national haemovigilance office · jvp jugular venous pressure ldh lactate dehydrogenase lvf left...

NationalHaemovigilanceOffice

Annual Report 2003

National Haemovigilance OfficeNational Blood Centre James’s Street Dublin 8.Tel: 01 432 2894Fax: 01 432 2930

Natio

nal H

aemo

vigilan

ce Office

An

nu

al Rep

ort 2003

designed byw

ww

.redd

og

.ie

Contents

1Annual Report 2003

List of Abbreviations 2Foreword 4Haemovigilance 6An Overview: The First Four Years of the National Haemovigilance Scheme 10Key Recommendations 17

Incorrect Blood Component Transfused 24

Incorrect Blood Component Transfused: Incidents involving Anti–D Immunoglobulin 72

Severe Acute Anaphylactoid or Anaphylactic Transfusion Reaction 80

Transfusion Associated Circulatory Overload 92

Delayed Haemolytic Transfusion Reaction 103

Acute Haemolytic and Other Severe Acute Transfusion Reaction 109

Transfusion Related Acute Lung Injury 115

Suspected Transfusion Transmitted Infection 119

Pre-Deposit Autologous Donor Incidents 123

Paediatric Incidents 128

Near Miss Project 141

Acknowledgements 146

National Haemovigilance Office Team 147References 148Appendix 1 151Appendix 2 152Appendix 3 155Appendix 4 156

AA Severe AcuteAnaphylactoid/Anaphylactic Reaction

AAA Abdominal Aortic AneurysmAABB American Association of Blood BanksACE Angiotensin-Converting EnzymeA&E Accident and EmergencyAHOSTR Acute Haemolytic or Other Severe

Acute Transfusion ReactionARDS Adult Respiratory Distress SyndromeBCSH British Committee for Standards in

HaematologyBMT Bone Marrow TransplantCCU Coronary Care UnitCJD Creutzfeldt Jacob DiseaseCMV CytomegalovirusCOAD Chronic Obstructive Airways Disease CVA Cerebral Vascular AccidentCXR Chest X-rayCPDA1 Citrate-Phosphate-Dextrose-AdenineDAT Direct Antiglobulin Test DHTR Delayed Haemolytic Transfusion

ReactionDIC Disseminated Intravascular

CoagulationDM Diabetes MellitusDOB Date of BirthDoHC Department of Health and ChildrenDVT Deep Venous ThrombosisECG Electrocardiograph

EPO ErythropoietinEU European UnionFBC Full Blood CountFDA Food and Drug AdministrationFMH Feto-Maternal HaemorrhageFFP Fresh Frozen PlasmaGI GastrointestinalGP General PractitionerGTN Glyceryl TrinitriteHb HaemoglobinHBV Hepatitis B VirusHCV Hepatitis C VirusHDN Haemolytic Disease of the NewbornHIV Human Immunodeficiency VirusHLA Human Leucocyte AntigenIBCT Incorrect Blood Component

TransfusedIBTS Irish Blood Transfusion ServiceICU/ITU Intensive Care Unit/Intensive

Therapy UnitID band Identity bandIgA Immunoglobulin AIgG Immunoglobulin GIgM Immunoglobulin MIM IntramuscularIMB Irish Medicines BoardINR International Normalised RatioITP Immune thrombocytopaenic purpuraIV Intravenous

List ofAbbreviations

2National Haemovigilance Office

JVP Jugular Venous PressureLDH Lactate DehydrogenaseLVF Left Ventricular Failure MERS-TM Medical Event Reporting System for

Transfusion Medicine.MRN Medical Record NumberMRSA Methicillin-Resistant Staphlococcus

AureusMSBOS Maximum Surgical Blood Ordering

ScheduleNAT Nucleic Acid Amplification TestingNCHCD National Centre for Hereditary

Coagulation DisordersNEQAS National External Quality Assurance

SchemeNHO National Haemovigilance OfficeOPD Out Patient DepartmentO2 OxygenPAD Pre-deposit Autologous DonationPAS Patient Administration SystemPBSC Peripheral Blood Stem CellPCC Prothrombin Complex ConcentratePCR Polymerase Chain ReactionPNH Paroxysmal Nocturnal

HaemoglobinuriaPO Per osPTP Post Transfusion PurpuraQA/QC Quality Assurance/Quality ControlRCA Root Cause Analysis

Rh RhesusRTA Road Traffic AccidentSD Solvent DetergentSHOT Serious Hazards of TransfusionSOP Standard Operating ProcedureSuspected TTI Suspected Transfusion Transmitted

InfectionTACO Transfusion Associated Circulatory

OverloadTA-GvHD Transfusion Associated Graft-versus-

Host DiseaseTHR Total Hip ReplacementTRALI Transfusion Related Acute Lung InjuryTSO Transfusion Surveillance OfficerTTP Thrombotic Thrombocytopaenic

PurpuravCJD variant Creutzfeldt Jacob DiseaseWNV West Nile Virus

3Annual Report 2003

The publication of the 2003 NationalHaemovigilance Office (NHO) annual reportcompletes four full years of reporting of seriousadverse reactions and events relating to bloodtransfusion in Ireland and thus is a useful measure ofthe extent and type of adverse events/reactionsassociated with transfusion practice in Irish hospitals.As expected, with growing confidence in thescheme, the rate of reporting continues to increase,as does hospital participation, with 100% ofhospitals that transfuse blood now taking part.

The vast majority of blood transfusions are givenwithin excellent standards of care, which makesadverse events/reactions rare in proportion to thenumber of transfusions given in Irish hospitals.When these occur, however, the consequences forpatients as well as the distress and concern of theprofessional caregivers involved can be considerable.

The findings and recommendations of this Report,which are based on detailed analysis of the reportsof adverse reactions and events submitted, aresummarised at the beginning of this report andexpanded upon in the relevant chapters that follow.Of particular concern are the Incorrect BloodComponent Transfused and Transfusion AssociatedCirculatory Overload events as these are preventable. These incidents, combined with events reported tothe Near Miss project, highlight errors and high-riskareas in the work process, providing an important

opportunity to effect improvements in practice andthe overall quality of care for patients in the contextof a no blame culture.

We suggest that multidisciplinary HospitalTransfusion Committees use the findings andrecommendations of this report as a benchmarkingtool. These committees should be in place in allhospitals that transfuse blood. Such committeesprovide a no blame environment within whichidentified errors and their causes can be openlyevaluated and also permits the initiation ofappropriate actions to improve future performanceand ultimately the safety and care of patients.

We are very grateful to the hospital-based TransfusionSurveillance Officers, (TSOs) for their continued workin raising awareness and in developing increasedopenness and alertness in hospitals to reporting suchincidents. The contribution of Transfusion MedicalScientists and Consultant Haematologists is alsocentral to this work.

The continued guidance and advice of the MedicalDirector and staff of the Irish Medicines Board (IMB)is also acknowledged. Special mention should bemade of the staff of the IMB’s PharmacovigilanceDepartment for their expertise and support.The EU Blood Directive 2002/98/EC will come intoforce in February 2005. This Directive will govern theactivities of Blood Transfusion Services and Hospital

Foreword


Blood Banks and has far reaching consequences forthe management and regulation of bloodtransfusion services in all member states of the EU.(EU Directive 2002)

From a haemovigilance perspective, Article 14 of theDirective contains specific provisions in relation totraceability of blood and blood components as far asthe patient. Article 15 requires that all seriousadverse reactions attributable to the quality andsafety of blood and blood components transfusedare captured and reported to the competentauthority. These provisions give haemovigilance afirm legislative basis within the EU and removediscretionary elements currently present in relationto reporting of serious adverse reactions.

Central to the concept of haemovigilance is theappropriate use of blood components.

While the risks of transmission of the known virusesHIV, HCV and HBV are now extremely small, theemergence of other infectious diseases such asvariant Creutzfeldt-Jakob Disease (vCJD) and WestNile Virus (WNV) as new transfusion risks emphasisethe need to use blood appropriately.

During the reporting year 2003, the UnitedKingdom reported a case of probable transmissionof vCJD via blood transfusion and a second possibletransmission has been reported while this report wasbeing compiled.

The guidelines published by the National BloodUsers Group provide a template for appropriate use.The TSOs, through promotion of guidelines in theappropriate use of blood, have an important role toplay in ensuring appropriate blood use, but in theend, appropriate use is the responsibility of eachclinical user. A copy of a letter sent in August 2004by Dr Willy Murphy, National Medical Director of theIBTS, to all registered medical practitioners in thecountry emphasising this, is included in Appendix 1.

The NHO gratefully acknowledges the continuedsupport of IBTS Chief Executive Mr. Andy Kelly andthe staff of the IBTS. Their continued efforts inrecruiting voluntary blood donors and in processingand distributing components to the highest safetystandards combined with the consistently generousresponse of voluntary blood donors to supportpatients in hospitals, are the essential precursors ofany haemovigilance scheme. Finally, particulargratitude is extended to all the staff of the NHO fortheir continued enthusiasm and support inpromoting best transfusion practice and in thewriting of this report.

Dr. Emer LawlorDirectorNational Haemovigilance Office

5Annual Report 2003

Haemovigilance has been defined as:

"A set of surveillance procedures, from the collectionof blood and its components to the follow-up ofrecipients, to collect and assess information onunexpected or undesirable effects resulting from thetherapeutic use of labile blood products, and toprevent their occurrence or recurrence" (French Law, regulation no.93-5, January 4th, 1993)

The national haemovigilance scheme is a confidentialanonymised system similar to that in place formonitoring drug safety, pharmacovigilance. It isdedicated to the achievement of a national standardin practice and quality of care for all patients, before,during and following completion of transfusion. It isthe responsibility of all healthcare professionals tosupport the concept of haemovigilance. From 2005,EU Directive 2002/98 makes reporting of seriousreactions observed during or after transfusion whichcan be attributed to the quality and safety of theblood mandatory.

The remit of the office is to:

• Receive, collate and follow up reports fromhospitals and general practitioners of adversereactions/events connected with transfusion ofblood components/products and provide

feedback information to those making thereport as appropriate.

• Advise on the follow-up action necessaryparticularly with regard to suspected hazards.

• Report adverse reactions to the Irish MedicinesBoard (IMB) according to an agreed procedure.

• Provide ongoing support to hospital-based TSOsand as appropriate to medical, nursing andtechnical staff.

• Provide medical, scientific and nursing analysisof reports of adverse reactions.

• Advise on improvements in safe transfusionpractice based on the data supplied by hospitals.

• Support development of clinical guidelines forhospitals in relation to the use of bloodcomponents/products.

• Support the audit function of hospitals inrelation to transfusion practice.

• Promote the development of fully traceabletransfusion records at hospital level.

Haemovigilance


• Report to the National Blood User’s Group on aperiodic basis with a view to developing nationalbest transfusion practice.

The NHO is located at the National Blood Centre,(NBC) James’s St., Dublin 8 and functions under thedirectorship of a Consultant Haematologist with twoand a half fulltime equivalent TSOs, a ProgrammeAdministrator and Assistant Administrator. A fulltimeTSO has also been appointed to co-ordinate the‘Near Miss Project’.

Hospital Transfusion CommitteesThe development of an adequately resourced, multi-disciplinary Hospital Transfusion Committee isactively encouraged by the NHO and supported bythe Department of Health and Children (DoHC).Smaller centres may share a committee with theirsupplying hospital. This Hospital TransfusionCommittee acts as a forum where local transfusionissues can be openly discussed in a no-blame, non-punitive environment. This multi-disciplinaryapproach to transfusion supports the developmentof best practice.

Irish Medicines BoardStaff of the NHO and representatives of the IMB metregularly during this reporting year to reviewreported incidents. In addition, theirPharmacovigilance Unit provides a valuable resourceto the NHO advising in relation to the overalldevelopment of the programme.

National Blood Users GroupThe Minister for Health and Children established theNational Blood Users Group for the purpose ofpreparing and disseminating guidelines for the useof blood components/products in Ireland.Membership for this group is drawn from a widevariety of transfusion interested hospital baseddisciplines, including haematologists, medicallaboratory scientists, perfusionists, anaesthestists,surgeons and nurses representing a considerablewealth of knowledge of transfusion practice. The following guidelines have been published:

"A Guideline for Transfusion of Red Blood Cells inSurgical Patients" (2001) "A Guideline for the Useof Blood and Blood Components in theManagement of Massive Haemorrhage" (2002) and"Guidelines for the Administration of Blood andBlood Components" (2004) according to theprinciples of evidence-based medicine. Furtherguidelines will be published shortly.

Near Miss Research ProjectThe IBTS has funded a three-year pilot project tocapture "near miss" events. Ten hospitals are currentlyparticipating, and details of the results are containedin the Near Miss Events chapter of this report.

Education, Promotion and DevelopmentsThe NHO encourages and actively supports thedevelopment of hospital in-service trainingprogrammes by working closely with hospital basedTSOs. The office also supports the development ofaudit functions at hospital level in an effort topromote best transfusion practice. Support is alsoprovided in transfusion education for nursing andlaboratory science students.

All newly appointed hospital based TSOs areprovided with an information pack and attend aninduction programme at the NBC which includes anintroduction to Good Manufacturing Practice (GMP)and an overview of the IBTS manufacturingprocesses at the NBC. As the majority of TSOappointments are confined to the centres with asizeable blood usage, the NHO has also developed‘in-service’ education programmes for smallercentres. Regular correspondence throughtelephone/e-mail communication and personal visitsallows networking among TSOs nationwide.

In October 2003 the NHO hosted an annualconference in Tullamore entitled "Haemovigilance-Learning from Mistakes and the Culture of Errors".Dr. Emer Lawlor, Director of the NHO, presented asummary of the incidents reported to the NHO in2002. The keynote speaker was Dr. Harold Kaplan,Professor of Clinical Pathology at the College of

7Annual Report 2003

Physicians and Surgeons of Columbia University andDirector of Transfusion Medicine, New YorkPresbyterian Hospital, who shared his experiences ofanalysing medical event reporting. Otherpresentations included:

• Transfusion Errors in Laboratory by Mr. GerryJudge, Chief Medical Scientist, Adelaide andMeath Hospital incorporating the NationalChildren’s Hospital Dublin.

• Traceability in a European Context by Mr. PaulAshford, Head of Planning, Facilities and IT,Welsh Blood Service.

• Residual and Emerging Threats to the Irish BloodSupply by Dr. Joan O’Riordan, ConsultantHaemotologist, IBTS.

• Neonatal Alloimmune Thromboctopenia NAITP byDr Joan Fitzgerald Consultant Haematologist IBTS.

• The Near Miss Project: The First 11 Months byMs. Derval Lundy NHO IBTS.

• Education in Haematology – Does it InfluenceNursing Practice? by Ms. Catherine Roche TSO.

The NHO also hosted a poster competition duringthis conference, which was kindly judged by Dr.Harold Kaplan. The winning poster displayed detailsof a restrospective transfusion request form auditand was compiled by the members of the NorthDublin Haemovigilance Working Group.

The NHO News, a newsletter circulated to all TSOs,provides an informal forum for the reporting ofwork carried out by TSOs, including results of audits,local education and training initiatives and socialevents which are of interest to other TSOs. Details ofevents of national interest are also reported.

Information on haemovigilance can be directlyaccessed on the IBTS website @ www.ibts.org.

Definition of Terms used in Haemovigilance Adverse Event: Definition: An undesirable experience occurringfollowing administration of a bloodcomponent/product.

Serious Adverse Event:Definition: Any untoward occurrence associated withthe collecting, testing, processing, storage anddistribution of blood and blood components thatmight lead to • Death • Life-threatening• Disabling or incapacitating conditions for

patients which results in, or prolongs,hospitalisation or morbidity

Adverse Reaction: Definition: A reaction which is harmful andunintended and which occurs following transfusionof therapeutic volume of a blood component.

Serious Adverse Reaction: Definition: An unintended response in the patientassociated with the collection or transfusion ofblood and blood component that is • Fatal • Life-threatening • Disabling• Incapacitating which results in, or prolongs

hospitalisation or morbidity

‘Did Not Progress’A total of 191 transfusion reactions/events werereported. Of these, 11 did not fulfil the criteria for ahaemovigilance event, as further investigationrevealed either that the symptom was attributable tothe patient’s underlying condition or that a seriousreaction had not occurred.


‘Nil to Report’100% (81) of hospitals participated in the scheme by returning a ‘Nil to Report Form’ in 2003. Forty seven ofthose hospitals (58%) reported a transfusion reaction or event compared to 41 hospitals (49%) in 2002. Thisshows an increase in hospital reporting of 9%.

NHO Reports by CategoryTable 1 NHO-Confirmed Reports by Category

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 InjuryTTI Suspected Transfusion Transmitted Infection.DHTR Delayed Haemolytic Transfusion ReactionPAD Pre-deposit: Autologous Donor incident

9Annual Report 2003

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

180 115 23 14 9 8 6 4 1100% 64% 13% 8% 5% 4% 3% 2% 1%

THE FIRST FOUR YEARS OF THENATIONAL HAEMOVIGILANCESCHEME

Findings: 2000-2003The NHO scheme has been fully operational sinceJanuary 2000, and has published annual reports for2000, 2001 and 2002. This year represents thefourth year of reporting and presents an opportunityto review the findings for the previous four years.

Approximately 693,818 blood components wereissued during the four-year period 2000–2003 and atotal of 564 adverse transfusion reactions/eventswere reported to the NHO. During 2000, the firstfull year of reporting, there were 85 incidents whichfulfilled the criteria for a reportable event (NHOAnnual Report, 2000). By 2003, the number ofevents has doubled with 180 incidents fulfilling thecriteria for a haemovigilance event.

Incorrect Blood Component Transfused (IBCT)This category captured 302 of the 564 incidents andin keeping with other haemovigilance schemes thatcollect similar data, it is the largest categoryreported. It also includes errors and omissionsrelating to blood products such as anti–D and factorconcentrates as these also allow evaluation of thequality of systems in place for transfusion practice.

However suspected adverse drug reactionsassociated with use of these licensed medicinalproducts continue to be reported to the IrishMedicines Board (IMB) as the competent authorityfor licensing of medicinal products.

In 2001, in response to feedback, the IBCT incidentswere divided into levels of severity (NHO AnnualReport, 2001).

• Level 1 incidents are defined as those with thepotential for permanent injury or are lifethreatening, and include wrong blood for wrongpatient and the transfusion of bloodcomponents/products, which were not required.Level 1 incidents include all blood and bloodcomponents intended for another patient, evenif ABO and Rhesus (Rh) D compatible,inappropriate transfusions, Rh D positivecomponents administered to a Rh D negativepatient in error and anti–D immunoglobulin orfactor concentrates administered or omitted inerror. During the three-year period 2001-2003,140 (52%) of all IBCT incidents reported werestratified as level 1 incidents.

• Level 2 incidents were classified as unlikely tocause permanent harm. Between 2001- 2003, 86 (31%) of all IBCT were captured in this group.

An Overview


• Level 3 incidents pose no risk to patients butindicate defects in the quality of servicedelivered. Between 2001-2003, 45 incidents(17%) were reported.

Wrong ABO TransfusionDuring the four-year period 2000- 2003, 18 reportswere received of incorrect ABO group red cellstransfused. In 12 of these cases, the red cells wereABO incompatible. The total number of red cells andwhole blood issued for this period was 502,968.Therefore, the risk of receiving a wrong ABO red celltransfusion is about 1:27,942 units issued and ofreceiving an ABO incompatible red cell transfusion isof the order of 1:41,914 units issued. Six of the 12

patients who received an ABO incompatible red celltransfusion had symptoms of an acute transfusionreaction. However, all recovered and no fatalitieswere reported from the reaction.

11Annual Report 2003

YEAR IBCT A/A TACO DHTR TTI TRALI PAD Unusual AHOSTR TOTAL

2000 31 22 8 2 7 - - 1 14 852001 69 35 16 1 2 3 3 3 12 1442002 87 31 10 9 3 2 5 - 8 1562003 115 23 14 9 4 1 6 - 8 180TOTAL 302 111 48 21 16 6 14 4 42 564

54% 20% 8% 4% 3% 1% 2% 1% 7% 100%

Table 2 Breakdown of NHO incidents (2000-2003) (n=564)

Figure 1 Breakdown of NHO incidents (2000-2003) (n=564)

IBCT (54%)

AA (20%)

TTI (3%)

AHOSTR (7%)TRALI (1%)

TACO (8%)

PAD (2%)Unusual (1%)

DHTR (4%)

IBCT Incorrect Blood ComponentTransfused

AA Anaphylaxis/ Anaphylactoid TTI Suspected Transfusion

Transmitted InfectionAHOSTR Acute Haemolytic or other

Severe Transfusion Reaction TRALI Transfusion Related Acute Lung

InjuryTACO Transfusion Associated

Circulatory OverloadAuto Autologous Pre-deposit

transfusion reactionDHTR Delayed Haemolytic Transfusion

ReactionUnusual Unusual Transfusion Reaction

Site of First Error

Prescription and RequestIn 104 cases (34%) the error was the first stage ofthe transfusion process i.e. at prescription andrequest indicating the importance of continuingeducation for medical and nursing staff involved inprescribing and ordering blood components.

Pre transfusion samplingPre transfusion sampling has been identified as the

site of first error in 27 (9%) cases. Five of theseevents were associated with the transfusion of ABOincompatible red cells. This highlights theimportance of secure procedures for positive patientidentification and emphasises the necessity for eachpatient to wear a secure ID band at the time ofsampling. The introduction of automated solutionsi.e. sample bar-coding (Turner et al, 2003),extended/24 hours phlebotomy services, as well asthe provision of an ongoing transfusion educationprogramme are key recommendations.


Year Total Total IBCT involving IBCT involving ABO Units of red cells &IBCT incorrect ABO group incompatible red whole blood issued

red cells administered cells administered

2000 31 3 2 124,7972001 69 6 4 120,4822002 87 4 1 127,6012003 115 5 5 130,088 Total 302 18 12 502,968Number per units transfused 1:27,942 1:41,914

Table 3 Wrong ABO red cell transfusions 2000-2003

Figure 2 Site of first error 2000-2003 (n=302)

Prescription/Request(104) 34%

Laboratory(89) 30%

Administration(35) 11%

Sampling(27) 9%

Site ofCollection(21) 7%

Supply Centre(15) 5%

Initial Clerking(3) 1% Unclear

(8) 3%

Laboratory ProceduresIn 89 cases (30%), the first error occurred in thelaboratory. In many cases, the error occurred on calland often involved staff from other laboratorydisciplines covering the transfusion laboratoriesindicating the importance of regular training of oncall staff. The use of automated grouping andautomated transmission of results would helpreduce human error through transcription andreading errors.

Site of Collection In 21 cases (7%), the first error was at the site ofcollection. These resulted from absence orinadequacy of checking procedures at the time ofcollecting the component. Adequate checkingsystems must be in place at the site of collection ofblood components/products from either the hospitaltransfusion laboratory or the satellite fridge.

Bedside administrationIn 35 cases (11%), the site of first error involved thefinal bedside checking procedure with a failure toaccurately identify the patient or thecomponent/product pre transfusion. This resulted inan incorrect component/product being administered.The reasons for such errors are varied but as thefinal bedside check provides the opportunity todetect and prevent earlier errors its importance ishighlighted. The patient must be positively identifiedand an identity (ID) band must be worn at the timeof the pre-transfusion sampling and must be inplace at the time of transfusion.

The site of first error in the remaining IBCT casesinvolved incidents occurring at the initial clerkingstage or at the supply centre or were unclear.

Wrong haematology values resulting inunnecessary transfusions In 24 cases (8%), transfusion was based oninaccurate or absent haematology results orinadequacy of the checking procedure. In 17 ofthese cases, transfusion of red cells was involved.Errors in communication can be minimised by using

automated transfer of laboratory information tohospital patient identification systems. All clinicalareas should have easy access to these systems andstaff should be trained in their use so thattransfusion decisions are based on the most up-to-date and correct results.

Inappropriate transfusion Inappropriate transfusions were reported in 33(10%) cases. Eleven (4%) of these cases resulted inan unnecessary transfusion of either SD plasma orFFP. In addition, nine reactions captured within theA/A category were as a result of the inappropriateuse of plasma. Adherence to national guidelines isimportant to avoid inappropriate use of bloodcomponents and unnecessary donor exposure.

