo

oled

plate

letco

ncen

trate

(2nd

trans

fusio

n)

One

unit

ofpo

oled

plate

letco

ncen

trate

(3rd

trans

fusio

n)

Age

Yrs

Gend

er

12 F 11 F 5 F 11 F 6 M

Reas

onfo

rtra

nsfu

sion

Plat

eletc

ount

54x1

09/L

Haem

atolo

gical

mali

gnan

cy,

seps

is.

Plat

eletc

ount

18x1

09/L

Haem

atolo

gical

mali

gnan

cy.

Anae

mia

Hb7.6

g/dl

Haem

atolo

gical

mali

gnan

cy,

activ

eble

eding

.

Anae

mia

Hb8.1

g/dl

Haem

atolo

gical

mali

gnan

cy.

Plat

eletc

ount

10x1

09/L

Malig

nanc

y.

Plat

eletc

ount

14x1

09/L

Malig

nanc

y.

Plat

eletc

ount

19x1

09/L

Malig

nanc

y.

Sym

ptom

s

Urtic

aria

desp

itepr

emed

icatio

nwi

thhy

droc

ortis

one

and

chlor

phen

iram

ineIV.

Urtic

aria,

itch

and

disco

mfo

rtde

spite

prem

edica

tion

with

hydr

ocor

tison

ean

dch

lorph

enira

mine

IV.

Urtic

aria,

perio

rbita

loe

dem

a.

Urtic

aria,

feve

rrise

of1.9

°C,c

hills,

rigor

s,ta

chyc

ardia

.

Urtic

aria

Urtic

aria,

coug

han

dlum

pin

thro

at.

Whe

eze,

coug

h,lum

pin

thro

atan

ditc

hde

spite

prem

edica

tion

with

hydr

ocor

tison

ean

dch

lorph

enira

mine

IV.

Inves

tigat

ions

None

None

None

ABO

incom

patib

ility

exclu

ded.

Cultu

reof

patie

ntan

dun

it,no

grow

th.

None

.

Stag

eTra

nsfu

sion

Deve

loped

Follo

wing

com

pletio

nof

trans

fusio

n

45m

inute

safte

rco

mm

encin

gtra

nsfu

sion.

Follo

wing

com

pletio

nof

trans

fusio

n.

With

inth

ree

hour

sof

com

men

cing

trans

fusio

n.24

0mls

had

been

trans

fuse

d.

Post

trans

fusio

n

Post

trans

fusio

n.55

minu

tesa

fter

com

men

cing

trans

fusio

n

Post

trans

fusio

n.30

minu

tesa

fter

com

men

cing

trans

fusio

n

Treat

men

t

None

Hydr

ocor

tison

eIV.

Chlor

phen

iram

ine

Hydr

ocor

tison

eIV,

para

ceta

mol.

Trans

fusio

ndis

cont

inued

.

None

.

None

.

Salbu

tam

olne

buliz

er.

Sequ

elae/

Reco

mm

enda

tions

forf

utur

etra

nsfu

sions

Reco

very

with

inth

irty

minu

tes.

Was

hed

com

pone

ntsh

ave

been

reco

mm

ende

dfo

rfu

ture

trans

fusio

ns.

Reco

very

with

inth

irty

minu

tes.

Futu

retra

nsfu

sions

with

wash

edco

mpo

nent

sha

vebe

enre

com

men

ded.

Reco

vere

dwi

thin

two

and

aha

lfho

urs

Subs

eque

nttra

nsfu

sions

with

prem

edica

tion

ofch

lorph

enira

mine

have

been

unev

entfu

l.

Reco

very

with

in4-

5ho

urs.

Prem

edica

tion

ofan

tihist

amine

hasb

een

reco

mm

ende

d.

Reco

very

with

inon

eho

ur.

Reco

very

with

inon

eho

ur.P

rem

edica

tion

prior

tofu

ture

trans

fusio

nsre

com

men

ded.

Reco

very

with

inon

eho

ur.W

ashe

dce

llsha

vebe

enre

com

men

ded

forf

utur

etra

nsfu

sions

.

TABL

E41

:AA

Paed

iatri

cIn

cide

nts

(N=7

)

*PInc

luded

asa

full

case

histo

ryin

this

chap

ter

Page 109: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Haemovigilance Office108

Case

No.