Blood product administrationForty-four of these IBCT reports related to errors inthe administration of blood products, 34 (77%) ofwhich involved the administration of anti-D. Eachhospital should have clear policies and proceduresfor the prescription and administration of anti-D andthe management of Rh D negative women duringpregnancy.

Reactions

Severe Acute Anaphylactoid or AnaphylacticTransfusion Reactions (A/A)Severe acute anaphylactoid or anaphylactictransfusion reactions were the largest category ofserious adverse reactions with 111 incidents (20%)reported. Of these 60 (55%), were associated withplatelets, the vast majority, 46 of 60 (77%),associated with the transfusion of pooled plateletconcentrates. Twenty-two cases involved the use offresh frozen plasma (FFP), six of which were forwarfarin reversal as a result of over anticoagulationnot in compliance with current guidelines (Appendix2). The number of reactions associated with plasmahas fallen consistently since the first year ofreporting. In 2003, there was only oneanaphylactoid / anaphylactic transfusion reactionassociated with the use of SD plasma. In all cases


the patients recovered from the reactions withoutcomplications. Some of these transfusions werehowever considered to be inappropriate.

Acute Haemolytic or Other Severe AcuteTransfusion Reaction (AHOSTR)There were 42 incidents (7%) reported in thiscategory. Red cells transfusion was involved in 37(88%). None showed evidence of haemolysis due tored cell incompatibility or evidence of bacterialcontamination. However, six of the 12 incidentsinvolving ABO incompatible red cell transfusions,reported in the IBCT category were accompanied bysymptoms of an acute transfusion reaction. In total,therefore, of 48 red cell transfusion reactionsreported to the NHO during this period, 6 (12.5%)were due to ABO incompatibility. This confirms theneed to fully investigate all reactions associated withthe transfusion of red cells.

Transfusion associated circulatory overload (TACO)was reported in 48 (8%) transfusions, of which 10(21%) were associated with the use of plasma. In atleast six of these 10 (60%), the transfusion wasconsidered inappropriate and in two cases may havecontributed to mortality. In light of these findings,the NHO issued an information leaflet on the use ofFFP. This leaflet outlined the firm indications for thetransfusion of FFP and highlighted the risksassociated with its use. This has since been updatedto reflect changes following the introduction ofsolvent detergent (SD) treated pooled plasma inMarch 2002 (Appendix 2).

Thirty-four (71%) TACO incidents related to thetransfusion of red cells. Thirty cases (63%) involvedpatients aged 70 years or over. There is an increasedrisk of volume overload in the elderly, with orwithout underlying cardiac, respiratory or renaldisease, highlighting the importance of carefulattention while transfusing this group of patients.Monitoring the patient’s fluid balance, transfusing asslowly as possible and observing closely for signsand symptoms of volume overload during and soonafter transfusion is recommended to minimise therisk. The use of prophylactic diuretics is alsorecommended.

Suspected Transfusion Transmitted Infection (TTI)There were 16 cases (3%) of suspected transfusiontransmitted infection (TTI) reported. Investigation ofthese reports confirmed one case of bacterialcontamination, which involved a pooled unit ofplatelets from which coagulase negativestaphylococcus was cultured from both the patientand the unit. The patient recovered withoutcomplications.

Thirteen cases of possible viral transmission wereinvestigated: five Hepatitis C virus (HCV), sixHepatitis B virus (HBV), two Humanimmunodeficiency virus (HIV) and one case of co-


Component transfused 2000 2001 2002 2003 Total

Red cells 3 9 10 12 34Pooled Platelets 1 - - - 1FFP or SD Plasma 3 6 - 1 10Multi components 1 1 1 3Total 8 16 10 14 48

Transfusion Associated Circulatory Overload (TACO)Table 4 Numbers of reports of TACO by component and reporting year

infection with both HBV and HCV. Transfusion hasbeen excluded as the source of infection in 14 ofthe 16 cases by re-testing of donors or the archivedsamples from the time of donation. In one case, onedonor could not be traced and so HBV could not beexcluded, although the patient had other riskfactors. In the outstanding case of suspected HBV,investigations are ongoing but the patient has otherrisk factors. This low incidence of confirmed TTI is inkeeping with the estimated risk of transfusiontransmitted viral infection which has been estimatedat 1 in 3.3 million units transfused for HIV, 1 in500,000 units transfused for HCV and 1 in 100,000units transfused for HBV (O’Riordan, 1999). Theseresidual risk estimates are based on serologicaltesting between 1993-1996, prior to theintroduction by IBTS of nucleic acid amplificationtesting (NAT) for HCV in November 1999, HIV inSeptember 2001 and Hepatitis B core antibodytesting in January 2002. The current risk is thereforeestimated to be considerably lower.

Delayed Haemolytic Transfusion Reaction (DHTR)There were 21 (4%) reports received which werecategorised as DHTRs during 2000-2003. There wereno fatalities. These reactions, which are largelyunavoidable, are likely to increase as our patientpopulation, particularly the elderly, receive moretransfusions. In 12 (57%) of the 21 cases, thepatients were aged over 70 years.

Transfusion Related Acute Lung Injury (TRALI)Six cases (1%) suggestive of Transfusion RelatedAcute Lung Injury (TRALI) were reported. Three casesinvolved red cells, one was associated with pooledplatelets, one with fresh frozen plasma and one caseinvolved multiple blood products. TRALI wasconfirmed in one case and considered highlyprobable in three cases, one of which wasassociated with fatality. It was considered possible inone case and unlikely in a final case.

Post-Transfusion Purpura (PTP) and Transfusion-Associated Graft-versus-Host Disease (TA-GvHD)There were no incidents reported in these categoriesduring the first four years.

Pre-deposit Autologous Donor Incident (PAD)In 2001 the NHO began to collect reports relating topre-deposit autologous donor incidents. Fourteen(2%) incidents were reported. None of the adverseevents involved hospitalisation of the patient orrescheduling of surgery. However, in a number ofcases, the donated blood was not required suggestingthe importance of careful donor selection for PAD.

Current ParticipationThe number of incidents submitted to the NHO hascontinued to rise. Because of the anonymity of thescheme, it is difficult to determine if the increase isas a result of an improved detection rate in hospitalsthat have always participated and/or a generalincrease in participation as further hospitals report tothe programme. The success of the scheme to datecan be directly attributed to the work andenthusiasm of the hospital based TSO’s, and thesupport they receive from transfusion medicalscientists and consultant haematologists. However,in order to encourage reporting and ensure therecommendations from the reports are adoptedfurther work is required.

A number of strategies are currently being examinedto improve the reporting rates, which include:

• A change to the "Nil to Report" form, whichwill allow anonymised feedback to hospitals oftheir reporting rates in comparison to hospitalswith similar transfusion requirements.


Year 2000 2001 2002 2003

Submitted incident 37% 50% 49% 58%Nil to Report 31% 27% 44% 42%Participation 68% 77% 93% 100%

Table 5 Hospital Participation (2000–2003)

• Two audits to evaluate the effectiveness of theNHO scheme have been carried out in 2004.The first audit measures the level of satisfactionamongst hospital based TSOs with the supportoffered by the NHO. The second aims to obtaina clear picture of requirements for effectivehospital-based haemovigilance. This will enablethe development of comprehensive guidelinesfor standard delivery of haemovigilance.

• NHO Steering GroupAs highlighted in the first SHOT report in 1996,transfusion is a complicated process involving amultidisciplinary team. While acknowledging theconsiderable help provided by the NationalBlood Users Group, a formal HaemovigilanceSteering Group composed of the majorstakeholders involved in transfusion is nowneeded. This strategic group could greatly assistin reviewing incident trends, promotingreporting and ensuring support at hospital levelfor practice improvement.


This section consolidates the key recommendationsfrom this year’s report. The full recommendationscan be found in the relevant chapter.

Incorrect Blood ComponentTransfused

Clinical areas

• Best transfusion practice should be an integralpart of induction training and educationprogrammes for all staff involved in prescribing,ordering and administering transfusions. Newstaff or those returning to work following acareer break or a long period of absence haveparticular training needs.

• Hospitals must have secure documentedprocedures in place and provide formal training forstaff involved in blood sampling and transfusion.

• Electronic forms of patient and bloodcomponent/product identification are now availableand are recommended as they provide the highestdegree of security. Where these systems are not inplace, manual bedside identification procedures atsampling and administration must be strictlyadhered to (NBUG, 2004).

• Positive patient identification at sampling isessential. The patient must have a secure ID bandin place at the time of pre-transfusion samplingand administration. This ID band must containthree identifiers, i.e. full name, date of birth and aunique identification number.

• In order to help reduce sampling errors extendedor 24 hour phlebotomy services arerecommended.

• In the absence of electronic forms of patient andblood component/product identification systems,two people must verify the ABO and Rh D groupidentity of the patient and unit at the bedside.Where possible, the patient must be involved.

• It is desirable where possible to transfuse onlywhen adequate staff are on duty and to avoidroutine transfusions at night wherever possible.

• Ongoing education is required to ensure correctadministration of blood components, and shouldinclude training on the use of medical devicessuch as infusion pumps.

• Hospitals need to have protocols to cover massivetransfusions (NBUG, 2002). These should includetimeframes for the provision of crossmatched,

Key Recommendations


group specific and un-crossmatched blood takinginto account the specific physical location of thelaboratory/blood fridges and clinical areas.

• There should be a designated person to checkand record units during transfusion for massivehaemorrhage to ensure traceability of all bloodcomponents and products.

• Alert stickers placed on the front of the medicalrecord to alert clinical staff of special requirementsis recommended. This is particularly importantwhen patients are being transfused in clinical areas not normally transfusinghaematology/oncology patients.

Laboratory Operations

• Hospital laboratories should have a standardoperational procedure or policy for acceptanceand or rejection of incorrectly labelled samples.This policy should cover amendments which areacceptable and those which require a furthersample to be taken.

• Formal written policies should be easily accessiblefor reference and all staff should be familiar withthese.

• Transfusion cover on call has been identified inthis report as presenting a particular problem. Thefive ABO incompatible red cell transfusionsreported this year occurred on call.

• Adequate numbers of properly trained laboratorystaff are needed to ensure the safety of transfusion.

• Medical scientists providing cross call cover fromother disciplines should have the opportunity forrotation through the transfusion laboratory.Regular training and updating should be providedin order to become familiar with current practiceand provide knowledge of appropriate productsavailable for issue. This is particularly important inthe neonatal setting.

• Difficulties may also arise from having only oneperson covering call for all laboratory areas.During emergencies a system should be in placeto contact additional staff members to assist.

• It is recommended that only emergency bloodsamples should be processed on-call

• Previous transfusion records should be available atall times and checked. The transfusion records ofpatients who may have been transfused inanother hospital should be confirmed with theoriginal hospital, wherever possible.

• It is of vital importance that an uninterruptedworking environment is maintained duringcrossmatch and issue of units to avoid distractionand or transposition.

• There should be a dedicated area in thelaboratory for labelling products. At the time aunit is issued, there shall be a final check oftransfusion service records and each unit of bloodor component (AABB, 2003). Only units for onepatient should be labelled up at any one time.Automated systems for labelling and checkingwould enhance the security of the process.

• Computer systems should be designed withaudible alarms/alerts to minimise opportunities tooverride screen warnings. Preferably any suchoverrides should require a reason or explanationas this should lead to questioning the need tooverride. An audit trail of any overrides shouldalso be kept.

• 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.

• Consideration should be given to issuing antibodycards to all patients with clinically significant


antibodies (NBUG 2002). The possibility of anational patient antibody register for patientswith red cell antibodies should also be evaluated.

• Systems are required to ensure that where care isshared between centres patients receive theappropriate blood components.

Improperly Stored or Handled Components

• Under no circumstances should any blood productor component that has been pierced or ‘spiked’with an administration set or other device bestored with the intention to re-transfuse. Theimportance of this cannot be over emphasised, asthere is a serious risk of bacterial contamination.

• It is important to ensure that the patient has apatent IV cannula and that all documentation iscorrect prior to collection of the unit.

• Documentation containing three minimum patientidentifiers must be brought to the fridge whencollecting a unit of blood in order to verify unitand patient details.

• Should an unforeseen delay in thecommencement of the transfusion occur, it isnecessary to return the unit to controlled storagewithin thirty minutes and inform the laboratory toensure the unit is being returned to theappropriate fridge.

• It is important that hospitals which accept bloodunits accompanying patients have policies in placeto determine the circumstances in which they canbe used for the patient rather than discarded.

• Systems are required which incorporate allsatellite fridges within the monitoring proceduresof the hospital blood bank. The transfusionlaboratory should collect crossmatched red cellunits from satellite fridges if they have not beenused within 24-48 hours of the time they wereoriginally requested (McClelland, 1999).

• There should be specifically designated areaswithin laboratories for blood components/productsassigned for discard, to ensure such units are notaccessible for transfusion.

Inappropriate/Unnecessary Transfusions

• All clinical staff involved in transfusion must befamiliar with guidelines for administration ofcomponents. Adherence to these guidelinesparticularly for plasma will help avoid unnecessarytransfusions.

• SD plasma or FFP is only required for the reversalof over anticoagulation in the presence of majorbleeding or emergency surgery (Appendix 2).

• Patients with iron deficiency respond quickly tospecific therapy and rarely need transfusion.

Transfusions Based on Inaccurate/AbsentHaematology Results

• Care is needed in laboratory identificationprocedures for haematology samples.

• The most recent Hb result must be checked priorto prescribing and administering a red celltransfusion. When transfusing more than oneunit, regular monitoring of post transfusion Hblevels is strongly recommended, ideally on a unit-by-unit basis.

• Where anomalous Hb results are found, a repeatHb sample should be obtained before a decisionto transfuse is made.


Improving Communication

• Ideally all requests for components should bemade in writing. Hospitals need to developprotocols for exceptions such as emergencies orremote geographical locations of laboratories.Such protocols could include a verbal requestfollowed by a confirmatory written request.

• An electronic ordering system for bloodcomponents would overcome this and should bedeveloped similar to systems already available forblood test ordering.

• It is important to provide clinical details on thetransfusion request form which would alertlaboratory personnel to any special requirementswhich may be necessary, or to previoustransfusion history.

• Systems and procedures need to be put in placeto ensure that patients with special transfusionrequirements e.g. CMV negative and/or irradiatedcellular components, receive the requiredcomponents. This is particularly the case wherecare is shared between two centers.

• Errors in communication can be minimised byusing automated transfer of laboratoryinformation to allow access to current records. All clinical areas should have easy access to thesesystems and staff should be trained in their use sothat transfusion decisions are based on the mostup-to-date and correct results.

• If results are taken over the phone, the detailsshould be clearly entered on the patient’s chartand should include details of date, time and nameof the person giving the result and signed by theperson taking the result.

Hospital Records

• Three of the incidents in 2003 involved errors as adirect result from the initial registration of the

patient at the hospital which emphasise the needfor accuracy during this procedure.

• Patients admitted must have a unique hospitalnumber assigned. Although full medical recordsmay not be available, it is necessary to haveaccess to the previous medical record number(MRN) and also have the facility to generate anew MRN on a 24-hour basis.

• The initial recording of the patients primaryidentifiers is of vital importance, as thisinformation allows access to all pertinentinformation should this patient have had aprevious admission.

• Staff admitting patients should take care toobtain details of previous admissions to ensurethat their previous MRN number and records are retrieved.

• If the patient is admitted via the A&E Departmentand given an emergency number, it must bepossible to merge this number at a later stagewith the actual unique hospital number in thecomputer system.

• All healthcare professionals must be aware of theimportance of correct patient identification andensure that details accompanying patientsrequiring transfer to another facility for furthertreatment are correct.

Anti-D immunoglobulin Incidents

• There is a need to develop a co-ordinated systemto ensure that decisions to issue and administerAnti-D are not made on assumptions but on thedocumented Rh group of the mother, herantibody status and the Rh group on the cordblood. The findings in this report illustrate thedifficulties in ensuring this happens.

• While many hospitals issue Anti-D through thelaboratory as they have access to both the mother


and/or baby’s group and antibody records and canissue the Anti-D labelled for the patient, thefindings suggest a co-ordinated approach toreview of all laboratory results is necessary toensure correct issue of product.

• Whether hospital blood banks or clinical obstetricareas take responsibility for prophylactic Anti-Dadministration, there is a need for ongoingeducation of all staff involved inprescription/administration of Anti-D prophylaxis.

• Hospitals should have a system in place to checkthe Rh D status of all deliveries in the previous 24hours to ensure that cord bloods are taken fromRh D negative mothers at the time of delivery. Ifan omission does occur, a sample can be then betaken from the baby for assessment.

• When a mother is found to be Rh D negative, analert to this fact should be placed on the medicalrecord/hospital computer to alert all staff to thenecessity of checking the Rh D group of the infant.

• As it is important to avoid errors due totranscription of results, a laboratory computergenerated alert is the safest option where theinformation system in the laboratory and hospitalare linked.

• Laboratory errors can occur during the nightwhen laboratory scientists, not normally workingin transfusion and often working alone, areproviding cross call cover. It may be prudent toprocess samples which lead to the issue of anti-Dthe following morning. However, this needs to bebalanced against the fact that patients are nowbeing discharged earlier following delivery so it isimportant that systems are in place to ensure thatthese patients are not missed (case 17).

• Systems are required to ensure easy access tocurrent laboratory results, either in written orelectronic format. Both the prescriber and theperson administering anti-D should always check

the most recent report of the patient’s Rh D andantibody screen and the Rh D status of the cordblood to assess the need for the product prior toadministration. Transcribed Rh D results must notbe accepted; the original reports must always be consulted.

• Where mothers or babies are being nursedoutside the normal clinical areas it should be theresponsibility of the referring unit to follow upthese patients and ensure that clinical staff areaware of specific requirements.

• Medical and Nursing staff working in all clinicalareas where Rh D negative women are beingtreated should be familiar with Anti-D guidelinesin order to avoid omission or delay in theadministration of Anti-D.

• Where Anti-D has not been administered withinthe 72 hour period every effort should still bemade to administer the anti-D within 9-10 days ofthe sensitising event as this may afford someprotection (BCSH,1999).

Transfusion Reactions

Serious Adverse Reactions including SevereAcute Anaphylactoid or Anaphylactic and AcuteHaemolytic and Other Severe Acute TransfusionReactions

• Protocols and training for the management ofsevere reactions should be in place in eachhospital and all staff involved in transfusionshould be familiar with their use.

• The importance of only prescribing transfusionsthat are necessary cannot be over emphasised.Inappropriate transfusions increase donorexposure unnecessarily and can put the patient atrisk of a transfusion reaction.

• Where patients are transfused in day caresettings, it is important that written post-


transfusion information is given to the patientprior to discharge explaining whom to contactand symptoms to look for, in case of a reactionfollowing discharge.

• Where patients are receiving shared care, systemsmust be in place so that all relevant detailsrelating to transfusion such as history ofreaction/allergy and/or premedicationrequirements can be communicated betweencentres effectively.

• Every patient should be carefully monitoredduring transfusion with special emphasis placedon the start of each new unit. Individual unitsshould be commenced slowly, and the patientobserved closely, for the first 15 minutes / 50mlsas severe reactions are most likely to occur withinthis time.

• Classical allergic or anaphylactoid reactions do notroutinely require culture of the unit or pack orserological investigations. However, where atypicalsymptoms such as fever are present in asuspected A/A reaction or where skinmanifestations are absent, it is important toculture the implicated unit/s and the patient torule out underlying sepsis and/or bacterialinfection in the unit and in the case of red cellsexclude red cell incompatibility.

Transfusion Associated Circulatory Overload

• All patients receiving blood components shouldbe assessed carefully but particular attentionshould be paid to at risk patients and to theidentification of such patients. At risk patientsinclude low weight patients, the elderly, infantsand children, medically compromised patientsespecially with a history of cardiac, respiratory andrenal insufficiency or chronic anaemia.

• In susceptible patients, transfusions should beadministered slowly (1ml/kg of body weight/hour)(Popovosky, 2001).

• An accurate intake and output record should bemaintained.

• The risk of overloading the circulation can beminimised by administering a prophylactic diureticin addition to maintenance diuretic therapy.

• Transfusion should be on a unit-by-unit basis,with a medical assessment of the patient prior tocommencing transfusion and before administeringany further component.

• It may be prudent to transfuse only one unit in a24-hour period in high-risk patients. Somesubjects take as long as 24 hours to readjustblood volume and the effects of the transfusionof large amounts of blood must always becarefully monitored, particularly in those patientswhose venous pressure is already raised beforetransfusion had begun (Mollison et al 1998).

Delayed Haemolytic Transfusion Reaction

• These reactions, which are largely unavoidable,are likely to increase as our patient population,particularly the elderly, receive more transfusions.A DHTR should be suspected when there is afalling Hb or jaundice some days post transfusion.

• Careful history taking in relation to transfusionand pregnancies by the requesting physician isimportant. However, up to 12% of patients donot realise that they have had a transfusion.Therefore, access to and checking of previoustransfusion records are essential.

• Use of three cell screening panels, sensitiveantibody screening techniques and satisfactoryparticipation in external quality assuranceschemes such as NEQAS, should minimise failuresto detect weak antibodies.

• As antibodies can develop rapidly, patientsrequiring repeated transfusion, depending on theinterval between transfusions should have a fresh


sample submitted within 24-72 hours of atransfusion.

• When investigating a DHTR, a serum sampleshould be used for antibody detection as someantibodies, particularly weakly complementbinding antibodies not detectable in plasmaspecimens may be detected in serum samples.

• Where there are multiple antibodies, it may notalways be possible to find fully compatible bloodand it may be necessary to issue leastincompatible blood. In these cases, specialistadvice should be sought as inordinate delays intransfusion may be detrimental to the patient andoutweigh the risks of transfusion.

Transfusion Related Acute Lung Injury

• It is important that hospital staff be made moreaware of this complication of transfusion whichoccurs within six hours of transfusion to recogniseit and treat it appropriately. This would alsofacilitate prompt investigation and case review.

• The IBTS has put in place measures to minimisethe risk from TRALI namely avoiding the use ofplasma from female donors both for suspensionof pooled platelets and as FFP. From early 2004new and lapsed female apheresis donors with ahistory of pregnancy have been deferred fromdonating.

• SD Plasma which is the standard plasma product,has not to date, been convincingly implicated in TRALI.

Pre Autologous Donation

• Pre-deposit Autologous Donation clinics musthave procedures to deal with donor reactions. All serious reactions should be documented andreported to the NHO.

• Particular attention at pre-donation assessmentshould be paid to first time donors, as these aremore likely to have reactions. Popovsky et al(1995) also identified an increased risk of adversereaction in female donors of lower weight.Attention should also be paid to psychologicalfactors such as fear of needles, which maypredispose the donor to an adverse reaction.

• It is essential that up to date criteria be used foridentifying procedures where blood is likely to beneeded. Donors should not be exposed to therisks of donation if the blood is unlikely to berequired.


Incorrect Blood Component Transfused

Definition: Incorrect blood componenttransfused (IBCT) is the transfusion of a bloodcomponent/ product which did not meetappropriate requirements and/or was intendedfor another patient (SHOT 1999).

This category accounted for 64% of incidentsreported (115 of 180).

Site of First Error

Figure 3 indicates the stage in the transfusion chainprocess where the IBCT first occurred.


Figure 3 Site of first error - IBCT Cases (n=115)

Prescription/Request(37) 32%

HospitalTransfusionLaboratory(37) 32%

Administration(11) 10%

Sampling(14) 12%

Site ofCollection(10) 9%

Supply Centre(1) 1%

Initial Clerking(3) 2%

Unclear(2) 2%

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 permanent injuryor to be life threatening.

• Level 2Events that are very unlikely to cause permanent harmor have the potential for minimal or transient harm.

• Level 3 Events with no realistic potential for harm.

See pages 10 and 11 for details of classifications.

In 2003, there were 62 cases (54%) which wereclassified as Level 1 incidents, 32 (28%) as Level 2and 21 (18%) as Level 3.

Summary of IBCT Findings andRecommendations

Tables of cases, detailed case histories and thedetailed findings and recommendations are includedin the relevant subsections. For the purpose of thisreport Anti D IBCT incidents are presented in aseparate section at the end of this chapter.

Blood components of the wrong ABO or Rhgroup, or wrong component given

Findings:

• There were 13 level one incidents where thepatient received blood of the wrong ABO groupor components not intended for that patient.

• Eleven of the incidents originated in thelaboratory and two occurred duringadministration when the units were remotelychecked from the patient.

• All recovered from the implicated transfusions andhad no long term complications, but in one case,the patient subsequently died from his underlyingcondition, two weeks later.

• Detailed findings are listed below by implicatedcomponent.

ABO incompatible red cells

• Five of these involved the transfusion of ABOincompatible red cells (Cases 28, 63, 70, 88 and118) all of which occurred in the laboratory on-call. Four of these (Cases 28, 63, 70 and 118)occurred when a medical scientist not normallyworking in blood transfusion provided cross call cover.

• Symptoms ranged from mild fever <1.50C,tachycardia, hypotension with temporary increasein bilirubin. In one patient (Case 88) who was ill,septic and hypotensive as a result of his underlyingcondition, the contribution of the incompatibletransfusion was impossible to determine.

• All five patients recovered from the transfusionbut in Case 88 the patient subsequently died twoweeks later of his underlying condition unrelatedto the transfusion.

• One case (Case 90) involved both red cells andplatelets transfused in an emergency to a postBMT transplant patient where the required groupsfor platelets and red cells were reversed in error.


ABO incompatible plasma

• Three incidents involved transfusion of ABOincompatible SD plasma. (Cases 39, 79 and 97)

Wrong blood component given to a patient

• In one case (Case 23), a compatibility label wasput on an uncrossmatched, but fortunatelycompatible, red cell unit.

• Three incidents (Cases 15, 49 and 101) involvedplatelet transfusions which were assigned for acertain patient being transfused to a differentpatient, two of which originated in the laboratoryon call. One occurred at administration when theunits were remotely checked from the patient.

Recommendations:

• An adequate number of appropriately trainedlaboratory staff are needed to ensure the safety of transfusion.

• Transfusion cover on-call has been identified inthis report as presenting a particular problem. The five ABO incompatible red cell transfusionsoccurred during the on-call period.

• The issue of cross call cover where medicalscientists from another discipline cover call intransfusion presents difficulties. These scientistsshould have the opportunity for rotation throughthe transfusion laboratory and regular updating to ensure familiarity with current practice tomaintain the requisite level of expertise.

• Difficulties may also arise from having only oneperson covering call for all laboratory areas.During emergencies a system should be in placeto contact additional staff members to assist.

• Formal written policies should be easily accessiblefor reference and all staff should be familiar withthese.

• An uninterrupted working environment must bemaintained during crossmatch and issue of units,to avoid distraction and/or transposition.

• Wherever possible only the units from onecrossmatch should be issued at any given time toavoid errors.

• The importance of the bedside checkingprocedure is again highlighted.

Failure to give antigen negative blood (n=8)

• There were 8 cases where patients had a previoushistory of antibodies or exposure to productsgiving rise to a risk of a delayed haemalytictransfusion reaction.

Recommendations

• The correct recording of the patient’s primaryidentifiers at admission is of vital importance.This information allows access to all previousrecords should this patient have had a previousadmission.

• The importance of filling in the patient’s clinicaland past transfusion history on the request formis highlighted as it enables the medical scientist tocheck previous transfusions which may haveoccurred and ensure that the correct product isbeing issued.

• Historical transfusion records, manual andcomputer, should be checked for all patientsrequiring transfusion.


• Antibody investigations for patients who mayrequire blood in an emergency should becompleted as soon as possible after receipt.Where this is not possible, the computer ormanual records should clearly document this. Incases of clinical emergency, it may be necessary toissue blood to these patients before investigationsare completed but computer alerts to incompleteantibody investigations should be difficult tooverride inadvertently.

• Hospital transfusion laboratories need to beinformed when patients are transferred betweenhospitals. This will enable them to contact thereferring hospital and confirm transfusion history.This information should also be included in thewritten communication accompanying the patientfrom the clinical team where possible.

• Consideration should be given to issuing antibodycards to all patients with clinically significantantibodies (NBUG 2002).

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

Errors surrounding collection, storage orimproper handling of products. (n=10)

Findings

• Three incidents concerned units of red cells leftout of the fridge in excess of the recommendedtime, then returned to the fridge and latertransfused.

• Two cases demonstrate the dangerous practice ofre-transfusing already pierced or ‘spiked’ units.The risk of bacterial contamination of these unitscannot be over-emphasised.

• One case (Case 53) involved a unit that had beendiscontinued because of a suspected transfusionreaction, stored in the wrong fridge while

awaiting investigation, collected and re-transfusedto the same patient, 24 hours later.

• The second (Case 32), where the pierced unit wasstored for 15 hours before transfusion, highlightsthe importance of ensuring that the patient haspatent venous access and that all documentationis correct prior to collection of the unit.

• A third (Case 73), highlights the importance ofensuring that all staff handling blood are aware ofstorage requirements.

• Two of the incidents were discovered duringinvestigation of febrile transfusion reactions.

• None of the patients suffered any adverse effects.

Recommendations

• Under no circumstances should any blood productor component that has been pierced or ‘spiked’with an administration set or other device bestored with the intention to re-transfuse. Theimportance of this cannot be over emphasised asthere is a serious risk of bacterial contamination.

• Should an unforeseen delay in starting thetransfusion occur, the unit must be returned tocontrolled storage within thirty minutes and thelaboratory informed to ensure the unit is returnedto the appropriate fridge.

• Documentation of patient details containing threeunique identifiers must be brought to the fridgewhen collecting blood or blood components.

• Inspection of the unit and documentation at thetime of collection may identify abnormalities ineither the unit or labelling.

• Systems are required which incorporate allsatellite fridges within the monitoring proceduresof the hospital blood bank. The transfusionlaboratory should collect crossmatched red cell


units from satellite fridges if they have not beenused within 24 to 48 hours of the time they wereoriginally requested (Mc Clelland, 2001).

• Computerised systems of blood storagemonitoring which prevent errors of collection arerecommended.

• It is important that hospitals that accept bloodunits accompanying patients have policies in placeto determine the circumstances in which they canbe used for the patient rather than discarded.

Transfusions based on incorrect or absenthaematology results (n=7)

There were seven reported cases, six involving redcells and one involving plasma, where thetransfusion was based on inaccurate or oldhaematology results.

Findings:

• In three cases transfusions were prescribed orcontinued based on old Hb results, althoughcurrent Hb results were available but not checked.

• Three cases involved incorrect Hb results. In onecase the sample was transposed in thehaematology laboratory. In a second case, anormal result was misread and in the final case, ithas not been possible to determine the reason.

• One of these cases resulted in the patient, anelderly female, receiving four units of blood,when the Hb level was actually 13g/dl.

• One case involved apparently abnormalcoagulation results. The sample was taken from anarterial line and the abnormal result was shownsubsequently to be due to heparin in the sample.This led to unnecessary plasma transfusions.

Recommendations:

• A current Hb result should be checked prior toprescribing and administering a transfusion.

• When Hb samples are taken between units asrecommended, it is important to check the resultprior to further transfusion.

• Medical and nursing staff must be educated incorrect blood sampling techniques.


• Where anomalous Hb results are found, a repeatHb sample should be obtained before a decisionto transfuse is made.

Failure to supply special requirements in CMVnegative and/or irradiated components (n=12)

Findings

There were 12 cases reported in this category.

• Eight cases occurred due to prescription and/orrequest errors where special requirements werenot stated or the clinical history, which wouldhave raised the laboratory’s awareness to therequirement, was omitted.

• None of the cases resulted in complications forthe patient.


Recommendations

• The number of cases reported in this categoryemphasises the need for ongoing education andtraining of staff involved in prescribing, orderingand administering transfusions. The significanceand importance of the bedside checkingprocedure cannot be over-emphasised.

• As eight of the twelve incidents are associatedwith failure to prescribe the correct products,systems need to be put in place within hospitalsto ensure that the requirements of such patientsare highlighted which include:

• Education of prescribing doctors to highlight theimportance of accurate completion of prescriptionand clinical details on request forms.

• Alert stickers placed on the front of the medicalrecord to alert clinical staff of the specialrequirements. This is particularly important whenpatients are being transfused outside clinical areasnormally transfusing haematology/oncologypatients.

• Systems need to be put in place to ensure thatwhere care is shared between centres, patientsreceive the correct products.

• On going education should be provided formedical scientists who are involved in cross callcover and do not normally work in transfusion tohighlight special requirements for certain patients.

• Once again a failure to heed computer warnings(Case 3) has highlighted the fact that asrecommended in the NHO Annual Reports 2001and 2002, computer systems should be designedwith audible alarms/alerts to minimise opportunitiesto override screen warnings. Preferably any suchoverrides should require a reason or explanation, asthis should question the need to override. An audittrail of any overrides should also be kept.

• In high risk areas such as busy haematology units,a blanket policy of the use of irradiated productfor all patients with suspected malignanthaematological disorders may be advisable.

IBCT transfused not using a filter or infusiondevice (n=5)

Findings

• Two incidents involved the administration of redcells and one case involved the administration ofSD plasma. All were transfused without using ablood administration set with an integral 160-220micron filter.

• In addition, one of the cases highlighted the needto ensure accurate recording of unit numberstransfused in emergency situations.

• Two cases involved the use of an electronicinfusion device.

Recommendations

• Ongoing education is required to ensure correctadministration of blood components.

• This should include training on the use of medicaldevices such as infusion pumps.

• There should be a dedicated person to check andrecord transfusions during massive haemorrhageto ensure traceability of all blood componentsand products.

Incorrect details recorded during initialadmission (n=5)

Findings

• Of the five cases reported in this section, tworesulted from a failure to check whether thepatient had been previously admitted to thehospital and a new MRN was assigned. Previoustransfusion records were then unavailable.


• One case involved a patient with two MRNs asthis hospital allows allocation of more than oneMRN per patient when the admission occurs outof hours. These numbers are never merged withinthe system.

• One case illustrates how poor and unclearcommunication resulted in a patient beinghospitalised and treated using a different patient’s record.

• None of the incidents were associated withcomplications.

Recommendations

• Patients admitted must have a unique hospitalnumber assigned, either their previous MRNnumber or a new number, if the patient has nohistory at this hospital.

• Staff admitting patients should take care toobtain details of previous admissions to ensurethat their previous MRN number and records areretrieved.

• If the patient is admitted via the A&E Departmentand given an emergency number, it must bepossible to merge this number at a later stagewith the actual unique hospital number in thecomputer system.


Incorrect details on samples (N=7)

• Hospital laboratories should have SOPs or Policiesfor 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 order to reduce sampling errors extended or 24hours phlebotomy services are recommended.

• It is important that existing policies are fullyunderstood and regularly updated. On-goingeducation must highlight to all medical, nursingand laboratory staff, especially those not regularlyworking in transfusion, the importance of strictcompliance.

• In an emergency where there is insufficient timeto obtain results from a fresh sample, the policyshould include the use of emergency O negativeblood until the patient has been regrouped.

• Automated barcode systems which printtransfusion labels at bedside from the patient’swristband, are available and would prevent theerrors described.

• The linkage of the laboratory computer systemand the hospital PAS system would also helpdetect these errors.

Incorrect/missing details on ID wristband (N=7)

• The importance of positive patient Identificationusing an accurate ID wristband has beenhighlighted over several years through both theNHO and SHOT Reports (NHO & SHOT).

• A secure patient identification procedure shouldbe in place in all hospitals. The ID wristbandshould be worn at the time of taking of thecrossmatch sample and should be in place beforetransfusion. This ID wristband should containthree unique identifiers, which include thepatient’s full name, date of birth and uniqueidentification number (NBUG 2004).

• The importance of asking the patient to identifythemselves prior to sampling and administrationin order to identify any discrepancies is againhighlighted.


• 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 must be strictly adhered to (BCSH 1999).

Unit labelling errors (n=9)

• Nine cases reported involved errors in labellingunits in the laboratory for transfusions.

• Electronic systems in the laboratory and at thebedside that reduce errors are recommended.

• As nurses are the last line of defence in providingsafe effective care for their patient, the finalbedside check provides an opportunity to detectand prevent preceding errors.



TAB

LE 6

WR

ON

G U

NIT

S TR

AN

SFU

SED

(N

=14

)

Leve

lC

ase

AB

O a

nd

AB

O a

nd

Rh

Vo

lum

e o

f In

corr

ect

Sym

pto

ms/

Sig

ns

Ou

tco

me

Cau

se o

f Er

ror

Nu

mb

erR

h D

Gro

up

D

Gro

up

of

Blo

od

Co

mp

on

ent

of

Pati

ent

IBC

T

1 1 1 1 1 1

IBC

T C

ase

28* IB

CT

Cas

e 63

* IBC

T C

ase

70* IB

CT

Cas

e 88

* IBC

T C

ase

118

* IBC

T C

ase

90*

Gro

up O

Rh

D p

ositi

ve

Gro

up O

Rh

D P

ositi

ve

Gro

up O

Rh

D p

ositi

ve

Gro

up B

Rh

D p

ositi

ve

Gro

up A

Rh

D p

ositi

ve

Gro

up A

Rh

D p

ositi

ve

Gro

up A

Rh

Dpo

sitiv

e

Gro

up A

Rh

DPo

sitiv

e

Gro

up B

Rh

D

posi

tive

Gro

up A

Rh

Dpo

sitiv

e

Gro

up A

BRh

D p

ositi

ve

Gro

up A

Rh

Dpo

sitiv

e an

dG

roup

O R

h D

posi

tive

Two

units

of

red

cells

Six

units

of

red

cells

Two

units

of

red

cells

200m

ls o

f re

d ce

lls

Two

units

of

red

cells

Eigh

t un

its o

f A

pos

itive

red

cells

and

tw

o un

its O

posi

tive

plat

elet

s

Mild

fev

er,

tach

ycar

dia

mild

hyp

oten

sion

.

Tem

pora

ry in

crea

se in

the

seru

m b

iliru

bin.

No

sym

ptom

s of

acu

teha

emol

ysis

. A

rai

sed

seru

m b

iliru

bin

was

note

d th

ree

days

pos

ttr

ansf

usio

n as

soci

ated

with

a f

allin

g H

b on

day

five.

Patie

nt h

ad b

een

adm

itted

with

sep

ticsh

ock,

ele

ctro

lyte

imba

lanc

e an

dco

agul

opat

hy.

Non

e

Non

e

Requ

ired

furt

her

tran

sfus

ion

but

reco

vere

d w

ith n

oco

mpl

icat

ions

.

Reco

vere

d w

ith n

oco

mpl

icat

ions

.

Requ

ired

furt

her

tran

sfus

ion

but

reco

vere

d w

ith n

oco

mpl

icat

ions

.

No

evid

ence

of

haem

olys

ispo

st t

rans

fusi

on.

Die

d tw

ow

eeks

late

r as

a r

esul

t of

the

unde

rlyin

g se

ptic

aem

iafo

llow

ing

two

furt

her

surg

ical

inte

rven

tions

.

Post

tra

nsfu

sion

DA

T po

sitiv

ebu

t th

e pa

tient

had

no

com

plic

atio

ns a

s a

resu

lt of

this

tra

nsfu

sion

.

No

com

plic

atio

ns a

s a

resu

ltof

thi

s tr

ansf

usio

n.

Two

sam

ples

wer

e pr

oces

sed

sim

ulta

neou

sly

lead

ing

to a

tra

nspo

sitio

n er

ror

and

this

ABO

inco

mpa

tible

tra

nsfu

sion

.

Labe

lling

err

or o

f th

e pa

tient

sam

ple

in t

hela

bora

tory

res

ulte

d in

the

pat

ient

bei

ngtr

ansf

used

with

six

uni

ts o

f A

BOin

com

patib

le r

ed c

ells

.

A la

pse

of c

once

ntra

tion

durin

g th

egr

oupi

ng p

roce

dure

led

to t

he r

ecor

ding

of

this

pat

ient

as

AB

Rh D

pos

itive

inst

ead

ofgr

oup

O R

h D

pos

itive

.

Failu

re t

o id

entif

y co

rrec

t pa

tient

sam

ple

for

test

ing

resu

lted

in a

n A

BO in

com

patib

letr

ansf

usio

n.

Inco

rrec

t gr

oup

resu

lt in

terp

reta

tion

com

plic

ated

by

the

abse

nce

in r

ever

segr

oup

of a

nti B

isoa

glut

inin

due

to

patie

nt’s

unde

rlyin

g co

nditi

on.

The

patie

nt w

as p

ost

BMT;

the

don

or g

roup

was

O R

h D

pos

itive

. H

ospi

tal p

olic

y st

ated

the

patie

nt r

equi

red

tran

sfus

ion

with

gro

upO

Rh

D p

ositi

ve r

ed c

ells

and

gro

up A

Rh

Dpo

sitiv

e pl

atel

ets.

D

urin

g an

em

erge

ncy

tran

sfus

ion

the

polic

y w

as m

isin

terp

rete

d.

* In

clu

ded

as

full

case

his

tory


TAB

LE 6

(C

ON

TIN

UED

) W

RO

NG

UN

ITS

TRA

NSF

USE

D (

N=

14)

Leve

lC

ase

AB

O a

nd

AB

O a

nd

Rh

Vo

lum

e o

f In

corr

ect

Sym

pto

ms/

Sig

ns

Ou

tco

me

Cau

se o

f Er

ror

Nu

mb

erR

h D

Gro

up

D

Gro

up

of

Blo

od

Co

mp

on

ent

of

Pati

ent

IBC

T

1 1 1 1 1 1

IBC

T C

ase

39* IB

CT

Cas

e 79

* IBC

T C

ase

97* IB

CT

Cas

e 49

* IBC

T C

ase

101

* IBC

T C

ase

15*

Gro

up A

Rh

D n

egat

ive

Gro

up B

Rh

D p

ositi

ve

Gro

up O

Rh

D p

ositi

ve

Gro

up A

Rh

D p

ositi

ve

Gro

up O

Rh

D p

ositi

ve

Gro

up O

Rh

D p

ositi

ve

Gro

up O

SD

Plas

ma

Gro

up A

SD

Plas

ma

Gro

up B

SD

Plas

ma

Gro

up A

Rh

Dpo

sitiv

e

Gro

up O

Rh

Dpo

sitiv

e

Gro

up O

Rh

D p

ositi

ve

Four

uni

ts o

f SD

pla

sma

One

and

a h

alf

units

of

SD

pla

sma.

One

uni

t of

SD

pla

sma

< 5

0mls

poo

led

plat

elet

conc

entr

ate

One

uni

t of

ap

here

sis

plat

elet

s

Two

units

of

pool

edpl

atel

et c

once

ntra

te

Non

e

Non

e

Non

e

Non

e

Non

e

Non

e

No

com

plic

atio

ns a

s a

resu

ltof

thi

s tr

ansf

usio

n.

No

com

plic

atio

ns a

s a

resu

ltof

thi

s tr

ansf

usio

n.

No

com

plic

atio

ns a

s a

resu

ltof

thi

s tr

ansf

usio

n.

No

com

plic

atio

ns a

s a

resu

ltof

thi

s tr

ansf

usio

n.

No

com

plic

atio

ns a

s a

resu

ltof

thi

s tr

ansf

usio

n.

No

com

plic

atio

ns a

s a

resu

ltof

thi

s tr

ansf

usio

n.

Inco

rrec

t bl

ood

grou

p re

sult

obta

ined

.Te

stin

g no

t pe

rfor

med

in a

ccor

danc

e w

ithla

bora

tory

pol

icy.

Two

inco

rrec

t SD

pla

sma

units

tha

wed

and

assi

gned

to

patie

nt o

f a

diff

eren

t bl

ood

grou

p in

labo

rato

ry.

One

uni

t of

SD

pla

sma

was

che

cked

at

the

nurs

e’s

stat

ion

and

hung

for

the

wro

ngpa

tient

who

was

sha

ring

the

sam

e ro

om a

sth

e in

tend

ed p

atie

nt.

Very

bus

y w

orkl

oad,

tw

o pa

tient

s re

ceiv

ing

plat

elet

tra

nsfu

sion

s at

the

sam

e tim

e.U

nits

tra

nspo

sed

in w

ard.

Two

patie

nts

with

the

sam

e na

me

in t

hew

ard.

Pl

atel

ets

orde

red

by p

hone

fro

m t

hew

ard,

no

MRN

req

uest

ed o

r gi

ven.

Pl

atel

ets

wer

e is

sued

for

the

wro

ng p

atie

nt.

The

patie

nt h

ad n

o w

ristb

and

due

to a

fau

ltypr

inte

r. T

wo

qual

ified

sta

ff c

arrie

d ou

t th

ebe

dsid

e ch

eck

rem

ote

from

the

pat

ient

.

One

of

the

units

of

plat

elet

s tr

ansf

used

was

actu

ally

for

a d

iffer

ent

patie

nt a

ndin

corr

ectly

labe

lled

in t

he la

bora

tory

.

* In

clu

ded

as

full

case

his

tory


TAB

LE 6

(C

ON

TIN

UED

) W

RO

NG

UN

ITS

TRA

NSF

USE

D (

N=

14)

Leve

lC

ase

AB

O a

nd

AB

O a

nd

Rh

Vo

lum

e o

f In

corr

ect

Sym

pto

ms/

Sig

ns

Ou

tco

me

Cau

se o

f Er

ror

Nu

mb

erR

h D

Gro

up

D

Gro

up

of

Blo

od

Co

mp

on

ent

of

Pati

ent

IBC

T

1 2

IBC

T C

ase

23* IB

CT

Cas

e 18

*

Gro

up O

Rh

D p

ositi

ve

Gro

up O

Rh

D n

egat

ive

post

BM

T

Gro

up O

Rh

D p

ositi

ve

Gro

up O

Rh

Dpo

sitiv

e

One

uni

t of

red

cel

ls

Two

units

red

cel

ls a

ndpo

oled

pla

tele

ts

Non

e

Non

e-

No

com

plic

atio

ns a

s a

resu

ltof

thi

s tr

ansf

usio

n.

No

com

plic

atio

ns a

s a

resu

ltof

thi

s tr

ansf

usio

n.

Labe

l for

cro

ssm

atch

ed u

nit

atta

ched

iner

ror

to a

n un

cros

smat

ched

, bu

t gr

oup

com

patib

le u

nit.

U

nit

then

issu

ed a

ndtr

ansf

used

une

vent

fully

.

Failu

re t

o re

cord

his

tory

of

BMT

on t

hetr

ansf

usio

n re

ques

t fo

rm le

d to

the

tran

sfus

ion

labo

rato

ry is

suin

g Rh

D p

ositi

vere

d ce

lls t

o a

Rh D

neg

ativ

e m

ale

patie

nt.

* In

clu

ded

as

full

case

his

tory

Blood components of the wrong ABO or Rhgroup or wrong component given. (n=14)

We describe all the cases in detail.

ABO incompatible red cells

Level 1 IBCT Case 28This 50-year-old female with symptomaticpostoperative anaemia Hb 5.9g/dl required anemergency transfusion of two units of red cells. The patient had been grouped before. A medicalscientist not normally working in the transfusionlaboratory processed the sample on call. Two pre-transfusion samples from different patients wereprocessed simultaneously. The scientist failed to carryout the necessary checking procedures which led toa transposition of the two samples. The patient wasgrouped as A Rh D positive. The historical groupingrecord was not checked against the current result.The patient’s correct group, group O RhD positive,was documented on the transfusion request formbut was also missed. Two units of group A Rh Dpositive red cells were crossmatched, issued andtransfused to this patient. The second patient’ssample was for type and screen and no blood wasactually crossmatched. During transfusion, symptomsof tachycardia and mild hypotension were recorded,but attributed to the underlying condition. There wasalso a low-grade fever. The error was discovered thenext working day by laboratory staff when routinelyrechecking all on-call work. Retrospective testing ofthe pre-transfusion sample and historical recordsconfirmed the patient was in fact group O Rh Dpositive. The patient recovered from this incident butrequired two further units of red cells Hb 7.3g/dl.This second transfusion episode was uneventful.