AHOS

TRCa

se20

*P

Com

pone

ntPr

escr

ibed

One

unit

ofre

dce

llsJk

ban

tigen

nega

tive

red

cells

.

Age

Yrs

Gend

er

3 M

Unde

rlying

cond

ition

Haem

atolo

gical

mali

gnan

cy

Volum

etra

nsfu

sed

onse

t

93m

ls

Sym

ptom

s/sig

ns

Tem

pera

ture

rise

>1.5°

C,ba

ckac

he,n

ause

a.

Inves

tigat

ions

Patie

ntcu

lture

d,no

orga

nism

siso

lated

.No

furth

erinv

estig

ation

sca

rried

out.

altho

ugh

patie

ntha

da

histo

ryof

prev

iousa

ntibo

dies.

Treat

men

t&Ou

tcom

e

Trans

fusio

nwa

sdisc

ontin

ued,

patie

ntre

cove

red

fully

.No

treat

men

twas

given

.

TABL

E42

AHOS

TRPa

edia

tric

Inci

dent

s(N

=1)

Case

No.

PAD

Case

1 PAD

Case

2 PAD

Case

4 PAD

Case

7 *

Plan

ned

Proc

edur

e

Rem

oval

ofsp

inalr

ods

Ganz

oste

osto

my

Orth

opae

dicsu

rger

y

Orth

opae

dicsu

rger

y

15 F 14 F 13 F 15 M

5 0 49 44 66

Hb g/dl

14.7

13.1g

/

14.6

15.4

Curre

ntMe

dicat

ion

Oral

iron

Oral

analg

esia

Oral

iron

Bron

chod

ilato

rinh

aler

Com

plica

tions

Naus

eaan

dhy

pote

nsion

post

dona

tion.

Light

-hea

ded

and

naus

eaat

end

ofdo

natio

n.

Naus

eaan

dvo

mitin

g30

mins

post

dona

tion.

Light

-hea

dedn

ess.

Faint

ed25

mins

post

dona

tion

Reac

tion

Dona

tion

Histo

ry

On1s

t

On1s

t

On1s

t.2n

dun

even

tful

On2n

d.1s

tun

even

tful.

Com

men

ts

Past

histo

ryof

naus

eaan

dfe

eling

weak

.50

0mls

ofIV

fluids

adm

iniste

red.

Reco

vere

dwi

thno

com

plica

tions

.Di

scha

rge

Hb10

.3.g/

dl.

Past

histo

ryof

need

leph

obia.

500m

lsof

IVflu

idsad

mini

stere

d.Re

cove

red

with

noco

mpli

catio

ns.

Disc

harg

eHb

8.9g/

dl.

Reco

vere

dwi

thno

com

plica

tions

.Di

scha

rge

Hb7.9

g/dl.

Reco

vere

dwi

thno

com

plica

tions

.Po

st-tra

nsfu

sion

Hb7.4

g/dl.

Disc

harg

eHb

.10.4

g/dl.

PAD

unit

(s)

trans

fuse

d

None

.

Auto

logou

sunit

trans

fuse

dan

d1u

nitof

allog

eneic

blood

adm

iniste

red.

One

unit

trans

fuse

d.

2un

itsof

auto

loguo

usan

d2

units

ofall

ogen

eicblo

odad

mini

stere

d.

TABL

E43

:Pre

-Dep

osit

Auto

logo

usDo

norI

ncid

ents

(N=4

)

Age YrsGender

Weight kg

1 1 3 3No PlannedDonations

*PInc

luded

asa

full

case

histo

ryin

this

chap

ter

*Inc

luded

asa

full

case

histo

ryin

appr

opria

tech

apte

r

Page 110: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

IntroductionA three year pilot project in Near Miss event reportingcommenced in November 2002. The objectives of theproject were to improve the safety of transfusion byanalysing the incidence of Near Miss events and theirroot causes so that changes could be introducedwhere weaknesses in the transfusion chain wereidentified.

The Medical Event Reporting System for TransfusionMedicine (MERS-TM), a system specificallydesigned to collect, classify and analyse events withpotential for compromising blood transfusion safetywas used to collect and analyse the data.

Ten hospital sites nationwide have been contributingto the project since it commenced and reporting rateshave been steadily growing. During 2004, the first fullyear of reporting, a total of 467 Near Miss eventswere received and analysed. The total number ofreports received within the IBCT category from thesame ten hospital sites during 2004 was 42,confirming that Near Miss events are occurring onaverage, 11 times more frequently than adverseevents causing harm.