Level 1 IBCT Case 63This patient presented with a symptomatic anaemiaHb 5g/dl following several episodes of melaena andrequired a transfusion of six units of red cells. Thepatient had no previous transfusion records. A basicgrade medical scientist, not normally working intransfusion, was doing the crossmatch on-call.

Simultaneously two other urgent specimens were alsobeing processed. When the scientist placed thesample test tube with a unique numbered sticker inthe centrifuge he was unaware that anotherspecimen had been left there from a previouscrossmatch. During the crossmatch procedure,repeated calls were received from the A&Edepartment for an urgent crossmatch for a differentpatient. When the scientist returned to the centrifugeto remove the specimen tube, the incorrect one wasinadvertently removed and labelled with this patient’sdetails. Following further interruptions, the scientist,realising the initial error, began the process with afresh specimen but as the other specimen was still inthe centrifuge the mistake was repeated and theincorrect specimen tube was again labelled withdetails from this patient. The patient’s blood groupwas recorded as group A Rh D positive. The patientsubsequently received the six units of group A Rh Dpositive blood within a 72-hour period. While heexperienced a slight rise in temperature during thefirst and second unit, it never rose above 1.50C andwas ascribed to an underlying chest infection and notthe transfusion. The error was discovered five dayslater when the patient was regrouped as O Rh Dpositive. The patient suffered no adverse effects as aresult of this transfusion apart from a temporaryincrease in bilirubin.

Level 1 IBCT Case 70This elderly female patient required transfusion oftwo units of red cells for a symptomatic anaemia ofchronic disease Hb 8.5g/dl. The pre-transfusionsample was processed over the weekend when onlya limited service is provided. The medical scientistwho did not normally work in transfusion wasdistracted by problems in another laboratory. Theblood group result was recorded incorrectly as groupAB Rh D positive as the grouping card in reverse inerror. The actual result was group O Rh D positive.The patient had been grouped at this hospitalpreviously but as the laboratory had only recentlybeen computerised, the historical grouping recordwas available on a manual system only and thecurrent group was not checked against the manual


historical records. The crossmatch, performedaccording to laboratory policy, was incompatible.However the medical scientist was simultaneouslyworking on another sample and failed to read thiscrossmatch result. Three units of group B Rh Dpositive red cells were labelled and issued (B Rh Dpositive red cells would have been appropriate for agroup AB patient). Two of the three units weretransfused over the weekend uneventfully.Laboratory staff discovered the error during routinechecking of all on-call work on the next workingday. There were no symptoms of acute intravascularhaemolysis but a transient rise in the serum bilirubinwas noted three days post transfusion. This wasassociated with a falling haemoglobin five daysfollowing transfusion and further transfusion wasrequired which was uneventful.

Level 1 IBCT Case 88This patient required an emergency transfusion oftwo units of red cells following major abdominalsurgery. The patient was extremely ill and septic onadmission. A medical scientist regularly working inblood transfusion did the crossmatch on-call. Thepatient grouped as A Rh D positive. Two units ofgroup specific crossmatched red cells were issued tothe ICU. Because of the patient’s deterioratingcondition, a decision was made to transfuse bothunits simultaneously. In the laboratory, the medicalscientist on-call was double-checking the resultsfrom call when the error was discovered. Followingshift changeover, the on-call medical scientist hadthought that there was only one specimen and onerequest form for processing. However, the previousmedical laboratory scientist had left another non-urgent specimen from a different patient on thebench, without a crossmatch form. This incorrectspecimen with the request form for the correctpatient was used in the crossmatch for this patient.Ward staff were immediately alerted and thetransfusion was discontinued. The patient regroupedas group B RhD positive. At this stage a combined200mls approximately of both units had beentransfused. Pre-transfusion the patient had anelectrolyte imbalance, coagulopathy and required

inotrophic support for hypotension. Laboratoryinvestigations did not show evidence of haemolysis.The patient required two further surgical proceduresas a result of his underlying condition andsubsequently died two weeks later following astormy post-operative period.

Level 1 IBCT Case 118 This patient with anaemia Hb 7.4g/dl and associatedimmunodeficiency required a transfusion of twounits of red cells. This was a non-emergencytransfusion, administered over a weekend periodand a medical scientist on-call, not normally workingin transfusion did the cross match. The patient’sblood grouped as AB RhD positive and two units ofgroup AB crossmatched blood were issued andtransfused to the patient without complications.Repeat testing of the pre-transfusion sample usingcolumn technology during routine check of on callwork showed the patient’s blood group was in factA RhD positive, but the patient sample lacked theanti B isoaglutinin. Post transfusion the antibodyscreen was negative and the DAT was positive in IgGbut the eluate was non reactive. The patientsuffered no complications. As a result of thisincident, column technology, which is felt to be lessprone to reading errors, will be introduced for allgrouping done on-call out of hours.

Level 1 IBCT Case 90This patient with a malignant haematologicaldisorder post Bone Marrow Transplant (BMT)required an emergency transfusion of eight units ofCMV negative and irradiated red cells and two unitsof CMV negative and irradiated platelets forbleeding. The BMT donor was O Rh D positive andthe patient was A Rh D positive. A specific policyoutlining requirements was entered on thelaboratory computer which advised that the patientshould receive group O Rh D positive red cells andgroup A Rh D positive platelets in the event oftransfusion. During this emergency transfusion, thepolicy was misinterpreted and eight units of group ARh D positive red cells and two units of group O RhD positive platelets were inadvertently issued. These


units were then transfused to the patient. Therewere no complications as the patient had notdeveloped anti A isoagglutinins. As a result of thisincident all laboratory staff have been reminded ofthe importance of ensuringing special requirementsare correctly interpreted.

Cases involving the transfusion of plasma

Level 1 IBCT Case 39This 55- year old male with a history ofhepatomegaly, hepatic congestion, underlyingmetastatic deposits and cardiomegaly suffered anepistaxis with bleeding uncontrolled by Vitamin K.The pre-transfusion INR was >10 and four units ofSD plasma were prescribed. A permanent memberof transfusion laboratory staff performed groupingon call. The medical scientist read the groupcorrectly as group A Rh D negative, but the resultwas recorded incorrectly as group O Rh D negative.Four units of group O SD plasma were issued andtransfused. During routine checking of on-call workthe following day, the error was discovered and thespecimen was grouped as A Rh D negative. Thepatient did not suffer any complications.

Level 1 IBCT Case 79This elderly patient required an emergencytransfusion for a massive haematemesis. There wasno previous transfusion history. The patient’s groupwas recorded as B Rh D positive and the patient wasissued with group B red cells. In addition two unitsof SD plasma were prescribed. A tray containinggroup A SD plasma was removed from the freezerand a laboratory medical scientist on-call who didnot regularly work in blood transfusion, thawed twogroup A units in error. The laboratory computer doesnot have the facility to print the patient’s group ontothe plasma issue labels or issue vouchers but thepatient’s blood group was documented on thelaboratory reference section of the transfusionrequest form. The error was not identified at thetime of administration as the group was not printedon the issue voucher and there was no previoustransfusion history in the medical record. The patient

had received one and a half units of incorrectlygrouped SD plasma when the laboratory staffrealised the mistake and communicated this to theward. The transfusion was discontinued. The patientexperienced no complications related to thistransfusion. As a result of this incident, proposedchanges to the laboratory computer system are inplace to print the patient’s group onto the issuelabels and issue vouchers of plasma.

Level 1 IBCT Case 97This group O Rh D positive male patient, with anunderlying malignancy received a transfusion of oneunit of group B SD plasma, which was intended foranother patient. Four units of SD plasma had beenordered as an emergency transfusion for the intendedpatient. The ward was extremely busy that night andthe transfusion took place at 02.00am. The first unitwas checked by two nurses at the nurse’s station andtaken to the room shared by two patients. The unitwas administered by a nurse covering a differentsection of the ward and did not include positivepatient identification at the bedside. The error wasnoticed during the checking procedure for the secondunit which was carried out at the bedside andincluded the patient in the process as per hospitalpolicy. The patient was reviewed immediately andrequired no treatment. The patient for whom theplasma was intended was then transfused with theremaining three units from this issue.

Incidents involving the transfusion of platelets

Level 1 IBCT Case 15This O Rh D negative patient required a transfusionof one unit of platelets for postoperative bleedingfor drug induced platelet dysfunction. Anotherpatient, group O Rh D positive, also required a preoperative transfusion of platelets. The two units ofplatelets were issued from the supply centre to thehospital laboratory. It was not noted on the deliverydocket that the units were for two differentpatients. Both units were labelled and issued duringnormal working hours by a transfusion medicalscientist for the one patient. The first unit of


platelets was transfused intra-operatively in theatreuneventfully. The nurses taking care of the patientwere assured by a nurse in theatre that the plateletshad been prescribed and all checking procedureshad been carried out and were correct and thesecond unit was commenced. The laboratory notedthe discrepancy during a review of routine work andcontacted ICU where transfusion of the second unitwas underway. The surgical team, when contacted,advised continuing the transfusion as the patientwas bleeding post operatively. The patient sufferedno complications as a result of this transfusion.There was delay supplying a further unit of plateletsfor the patient for whom they had been intended.

Level 1 IBCT Case 49This young male patient (patient X) requiredtransfusion for thrombocytopenia secondary to amalignant haematological disorder. A second patienton the same ward, patient Y, required a platelettransfusion and both units were delivered to theclinical area in the early evening. Two nurses tookboth units on two different trays with accompanyingdocumentation and checked the unit for patient Xoutside his room on the corridor. During thechecking procedure, they were interrupted and thestaff nurse, who was to commence the transfusion,was called away. On her return, she picked up thetray with platelets labelled in patient Y on it andwent alone to the bedside of patient X andcommenced the transfusion without any formalidentification of the patient. She then proceeded tocheck the second unit for transfusion to patient Ywith a second nurse. During this procedure the errorwas identified and the transfusion was discontinued.Less than 50mls of incorrect platelets had beentransfused. There were no complications to thistransfusion as the incorrect platelets were ABO andRh D compatible and both units of platelets werealso CMV negative and irradiated. This staff nursewas the only nurse on her team that day certifiedcompetent to administer drugs, fluids or blood via aHickman line. However, three nurses competent toaccess a Hickman line were on another team in thesame ward but were not asked for assistance.

Level 1 IBCT Case 101This young man with a malignant haematologicaldisorder required a non-emergency transfusion ofCMV negative and irradiated platelets. The requestwas telephoned to the laboratory. The MRN was notchecked at the time of the request. There were twopatients with the same name in the ward both ofthe same blood group and same specialrequirements and a unit for the wrong patient wasissued. The pre-transfusion check took place remotefrom the patient. The date of birth and the MRN didnot match but the error was not detected. Thepatient was not wearing a wristband, as thewristband printer was out of order but the patientshould have been given a handwritten wristband.The patient suffered no complications as a result ofthis transfusion. The laboratory staff realised theerror on the next issue of platelets for this patient.

Uncrossmatched Unit Red Cell Issued

Level 1 IBCT Case 23This baby required a non-emergency transfusion ofone unit of red cells for symptomatic anaemiasecondary to sepsis Hb 6.2 g/dl. A laboratoryscientist not normally working in transfusionprocessed the sample during on-call hours. One unitof group compatible red cells was issued. Howeverthe issue label was inadvertently attached to anuncrossmatched group compatible unit, which wasthen placed in the issue fridge for transfusion. Thediscrepancy between the issue label and thedonation information on the front of the pack wasnot identified at time of collection, nor during thepre-transfusion checking procedure and thetransfusion proceeded uneventfully. Laboratory staffdiscovered the error when checking stocks thefollowing day. Retrospective cross-matching of thepre-transfusion sample and transfused unit wasperformed and the unit was confirmed to becompatible. There were no complications to thisincorrect transfusion.


Rhesus incompatible units transfused

Level 2 IBCT Case 18 This male patient received one unit of pooled CMVnegative irradiated platelet concentrate forthrombocytopenia associated with a malignanthaematological disorder. The patient details on thetransfusion request form did not include the factthat the patient had had a BMT two monthspreviously at another centre. The patient had beentransfused one year earlier at this hospital and hadgrouped as group O Rh D positive on that occasion.On this occasion, he again grouped as O Rh Dpositive. One unit of group O Rh D positive plateletswere issued and transfused uneventfully. Twelvedays later there was a request for two units of redcells for anaemia –Hb 8.1 g/dl. Again there was noreference to the BMT on the transfusion requestform. He grouped as O Rh D positive and two unitsof crossmatch compatible red cells were issued andtransfused uneventfully. Three weeks later a samplesent to the laboratory showed a "mixed fieldreaction" on Rh grouping. It was then discoveredthat this patient had received a BMT two monthspreviously and the donor had been group O Rh Dnegative. The BMT recipient should be transfusedwith the bone marrow donor’s Rh group posttransplant. The patient did not suffer anycomplications.

Failure to give antigen negative red cells (n=8)

Seven cases were reported where antigen negativeblood should have been provided as the patient hadcurrent or previously detected antibodies. Anadditional case involved the continued use of Rhpositive blood in a Rh negative patient after theinitial exposure due to a communication failure.

In four cases the antibodies were anti-E (one ofwhich only reacted in enzyme and therefore was ofdoubtful clinical significance only). In the remainingfour cases, the antibodies were an anti Jka, an antiFya, an anti-E and anti-Jkb and an anti-C, -D, -E.

Failure to provide antigen negative blood leads tothe risk of a delayed haemolytic transfusion reactionbut in these eight cases there were no reportedcomplications.

Findings

• In three cases (Cases 21, 60 and 24), the patient’shistorical records were not accessed eitherthrough failure of initial patient identification atadmission (Case 21), or failure to check manualrecords (Case 60) or retrieval of the wrong records(Case 24). In one further case (Case 59), themedical record was accessed but the informationin the medical record was ignored.

• Three cases (Cases 24, 50 and 62) involved failurein laboratory workup procedures.

• In one case (Case 24), where the incorrecthistorical records were retrieved, the currentantibody screen was negative and antigennegative blood was not selected.

• In a second case (Case 50), an antibodyinvestigation was not completed at the end ofthe working day and when blood was urgentlyrequired, the incomplete antibody investigationwent unnoticed and antigen negative bloodwas not selected.

• In the final case (Case 62), the sample used forcrossmatch was seven days old and a freshsample was not requested although the patienthad a subsequent transfusion. In this case, thepatient had developed antibodies since theprevious transfusion.

• Four of these cases (Cases 24, 59, 60 and 62) alsoinvolved on-call cover, which in three cases wasbeing provided by a medical scientist not normallyworking in the transfusion laboratory.


• Two cases (Cases 56 and 68) highlighted the lackof communication between hospitals and thefailure of medical staff to realise the importanceof this clinical information. Case 56 involved apatient previously transfused in another hospitalwhere he had had a transfusion reaction.However, the clinical details were not recorded onthe request form in the second hospital and asthe antibody screen was currently negative,antigen negative blood was not issued.

• Case 68 involved a massive transfusion of Rh Dpositive red cells to a male Rh D negative patientin line with guidelines. When the patient wastransferred to another hospital, this informationwas not passed on. The patient, who grouped asRh D positive, went on to receive furthertransfusions of Rh D positive blood. While it wasappropriate to continue to transfuse Rh D positiveblood until the acute bleeding episode wasresolved, transfusion of Rh D positive blood afterthat ran the risk of a delayed haemolytic reaction.A post transfusion antibody screen some monthslater was positive for anti-C, -D, -E.

Recommendations

• The patient’s primary identifiers at admission mustbe recorded correctly. This information allowsaccess to all previous records should this patienthave had a previous admission.

• The importance of filling in the patient’s clinicaland past transfusion history on the request formis highlighted as it enables the medical scientist tocheck previous transfusions which may have beenadministered and ensure that the correct productis issued.

• Historical transfusion records, manual andcomputer, should be checked for all patientsrequiring transfusion.

• Antibody investigations for patients who mayrequire blood in an emergency should becompleted as soon as possible after receipt.Where this is not possible, the computer ormanual records should clearly document this. Incases of clinical emergency, it may be necessary toissue blood to these patients before investigationsare completed but computer alerts to incompleteantibody investigations should be difficult tooverride inadvertently.

• Hospital transfusion laboratories need to beinformed when patients are transferred betweenhospitals. This will enable them to contact thereferring hospital and confirm transfusion history.This information should also be included in thewritten communication accompanying the patientfrom the clinical team where possible.

• Consideration should be given to issuing antibodycards to all patients with clinically significantantibodies (NBUG, 2002).

• The possibility of a national antibody register forpatient with red cell antibodies should also beevaluated.



TABLE 7 FAILURE TO GIVE ANTIGEN NEGATIVE RED CELLS (N=8)

Level Case Number

AntibodySpecificity

Volume ofred cellstransfused

Symptoms &Outcome

Cause of Error

1 IBCT Case 21*

Anti-Jka Three units No complicationsas a result of thistransfusion.

Incorrect DOB and addressgiven on admissioncreating a new patient ID.Patient had been an in-patient previously. Whenoriginal MRN and recordswere retrieved the patienthad a documented anti-Jka

antibody.

1 IBCT Case 24*

Anti-E Two units No complicationsas a result of thistransfusion.

Failure to check historicalrecords. Compatibleantigen negative red cellsnot selected.

1 IBCT Case 50*

Anti-E < 50mls No complicationsas a result of thistransfusion.

Product issued from thelaboratory prior tocompletion of alloantibodyidentification.

1 IBCT Case 56*

Anti-Fya Two units No complicationsas a result of thistransfusion.

Failure to check historicalrecords.

1 IBCT Case 59*


Antigen negative blood notselected by on-calllaboratory scientist asantibody screen negative.Previous antibodies onhistorical record notnoticed.

1 IBCT Case 60


Patient had a previouslydocumented anti-E inenzyme only. Antibodyscreen negative. Previousrecords not checked andantigen negative red cellsnot selected.

* Included as full case history

Failure to give antigen negative red cells (n=8)

We describe seven cases in detail

Level 1 IBCT Case 21This male patient was admitted via the A&EDepartment. He had a historical record but on thisoccasion was given a new MRN because theambulance crew gave the location where the patientwas collected which was not his home address andan incorrect date of birth was found on a letter froma GP in the patient’s pocket. When this data wasentered onto the hospital computer patient system,the patient was not recognised. A new patientidentity was generated and a new MRN issued. The patient was not well enough to confirm thesedetails. The pre-transfusion sample sent to the

laboratory grouped as O Rh D positive, antibodyscreen negative and three units of red cells werecrossmatched and issued for transfusion. The firsttwo units were transfused while the patient was stillunwell and unable to confirm his details. By the pre-transfusion checking of the third unit, his conditionhad improved. When asked to state his full nameand date of birth it became evident that the wrongdate of birth had been used and the clinical staffcontacted the laboratory to inform them of theerror. It was decided that this was a clerical error butthat it was safe to proceed with the transfusion. Allthree units were transfused uneventfully. Thefollowing day it was discovered the patient had infact a historical record and the original medicalrecord number was retrieved. Using this informationthe transfusion laboratory staff found this patient


TABLE 7 (CONTINUED) FAILURE TO GIVE ANTIGEN NEGATIVE RED CELLS (N=8)

Level Case Number

AntibodySpecificity

Volume ofred cellstransfused

Symptoms &Outcome

Cause of Error

1 IBCT Case 62*

Anti-EAnti-Jkb

Four units DAT positive posttransfusion. Nocomplications as aresult of thistransfusion.

The crossmatch was doneon a seven-day-old sampleinstead of a new sample.The patient had developedantibodies since theprevious transfusion.

2 IBCT Case 68*

Anti-C, -D, -E

Five units andtwo units ofpooled plateletconcentrate

No complicationsas a result of thistransfusion.

Massively haemorrhagingRh D negative male patienttransfused with eight unitsof Rh D positive red cells inline with policy. Ontransfer to a tertiary carecentre staff were unawareof the original Rh groupand the patient grouped asRh positive. A further fiveunits of RhD positive redcells and two units of RhDpositive platelets weretransfused.


had an anti-Jka previously. The units he receivedduring this transfusion episode were crossmatchcompatible but had not been antigen screenedbecause the patient history was not elicited. Thesecond and third units transfused were checked forantigen compatibility and found to be compatiblebut the first unit transfused had been discarded inthe A&E Department. Retrospective testing of thepre-transfusion sample confirmed that the patientwas currently antibody negative. Post transfusiontesting showed the same results.

Level 1 IBCT Case 24This postoperative patient with pneumonia requiredtransfusion of two units of red cells for a anaemia Hb 9.8g/dl. The crossmatch sample was drawnoutside normal working hours and details ofprevious transfusion including the group and thefact that the patient had antibodies was recorded onthe request form in the laboratory. The historicalgroup was checked using manual records, but theunique hospital identification number or date ofbirth were not checked and the name only was usedto confirm sample identification. As a result, anincorrect patient of the same name and blood groupwas chosen. The pre-transfusion sample wasantibody screen negative. Crossmatch compatiblecells were issued but antigen negative red cells werenot selected. The error was identified the followingday during review of all on-call work. A fresh sampleidentified the antibody specificity as anti-E.Subsequent investigation revealed that the two unitswere in fact E antigen negative.

Level 1 IBCT Case 50This patient with a history of malignancy required oneunit of red cells for anaemia Hb 7.1g/dl. An antibodywas detected but the investigations were notcompleted by the end of routine working hours. Thefollowing day, an alert warning of the incompleteantibody investigation went unnoticed and acrossmatched unit of red cells was issued fortransfusion from the laboratory prior to completion ofalloantibody investigations. When two further units ofred cells were required that day the laboratory

scientist noticed the computer warning. The wardwas contacted and advised to stop the transfusion.The alloantibody was identified as being an Anti-E.The remains of the component was sent to thelaboratory for retrospective genotyping. This testingfound the component was E antigen negative.

Level 1 IBCT Case 56This middle-aged male patient with an underlyingmalignancy required a transfusion of two units ofred cells pre operatively for anaemia due to activebleeding Hb 7 g/dl. The patient had been transfusedin the past in a different hospital and had had aprevious transfusion reaction but this informationwas not recorded on the transfusion request form.Pre-transfusion the antibody screen was negative.Two units of red cells were transfused uneventfully.The patient became very unwell as a result of hisunderlying illness and surgery was cancelled due toprogression of an underlying sepsis. Three weekslater, a pre operative transfusion sample showed apositive antibody screen with anti Fya specificity. Themedical scientist processing this sample checked thehistorical records from the previous hospital andfound the patient previously had antibodies andshould have received antigen negative red cells butthis information had not been relayed to thetransfusion laboratory.

Level 1 IBCT Case 59This female patient with a symptomatic anaemia Hb7.6 g/dl, required a transfusion of two units of redcells. The sample was sent to the laboratory on call.The patient had a history of a previous anti-E onlaboratory computer. On this occasion the patient’santibody screen was negative. The on-call medicalscientist, who does not normally work in thetransfusion laboratory, consulted the historicalrecord but did not notice the antibody results anddid not select antigen negative red cells forcrossmatch and issue. The error was discovered bylaboratory staff the following morning whenchecking on-call work. A repeat antibody screenpost transfusion was also negative.


Level 1 IBCT Case 62This elderly male patient required a transfusion ofred cells for a symptomatic anaemia, following agastrointestinal bleed, Hb 6.4g/dl. A telephonerequest was made to the laboratory to crossmatchfour units on call. The medical scientist processingthe request did not regularly work in the bloodtransfusion laboratory. The patient had beentransfused seven days earlier but a new specimenwas not requested and the four units werecrossmatched using the original specimen which hadbeen stored. The crossmatch was negative and thepatient was transfused uneventfully with one ofthese units. The following morning during a checkof on-call work, the laboratory staff noted the errorand a new sample from the patient was requested.The antibody screen was now positive with anti Eand Jkb antibodies. The DAT was positive for IgG andC3d. Antigen negative blood was selected for theremaining three units, which were transfuseduneventfully. The patient remained symptom freeand made a good recovery from his underlyingillness. Five days later a fresh sample was requestedfrom the laboratory and the antibody specificity wasconfirmed as anti-E plus Jkb.