The distinguishing difference between a Near Missevent and an adverse event causing harm, is that in aNear Miss event there is always a ‘recovery’ step that

prevents harm to the patient. Recovery can either bein the form of a planned checking step in the workprocess or, an event can be simply caught by chance.Information about recovery within an organisation canprovide us with insight about which barriers to errorare effective or which are weak or missing.

The risk index of each event was calculated using therisk assessment tool provided by MERS-TM. Eachevent was classified into either high medium or lowrisk depending on the degree of risk the event posedto either the patient or the organisation.

Root causes were divided into Human,Organisational, Technical or Patient Related Failures.Most events involved more than one root cause; onlysignificant root causes where patterns or trends inerror emerged will be discussed in this report.

By analysing Near Miss event data, we can identifyhigh risk clinical areas and steps in the work processin addition to many other factors that contribute toerror. By studying the circumstances surroundingeach event, we can gain vital insight into the realreasons why errors occur in the transfusion setting.Most importantly, as the lessons we can learn fromNear Miss event data do not involve the patient beingexposed to harm, we can improve the safety oftransfusion in a way that benefits both the patient and

The Near Miss Project The First Full Year of Reporting

109

Page 111: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

the organisation.

RESULTS

Fig 6: Near Miss Events versus Adverse Eventsreported in the 10 Project SitesJan - Dec 04

Near Miss events in the 10 project sites are occurringon average 11 times more frequently than adverseevents causing harm

Fig 7: Risk Index of Events

There were 353 events that were classified as lowrisk, 81 as medium risk and 33 as high risk.

Fig 8: Step in the Work Process where Eventswer Discovered N = 467

The majority of events 273 (58%) were discovered atthe Sample Handling step in the laboratoryhighlighting this step as an effective barrier to error.There were 66 (13%) events that were notdiscovered until Unit Transfusion ie: at some pointafter the unit was issued, but before it was transfusedto the patient. These relate to events discovered ateither collection from site of storage or the finalbedside check. A further 60 (13%) events werediscovered at some point outside recognisedchecking steps in the work process, these eventswere classified as being discovered at‘miscellaneous’ steps.

National Haemovigilance Office110

0

100

200

300

400

500

Actual Errors Reported

42

Near Miss Events Reported

467

0

50

100

150

200

250

300

350

400

Low Risk Medium Risk

353

81

High Risk

33

Sampling Handling273 (58%)

Selection1 (1%)

Storage2 (1%)

Unit Transfusion66 (14%)

SampleCollection

21 (4%)

Miscellaneous60 (13%)

Issue9 (2%)

Check In6 (1%)

Avail for Issue5 (1%)

Pres. Req.3 (1%)

Testing21 (4%)

Page 112: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Fig 9: 1st Site of Error

Sample Collection was the first site of error in 300(64%) events, identifying it as the highest risk step inthe work process. There were 33 (7%) eventsinvolving errors made during Prescription or Request.In addition, there were 70 (15%) events where thefirst site of error occurred at some point outsiderecognised steps in the work process, these eventswere classified as first occurring at ‘Miscellaneous’steps.

Fig 10: Who was involved

Errors most frequently involved medical & nursingstaff, 261 (56%) events involved doctors and 138(29%) involved nurses. Laboratory staff were alsoinvolved in a significant number of events 50 (10%).A further 50 (10%) events involved ‘other’ grades ofstaff including portering and phlebotomy staff. Mostevents involved more than one grade of staff.

Fig 11: Where Events are Occuring

The high risk clinical areas identified were the generalward areas where 274 (59%) events occurred andA&E where 66 (14%) events occurred. A significantnumber of events, 47 (10%) occurred in thetransfusion laboratory which has been traditionallyviewed as an area where risk of error is low.

111Annual Report

Sample Collection300 (64%)

Manipulation1 (0.5%)Order Entry

1 (0.5%)

Storage1 (0.5%)

Miscellaneous70 (15%)

Unit Transfusion23 (5%)

Pres Req.33 (7%)

Issue10 (2%)

Selection8 (2%)

Sample Handling6 (1%)

Check In4 (0.5%)

Testing10 (2)

Medical Staff261 (56%)

Nursing Staff138 (29%)

Laboratory Staff50 (10%)

Others including Portering & Phlebotomy staff

50 (10%)

Clerical Staff10 (2%)

A&E66 (14%)

Wards274 (59%)

Clinics7 (1%)

Others including Portering & Phlebotomy staff

50 (10%)

ICU15 (3%)

Labour & Delivery26 (6%)

Theatres6 (1%)

Laboratory47 (10%)

Page 113: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Fig 12: Time Events Occured

263 (56%) events occurred during routine workinghours, the remaining 204 (44%) events occurred outof hours or at weekends

Fig 13: Planned versus Unplanned Recovery

The majority of events 383 (82%) were caught andharm to the patient prevented by planned checkingsteps in the work process. The remaining 84 (18%)events were caught by chance.

Fig 14: Human Failures

Fig 15: System Failures

National Haemovigilance Office112

8am - 4pmMon - Fri263 (56%)

Out of HoursWeekends204 (44%)

0

50

100

150

200

250

300

350

400

Planned Recovery

383

Unplanned Recovery

84

0

50

100

150

200

250

300

KnowledgeBased Errors

Verification Errors

InterventionErrors

HumanSlips

0

50

100

150

200

TechnicalDesign

Policies/Procedures

OrganisationalKnowledge

Management Priorities

Page 114: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Root Causes – FindingsTo date, there appears to be several significant trendsemerging from the data in relation to the root causesof error. Most events involved more than one rootcause and single events often contained acombination of both system and human failures.

Human FailuresHuman slips are the most frequently occurring causeof human error. Most of the human slips involved staffforgetting to complete tasks, such as sample labellingor making transcription errors on samples andrequests. These types of errors occur when staff areinattentive while carrying out a task. Reasons sited forthese types of errors were tiredness and distractionscaused by busy workloads and long working hours.

Other root causes relating to human failurehighlighted were staff failing to verify patient orproduct identification at the bedside, failure to carryout cross checks correctly or at all and failure to verifytest results prior to prescribing.

Failure to follow policies/procedures was also shownto be a significant root cause. Practices such as prelabelling of sample tubes, remote labelling andchecking , taking samples from patients with no IDbands and failing to adhere to maximum surgicalblood ordering schedules were all associated witherror.

Finally lack of knowledge was also shown tocontribute to error in a smaller number of events, forexample medical staff prescribing plasma for warfarinreversal inappropriately or being unaware of basicprocedures to follow despite having received training.

System FailuresManagement priorities were the most frequentlyoccurring cause of system failure. For example,decisions made about staffing levels such as notreplacing staff on annual or sick leave were found tocontribute to error. Short staffing in the clinical areaswas frequently cited as a contributory factor when

error occurred.

The absence of systems for gaining access tomedical records out of hours was highlighted as asignificant cause of error in some sites. This led tosituations where patients who were admitted out ofroutine hours could not be assigned a medical recordnumber. The hospitals involved had to use asupplementary numbering system so that eachpatient could have a unique transfusion number. Thissupplementary system was found to be flawed andvery prone to user error and was frequentlyassociated with sample collection errors.

Another significant management failure that emergedfrom the data relates to the limited phlebotomyservices available in some hospital sites. Routinephlebotomy services were found to be minimal orabsent after 1pm in many sites and were frequentlynot available at all in accident and emergencydepartments. This led to situations where medical andnursing staff were expected to take pre transfusionsamples in addition to their already demandingworkload.

Failures on behalf of management to ensure thatsystems are in place for ensuring all staff involved intransfusion are given appropriate training for the tasksthey are expected to carry out was also found to be aroot cause of error. Absence of mandatory trainingprogrammes for certain groups of staff such asagency, locum and medical staff was highlighted.Despite most sites having an establishedHaemovigilance training programme, lack of systemsfor ensuring all staff attended these trainingprogrammes was found to be a particular problem.Lack of appropriate training for staff doing cross callcover in the transfusion laboratory was also found tocontribute to laboratory errors.

Technical failures such as computer systems in thehospital not being fully linked with computer systemsin the transfusion laboratory were also highlighted.This led to situations where updated information on

113Annual Report

Page 115: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

hospital patient information systems (PAS) were notcarried across to the laboratory system (LIS). As aresult, vital information relating to patient details weremissed.

Finally, failure to ensure that current policies andprocedures relating to the transfusion process wereavailable in all clinical areas and are reviewed andupdated at regular intervals was also found tocontribute to error in some sites.