Level 2 IBCT Case 68This young male patient was admitted to a regionalhospital following an RTA with a massivehaemorrhage as a result of multiple injuries. Thepatient grouped as O Rh D negative. During theresuscitation period 14 units of red cells, four units ofSD Plasma and four units of platelets weretransfused. However in accordance with the massivetransfusion policy to conserve stocks of Rh Dnegative blood, eight of the 14 units of red cellstransfused during this episode were group O Rh Dpositive. When the patient had stabilised he wastransferred to a tertiary care centre for furthermanagement. The nursing and medical transferletters outlined the blood components and productstransfused during the resuscitation period but failedto state that it had been necessary to change togroup O Rh D positive red cells. A pre-transfusionsample was taken on arrival. The group was recorded

as O Rh D positive, antibody screen negative. Twounits of group O Rh D positive pooled plateletconcentrates and five units of group O Rh D positivered cells were transfused uneventfully over thefollowing 72 hours. A sample was processed threedays later and again the group was O Rh D positive.At this point the patient was transferred to anothertertiary care centre for specialist management andgrouped as O Rh D positive, although he did notrequire further transfusion.Eleven weeks later he was re-admitted to the tertiaryhospital for evaluation. The pre-transfusion sampleat this point confirmed that he was in fact group ORh D negative. At this time because of his previousexposure to Rh D positive blood he now had anti-C,-D,-E antibodies and a positive DAT. Thecommunication error was discovered when historicalrecords were checked and a full investigation wascarried out by the TSO.

Transfusion based on incorrect result (n=7)

There were seven reported cases, six involving redcells and one involving plasma, where thetransfusion was based on inaccurate or oldhaematology results.

Findings:

• In three cases (Cases 11, 102 and 109),transfusions were prescribed and administeredbased on old Hb results, although current Hbresults were available but not checked.

• Three cases involved incorrect Hb results. In onecase (Case 54), the sample was transposed in thehaematology laboratory. In a second case, anormal result was misread (Case 99) and in thefinal case (Case 91), it has not been possible todetermine the reason.

• One of these cases (case 54) resulted in an elderlyfemale patient receiving four units of blood,when the pre transfusion Hb level was actually13g/dl.



• One case (Case 9) involved apparently abnormalcoagulation results. The sample was taken froman arterial line and the abnormal result wasshown subsequently to be due to heparin in thesample. This led to unnecessary plasmatransfusions.

Recommendations:

• A current Hb result should be checked prior toprescribing and administering a transfusion.

• When Hb samples are taken between units asrecommended, it is important to check the resultprior to further transfusion.

• Medical and nursing staff must be educated incorrect blood sampling techniques.


• Where anomalous Hb results are found a repeat Hb sample should be obtained before a decisionto transfuse is made.

Level Case Number

Volume of IncorrectBlood Component orProduct Transfused

Symptoms & Outcome

Cause of Error

1 IBCT Case 11*

Two units of red cells No complications asa result of thistransfusion.

Hb 5.9g/dl. Transfused with twounits of red cells. Hb posttransfusion 10.2g/dl. Report notnoted by clinical staff and afurther two units administered.After this second transfusion Hb 12.9g/dl.

1 IBCT Case 54*

Four units of red cells No complications asa result of thistransfusion.

Incorrect Hb result due totransposition of FBC sample.This elderly female patient had apost transfusion Hb 16.9g/dl.

1 IBCT Case 91*

One unit of red cells No complications asa result of thistransfusion.

Hb result of 7g/dl reported actualresult 10.3g/dl.

1 IBCT Case 99


Near patient testing Hb level 8.5g/dl misread. Repeat Hb12.2g/dl.

TABLE 8 TRANSFUSION BASED ON INCORRECT RESULT (N=7)



Transfusion based on incorrect results (n=7)

We describe six cases in detail. None of the casessuffered complications but all were exposed tounnecessary transfusion(s).

Red Cells

Level 1 IBCT Case 11This elderly female patient required a transfusion oftwo units of red cells for anaemia Hb 5.9g/dl due topost-operative oozing. The transfusion wasuneventful and the post transfusion Hb was10.2g/dl. However, medical staff did not see thisreport and went on to prescribe a further two unitsof red cells. Post transfusion of these two units. TheHb was 12.9g/dl. The TSO discovered this errorduring a routine review.

Level 1 IBCT Case 54This elderly female patient required an emergency

transfusion of four units of red cells for an apparentanaemia associated with haemoptysis Hb 7.3g/dl. A transposition error occurred in the laboratorywhen entering data from two different patients FBCsample tubes onto the laboratory computer on call.As a consequence the results were transposed andincorrect haemoglobin results were assigned to eachpatient. The patient’s actual Hb was 13.1g/dl. Onthe basis of this inaccurate result and clinicalsymptoms the patient was transfused with four unitsof red cells without checking the Hb between units.The patient was over transfused with a posttransfusion Hb of 16.9g/dl but did not suffer anyadverse symptoms or complications.

Level 1 IBCT Case 91This male patient presented with haematemesis anda transfusion of three units of red cells wasprescribed for anaemia Hb 7.1g/dl. Followingtransfusion of the first unit of red cells the nurselooking after the patient repeated the FBC and the

Level Case Number


Symptoms & Outcome

Cause of Error

1 IBCT Case 102*


Prescribed and administeredwithout checking the mostrecent Hb. Actual Hb pre-transfusion was 12.7g/dl.

1 IBCT Case 109*

Two units of red cells No complications asa result of thistransfusion.

Prescription based on an old Hbresult in the patient’s chart.

1 IBCT Case 9*

Three units of SDplasma

No complications asa result of thistransfusion.

The initial PT and APTT had beentaken from the arterial line andthree units of plasma wereprescribed on the result. A second specimen posttransfusion identified heparin inthe first sample as the cause.

TABLE 8 (CONTINUED) TRANSFUSION BASED ON INCORRECT RESULT (N=7)


actual Hb was found to be 10.3g/dl. The initialsample, which was still in the laboratory, wasrechecked and the Hb result was 7.1g/dl. Either aspecimen mix up or insufficient blood in the sampletube to perform accurate testing was suspected butneither possibility could be confirmed.

Level 1 IBCT Case 102This elderly patient with an underlying history ofcarcinoma, hypertension and anaemia requiredtransfusion over a seven-day period with seven unitsof red cells. Hb on admission was -6.4g/dl and thetransfusions were administered uneventfully. Prior tothe administration of the seventh unit, a Hb result of12.7g/dl was available on the ward but was notchecked prior to prescription or administration.

Level 1 IBCT Case 109This postoperative patient was prescribed atransfusion of two units of red cells overnight for ablood loss of 1420 ml which was not symptomatic.The prescription was based on a pre operativehaemoglobin result of 12g/dl. This was in fact an oldreport dated from the previous year and the preoperative Hb had in fact been 15g/dl. As it wasnight-time, the clinical staff were reluctant tocontact the prescribing physician. Both units weretransfused and the postoperative Hb three days laterwas 13g/dl.

Plasma

Level 1 IBCT Case 9An elderly patient was prescribed an emergencytransfusion of three units of SD plasma for anelevated PT 47.6 and APTT>120 attributed todisseminated intravascular coagulation (DIC). Theoriginal coagulation studies had been carried outusing the arterial line. The transfusion wasuneventful, but repeat coagulation studies posttransfusion showed no improvement (PT 20.3, APTT180). Following consultation with the haematologistwho suspected heparin contamination of thesample, a peripheral line sample was tested and therepeat results were normal with no evidence of DIC.

Laboratory investigation confirmed that the resultswere due to heparin. Following discussion withhospital staff, there was no evidence that the arterialline had been flushed with heparin. Investigation ofthe possibility that the line was manufactured with aheparin coating also proved negative. One possibility isthat a blood gas sample, which had been taken beforethe coagulation sample, left a heparin residue in thearterial line. The patient subsequently died as a resultof his underlying condition unrelated to transfusion.

Unnecessary components transfused (n=11)

We received 11 reports of unnecessary transfusions.

Findings

Five of these cases (Cases 64, 87, 93, 98 and 105)involved the use of plasma.

• All of these incidents involved an inappropriateprescription of plasma where national guidelineswere not followed.

Four cases involved the use of red cells (Cases 51,112, 115 and 119).

• Three cases (Cases 112, 115 and 119) involvedinappropriate prescription, two of which (Cases115 and 119) were for treatment of irondeficiency in young women. The third was in apostnatal patient.

• In one case, (Case 51) a further prescription waswritten without cancelling the previous one.

Two cases involved the transfusion of platelets(Cases 72 and 110).

• In one case (Case 72), the initial platelet countwas incorrect but the prescription for plateletswas not cancelled.

• The other case (Case 110) involved an extra unitof platelets transfused based on prescription byvolume in a paediatric patient and is described inthe Paediatric chapter.



Recommendations

• Adherence to guidelines for the appropriate useof components, in particular the use of plasma,will avoid unnecessary transfusions. SD plasmashould not be used for the reversal of overanticoagulation with warfarin where there is noevidence of severe bleeding or for reversal of overanticoagulation with warfarin prior to surgeryexcept in emergency situations. Reversal can beachieved by stopping warfarin and/or use of lowdose vitamin K (NHO leaflet, 2003, Appendix 2)

• Patients with iron deficiency anaemia respondquickly to specific iron therapy and rarely needtransfusion.

• Unused and discontinued versions ofdocuments should be removed from circulationwhen a new version is issued.

TABLE 9 UNNECESSARY COMPONENT TRANSFUSED

Level Case Number

Volume of IBCTtransfused

Symptoms & Outcome

Cause of Error

1 IBCT Case 64*

Two units No complications asa result of thistransfusion.

Guidelines for the use of SDplasma not followed.

1 IBCT Case 87

Four units No complications asa result of thistransfusion.


1 IBCT Case 93

Three units No complications asa result of thistransfusion.


1 IBCT Case 98*



1 IBCT Case 105*

Five units No complications asa result of thistransfusion.


Cases involving SD plasma

* Included as full case history*p Included as full case history in Paediatric Chapter


TABLE 9 (CONTINUED) UNNECESSARY COMPONENT TRANSFUSED

Level Case Number

Volume of IBCTtransfused

Symptoms & Outcome

Cause of Error

1 IBCT Case 112*


Inappropriate prescription of redcells. Discontinued onconsultant’s advice.

1 IBCT Case 115

Three units No complications asa result of thistransfusion.

Inappropriate prescription of redcells. Discontinued on consultantadvice.

1 IBCT Case 119*

One unit No complications asa result of thistransfusion.

Postnatal patient requiredtransfusion for symptomaticanaemia –Hb 6.7g/dl- Followingtwo units red cells, symptomsresolved, Hb 8.5g/dl. One furtherunit given inappropriately basedon prescription.

1 IBCT Case 51*


The first prescription stated sixunits of red cells, three of whichwere transfused. The patient wasreviewed and two of theremaining three units wereprescribed, but the oldprescription was not cancelled.The patient received all threeunits before the mistake wasdiscovered.

1 IBCT Case 72*

One unit of apheresisplatelets


Discrepant platelet result.Prescription for platelets notcancelled in writing.

2 IBCT Case 110*p

Two units of CMVnegative andirradiated apheresisplatelets


300mls of platelets wereprescribed pre-operatively plateletcount 19X109 One unit contained200mls. The platelet count posttransfusion of this unit was 118 X109/L. The patient was transfusedwith a further unit of platelets.Post transfusion platelet count155X109/L.

Cases involving red cells

Cases involving platelets


Unnecessary component transfused

PlasmaWe describe three cases in detail involving thetransfusion of Plasma.

Level 1 IBCT Case 64This patient with newly diagnosed atrial fibrillation wasadmitted with nocturnal dyspnoea, excessive sweatingand a possible chest infection. The initial managementinvolved the use of antibiotics and warfarin. Followingwarfarin treatment for three days, the INR was 3.However the following day, the INR was 9.9 with noevidence of bleeding. The patient was transfused withtwo units of SD plasma. This was discovered during aroutine audit by the TSO. The prescribing doctor wasnot aware of current National Guidelines (Appendix 2).This incident has highlighted the importance ofeducation in the hospital.

Level 1 IBCT Case 98 This elderly patient with a history of ischaemic heartdisease, TIAs and a deep vein thrombosis, was referredto hospital by his local GP for management of anINR>10, as a result of over anticoagulation. Thepatient had no signs or symptoms of bleeding orbruising at the time of admission. Two units of SDplasma and 10mg of intravenous Vitamin K wereprescribed and administered uneventfully. This incidentwas discovered during a routine audit of transfusionby the TSO.

Level 1 IBCT Case 105This postoperative patient on warfarin therapy whichhad not been discontinued pre-operatively, had araised INR 3.8 and was prescribed a non-emergencytransfusion of five units of SD plasma. The approvedprotocol in this hospital for reversal of overanticoagulation is Vitamin K orally. The nurse on theward was aware of this protocol and informed theprescribing doctor but it was decided to go aheadwith the transfusion, as there were reservationsexpressed as to the efficiency of Vitamin K and how easily control of anticoagulant therapy could be restored.

Red CellsWe describe in detail three of the four casesinvolving red cells.

Level 1 IBCT Case 112This young patient with an underlying congenitalcoagulation disorder required investigation of severeiron deficiency anaemia Hb. 6.9 g/dl associated withweakness and menorrhagia. The presentingsymptoms in the A&E Department includeddyspnoea and syncopal episodes. However, thepatient’s vital signs were stable and the patient wastaking oral iron and transexamic acid. Three units ofred cells were prescribed on-call. Two units of redcells were transfused. During review the followingmorning by the Consultant Haematologist it wasdecided that it was an inappropriate transfusion andno further transfusions were administered.

Level 1 IBCT Case 119This young female postnatal patient required atransfusion of red cells for a symptomatic anaemia Hb 6.7g/dl. There was no history of post partumhaemorrhage. The patient was reluctant to agree toa blood transfusion but following detailed discussionconsented and two units of red cells were prescribedand transfused. The patient’s symptoms resolved. A third unit of red cells was transfused as theprescription stated that if the haemoglobin was lessthan 10g/dl one further unit of red cells was to betransfused. The Consultant Haematologistsubsequently reviewed the case and highlightedcurrent guidelines for red cell transfusion.

Level 1 IBCT Case 51This elderly male patient with underlying cardiacdisease and a stable abdominal aortic aneurysmpresented with anaemia Hb 4.9 g/dl, and requiredtransfusion with six units of red cells with diureticcover. Following transfusion of the first three units,the patient asked for a rest from transfusion as hewas having difficulty getting any sleep. Duringmedical rounds the next morning, two units of redcells were prescribed to replace the previousprescription which was not cancelled. Later that day,a third unit of red cells was requested from the



laboratory on the basis of the old prescription. Theerror was discovered while writing the nursingreport at the end of shift by which time the thirdunit was in progress.

Platelets We describe one case in detail involving platelets.Case 110 is detailed in the Paediatric chapter.

Level 1 IBCT Case 72This elderly female patient with sepsis required atransfusion of platelets for a platelet count recorded as20X10/9L. A second sample requested by thelaboratory taken that day showed the patient’s actualplatelet count was 115X10/9L but the doctor hadwritten the prescription before the repeat result wasavailable to save time. The doctor felt that she hadsubsequently cancelled the order for platelets with thetransfusion laboratory. However there was no recordof this in the laboratory and the prescription was notcancelled on the prescription form. The unit wasissued by the laboratory, checked against theprescription and transfused uneventfully. Oninvestigation of this incident, the ward had twodifferent prescription forms in circulation; the outdatedone contained the original platelet prescription whichhad not been cancelled. A new updated prescriptionform was also used to prescribe a unit of red cells forthis patient. As the platelet prescription was not onthis form, the doctor would not have been promptedto cancel the previous platelet prescription.

Wrong Components Issued or Administered(n=4)

Findings

There were three incidents reported in this sectionwhere cross call cover was being provided out ofhours in the laboratory and a lack of knowledge ofthe appropriate product currently in use allowedissue of a wrong component. One case involved anadult and the other two were paediatric cases. Thefinal case (Case 42) involved the inappropriate useof Rh D negative emergency stock by medical staff.

• Cases 13, 27 and 45 involved a lack ofknowledge of the appropriate product for issuefrom the laboratory and of those, two wereissued by medical scientists not regularly workingin blood transfusion but providing cross call cover.

• In two of the cases (Cases 13 and 27) involvingneonatal patients, the product of choice wouldhave been group specific SD plasma but Uniplaswas selected and issued. These two cases aredescribed in detail in the Paediatric chapter.

Recommendations

• Continuing education is necessary for staffproviding cross call cover who may not be familiarwith current guidelines.

• Medical staff need to be aware of the appropriateuse of Rh D negative emergency stock.

Wrong Components Issued or Administered(n=4)

We describe one case in detail, Cases 13 and 27 arediscussed in the Paediatric chapter.

Level 2 IBCT Case 42 This elderly female patient was admitted forinvestigations of a gastrointestinal bleed Hb 6g/dl. Asample was taken for crossmatch and was beingprocessed in the laboratory. At the same time, adecision was made by the doctor on-call to transfusethe patient with two units of the designatedemergency O Rh D negative blood stock. However,each unit of blood was to be administered over athree-hour period. Clinical staff questioned theappropriateness of the units for transfusion duringthe final bedside administration check, as there wasno crossmatch report form available, but as theywere junior staff, they were encouraged to continuewith the transfusion. There were no complications asa result of this transfusion. The TSO discovered theincident during a routine audit of emergency O Rh Dnegative stock.


Errors surrounding collection, storage orimproper handling of components n=10

Findings

• Three incidents (Cases 73, 82 and 89) concernedunits of red cells left out of the fridge in excess ofthe recommended time, then returned to thefridge and later transfused.

• Two cases (Cases 32 and 53) demonstrate thedangerous practice of re-transfusing already piercedor ‘spiked’ units. The risk of bacterial contamination

of these units cannot be over-emphasised. In case32, the pierced unit was stored for 15 hours beforetransfusion, which highlights the importance ofensuring that the patient has patent venous accessand that all documentation is correct prior tocollection of the unit.

• Case 53 involved a unit that had beendiscontinued because of a suspected transfusionreaction, stored in the wrong fridge whileawaiting investigation, collected and re-transfusedto the same patient, 24 hours later.

TABLE 10 WRONG COMPONENTS ISSUED OR ADMINISTERED (N=4)

Level CaseNumber

ABO and RhD Group ofPatient

ABO and RhD Group ofIBCT

Volume ofIBCTTransfused

Symptoms &Outcome

Cause of Error

1 IBCT Case 13*p

Group A RhD positive

Uniplas 18mls ofUniplasgiven


Transfusion scientiston call thoughtUniplas was theproduct of choicefor neonates.

1 IBCT Case 27*p

Group A RhD Positive

Uniplas Less than50mls ofUniplas


Transfusion scientistthought Uniplas wasthe product ofchoice for neonates.

2 IBCT Case 45

Group ABRh D positive

Group A SDplasma

12 units ofA SDplasma


Incorrect units issuedon-call by personnot normallyworking intransfusionlaboratory. Productof choice Uniplas.

2 IBCT Case 42*

N/A N/A Two units ofemergencyO Rh Dnegativeblood


Failure to prescribecorrect component.



• Case 73 highlights the importance of ensuringthat all staff handling blood are aware of storagerequirements.

• Two of the incidents (Cases 6 and 82) werediscovered during investigation of febriletransfusion reactions.

• None of the patients suffered any adverse effects.

Recommendations

• Under no circumstances should any blood productor component that has been pierced or ‘spiked’with an administration set or other device bestored with the intent of re-use. The importanceof this cannot be over emphasised as there is aserious risk of bacterial contamination.

• Should an unforeseen delay in starting thetransfusion occur, it is necessary to return the unitto controlled storage within thirty minutes andinform the laboratory to ensure the unit is beingreturned to the appropriate fridge.

• Documentation containing details of threeminimum patient identifiers must be brought tothe fridge when collecting a unit of blood inorder to verify unit and details.

• Inspection of the unit and documentation at thetime of collection may identify abnormalities ineither the unit or labelling.

• Systems are required which incorporate allsatellite fridges within the monitoring proceduresof the hospital blood bank. The transfusionlaboratory should collect crossmatched red cellunits from satellite fridges if they have not beenused within 24 to 48 hours of the time they wereoriginally requested (Mc Clelland, 2001).

• Computerised systems of blood storagemonitoring which prevent errors of collection arerecommended.

• It is important that hospitals that accept bloodunits accompanying patients transfered fromother hospitals have policies in place to determinethe circumstances in which they can be used forthe patient rather than discarded.

TABLE 11 ERRORS SURROUNDING COLLECTION, STORAGE OR IMPROPERHANDLING OF PRODUCTS N=10

Level Case Number


Symptoms & Outcome

Cause of Error

1 IBCT Case 32*

Less than 50mls of redcells.

Nocomplicationsas a result ofthis transfusion.

Transfusion set up prior to checkingpatency of access. Transfusion notcommenced until the following morning.Pierced unit stored for 15 hours in thesatellite fridge before transfusion.

1 IBCT Case 53*

Less than one unit ofred cells.

Nocomplicationsas a result ofthis transfusion.

Fever after first 50mls of cells.Transfusion discontinued. Placed insatellite fridge in error instead of beingreturned to laboratory. Unit collected 24hours later for subsequent transfusion.Cord clamp used to seal the unit was notnoticed during pre-transfusion check.



TABLE 11 (CONTINUED) ERRORS SURROUNDING COLLECTION, STORAGE ORIMPROPER HANDLING OF PRODUCTS N=10

Level Case Number


Symptoms & Outcome

Cause of Error

1 IBCT Case 37*p

32mls of red cells No complicationsas a result of thistransfusion.

Emergency un-crossmatched group ORh D negative red cells for adult usecollected from a satellite fridge insteadof emergency group O Rh D negativepaedipack for emergency neonatal use.

2 IBCT Case 4*

Two units of red cells. No complicationsas a result of thistransfusion.

Two units of un-crossmatched O redcells removed from stock shelf of fridgefor unexpected blood loss. Two units ofdesignated emergency group O Rh Dnegative red cells were available.

2 IBCT Case 89*p

One unit of red cells No complicationsas a result of thistransfusion.

Unit out of fridge for one hour thenreturned to fridge for twenty minutesthen removed and transfused.

2 IBCT Case 73*

One unit of red cells No complicationas a result of thistransfusion.

Blood out of fridge for 2 hrs 25 minsthen returned to the fridge byuntrained attendant and subsequentlyremoved six hours later and transfused.

3 IBCT Case 6

Four units of red cells. Fever >1.50CNo complicationsas a result of thistransfusion. ABOincompatibilityoutruled.

Incident discovered during febriletransfusion reaction investigation. The units should have been withdrawn48 hrs after crossmatch in compliancewith hospital policy.

3 IBCT Case 61*

Two units of red cells No complicationsas a result of thistransfusion.

Two units accompanied the patient ontransfer from a different hospital andwere transfused as no crossmatchedblood was available.



Errors surrounding collection, storage orimproper handling of products. (n=10)

We describe five cases in detail. Cases 37 and 89 aredetailed in the Paediatric chapter.

Level 1 IBCT Case 32 This patient required transfusion of two units of redcells for anaemia of malignancy Hb 8.6 g/dl. Thefirst unit was collected from the satellite refrigeratorand signed out of the laboratory register. However,the patient’s venous access was not checked prior todelivering the unit to the clinical area. Two staffnurses checked and set up the transfusion at thebedside performing the pre-transfusion checkingprocedure as per policy. The component wasattached to the administration set for transfusion viaa central line. Immediately prior to commencing thetransfusion there was no blood return from thecentral line and the transfusion could not be

commenced. It was then decided that the unit,intact with the administration set, would bereturned to the satellite refrigerator overnight andfurther attempts to transfuse would begin in themorning. The central line was accessed successfullythe following morning and the same unit which hadbeen pierced more than 15 hours previously wasrecommenced. The error was identified whenlaboratory staff contacted the TSO and advised thata pierced unit had been stored in the satelliterefrigerator overnight. On investigation thetransfusion had just begun and was discontinuedwhen less than 50mls had transfused.