Although these findings are only taken from one fullyear of reporting, significant trends in error areemerging and it is hoped that through continuedreporting into the project a much betterunderstanding of transfusion error will be gained atthe end of the three year period.

The data provided in this report would not existwithout the ongoing contribution of all staff involved inthe transfusion chain at hospital level. In particular, theHaemovigilance Officers and laboratory staff whohave coordinated this project in their individual sitesin addition to their existing workload. It is hoped thatreporting rates will continue to grow in the final yearof the project and that the data produced will be usedto target resources where they are needed most inorder to reduce error and improve transfusion safety.

National Haemovigilance Office114

Page 116: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

The NHO would like to thank a number of people fortheir invaluable contribution to the compilation of thisreport and gratefully acknowledge the assistancethey provided.

Mr Geoff Lucas and Staff at the International BloodGroup Reference Laboratory, National Blood GroupReference Laboratory, National Blood Service,Bristol.

Dr Joan Gilvarry, Ms Niamh Arthur, Mr John Lynch andMr. Patrick Costello at the Irish Medicines Board,Dublin

Dr. Beatrice Nolan for her contribution towards theTransfusion Associated Circulatory Overload chapter.

Mr Geoff Connell and staff in the Virus ReferenceLaboratory, University College Dublin for their help insuspected transfusion transmitted donorinvestigations.

For those from within the IBTS, thanks are extendedto:

Ms Bernie Quirke and the staff of the VirologyLaboratory, Carmel Sheridan, Recipent Tracing Unitand Pauline Coakley QA Manager IBTS.

Dr Joan O’Riordan for her contribution towards thegeneral content of this report, to Dr Joan Fitzgerald forher input into the Anti-D section and also to Mr DonMullahy for his advice on laboratory matters.

Dr Joan Power, Dr Nuala Moore, Dr Michael Thomas, Communications Officer, Ms Mirenda O’Donovan,Training Officer, Mr Peter McDonnell, and staff of theLibrary Services, Ms Niamh O’Sullivan, Ms LucyO’Doherty and Ms. Janet Kelleher.

115

Acknowledgements

Page 117: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

NHO DirectorDr. Emer Lawlor FRCPath, FRCPIConsultant HaematologistDirector NHO

Haemovigilance OfficersMs. Donna Harkin RGN RM DSMHaemovigilance Officer e-mail [email protected]: (01) 432 2890

Ms. Marcia Kirwan RGN RM MScEd Haemovigilance Officer,e-mail [email protected]

Ms Mairead Sheahan RGN DSMHaemovigilance Officere-mail [email protected]: (01) 4322891

Ms. Jackie Sweeney, RGN RM CHN BscNursing(Ord)Haemovigilance Officer, e-mail: [email protected]: (01) 4322891

Near Miss ProjectMs. Derval Lundy RGNHaemovigilance Officer e-mail [email protected]: (01) 432 2825

NHO AdministrationMs. Cathy Scuffil Nat Dip Man & Bus, CISMNHO Programme Administrator e-mail [email protected]: (01) 432 2894

Ms. Marie CarolanAssistant Administratore-mail [email protected]: (01) 432 2854

116

Contacts

Page 118: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

A National Blood Conservation Strategy for National Blood

Transfusion Committee (NBTC) and National Blood Service

(NBS) A report from the working party on Autologous

Transfusion and the Working Party on Alternatives to

Transfusion of the NBS Sub-Group on Appropriate Use of

Blood 2004.www.dh.gov./uk/PolicyAndGuidance

Andrzejewski, C. and Popovsky, M.A. (2005) Transfusion-

associated adverse pulmonary sequelae: widening our

perspective. Transfusion. 45: 1048-1050.

Anand, I.S, Kuskowski, M. A, Rector, T.S, et al. (2005)

Anemia and Change in Hemoglobin Over Time Related to

Mortality and Morbidity in Patients With Chronic Heart

Failure: Results from Val-HeFT. Circulation. 112: 1121-

1127

Bailie, G.R., Clark J.A., Lane C.E., Lane et al. (2005)

Hypersensitivity reactions and deaths associated with

intravenous iron preparations: Nephrol Dial Transplant. 20

(7) 1443-9

Bux, J. (2005) Transfusion–related acute lung injury

(TRALI): A serious adverse event of blood transfusion. Vox

Sanguinis. 89: 1-10.

BCSH Guidelines (2004) Guidelines for compatibility

procedure in blood transfusion laboratories Transfusion

Medicine 14: 59-73.

British Blood Transfusion Society (BBTS) and The Royal

College of Obstetrics and Gynaecologists (1999)

Recommendations for the use of Anti-D immunoglobulin for

Rh prophylaxis. Transfusion Medicine. 9: 93-97.

Boehlen, F., Clemeston, K.J., (2001) Platelet chemokines

and their receptors ;what is their relevance to platelet

storage and transfusion practice. Transfusion Medicine

11:403-417.

Bilotte, D, Glisson, S, Green, D, et al. (2002) A Prospective

Autologous Donation for Hip Replacement Surgery. The

Journal of Bone and Joint Surgery. 84 1299- 1304

Brecher, M.E, Combs, M.R, Drew, M.J.et al (2002)

American Association of Blood Banks Technical Manual.

14th Edition. Bethesda, AABB Press.

British Committee for Standards in Haematology (BCSH)

1994. Autologous Transfusion. Prepared by the Autologous

Transfusion Working Party of the National Blood

Transfusion Service for the Blood Transfusion Task Force.

21: 250-260. Reprinted from Transfusion Medicine 1993,

3: 307-316.

References

117

Page 119: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

Carless, P, Moxey, A, O’Connell, D, et al. (2004)

Autologous transfusion techniques: a systematic review of

their efficacy. Transfusion Medicine. 14: 123- 144.

Commission Directive 2002/98/EC of the European

Parliament and of the Council of 27 January 2003 Setting

Standards of Quality and Safety for the Collection, Testing,

Processing, Storage and Distribution of Blood and Blood

Components and amending Directive 2001/83/EC.

Domen, R, E., Hoeltge, G, A., (2003) Allergic transfusion

reactions. Archives of Pathology and Laboratory Medicine,

127; 316-320.

European Commission: Technical meeting of blood experts

related to vCJD transmission. Luxembourg, 20 January

(2004) FMD/360007.Luxembourg, European Commission.

Gilstead, C,W. (2003) Anaphylactic transfusion reactions.

Current Opinion in Haematology. 10: 419-423.

Goldman, M, Savard, R, Long, A, et al. (2002) Declining

values of preoperative autologous donation. Transfusion.

42, 819-823.

Heddle, N.M., Blajchman, M.A., Meyer, R.M., et al. (2002). A

randomized controlled trial comparing the frequency of

acute reactions to plasma –removed platelets and

prestorage WBC –reduced platelets. Transfusion. 42:556-

566.

Innerhofer P., Klingler A., Klimmer C., et al. (2005) Risk for

postoperative infection after transfusion of white blood cell-

filtered allogeneic or autologous blood components in

orthopaedic patients undergoing primary arthroplasty.

Transfusion. 45: 103-110.

Kaplan H.S., Callum J.L., Fastman B.R., et al. (2002) The

Medical Event Reporting System for Transfusion Medicine:

Will it help get the Right Blood to the Right Patient,

Transfusion Medicine Reviews, 16,; 86-102

Kleinman, S., Caulfield, T., Chan, P., et al. (2004) Toward an

understanding of transfusion –related lung injury: statement

of a consensus panel. Transfusion. 44: 1774-1789.

Koda, Y., Watanabe, Y., Soejima,M., et al. (2000) Simple

PCR detection of haptoglobin gene deletion in

anhaptoglobinemic patients with antihaptoglobiin antibody

that causs anaphylactic transfusion reactions. Blood

95:1138-1143.

Lariat S., Fisher B., (2005) The Western Australian

Experience with a Register of Atypical Antibodies.

Transfusion Medicine 15: 72

Love, E. M., Soldan, K., Jones, H., et al (2002) Serious

Hazards of Transfusion (SHOT. Annual Report 2000-2001.

Manchester, SHOT Office.

Linden, J.V., and Krushkall, M.S. (1997) Autologous blood:

always safer? Transfusion 37: 455-456.

Llewelyn, C.A., Hewitt, P. E., Knight, R.S.G .et al (2004)

Possible transmission of variant Creutzfeld –Jakob disease

by blood transfusion. The Lancet, 363: 417-421.

Mancini DM, Katz,SD, Lang, CC, et al. 2003. Effect of

Erythropoietin on exercise capacity in patients with

moderate to severe chronic heart failure. Circulation 107:

294-299

Mollicen P.L., Engelfriet C.P, Contreras M. (1998) Blood

Transfusions in Clinical Medicine 10th Edition Oxford,

Blackwell Scientific Publications 304-307.