Level 1 IBCT Case 53This patient required an emergency transfusion offour units of red cells for anaemia secondary to apost-partum haemorrhage Hb 6.4 g/dl. Whenapproximately 50mls of the first unit had beentransfused, the patient developed a fever and the

TABLE 11 (CONTINUED) ERRORS SURROUNDING COLLECTION, STORAGE ORIMPROPER HANDLING OF PRODUCTS N=10

Level Case Number


Symptoms & Outcome

Cause of Error

3 IBCT Case 82

One unit of red cells Fever > 1.50C Nocomplicationsas a result ofthis transfusion.Cultures frompatient & unitnegativeABOincompatibilityoutruled.

Incident discovered during febriletransfusion reaction investigation. Unitremoved from controlled storage for over45 minutes and returned to thefridge.Subsequently removed andtransfused to the patient over 90minutes later.

3 IBCT Case 116

One unit of red cells Nocomplicationsas a result ofthis transfusion.

The transfused unit had been stored inthe satellite fridge and had expired theprevious day.


unit was discontinued. The unit was disconnectedfrom the administration set and sealed with a cordclamp. The incompletely transfused unit was placedin error in the satellite fridge with the remainingthree units from the same crossmatch, all of whichshould have been returned to the laboratory forinvestigation. Twenty-four hours later the patientwas transferred to another ward and transfusionwas again attempted. The incompletely transfusedunit, with the cord clamp in place, was collected inerror from the satellite fridge. The presence of thecord clamp went unnoticed during the pre-transfusion checking procedure. The transfusion wascommenced spiking the pack via the other port witha new blood administration set. Some time later theerror was discovered as the use of the cord clampon the unit was questioned. This unit was thendiscontinued and the error was reported to the TSO.The unit was returned to the laboratory forinvestigations. However, the remaining units fromthis crossmatch were not recalled as per the hospitalreaction investigation protocol and the patient wastransfused later with the two units of blood whichremained in the satellite fridge.

Level 2 IBCT Case 4This elderly Rh positive female patient required anemergency transfusion of two units of red cells foran unexpected blood loss via a surgical drain postoperatively. Pre-operatively a group and screen onlyhad been requested. As there were no red cellscrossmatched for this patient, two units of un-crossmatched O red cells were collected from theblood bank. However they were not the groupconfirmed O negative units designated foremergency stock. In this hospital, stock blood andblood for issue are stored in the same fridge.However the shelf for group O Rh D negative redcells for emergency use is clearly marked and isseparated from the stock units. The two units werechecked at the bedside and transfused uneventfully.The error was discovered the following morning bylaboratory staff when checking stock levels.

Level 2 IBCT Case 73This patient with a malignant haematologicaldisorder required a non- emergency transfusion ofone unit of red cells for anaemia Hb 8.1g/dl. Theunit was collected from the laboratory but at thattime the patient was unavailable for transfusion andit was decided the unit should be returned to thesatellite fridge. The unit was not returned for 2hours and 25 minutes. Staff were unaware of thetime lag and the attendant who returned the bloodto the fridge was not aware of the 30 minute returnguideline. Six hours later the same unit wascollected and transfused uneventfully. All times ofremoval and return were recorded accurately in thelaboratory register and subsequently the laboratorydiscovered the error during a review of the records.

Level 3 IBCT Case 61This young male patient required surgery followingan RTA. He had initially been evaluated andresuscitated at the nearest hospital and thentransferred from this hospital for furthermanagement. He had been crossmatched for fourunits of blood and these units along with acrossmatch form accompanied the patient ontransfer. In the second hospital, the patient wasstable and not considered an emergency. The blood,which should have been returned to the primaryhospital, was put into the bottom shelf of the fridgefor discard at a later date. No specimen was takenfor crossmatch at the second hospital. Thecrossmatch report from the original hospital wasfiled in the patient’s chart. Later that evening adecision was made to operate and the patiententered the theatre suite still wearing the IDwristband from the original hospital that containedname, date of birth and unique hospital number.Once the surgery had commenced the patient bledheavily and two of the units on the crossmatch formwere requested. As there were no crossmatchedunits available, a clinical decision was taken to usethe units in the fridge, which had been set aside fordiscard while a fresh specimen was beingcrossmatched. These two units were checked intheatre using the original hospital ID wristband, the


original hospital crossmatch report form and labels,which had been attached by the original hospital.

Failure to supply special requirements in CMVnegative and/or irradiated components (n=12)

Findings

There were 12 cases reported in this category, 11which are classified as level 2 incidents. Theremaining incident was classified as level 3 as theunit was actually CMV negative and irradiated, butthis information was incorrectly entered on thelaboratory computer.

• Eight cases occurred due to prescription and/orrequest errors where special requirements werenot stated or the clinical history, which wouldhave raised the laboratory’s awareness to therequirement, was omitted (Cases 1, 8, 40, 58, 66,78, 100 and 34).

• None of the cases resulted in complications forthe patient.

• In three cases (Cases 3, 43 and 44), errors in thehospital transfusion laboratory led to the issue ofunits that did not meet the special requirements.

• In one of these cases (Case 3), a visual computerwarning which prompted that CMV antibodynegative and irradiated components had beenissued for this patient in the past, was displayedon screen but overridden because the laboratorystaff were very busy.

• In one case (Case 41), CMV negative and irradiatedplatelets were requested from the IBTS. However,due to stock shortage, CMV safe leucodepletedplatelets were issued but the irradiation requestwas overlooked. This error went undetected whenthe unit was received and processed through thehospital laboratory out of hours.

• In six cases (Cases 1, 3, 8, 41, 43 and 100), thefinal bedside checking procedure should havealerted clinical staff to the lack of provision ofspecial requirements and prevented thetransfusion of these components.

Recommendations

• The number of cases reported in this categoryemphasises the need for ongoing education andtraining of staff involved in prescribing, orderingand administering transfusions. The significanceand importance of the bedside checkingprocedure cannot be over-emphasised.

• As eight of the twelve incidents are associatedwith failure to prescribe the correct products,systems need to be put in place within hospitalsto ensure that the requirements of such patientsare highlighted, which include:

• Education of prescribing doctors to highlight theimportance of accurate completion of prescriptionand clinical details on request forms.

• Alert stickers placed on the front of the medicalrecord to alert clinical staff of the specialrequirements. This is particularly important whenpatients are being transfused outside clinical areasnot normally transfusing haematology/oncologypatients.

• Systems need to be put in place to ensure thatwhere care is shared between centres, patientsreceive the correct products.

• On going education should be provided formedical scientists who are involved in cross callcover and do not normally work in transfusion tohighlight special requirements for certain patients.

• Once again a failure to heed computer warnings(Case 3) has highlighted the fact that asrecommended in the NHO Annual Reports 2001and 2002, computer systems should be designedwith audible alarms/alerts to minimise



opportunities to override screen warnings.Preferably any such overrides should require areason or explanation, as this should question theneed to override. An audit trail of any overridesshould also be kept.

• In high risk areas such as busy haematology units,a blanket policy of the use of irradiated productfor all patients with suspected malignanthaematological disorders may be advisable.

TABLE 12 ERROR IN CMV NEGATIVE AND IRRADIATED COMPONENTADMINISTRATION (N=12)

Level CaseNumber

Volume of IncorrectBlood Component

Symptoms andOutcome

Cause of Error

2 IBCTCase1p*

Three units of SAG-Mred cells. Sevenaliquots of paedipackred cells


Failure to prescribe/request specialcomponent needs.

2 IBCT Case 3*

Three units of red cells No complicationsas a result of thistransfusion.

Requirement for CMV negativeirradiated components not noticed inlaboratory.

2 IBCT Case 8p*

Three units of SAG-Mred cells, two units ofapheresis platelets.Five aliquots of onepaedipack.


Failure to prescribe/request irradiatedcellular components.

2 IBCT Case 34

One unit of pooledplatelet concentrate


Failure to prescribe CMV negativeirradiated platelets.

2 IBCT Case 40*


Irradiated red cells not prescribed forpatient awaiting transplant. Noted byanaesthetist prior to transfusion butunit required urgently for intra-operative bleed.

2 IBCT Case 41*

One unit of apheresisplatelets.


CMV negative platelets not availablefrom IBTS. CMV safe platelets issuedinstead on advice from ConsultantHaematologist but request forirradiated platelets not fulfilled. Nonirradiated platelets issued from IBTS,processed through hospital laboratoryand transfused without noticing error.



TABLE 12 (CONTINUED) ERROR IN CMV NEGATIVE AND IRRADIATEDCOMPONENT ADMINISTRATION (N=12)

Level CaseNumber


Symptoms andOutcome

Cause of Error

2 IBCT Case 44*p

45mls red cells Nocomplications asa result of thistransfusion.

CMV negative red cells not selectedalthough available in laboratory.

2 IBCT Case 58

Two units of red cells Nocomplications asa result of thistransfusion.

Failure to prescribe CMV negativeirradiated components.

2 IBCT Case 66*

Two units of red cells Nocomplications asa result of thistransfusion.

Failure to prescribe CMV negativeirradiated components.

2 IBCT Case 78

Four units of red cells Nocomplications asa result of thistransfusion.

Failure to request/prescribe CMVnegative irradiated red cells for apatient with a suspected malignanthaematological disorder.

2 IBCT Case100

Two units of red cells and one unit ofpooled platelets

Nocomplications asa result of thistransfusion.

CMV negative irradiated products notprescribed for patient awaitingtransplant. Peri-operatively three unitsred cells and one unit of platelets weretransfused.

3 IBCT Case 43

One unit of apheresisplatelets, CMVnegative andirradiated

Nocomplications asa result of thistransfusion.

CMV negative irradiated blood issuedby IBTS but special requirements notentered onto the laboratory computersystem or not documented on thecompatibility label or crossmatch reportform.



Error in the administration of CMV negative orirradiated products (n=12)

We describe four cases in detail. Cases 1, 8 and 44are covered in Paediatric chapter

Level 2 IBCT Case 3Three units of irradiated CMV negative red cellswere prescribed and requested for this patient witha haematological malignancy. The computer alerted(visually, not an audible alarm) the medical scientistto the CMV and irradiated requirement in the past.This went unnoticed and three units were issuedwhich were not CMV negative or irradiated. Theissue was within normal working hours but thelaboratory workload was extremely heavy. The errorwas not noted during the pre-transfusion check atthe bedside although the prescription form statedthe requirements. When the workload had eased,the error was recognised by the medical scientist.

Level 2 IBCT Case 40This patient with cardiac and underlying renal diseaseawaiting transplant required a transfusion of one unitof CMV negative and irradiated red cells for anemergency intraoperative bleed, Hb 7.6g/dl. Thecorrect component was not prescribed or requestedpreoperatively. Standard red cells were cross-matchedand issued for surgery. This was the patient’s firsttransfusion in this hospital. When surgery hadcommenced, the anaesthetist noted that specialrequirements had been omitted and contacted thelaboratory to order the correct product. However, thepatient began to bleed and as the correct blood wasnot immediately available, a decision was made touse one unit of the non-irradiated CMV untestedblood as an emergency.

Level 2 IBCT Case 41This patient, with a malignant haematological disorder,required transfusion with one unit of CMV negativeand irradiated platelets for aspirin induced plateletdysfunction. The hospital transfusion laboratory madethe request to the IBTS, but CMV negative plateletswere not available. Following a discussion with theConsultant Haematologist at the IBTS it was decidedto issue CMV leucodepleted ‘safe’ platelets for this

patient. However, in error, the request for irradiatedcomponents was not filled and one unit of CMV‘safe’, non-irradiated platelets were issued from theIBTS. The hospital transfusion laboratory received thisunit on call and issued it to the clinical area wherethey were transfused without noticing the error. Asenior medical scientist identified the error whenreviewing all on-call work the following day.

Level: 2 IBCT Case 66This patient, with a relapsing malignanthaematological disorder post BMT required atransfusion of two units of CMV negative andirradiated red cells. The patient was being transfusedin the day ward setting. Neither the prescription norrequest form stated that special requirements wouldbe needed. The patient had never been transfusedpreviously in this facility and the laboratory had noprevious record so two units of standard red cellswere issued. As the prescription did not state therequirements, the error was not identified during thebedside administration. The TSO identified the errorduring a routine hospital audit of transfused units.

IBCT transfused not using a filter or infusiondevice (n=5)

Findings

• Two incidents involved the administration of redcells (Cases 33 and 35) and one case (Case 7)involved the administration of SD plasma. All weretransfused without using a blood administration setwith an integral 160-220 micron filter.

• In addition, one case (Case 35) highlighted theneed to ensure accurate recording of unitnumbers transfused in emergency situations

• Two cases involved the use of an electronicinfusion device (Cases 65 and 76).

• Case 65 involved the transfusion of plateletsusing a device unsuitable for this purpose.

• Case 76 involved an incorrect timeframeentered on the infusion pump, which delivereda unit of red cells more quickly than prescribed.


TABLE 13 IBCT TRANSFUSED NOT USING A FILTER OR THROUGH INCORRECTINFUSION DEVICE (N=5)

Level CaseNumber


Symptoms &Outcome

Cause of Error

2 IBCTCase 7

Two units of SDPlasma


Two units of SD plasma administeredunfiltered through a fluidadministration set.

2 IBCT Case 33

Between 50-100mls ofred cells

An urticarial rashdevelopedduringtransfusion,patient recoveredwith no ill effectswithoutmedication.

Transfusion given via a standard fluidadministration set without anappropriate filter in place.

2 IBCT Case 35*

11mls of red cells No complicationsas a result of thistransfusion.

Transfusion to neonate via a syringewithout an integral filter in place.Unsure which unit of red cells wasused.

2 IBCT Case 65*p

One unit of plateletsfor neonatal use

No incrementalrise followingtransfusion. Theinfant required afurthertransfusion toincrease theplatelet count toacceptable levels.

This platelet transfusion was given viaan electronic infusion device unsuitablefor infusing platelets.

2 IBCT Case 76


Unit transfused through infusion pump,which had been inadvertently set torun over 1.5 hours instead of fourhours as prescribed.



Recommendations

• Ongoing education is required to ensure correctadministration of blood components

• This should include training on use of medicaldevices such as infusion pumps.

• There should be a dedicated person to check andrecord transfusions during massive haemorrhageto ensure traceability of all blood componentsand blood products.

IBCT transfused not using a filter or throughincorrect infusion device

We describe one of these cases in this sectionbecause, although it is a neonatal case, the problem occurred in an adult centre. The incidentalso highlights the importance of accurate recordingof units transfused event during emergencysituations. Details of Case 65 are included in the Paediatric chapter

Level 2 IBCT Case 35 This infant required a transfusion of red cells as a lifesaving measure post delivery in a tertiary adult carecentre. The blood was taken from a uncrossmatchedunit of O Rh D negative designated emergency stock.This incident took place in a busy A&E departmentwhere two resuscitation rooms were in usesimultaneously. Six units of emergency un-crossmatched O Rh D negative blood were brought tothe A&E resuscitation rooms. 11mls of red cells wereremoved from an un-crossmatched unit and thetransfusion was administered via a syringe throughthe umbilical vein without using a bloodadministration set. The unit from which this bloodwas transfused could not be subsequently identified.


Findings

• Of the five cases reported in this section, two(Cases 10 and 26) resulted from a failure to check

whether the patient had been previously admittedto the hospital and assigning a new MRN.Previous transfusion records were then unavailable.

• The third case (Case 19) involved a patient withtwo MRNs as this hospital allows allocation ofmore than one MRN per patient when theadmission occurs out of hours. These numbers arenever merged within the system.

• The fourth case (Case 48) illustrates how poorand unclear communication resulted in a patientbeing hospitalised and treated using a differentpatient’s record.

• The final case (Case 85) relates to old case notesbeing used on this admission, which contained anincorrect DOB for the patient and despite thecurrent notes being available during transfusion,this error went unidentified.


Recommendations

• Patients admitted must have a unique hospitalnumber assigned, either their previous MRNnumber or a new number, if the patient has nohistory at this hospital.

• Staff admitting patients should take care to obtaindetails of previous admissions to ensure that theirprevious MRN number and records are retrieved.

• If the patient is admitted via the A&E Departmentand given an emergency number, it must bepossible to merge this number in the computersystem at a later stage with the actual uniquehospital number.



TABLE 14 INCORRECT DETAILS RECORDED DURING INITIAL ADMISSION (N=5)

Level CaseNumber


Symptoms andOutcome

Cause of Error

1 IBCT Case 48*

Two units of red cells. No complicationsas a result of thistransfusion.

Patient transferred from a residentialcentre using a different date of birthand first name, which referred toanother patient. This other patient’schart was then used throughout thispatient’s hospital stay.

3 IBCTCase 10*


Pre-transfusion sample labelledcorrectly, no ID wristband. Duringclerical admission, incorrect DOBentered and new unique identificationnumber created. Remote checking ofthe unit failed to note thesediscrepancies.

3 IBCT Case 19*

Three units of redcells


Patient’s first name and unique hospitalnumber incorrect on the pre-transfusion sample. This error carriedon throughout the transfusion.

3 IBCT Case 26

Two units ofRed Cells


Admissions staff issued this patientwith a second MRN without searchingcomputerised records for an originalidentification number.

3 IBCT Case 85


Addressograph labels from old casenotes were used for this admission.They contained the wrong DOB. Thiswas used on the sample tube, requestform, issue label, compatibility formand the patient’s ID wristband.



Of the five cases received, we describe three casesthat illustrate the problems that arise.

Level 1 IBCT Case 48This patient (Patient X) was admitted via theadmissions unit having been referred from a residentialcentre by a general practitioner (GP). The details on the referral letter stated the patient’spreferred name, which was not her birth-registeredname and an incorrect date of birth (that of anotherresident who had the same surname). The correctsurname and address were used. At this hospital, themedical records tracking system relies primarily on thecorrect date of birth to identify patients on thehospital computer system during the admissionprocedure. On this occasion, the hospital records of adifferent patient, patient Y, were identified with thisdate of birth, address, surname, and first name. As thepatient was unable to confirm her own details, patientY’s chart was used throughout her ten-day admission,during which time she received two units of red cells.The error was identified when the discharge letter wasreceived at the residential centre at which bothpatients lived. Both patients had a history at thishospital but only one, patient X, had a transfusionhistory. As a result of this incident this patient’shistorical transfusion record was not retrieved. Allpatient X’s records have been amended accordingly.

Level 3 IBCT Case 19This elderly female required a transfusion for asignificant bleed associated with underlyingmalignancy Hb 5g/dl. The ID wristband contained anincorrect first name. A failure to verbally identify thepatient led to this information being recorded ontothe sample. There was also a discrepant MRN as thishospital allows allocation of more than one hospitalnumber per patient if the admission occurs out ofhours. A previous MRN was recorded on the outsidecover of the patient’s chart with a different one onthe inside. These numbers are never merged withinthe system. There is no link between the laboratory

and admissions computer systems and thelaboratory staff are totally dependent on a correctlylabelled sample and request form as they have noother means of checking details. During bedsideadministration, verbal patient identification was notcarried out and the ID wristband, compatibility formand the unit all contained this incorrect information.The patient’s medical record, however, contained thecorrect patient name. Three units were transfusedwithout incident. During bedside checking of thefourth unit, the difference in the MRN was notedand when questioned, the patient stated her correctname. The laboratory was contacted and a repeatcrossmatch specimen was taken.

Level 3 IBCT Case 10This patient with severe symptomatic iron deficiencyanaemia, a history of CCF and a right pleuraleffusion required an emergency transfusion of twounits of red cells Hb 8.2g/dl. The patient had ahistory of underlying severe CCF. The pre-transfusionsample was taken in the A&E and correctly labelledwith a unique transfusion label, as no MRN wasavailable. The patient had no ID wristband as noclerical cover is provided outside normal workinghours. During clerical admission the following day,an incorrect DOB was recorded and entered into thehospital identification system. No matching detailswere found and a new patient record was createdwith a new MRN and the wrong date of birth. Twounits of red cells were issued with the correctpatient details and unique transfusion stickernumber, which had been taken from the sample.Remote checking of the unit pre-transfusion failedto identify that the ID wristband contained adifferent date of birth and MRN number to the labelon the unit and the crossmatch form. The error wasonly discovered during the pre-transfusion bedsidechecking of the second unit. The patient suffered nocomplications as a result of this transfusion.



Incorrect details on ID wristband/Missing IDwristband (n=7)

Findings

• Three reports involved problems with specialtransfusion stickers used for patient identificationat transfusion sampling and administration.

• A further three involved incorrect DOB details onthe ID wristband.

• In the final case, there was no ID wristband onthe patient.

Recommendations:

• The importance of positive patient identificationusing an accurate ID wristband has beenhighlighted over several years through both theNHO and SHOT reports. (NHO 2002, SHOT 2003)

• A secure patient identification procedure shouldbe in place in all hospitals and the ID wristbandshould be worn at the time of taking of thecrossmatch sample and should be in place beforetransfusion. This ID wristband should containthree unique identifiers which include thepatient’s full name, date of birth and uniqueidentification number. (NBUG, 2004).

• The importance of asking the patient to identifythemselves prior to sampling and administrationin order to identify any discrepancies is againhighlighted.

• 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 must be strictly adhered to (BCSH,1999).

TABLE 15 INCORRECT DETAILS OR MISSING IDENTITY BAND (N=7)

Level CaseNumber


Symptoms &Outcome

Cause of Error

2 IBCTCase 95*


The patient’s ID wristband was removedprior to transfusion and the patient wasnot positively identified at the bedside.

3 IBCT Case 74



Incorrect DOB on wristband. Transfusedwith unique blood transfusion number,correct hospital number and patientname.

3 IBCT Case 92



Pre-transfusion sample had newTypenex number. Patient not wearingcorresponding ID wristband.

3 IBCT Case 94


ID wristband contained incorrect DOB.Completed report not received beforegoing to press.



TABLE 15 INCORRECT DETAILS OR MISSING IDENTITY BAND (N=7)

Level CaseNumber


Symptoms &Outcome

Cause of Error

3 IBCT Case103


Unit of blood commenced using onlytwo identifiers. No chart number on IDwristband and the unique transfusionsticker had fallen off.

3 IBCT Case113



Incorrect DOB on wristband notverified during sampling or at the finalbedside check. Unique transfusionsticker also missing from ID wristband.

3 IBCTCase117

Four units of red cells No complicationsas a result of thistransfusion.

Incorrect DOB on wristband, issuevoucher and unit. Not verballychecked with the patient who wasconscious and coherent.

Incorrect details or missing identity band (n=7)

We describe one case to emphasise that the bedsidecheck is still not being performed correctly in allinstances.

Level 2 IBCT Case 95This elderly patient with an underlying malignancyrequired a transfusion of three units of red cells for apostoperative anaemia Hb 7.5/dl. The patient’s IDwristband was removed prior to the transfusion. Thenurse intended to replace the ID wristband but forgotand the final bedside check did not includeconfirmation of the patient’s identity at the bedsideby two people. One unit of red cells was administereduneventfully and the error was identified on the wardprior to administration of subsequent units. Whenasked about the omission of bedside check, the nursefelt that she knew the patient really well andtherefore did not check her identity.

Incorrect details on sample (n=7)

Findings

Seven incidents related to pre-transfusion sampleerrors resulting in errors in the unit issue labels. Themistakes were not identified prior to administration

but all errors were subsequently identified by clinicalward staff and reported to the TSO.

• In four cases, an incorrect date of birth wasrecorded on the sample and in one case thesample contained an incorrect name.

• Four cases involved samples labelled with an incorrect MRN and of these two had anadditional incorrect date of birth and one an incorrect first name.

• In one case (Case 12), the wrong date of birth onthe sample led to failure to access previous records.

• In three cases (Case 12, 46 and 104), the errorwas discovered pre-transfusion but despitehospital policy, the decision was made totransfuse the units.

• This can, as in Case 46, cause considerable distressfor the clinical staff involved as the advice givenwas in direct contradiction to the hospital policy.

• In three cases, the errors were discoveredfollowing transfusion of subsequent units fromthe crossmatch.