National Blood Users Group (NBUG 2004) Guidelines for

the Administration of Blood and Blood Components.

Dublin, Department of Health and Children.

National Blood Users Group (NBUG) (2001) A Guideline

for Transfusion of Red Blood Cells in Surgical Patients.

Dublin, Department of Health and Children.

National Blood Users Group (NBUG) (2002) A Guideline

for the use of Blood and Blood Components in the

Management of Massive Haemorrhage. Dublin, Department

of Health and Children.

National Blood Strategy Implementation Group, Report to

the Minister for Health and Children; Chairperson, Dr.

Orlaith O’Reilly, 2004

National Haemovigilance Office118

Page 120: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

National Institute for Clinical Excellence for the National

Collaborating Centre for Chronic Conditions (July 2003)

Management of chronic heart failure in adults in primary and

secondary care Clinical Guideline 5 UK NHS

O’Riordan, J (2003) Personal Communication with. As Per

Schreibner S.H, Busch B.B., Kleinman S., Korelitz J. B. The

Risk of Transfusion Transmitted Viral Infection 1993-1996,

New England Journal of Medicine. 1996: 334, 1685-1690

Peden, A. H., Head, M. W., Ritchie, D.L., Bell, J.E., et al.

(2004 ) Preclinical vCJD after blood transfusion in a PRNP

codon 129 heterozygous patient. The Lancet, 364: 527-

529

Politis, C, Richardson, S, C. (2004) An update on

predeposit autologous blood donation and transfusion in

Europe. Vox Sanguinis .87: 105-108.

Politis, C, Richardson, C. (2001) Autologous blood

donation and transfusion in Europe, Vox Sanguinis 81: 119-

123.

Popovsky, M.A, Whitaker, B, and Arnold, .N.L. (1995).

Severe outcomes of allogeneic and autologous blood

donation: frequency and characterization. Transfusion.35:

734- 737.

Popovsky, M.A. (2001) Transfusion Related Acute Lung

Injury (TRALI). In: POPOVSKY M.A. Transfusion Reactions.

2nd Edition, Maryland , AABB Press.

Popovsky, M.A. (2004) Transfusion and the lung: circulatory

overload and acute lung injury. Vox Sanguinis. 87: 62.

Popovsky, M.A. and Taswell H.F. (1985) Circulatory

overload: An underdiagnosed consequence of transfusion

(abstract). Transfusion. 25: 469.

Rao, S.V, Jollis, J.G, Harrington R.A, et al. (2004)

Relationship of blood transfusion and clinical outcomes in

patients with acute coronary syndromes. Journal of the

American Medical Association. 292 (13): 1555-1562

Spies, B.D., Sassetti, R, Mc Carthy, R.J., et al. (1992)

Autologous blood donation: hemodynnamics in a high–risk

patient population. Transfusion. 32: 17-22.

Saxena, S, Rabinowitz, A.P, Johnson, C, et al. (1993) Iron-

deficiency anaemia: a medically treatable chronic anaemia

as a model for transfusion overuse. The American Journal of

Medicine, 94: 120-124.

Silverberg DS, Wexler D Sheps D et al (2001) The effect

of correction of mild anaemia in severe resistant congestive

heart failure using subcutaneous erythropoietin and

intravenous iron; a randomised controlled study JAM Coll

Cardiol 37: 1775 -1780

Stack, G., Judge, J.V. and Snyder, E.L. (1996) Febrile non-

immune transfusion reactions. In: Rossi, E.C, Simon, T.L,

Moss, G.S. and Gould, S.A. Principles of Transfusion

Medicine. 2nd Edition. Williams and Williams, Baltimore.

Turner, C.L., Casbard, A.C., Murphy, M.F. (2003) Barcode

technology: its role in increasing the safety of blood

transfusion. Transfusion 43: 1200-1209.

Unsworth,D.J.,(2005); Urticarial and anaphylactic reactions

; in Murphy, M,F., Pamphilon,D, H., Practical Transfusion

Medicine, 2nd Edition. Blackwell Publishing179-183.

Vamvakas, E.C, Pineda, A, A. (2001) Allergic and

Anaphylactic Reactions. In Popvosky, M.A. Transfusion

reactions. 2nd Edition, Maryland, AABB Press, 83-120.

Vamvakas, E.C, Pineda, A, A. (2000) Autologous

transfusion and other approaches to reduce allogenic blood

exposure. In Ballière’s Clinical Haematology. 13: 533-547.

Yomotovian, R and Praprotnik, D. (2001) Adverse

Consequences of Autologous Transfusion Practice. In

Popovsky MA. Transfusion Reactions. 2nd Edition,

Maryland, AABB Press, 261- 302.

Zhou, I, Giacherio, D, Cooling, L. and Davenport, R.D.

(2005) Use of B-natriuretic peptide as a diagnostic marker

in the differential diagnosis of transfusion-associated

circulatory overload. Transfusion. 45: 1056 -1063.

119Annual Report

Page 121: National Haemovigilance Office - giveblood.ie · JVP Jugular Venous Pressure ... SOP Standard Operating Procedure ... The national haemovigilance scheme is a confidential

�� ���� ������ ���

���� �� �� ���������������

������ �� ��������� ������

����������� ��� � ����� �������������� ���� ��� ����������� ���������� ����������� ��� ������� ������������ ������ ������������ ���� �����������

������ ���������� ����� �� ��������

���� ����!

����� ��������������������������

��������� ���������

��������

������� ����������������������

� ��

������� ��� ��� ����! ��� ��� ���� ��� �������" �����������# �����# $�# ���������� ����# �%�&�� ���������� ����" ���� ��� ������ �� ���

�������# ������ �� ��� ��� ��� ������������ ������

������������� ! �� �� ���! ��� "������'����# �����# ����������# ������&# �������# ����(������(�����(�������� ���# ������# ��������# ��������# ����(�����������# ���" ���� �� ������

&�������� �������

#������ ������������� �����

�� �� �����������������������������

����� ��� ��� ����������� ����)���� ������� � ����� ��� ��� �� ���� ����������� ����*���� +, ����� ���������"� ����� �������� ��� ������� ��������� &����(����������(-��# '$�#���&������ ������# ���������������" ��� �����&������� ��� ���������� �������.����� ���� ������ �� / 00���(������� �$ ���������� ����������� �!� ������� �������� ����������% ����� ��� ��� ��� ����(������ ���� ��������� ���������� ����������+����� ���������� ���������� ��� ���"�%���� ���������&���(������ ������

&��� ������� ������

1������(���� �������� 0�& �������������� ������ +, ���������� ������ �� ������ �����

����� ������������������� ������

����������# �������� ��� ���&�#����2�&# ������# ��&������ 3����� ����� ���# ���� �� ���&��4*��� ��������������� ��� ������ ������������� �%�&������ �������������� 0�& ������ +, ���������������� 005600�& +,�+� ���������� �������� �� ������ �� ������&�� ���������� ����������! ������������ ���'7 ����������# ���5������� �� �������� ���# �������&��������# �����&��� ������# ��������������������# ���������(��� ��������� )����������* +,+---�� ��� -%.�/ ).-- �������* �& �������� ������ ! ��� �����% ����� ���� ����� � ������ � �� ���������������� �� ������������*��" �%���� ������ ����� �� ���� ����������+�����&����*��� ������ ��� +&8 ������

���! ��� "������ �� �� / �� ��0 �) "�/�*

������ �������� �� ����� ��� �����&������������ ������*��� �������������� �%�&�� ��� �������� � ��������������� ����������� ��� ������� ����&�������� �����&�����

�� �� �������� �� � ����������

*��� �������������� �%�&�� ��� �������� 905:0�& +,�

;��

<�1������

<�

;��

<�

�� <������,�(=,�

���� �,�(=,�

;��

.�� '����

&

���� 1+%. 2 �������3 ���������3

���' ����

��

;��

4�� ��� ���� ��� ���������������! ���

����� ��� ��� &��& ����)���� ������� � ����� ��� ��� �� �������������� ����*���� +, ����� ���������!� ��� ����! ��� ����������������� �� ����� ������� ����� �� ��' ! �������� ������������� ���% ����� ��� ����� �� ������� ����������������������! ��� ����������� ��� ����� ��������&���� ��� ����&����� �� ����� �� ��������� ��� ���" �%�������������&���( ������ ����� �

;��

*��" >��������&��� ����� ����� ������ ����� �������� �����

National Haemovigilance Office120

Appendix 1Management of an Acute Transfusion reaction