• In Case 84, the wrong MRN used would havebeen detected if the laboratory computer and thehospital computer systems were interfaced.

Recommendations

• Hospital laboratories should have SOP or Policiesfor 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 order to reduce sampling errors extended or 24hours phlebotomy services are recommended.

• 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, especially

those not regularly working in transfusion, theimportance of strict compliance.

• In an emergency, where there is insufficient timeto obtain results from a fresh sample, the policyshould include the use of emergency O negativeblood until the patient has been regrouped.

• Automated barcode systems which printtransfusion labels at bedside from the patient’swristband are available and would prevent theerrors described.

• The linkage of the laboratory computer systemand the hospital PAS system would also helpdetect these errors.

TABLE 16 INCORRECT DETAILS ON SAMPLE (N=7)

Level Case Number


Symptoms &Outcome

Cause of Error

2 IBCT Case 12*


Wrong DOB used on pre-transfusionsample and no unique hospital numberused.

2 IBCT Case 46*

One unit of red cells No complications as a result of thistransfusion.

Incorrect first name and no MRN onsample and request form. Patientunable to self identify. MRN addedafter nurse brought omission to thenotice of laboratory personnel and unittransfused against hospital policy.

2 IBCT Case 104


Incorrect DOB on sample tube,wristband, request and crossmatchform. Units transfused despite patientgiving correct DOB during finalchecking procedure.

3 IBCT Case 5

Four units of red cells No complicationsas a result of thistransfusion

Incorrect DOB and MRN transcribedonto sample tube.



TABLE 16 (CONTINUED) INCORRECT DETAILS ON SAMPLE (N=7)

Level Case Number


Symptoms &Outcome

Cause of Error

3 IBCT Case 29



Patient’s surname mis-spelt on initialsample. Further transcription error inlaboratory giving totally new name.Three units administered before theerror was noticed.

3 IBCT Case 80


One digit of DOB transcribedincorrectly on crossmatch form andsample tube. One unit of red cells wastransfused before error detected.

3 IBCT Case 84


Incorrect MRN on sample tube andrequest form. Incorrect MRNtranscribed onto the blood pack andcompatibility form. No MRN onwristband.

Incorrect details on sample (n=7)

We report two cases in detail as they illustrate theproblems that are caused when patient details arenot filled in correctly on pre-transfusion samples.

Level 2 IBCT Case 12This female patient who had previously been an in-patient in this hospital was admitted via the A&EDepartment with a suspected ectopic pregnancythat required immediate surgery. A pre-transfusiongroup and crossmatch was taken. The patient wasnot wearing an ID wristband and did not have anMRN at the time of sampling as the A&EDepartment cannot assign a new MRN out-of-hours.A wrong date of birth was recorded on the sample.Hospital policy states that incorrectly or incompletelylabelled pre-transfusion samples should be rejectedand a repeat sample requested. In this instance,policy was not adhered to as it was felt that thecross matching should proceed due to the nature ofthe emergency. However there were four units of

designated emergency group O Rh D negative redcells available. Three units of red cells werecrossmatched and issued on-call without an MRNand with a wrong date of birth by a medicalscientist who does not regularly work in transfusion.The transfusion took place in theatre and the errorwas not identified during the checking procedures atthe time of collection or during the pre-transfusionchecking procedure. During the bedside checkingprocedure of the third unit, the error was discoveredand the unit was returned to the laboratory for re-labelling. There were no complications to thistransfusion. Re-education regarding pre-transfusionchecking procedures has been undertaken.

Level 2 IBCT Case 46This elderly patient with symptomatic anaemia Hb3.9g/dl was prescribed five units of red cells. Thesample and the request form contained an incorrectfirst name and no MRN. The patient had notpreviously been transfused in this hospital. The on-call medical scientist who did not normally work in



the transfusion laboratory processed the samplewithout the MRN and crossmatched the units. Thefirst unit was collected from the laboratory andduring the final bedside administration check,clinical staff noticed the first name was incorrect andthere was no MRN on the crossmatch form. Whenthe medical scientist was contacted about this, theMRN was added to the unit and clinical staff wereadvised to transfuse the unit. Although contrary tohospital policy, the doctor on-call advised that thetransfusion could proceed and the first unit of redcells was transfused. The TSO was informed the nextmorning and a repeat specimen was taken from thepatient. Four further units were issued andtransfused. The patient suffered no complications asa result of this incident. However, it caused delay intransfusion for the patient and considerable distressfor staff as the hospital policy was not adhered to.

Unit labelling errors (n=9)

Findings

Nine cases reported involved errors in the laboratoryin labelling units for transfusion. These incidentshighlight the importance of accurate patientidentification and checking documentation duringbedside administration. In all cases, these errorswent unnoticed during the final bedside check.None caused complications for the patients.

• Two cases (Case 38 and 86) involved thetransfusion of pooled platelets and SD plasmawithout unit labels.

• In two cases (Cases 71 and 81), the labels onunits which were crossmatched for the intendedpatient were inadvertently transposed.

• In one case (Case 108), the crossmatch reportforms issued with two units were mixed upduring an emergency massive haemorrhage.

• The final four cases (Cases 2, 57, 75 and 114)contained discrepancies in MRN numbers, date ofbirth or laboratory unit number.

Recommendations

• An uninterrupted working environment isrecommended at all stages during the transfusionprocess.

• As nurses are the last line of defence in providingsafe effective care for their patient, the finalbedside check provides an opportunity to detectand prevent preceding errors.

• There should be a designated person to checkand record units during transfusion for massivehaemorrhage to ensure traceability of all bloodcomponents and products.

• Electronic systems in the laboratory and at thebedside that reduce errors are recommended.


TABLE 17 UNIT LABELLING ERRORS (N=9)

Level Case Number


Symptoms &Outcome

Cause of Error

2 IBCT Case 38

One unit of pooledplatelet concentrate


One unit of unlabelled pooled plateletconcentrate delivered directly to ward.Advice from laboratory was toadminister the unit and return the bagfor labelling in the morning. Plateletswere administered with no issue formor label to cross check against.

2 IBCT Case 71


Two compatible units where issue labelswere transposed were not discovereduntil checking the second unit.

2 IBCT Case 81

Two units of red cellsas a result of thistransfusion


During the labelling procedure atransposition of labels occurred on twocompatible units designated for thispatient. Error not detected prior totransfusion.

2 IBCT Case 86

Six units of SDplasma


Six units of SD plasma were issued andtransfused with no patient issue labelattached to the bag.

2 IBCT Case 108


Massive transfusion occurred on-calland the compatibility issue reports weremixed up for two of the units involved.Both units were for the same patient.

3 IBCT Case 2

Three units of redcells.


Error in patient’s DOB by one digit onthe request form which was amendedbut incorrect on unit issue label andcompatibility report.

3 IBCT Case 57


Erroneous entry of MRN into laboratorycomputer resulting in wrong MRN oncomputer generated issue label.

3 IBCT Case 75


Number on the unit label did notcorrespond with the number on thecrossmatch form. At collection andadministration only one side of the unitwas checked with the compatibilityreport form.

3 IBCT Case 114


IT failure led to handwritten issue labelwhich was incorrectly transcribed fromthe sample tube.


TABLE 18 MISCELLANEOUS INCIDENTS (N=5) Due to the relatively minor nature of these incidents (apart from case 52) they are included in Table form only

Level Case Number


Symptoms &Outcome

Cause of Error

1 IBCT Case 52*p

8000 iu of Refacto No complicationsas a result of thistransfusion.

Refacto was prescribed instead ofRecombinate for a patient with highresponding inhibitors. It washighlighted on the computer systemthat this patient normally receivesRecombinate or Novoseven.Laboratory staff questioned requestbut were asked to issue the product.

2 IBCT Case 20

One unit of apheresisplatelets

No complicationsas a result of thistransfusion

Verbal order for platelets, writtenprescription for FFP. Platelets issuedand transfused, error in writtenprescription not noted.

2 IBCT Case 77


Daily red cell requirement for four daysdocumented in patients medicalrecord. The Hb was being checkeddaily following each unit. The last unitwas not prescribed until after unit hadcommenced.

2 IBCT Case 96


Crossmatch sample should have beenrepeated as more than 72 hours hadelapsed since the original crossmatchhad been taken. The patient had beentransfused within that time.

3 IBCT Case 83


Incorrect DOB recorded on pastadmission. Historical record used toprint crossmatch form.

IBCT involving Factor Concentrate (n=1)

Prescription (n=2)

Expired sample (n=1)

Crossmatch Form (n=1)



Incorrect Blood Component Transfused: Incidents involvingAnti–D Immunoglobulin

Incidents involving errors or omissions relating toAnti-D or factor concentrates are collected by theNHO as they also relate to transfusion practice. Anyadverse reactions to the administration of Anti-D orfactor concentrates are reportable directly to theIMB under the Pharmacovigilance Scheme. Ifreceived by the NHO, these reports are forwarded tothe IMB and are not covered in this report.

Findings:

• There were eleven incidents involving theadministration of Anti-D. Ten were classified asserious or level 1. Six incidents involved errors inadministration of Anti-D, four involved a delay inadministration and there was one incident whereAnti-D was omitted.

• Four of these occurred due to errors in the clinicalarea, four in the laboratory and two involvedcommunications between the laboratory andclinical area.

Anti-D given in error (n=6)

• In one of the six cases involving errors inadministration of Anti-D, the patient was Rhpositive (Case 30).

• In three cases (Cases 30, 36, and 107), instead ofchecking the records, assumptions were made onthe basis of cord blood or Kleihauerrequests/results that the mother required Anti-D.In case 30, the mother was in fact Rh positive, incase 36, the mother was already alloimmunisedand in case 107, the baby was Rh negative andAnti-D was not required.

• One case involved an error in cord blood groupingby on-call medical scientist not normally workingin blood transfusion (Case 16).

• One case involved a prescription written up forthe wrong patient and administered withoutchecking the baby’s group which would havedetected the error (Case 47).

• In the final case (Case 106), the vial of anti D hada label which contained incorrect patient details.

• None of the patients suffered complications as aresult of these incidents but in five of the caseswere exposed unnecessarily to a blood product.

Omission/delay (n=5)

In four of the five cases, Anti-D was given five tonine days after delivery and in the final case, Anti-Dwas never given.

• Two errors arose in the clinical area (Case 31 and22), two involved the clinical/laboratory interface(Case 17 and 69) and one occurred in thelaboratory (Case 25).

• In the one incident where Anti-D was never given(Case 17), a number of factors were responsible.The patient’s chart was not stamped as Rhnegative, as was hospital policy, the patientwished to leave hospital very soon after deliverybefore antenatal arrangements were made andthe maternal Rh and cord blood results were notyet available. When available, they seem to havebeen filed in the chart without review.

• One incident (Case 25) was a transcription error ofa cord blood result which was recorded correctlyin the laboratory record book and computer butincorrectly on the manually generated report formwhich was sent to the clinical area.

• One incident (Case 69) involved a telephonedresult from the laboratory to the ward but theward had no recollection or record of the call.

• In one incident (Case 31), cord bloods were nottaken following an elective Caesarean section.

• The final incident (Case 22) involved a patient in ageneral hospital nursed in a general surgical wardwhere the omission was only detected on transferto the gynaecology ward.

All of the patients are being followed up to excludesensitisation but the period of follow up to date istoo short to completely exclude sensitisation.

Recommendations

• There is a need to develop a co-ordinated systemto ensure that decisions to issue and administerAnti-D are not made on assumptions but on thedocumented Rh group of the mother, herantibody status and the Rh group on the cordblood. The findings in this report illustrate thedifficulties in ensuring this happens.

• While many hospitals issue Anti-D through thelaboratory as they have access to both the motherand/or baby’s group and antibody records and canissue the Anti-D labelled for the patient, thefindings suggest a co-ordinated approach toreview all laboratory results is necessary to ensurecorrect issue of product.

• Whether the hospital blood banks or clinical areastake responsibility for prophylactic Anti-Dadministration, there is clearly a need foreducation of all staff involved inprescription/administration of Anti-D prophylaxis.Assumptions are made when theknowledge/understanding is lacking.

• Hospitals should have a system in place to checkthe Rh D status of all deliveries in the previous 24hours to ensure that cord bloods are taken fromRh D negative mothers at the time of delivery. Ifan omission does occur a sample can then betaken from the baby for assessment.

• When a mother is found to be Rh D negative, analert to this fact should be placed on the medicalrecord/hospital computer to alert all staff to thenecessity of checking the Rh D group of the infant.

• As it is important to avoid errors due totranscription of results, a laboratory computergenerated alert is the safest option where the



information system in the laboratory and hospitalare linked.

• The importance of access via computer to thecurrent results or to a written or computergenerated report on mother and baby and not averbal report is emphasised. Wherever possible,these written results rather than telephone resultsshould be used to prescribe and administer Anti-D.

• If results are taken over the phone. details shouldbe clearly entered on the patient‘s chart andshould include date, time and name of the persongiving the result and signed by the person takingthe result.

• Where possible, cord blood specimens taken andsent to the laboratory at the time of delivery outof hours should be tested the following morning.This will avoid testing by scientists not normallyworking in transfusion, Anti-D can then be issuedand administered during day-time working hours.

• However this needs to be balanced against thefact that patients are now being dischargedearlier following delivery so it is important thatsystems are in place to ensure that these patientsare not missed. (Case 17)

• Where mothers or babies are being nursedoutside the normal clinical areas, it should be theresponsibility of the referring unit to follow upthese patients and ensure that clinical staff areaware of specific requirements.

• Medical and Nursing staff working in all clinicalareas where Rh D negative women are beingtreated should be familiar with Anti-D guidelinesin order to avoid omission or delay in theadministration of Anti-D.

• Where Anti-D has not been administered withinthe 72 hour period every effort should still bemade to administer the anti-D within 9-10 days ofthe sensitising event as this may afford someprotection (BCSH, 1999).

Incorrect administration or omission of Anti-D(n=6)

Cord blood sent to laboratory and theassumption made that the mother must be RhD negative

Level 1 IBCT Anti-D Case 30This baby delivered by caesarean section to a Rh Dpositive mother during normal working hours had acord blood sample taken for antibody screen only asAnti-M antibodies had been identified in themother’s sample during the antenatal period. Clinicaldetails were not documented on the request form,although there was a record of unidentifiedantibodies on the laboratory computer system.Inadvertently, a group was also performed and thebaby was correctly found to be Group O Rh Dpositive. The medical scientist processing the requestnormally works in the transfusion laboratory andassumed that if a baby’s cord blood sample wasreceived, then the mother must be Rh D negative.Without checking the mother’s historical groupingrecords, anti-D was labelled and issued for themother. The product compatibility report formgenerated stated the ABO and Rh D status of boththe mother and the baby, but this information wasoverlooked. Clinical staff were informed that theanti-D was available for collection for this patient.Subsequently Anti-D was prescribed, collected andadministered without reference to the Rh D status ofthe mother. A senior transfusion scientist discoveredthe error during routine checking of all work at theend of the working day. By this time, the Anti-D hadbeen administered. The laboratory computer systemhas been reviewed and an alert has been put inplace to warn the user not to issue Anti-D to Rh Dpositive mothers.


TAB

LE 1

9 A

DM

INIS

TRA

TIO

N O

F A

NTI

-D IN

ER

RO

R

(N=

6)

Leve

lC

ase

Nu

mb

erA

BO

an

d

Rh

D G

rou

p o

fPa

tien

t

AB

O a

nd

Rh

DG

rou

p o

f IB

CT

Vo

lum

e o

f In

corr

ect

Blo

od

C

om

po

nen

t o

r Pr

od

uct

Tra

nsf

use

dSy

mp

tom

s &

Ou

tco

me

Cau

se o

f Er

ror

1IB

CT

Ant

i-DC

ase

16*

Gro

up A

B Rh

Dne

gativ

eC

ord

Blo

od

:G

roup

AB

Rh

D n

egat

ive

1250

iu A

nti-D

No

com

plic

atio

ns.

Cor

d bl

ood

grou

ped

as R

h D

pos

itive

iner

ror

and

Ant

i-D g

iven

acc

ordi

ngly.

1IB

CT

Ant

i-DC

ase

30*

Gro

up O

Rh

Dpo

sitiv

eB

aby:

G

roup

O R

h D

posi

tive

1250

iu A

nti-D

No

com

plic

atio

ns.

Cor

d bl

ood

sent

for

ant

ibod

y sc

reen

onl

ybu

t gr

oup

done

as

rout

ine

on t

his

sam

ple.

Baby

Rh

D p

ositi

ve.

Nee

d fo

r A

nti-D

was

assu

med

with

out

chec

king

the

mot

hers

Rh

D s

tatu

s.

1IB

CT

Ant

i-D

Cas

e 36

*G

roup

B R

h D

ne

gativ

eB

aby:

Gro

up B

Rh

Dpo

sitiv

e

1250

iu A

nti-D

No

com

plic

atio

ns.

Unn

eces

sary

Kle

ihau

er r

eque

sted

.Pr

ophy

lact

ic A

nti-D

issu

ed a

nd a

dmin

iste

red

in e

rror

to

alre

ady

sens

itise

d pa

tient

.

1IB

CT

Ant

i-DC

ase

47*

Gro

up O

Rh

Dne

gativ

eB

aby:

G

roup

A R

h D

neg

ativ

e

1250

iu A

nti-D

No

com

plic

atio

ns.

Pres

crip

tion

writ

ten

in w

rong

pat

ient

’s dr

ugre

cord

. A

nti-D

issu

e re

port

for

m a

nd b

aby’

sgr

oup

not

incl

uded

in t

he c

heck

ing

proc

edur

e.

3IB

CT

Ant

i-DC

ase

106

G

roup

A R

h D

nega

tive

Bab

y:G

roup

A R

h D

nega

tive

I250

iu v

ial A

nti-D

N

o co

mpl

icat

ions

.Is

sue

labe

l and

issu

e vo

uche

r co

ntai

ned

inco

rrec

t su

rnam

e of

pat

ient

. N

oted

at

the

time

of c

olle

ctio

n bu

t ad

min

istr

atio

nco

ntin

ued

on t

he a

dvic

e of

the

labo

rato

rysc

ient

ist.

1IB

CT

Ant

i-DC

ase

107*

Gro

up O

Rh

Dne

gativ

eB

aby:

Gro

up O

Rh

D n

egat

ive

1250

iu A

nti-

D

No

com

plic

atio

ns.

Posi

tive

Kle

ihau

er r

esul

t fo

llow

ing

larg

eFM

H.

Baby

’s gr

oup

assu

med

Rh

posi

tive

and

not

chec

ked.

A

nti-D

adm

inis

tere

d.

* In

clu

ded

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r


TAB

LE 2

0 O

MIS

SIO

N/D

ELA

Y IN

AD

MIN

ISTR

ATI

ON

OF

AN

TI-D

(N

=5)

Leve

lC

ase

Nu

mb

erA

BO

an

d

Rh

D G

rou

p o

fPa

tien

t

AB

O a

nd

Rh

DG

rou

p

Del

ay/o

mis

sio

n in

ad

min

istr

atio

no

f A

nti

-DSy

mp

tom

s &

Ou

tco

me

Cau

se o

f Er

ror

1IB

CT

Ant

i DC

ase

17*

Gro

up O

Rh

Dne

gativ

eC

ord

Bloo

d:G

roup

O R

h D

posi

tive

Ant

i-D o

mitt

edN

egat

ive

antib

ody

scre

en t

wo

mon

ths

late

r.C

ord

bloo

d gr

oupe

d as

Rh

D p

ositi

ve.

Patie

nt d

isch

arge

d pr

ior

to r

epor

t be

ing

avai

labl

e. R

epor

t fil

ed in

cha

rt u

nsee

n

1IB

CT

Ant

i-DC

ase

22*

Gro

up O

Rh

Dne

gativ

eC

ord

Bloo

d: N

/A

Five

day

del

ay.

No

com

plic

atio

ns.

Ant

ibod

ysc

reen

neg

ativ

e th

ree

wee

ksla

ter.

Patie

nt w

as o

n a

gene

ral s

urgi

cal w

ard,

omis

sion

not

not

ed u

ntil

the

patie

nt w

astr

ansf

erre

d to

gyn

aeco

logi

cal w

ard

1IB

CT

Ant

i-DC

ase

25*

Gro

up O

Rh

Dne

gativ

eC

ord

Bloo

d:G

roup

O R

h D

posi

tive

reco

rded

in e

rror

Ten

day

dela

yN

o co

mpl

icat

ions

Dis

crep

ancy

in la

belli

ng o

f sa

mpl

e an

dre

ques

t fo

rm le

d to

sam

ple

not

bein

gpr

oces

sed

in s

eque

nce

and

inco

rrec

tlytr

ansc

ribed

as

Rh D

neg

ativ

e.

Dis

crep

ancy

not

disc

over

ed d

urin

g fin

al c

ross

che

ck a

snu

mbe

r ou

t of

seq

uenc

e

1IB

CT

Ant

i-DC

ase

31*

Gro

up O

Rh

Dne

gativ

eBa

by:

Gro

up B

Rh

Dpo

sitiv

e

Five

day

del

ayN

o co

mpl

icat

ions

. F

oran

tibod

y sc

reen

six

mon

ths

post

inci

dent

.

Cor

d bl

ood

not

take

n at

del

iver

y.

Erro

rno

ted

prio

r to

dis

char

ge w

hen

baby

’s gr

oup

chec

ked

and

foun

d to

be

Rh D

pos

itive

.

1IB

CT

Ant

i DC

ase

69*

Gro

up O

Rh

Dne

gativ

eC

ord

bloo

d:G

roup

O R

hpo

sitiv

e

Five

day

del

ayN

o co

mpl

icat

ion.

For

antib

ody

chec

k si

x m

onth

spo

st in

cide

nt.

Phon

ed r

epor

t th

at c

ord

bloo

d w

as R

h D

posi

tive

not

acte

d on

.

* In

clu

ded

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r

Assumption that anti-D needed becauseunnecessary Kleihauer sent as mother alreadysensitised

Level 1 IBCT Anti-D Case 36This Rh D negative mother who had documentedAnti-D antibodies during pregnancy had a bloodsample taken for grouping, antibody screening andestimation of feto-maternal haemorrhage (FMH)following the delivery of a healthy Rh D positivebaby. The grouping sample was processed outsidenormal working hours and again anti-D wasdetected. The following morning, a locum basicgrade transfusion scientist processed the FMHestimation request unnecessarily and issued anti-Dto this already sensitised patient. The Anti-D wassubsequently delivered to the clinical area,prescribed and administered unnecessarily.Laboratory staff detected the error later that daywhen retrospectively checking all work, by whichtime the anti-D had been administered.

Assumption based on results of Kleihauer testthat the baby was Rh D positive

Level 1 IBCT Anti-D Case 107 Post emergency caesarian section, this Rh D negativemother had a Kleihauer test in order to quantify theextent of a large foetal maternal haemorrhage. Theresult of the Kleihauer, 24mls was sent to the postnatal ward. The baby was being nursed at this timein the special care baby unit. The baby’s blood groupwas not done but presumed by the staff caring forthe mother to be Rh D positive due to the Kleihauerresult. Because of the extent of the fetomaternalhaemorrhage, intravenous Anti-D was administered.Subsequently blood for flow cytometry was sent toanother laboratory to determine if an adequateamount of Anti-D had been given. Testing showedthe baby to be Rh D negative. This administrationwas contrary to local guidelines, which require anofficial report to be viewed prior to the prescriptionand administration of Anti-D.

Prescription written in the incorrect drug recordand Anti-D administered in error to the wrongpatient

Level 1 IBCT Anti D Case 47A Rh D negative mother delivered an Rh D positivebaby and Anti-D was labelled and issued from thelaboratory to the clinical area for her accompanied bythe issue report form containing her details. Althoughhospital policy states that the record of the Rh D statusof both the mother and the baby must be seen beforeprescribing and administering Anti-D, the prescribingdoctor wrote the prescription on the wrong patient’sdrug record, the Rh D status of the wrong patient’sbaby who was Rh D negative was not checked norwere the details on the Anti-D issue report form. Theerror was discovered by the staff who administeredthe anti-D when filing the issue report form. The Rhnegative patient for whom the Anti-D was intendedreceived Anti-D within 72hrs of delivery asrecommended. The patient who had received theAnti-D in error was informed of the event.

Error in cord blood testing

Level 1 IBCT Anti-D Case 16This Rh D negative mother delivered her baby duringthe weekend. A medical scientist not normallyworking in transfusion processed the cord blood oncall. The cord blood was grouped in error as Rh Dpositive and Anti-D was issued and administeredaccordingly. During a routine check of all on-call workon the next working day, the error was identified andthe clinical staff were alerted to the error. At this timethe anti-D had already been given and the patientexposed to an unnecessary blood product. The cordblood had been grouped by column technology and itis unclear how the error occurred.


Omission/ Delay in the Administration of Anti-D (n=5)

Failure to check Rh group prior to earlydischarge and failure to follow up cord bloodresults

Level 1 IBCT Anti-D Case 17 This young Rh D negative mother had a cord bloodsample taken following delivery. The mother wasextremely anxious for discharge and followingreview by the obstetric team was discharged quicklybefore arrangements had been completed forpostnatal care. In this hospital, all of the group andantibody screen reports are filed in the patient'snotes on a mount sheet. The midwives and doctorsrefer to these reports prior to Anti-D administration.However the blood group and antibody screenresults are transcribed with a 'Rh Negative' stamp onthe front of the patient's notes. This serves tohighlight women who are Rh D negative. On thisoccasion, the patient’s blood group was nottranscribed on the front of the medical record andthe staff were not alerted to the Rh D negativestatus of the mother. Prior to discharge the patientsRh D negative status went unnoticed and the cordblood, which was Rh D positive, was unavailable. Itis unknown how the cord result ended eventually inmedical records for filing. The omission wasdiscovered six weeks later by the TSO during aroutine audit of Anti-D usage. The patient returnedto the clinic two months post delivery and wasinformed of the ommission. An antibody screentaken at this time was negative.

Transcription error in cord blood group

Level 1 IBCT Case 25 A cord blood from a Rh D negative mother was sentto the laboratory for ABO and Rh D grouping. Due toa recent change in the allocation of hospital numbers(all newborns now have their own unique hospitalnumber), a discrepancy occurred in the initial labellingof the cord blood and request form. The persontaking the specimen was contacted and during

correction of the discrepancy, the sequencing oflaboratory numbers was interrupted. The result of thescreening obtained was manually recorded correctly inthe group and antibody book as O Rh D positive butincorrectly recorded manually on the report form as ORh D negative. This manual report was sent to theward. The final cross-reference check of the groupbetween the antibody record book, the informationrecorded on the laboratory computer system and thegenerated report failed due to discrepant sequencingof numbers. This hospital always manually records theRhD status of the mothers on the original requestform, which comes from the ward and a copy of thisis retained in the lab. This is because the form is adifferent colour and alerts ward and laboratory staffto the Rh D status of their patients.During a routinecheck by the TSO of the antibody record book, theomission of Anti-D immunoglobulin was noted. Thepatient was contacted and received anti-D within 10days post delivery.

Failure to take cord samples

Level 1 IBCT Anti-D Case 31 This Rh D negative mother delivered a healthy infantby elective caesarean section during normal workinghours. Cord bloods to confirm the Rh D group of thebaby were not taken at the time of deliveryaccording to hospital policy. The error was discoveredfive days later, prior to discharge, and a sample takenthen found the baby was Rh D positive. The antibodyscreen taken from the mother at this time wasnegative. Anti-D was given five days post delivery. Asa result of this incident, the transfusion laboratorywill in future check the Rh D status of all womenwho have delivered in the previous 24 hours toensure that cord bloods have been taken.


Problem with telephone results

Level 1 IBCT Anti-D Case 69 This Rh D negative mother delivered a Rh D positivebaby which was confirmed on the cord blood sample.The ABO and Rh D group results of mother and infantwere telephoned from the laboratory to the ward. Thestaff on the ward did not recall this telephonedinformation and there was no documented note of it.However, the mother’s Rh D negative status wasalready clearly documented in her medical record. Fivedays later, it was noticed that the patient had notreceived Anti-D. The patient was contacted and Anti-Dwas then administered five days post delivery. As aresult of this incident, the hospital have issuedadditional local policy recommendations regarding theadministration of Anti-D.

Lack of awareness in general hospital of Anti-Drequirements

Level 1 IBCT Anti-D Case 22 This Rh D negative female patient underwentemergency surgery for an ectopic pregnancy. For thefirst four days post operatively the patient wasnursed on a general surgical ward. On day five thepatient was transferred to a gynaecological wardwithin the hospital and it was discovered thatadministration of Anti-D had been omitted. Fivedays post-operatively, the patient received one vialof Anti-D.The patient had an antibody screen threeweeks post operatively which was negative.



Severe Acute Anaphylactoid or Anaphylactic Transfusion Reaction

Definition: Allergic, anaphylactoid andanaphylactic transfusion reactions span a rangeof symptoms of varying severity. The symptomsencompass simple allergic-type reactions suchas urticaria/pruritis associated with or withoutgastrointestinal discomfort, to more severereactions such as stridor, wheeze,bronchospasm, laryngeal oedema andhypotension. The onset of intractablehypotension or shock with loss ofconsciousness is commonly designated as ananaphylactic reaction. In its severest formanaphylaxis can be fatal. (Vamvakas, 2001)

This category accounted for 23 (13%) of incidentsreported during this reporting year. This represents adecrease of 8% on 2002 figures.

Findings:

• There were 23 reports received in total. Nine of the 23 cases (39%), involved children ≤ 18yrsof age.

• As in 2002, most A/A (57%) reactions wereassociated with transfusion of platelets. Of thethirteen reactions associated with platelettransfusions, seven involved pooled platelets andsix involved apheresis platelets.

• The number of reported reactions associated withplasma continues to fall with only one case (4%)involving SD plasma.

• Nine (39%) were associated with red celltransfusions. One reaction was associated withred cells where the transfusion was consideredinappropriate as the patient had iron deficiencyanemia but was haemodynamically stable. (Case10) This patient then went on to receive a furthertwo units three days later which were alsoconsidered unnecessary for the same reason.

• In three cases (Cases 8, 9 and 22), there wasfailure to prescribe pre-medication cover whichhad been recommended as a result of previousrepeated transfusion reactions. In one case (Case22), the patient was a known asthmatic. A single

National Haemovigilance Office


patient who had a previous history of medicationallergy was involved in the other two reactions.(Cases 8 and 9). In all three cases, receiving pre-medication cover may have prevented or lessenedthe severity of the patient’s symptoms.

• One case (Case 13), involved transfusion in a daycare setting. The patient developed symptomsfour hours later at home requiring return tohospital and overnight admission. This highlightsthe importance of ensuring that all patientstransfused in outpatient settings receive post-transfusion information including whom tocontact in the event of a transfusion reactionfollowing discharge.

• In most cases, the reactions were not severe andresponded quickly to treatment with the patientmaking a full recovery within hours. However, inone case (Case 16), the patient requiredadrenaline to control the symptoms. None of the22 patients required ITU admission as a result oftheir reaction.

• Eight patients (35%) - seven of them children -were prescribed washed components as a resultof A/A reactions.

• The causes of A/A are not always clear. Sixteen(70%) of the patients who suffered A/Atransfusion reactions required transfusions forunderlying malignant or hematological diseaseand were on multiple medications, including IVantibiotics and/or chemotherapy. This can make itdifficult to be certain if all of these reactions wereactually related to transfusion.

• However a number of patients had repeatedreactions and/or a previous history of allergy orasthma. In one case (Case 3), the reaction wasassociated with HLA antibodies in the patient.

• In five cases (Cases 4, 7, 10, 22 and 23), it wasunclear if the reaction was actually A/A as therewere no skin manifestations. In two of these

cases, (Cases 4 and 22) the patient’s symptomsincluded fever. In Case 7, an elderly femaleexperienced hypotension associated withrespiratory symptoms and tachycardia but fullinvestigation of the reaction was not carried out. InCase 10, the patient had rigors and hypertension.In Case 23, the development of oedema in bothhands forearms and face had initially been reportedas an unusual reaction but in view of thesymptoms it was captured as an A/A.

Recommendations

• Protocols and training for the management ofsevere A/A reactions should be in place in eachhospital and all staff involved in transfusionshould be familiar with them.

• The importance of only prescribing transfusionsthat are necessary cannot be over emphasised.Inappropriate transfusions increase donorexposure unnecessarily and can put the patient atrisk of a transfusion reaction.

• As iron deficiency produces a chronic anaemia, itdoes not normally require immediate correctionby transfusion. Oral or parenteral iron therapy iseffective as first line treatment for patients withiron deficiency anemia (Saxena, 1994).Transfusion therapy for these patients should notbe based on laboratory results, but should bebased on the clinical status of the patient i.e.patients with symptomatic anemia or whereurgent surgical intervention is necessary.

• Where patients are transfused in day caresettings, it is important that written post-transfusion information is given to the patientprior to discharge explaining whom to contactand symptoms to look for in case of a reactionfollowing discharge.

• Where patients are receiving shared care, systemsmust be in place so that all relevant detailsrelating to transfusion such as history of


reaction/allergy and/or premedicationrequirements can be communicated betweencentres effectively.

• 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 washedplatelets for patients with a history of transfusionreactions to pooled products, a trial of apheresisplatelets should be undertaken as patients whoreact to pooled platelets may often tolerateapheresis platelets. (see Case 19).

• IgA deficiency with anti IgA antibodies can causesevere anaphylactoid reactions and anaphylaxis.Since the transfused product may containappreciable quantities of IgA, where possible,samples taken pre-transfusion should be used tocheck for IgA levels.

• Classical allergic or anaphylactoid reactions do notroutinely require culture of the unit or pack orserological investigations. However, where atypicalsymptoms such as fever are present in a suspectedA/A reaction or where skin manifestations areabsent, it is important to culture the implicatedunit/s and the patient, to rule out underlyingsepsis and/or bacterial infection in the unit and inthe case of red cells to undertake sociological teststo exclude incompatibility.


TAB

LE 2

1A

NA

PHY

LAC

TOID

/AN

APH

YLA

CTI

CTR

AN

SFU

SIO

N R

EAC

TIO

N (

N=

23)

Cas

e N

oA

ge

ye

ars

Gen

der

Co

mp

on

ent

Rea

son

fo

r Tr

ansf

usi

on

Sym

pto

ms

Inve

stig

atio

ns

Stag

e Tr

ansf

usi

on

R

eact

ion

d

evel

op

ed

Trea

tmen

tSe

qu

elae

/Rec

om

men

dat

ion

s fo

r fu

ture

tra

nsf

usi

on

AA

Cas

e1*p

16

MO

ne u

nit

ofre

d ce

lls

Ana

emia

H

b 8

.7g/

dlU

rtic

aria

, hy

pote

nsio

n,dy

spno

ea,

rest

less

ness

,an

xiet

y, p

erio

rbita

loe

dem

a an

d sk

inw

heal

s.

IgA

leve

ls n

orm

al.

Red

Cel

lin

com

patib

ility

excl

uded

.

Follo

win

g th

e fir

st50

mls

.H

ydro

cort

ison

e an

dch

lorp

heni

ram

ine

IV.

Reco

vere

d fu

lly la

ter

that

day

with

no

com

plic

atio

ns.

Was

hed

cellu

lar

com

pone

nts

to b

e tr

ansf

used

infu

ture

if r

equi

red

with

pre

med

icat

ion

of c

hlor

phen

iram

ine

IV.

AA

C

ase

2*

34

FO

ne u

nit

ofre

d ce

llsPo

st-

oper

ativ

ean

aem

ia

Hb

6.6

g/dl

.

Dys

pnoe

a, s

trid

or,

cyan

osis

and

gast

roin

test

inal

sym

ptom

s.

Bact

eria

l cul

ture

of

patie

nt a

nd u

nit

perf

orm

ed –

no

orga

nism

s is

olat

ed.

IgA

leve

ls n

ot d

one.

Less

tha

n 50

mls

.Tr

ansf

usio

ndi

scon

tinue

d.C

hlor

phen

iram

ine

and

hydr

ocor

tison

eIV

.

Reco

vere

d w

ith n

o ill

eff

ects

with

info

ur h

ours

. N

o fu

rthe

r tr

ansf

usio

nne

cess

ary

to d

ate.

Com

men

ced

oral

iron

ther

apy.

AA

Cas

e 3

*

35

FO

ne u

nit

ofC

MV

nega

tive

and

irrad

iate

dre

d ce

lls

Hae

mat

olog

ica

l dis

orde

rH

b. 9

.4g/

dl.

Urt

icar

ia,

dysp

noea

,st

ridor

, w

heez

e,re

stle

ssne

ss,

anxi

ety,

dizz

y, w

eak,

and

fee

ling

of im

pend

ing

doom

.

IgA

leve

ls n

orm

al.

HLA

cla

ss 1

ant

ibod

ypr

esen

t.

Follo

win

g th

e fir

st10

0mls

.H

ydro

cort

ison

e an

dch

lorp

heni

ram

ine

IV.

Reco

vere

d w

ithou

t co

mpl

icat

ions

with

in a

few

hou

rs.

Sub

sequ

ent

tran

sfus

ions

with

pre

med

icat

ion

unev

entf

ul.

AA

Cas

e4*

71

FO

ne u

nit

ofre

d ce

lls.

Ana

emia

H

b. 7

g/dl

.D

yspn

oea,

chi

lls,

rigor

s,pe

riorb

ital o

edem

a an

dpy

rexi

a (3

9o C).

Uni

t no

t cu

lture

d.Pa

tient

cul

ture

d -n

ogr

owth

. R

ed c

ell

inco

mpa

tibili

tyex

clud

ed.

IgA

leve

ls n

ot d

one.

Less

tha

n 50

mls

.H

ydro

cort

ison

e an

dch

lorp

heni

ram

ine

IV.

Reco

vere

d w

ithou

t co

mpl

icat

ions

with

in f

ive

hour

s.

Subs

eque

nttr

ansf

usio

ns w

ith p

re m

edic

atio

nun

even

tful

.

Rea

ctio

ns

to r

ed c

ells

* In

clu

ded

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r


TAB

LE 2

1 (C

ON

TIN

UED

) A

NA

PHY

LAC

TOID

/AN

APH

YLA

CTI

C T

RA

NSF

USI

ON

REA

CTI

ON

(N

=23

)

Cas

e N

oA

ge

ye

ars

Gen

der

Co

mp

on

ent

Rea

son

fo

r Tr

ansf

usi

on

Sym

pto

ms

Inve

stig

atio

ns

Stag

e Tr

ansf

usi

on

R

eact

ion

d

evel

op

ed

Trea

tmen

tSe

qu

elae

/Rec

om

men

dat

ion

s fo

r fu

ture

tra

nsf

usi

on

AA

C

ase

636

F

One

uni

t of

red

cells

Ana

emia

of

chro

nic

dise

ase,

asso

ciat

edw

ith s

epsi

s H

b7.

9g/d

l.

Urt

icar

ia o

f up

per

and

low

er li

mbs

, dy

spno

ea,

subs

tern

al d

isco

mfo

rtan

d fe

ver.

Both

pat

ient

and

uni

tcu

lture

d ne

gativ

e.Ra

ised

IgA

leve

lsRe

d C

ell

Inco

mpa

tiblit

yex

clud

ed.

100m

ls

tran

sfus

edov

er f

our

hour

s.Tr

ansf

usio

ndi

scon

tinue

d.C

hlor

phen

iram

ine

and

para

ceta

mol

.

Tran

sfus

ion

stop

ped,

rec

over

ed w

ithno

ill e

ffec

ts w

ithin

one

hou

r.Pr

ophy

lact

ic c

hlor

phen

iram

ine

pres

crib

ed d

aily

for

ong

oing

ras

hes

and

itch.

Su

bseq

uent

tra

nsfu

sion

unev

entf

ul.

AA

C

ase

7 *

89

FO

ne u

nit

red

cells

Post

oper

ativ

ean

aem

ia

Hb

9.2g

/dl.

Patie

nt c

lam

my,

with

hypo

tens

ion,

dys

pnoe

a,ta

chyp

noea

and

tach

ycar

dia.

Patie

nt o

r un

it no

tcu

lture

d.

IgA

leve

lsno

t ch

ecke

d.Tr

ansf

usio

nIn

com

patib

ility

excl

uded

.

With

in m

inut

es.

Tran

sfus

ion

disc

ontin

ued

com

plet

ely.

No

med

icat

ion

pres

crib

ed.

Patie

nt r

ecov

ered

with

out

com

plic

atio

ns w

ithin

sev

en h

ours

.

AA

Cas

e10 *

39 MO

ne u

nit

red

cells

Iron

defic

ienc

yH

b 6.

8g/d

l.

Rigo

rs a

nd m

ildhy

pert

ensi

on.

Rais

ed Ig

A le

vels

U

nit

cultu

red

nega

tive.

Follo

win

g <

50m

lsof

thi

rd u

nit.

Tran

sfus

ion

aban

done

dfo

llow

ing

med

ical

revi

ew.

Patie

nt r

ecov

ered

ful

ly w

ithin

min

utes

.Fu

rthe

r tw

o un

its w

ith p

re-m

edic

atio

nun

even

tful

but

inap

prop

riate

.

AA

C

ase

13 *p

10

M40

0mls

of

red

cells

Ana

emia

H

b 6.

9g/d

l.Se

vere

urt

icar

ial b

ody

rash

with

wee

ping

rais

ed w

heal

s on

ski

n.

Non

eFo

ur h

ours

follo

win

gtr

ansf

usio

n. P

atie

ntat

hom

e.

Chl

orph

enira

min

eA

dmitt

ed t

o ho

spita

l ove

rnig

ht.

Reco

vere

d fu

lly w

ithin

24

hrs

Subs

eque

nt t

rans

fusi

ons

unev

entf

ulfo

llow

ing

pre-

med

icat

ion.

AA

Cas

e23 *

61 FTw

o un

its o

fre

d ce

llsPo

stop

erat

ive

bloo

d lo

ss

Oed

ema

of h

ands

,fo

rear

ms

and

face

.A

ntib

ody

scre

en a

ndD

AT

nega

tive.

End

of s

econ

d un

it.Fr

usem

ide

and

IVflu

ids.

Resp

onse

to

diur

etic

med

icat

ion

and

IV f

luid

s no

t do

cum

ente

d.

Rea

ctio

ns

to r

ed c

ells

* In

clu

ded

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r


TAB

LE 2

1 (C

ON

TIN

UED

) A

NA

PHY

LAC

TOID

/AN

APH

YLA

CTI

C T

RA

NSF

USI

ON

REA

CTI

ON

(N

=23

)

Cas

e N

oA

ge

ye

ars

Gen

der

Co

mp

on

ent

Rea

son

fo

r Tr

ansf

usi

on

Sym

pto

ms

Inve

stig

atio

ns

Stag

e Tr

ansf

usi

on

R

eact

ion

d

evel

op

ed

Trea

tmen

tSe

qu

elae

/Rec

om

men

dat

ion

s fo

r fu

ture

tra

nsf

usi

on

AA

C

ase

8*

36

FO

ne u

nit

pool

edpl

atel

etco

ncen

trat

e

Plat

elet

coun

t 14

x10

9 /L

Urt

icar

ia,

dysp

noea

and

ches

t tig

htne

ss.

Non

eLe

ss t

han

50m

ls o

ftr

ansf

used

.C

hlor

phen

iram

ine

and

hydr

ocor

tison

e.Re

cove

red

imm

edia

tely

fol

low

ing

trea

tmen

t. S

ubse

quen

t pl

atel

ettr

ansf

usio

ns h

ave

been

giv

enun

even

tful

ly w

ith p

re-m

edic

atio

n.

AA

C

ase

9*

36

FO

ne u

nit

aphe

resi

spl

atel

etco

ncen

trat

e

Plat

elet

coun

t 26

x10

9 /L

Urt

icar

ia,

chill

s an

d itc

h.

Non

eFo

llow

ing

50-7

5mls

of

tran

sfus

ion.

Tran

sfus

ion

disc

ontin

ued.

Hyd

roco

rtis

cone

and

chlo

rphe

nira

min

e.

Reco

vere

d fu

lly w

ithin

one

hou

r.Su

bseq

uent

pla

tele

t tr

ansf

usio

nsus

ing

pre-

med

cov

er h

ave

been

giv

enun

even

tful

ly.

AA

C

ase

11

*p

17

MO

ne u

nit

ofC

MV

nega

tive

and

irrad

iate

dap

here

sis

plat

elet

conc

entr

ate

Plat

elet

coun

t 10

X10

9 /L

Hyp

oten

sion

,ta

chyc

ardi

a,ur

ticar

ia,

ches

ttig

htne

ss,

coug

hing

and

falli

ng O

2sa

tura

tion.

IgA

leve

ls p

ost

tran

sfus

ion

low

-0.

37g/

L (r

elat

es t

oim

mun

osup

pres

sant

ther

apy

rece

ived

).

Whe

n 85

mls

of

plat

elet

s ha

d be

entr

ansf

used

.

Hyd

roco

rtis

one

and

chlo

rphe

nira

min

e.

Patie

nt r

ecov

ered

with

in n

inet

ym

inut

es w

ithou

t co

mpl

icat

ions

.Su

bseq

uent

tra

nsfu

sion

s us

ing

aphe

resi

s pl

atel

ets

and

pre-

med

cove

r ha

ve b

een

unev

entf

ul.

AA

C

ase

12

*p

6 M12

0mls

CM

Vne

gativ

e an

dirr

adia

ted

aphe

resi

spl

atel

etco

ncen

trat

e

Plat

elet

coun

t11

X10

9 /L

Itchi

ng,

hype

rten

sion

,dy

spno

ea r

estle

ssne

ssw

heez

e, n

ause

a an

dab

dom

inal

cra

mps

.

IgA

leve

ls n

orm

al.

30–3

5 m

ins.

into

tran

sfus

ion

120m

lstr

ansf

used

.

Pre-

med

cov

er p

rior

to t

his

tran

sfus

ion.

Tem

pora

rily

stop

ped,

sal

buta

mol

nebu

liser

giv

en.

Rem

aind

er o

f un

itth

en t

rans

fuse

d.

Shor

tnes

s of

bre

ath

reso

lved

with

inm

inut

es a

nd r

ash

reso

lved

late

r th

atev

enin

g.

Was

hed

prod

ucts

wer

ere

com

men

ded

for

futu

re t

rans

fusi

ons

and

have

bee

n tr

ansf

used

unev

entf

ully.

Rea

ctio

ns

to P

late

lets

* In

clu

ded

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r


TAB

LE 2

1 (C

ON

TIN

UED

) A

NA

PHY

LAC

TOID

/AN

APH

YLA

CTI

C T

RA

NSF

USI

ON

REA

CTI

ON

(N

=23

)

Cas

e N

oA

ge

ye

ars

Gen

der

Co

mp

on

ent

Rea

son

fo

r Tr

ansf

usi

on

Sym

pto

ms

Inve

stig

atio

ns

Stag

e Tr

ansf

usi

on

R

eact

ion

d

evel

op

ed

Trea

tmen

tSe

qu

elae

/Rec

om

men

dat

ion

s fo

r fu

ture

tra

nsf

usi

on

AA

C

ase

14

*p

2 MO

ne u

nit

ofC

MV

nega

tive

and

irrad

iate

dpo

oled

plat

elet

conc

entr

ate

Plat

elet

coun

t9X

109 /L

Urt

icar

ia,

strid

or,

whe

eze

and

seve

refa

cial

hiv

es.

Non

e.W

ithin

tw

o ho

urs

of s

tart

ing

tran

sfus

ion.

Pre-

med

cov

er p

rior

to t

rans

fusi

onC

hlor

phen

iram

ine

and

salb

utam

olne

bulis

ers.

Subs

eque

nt t

rans

fusi

ons

with

was

hed

plat

elet

s ha

ve b

een

unev

entf

ul.

AA

C

ase

15

*p

6 FO

ne u

nit

ofC

MV

nega

tive

and

irrad

iate

dap

here

sis

plat

elet

conc

entr

ate

Plat

elet

coun

t 8X

109 /L

Urt

icar

ial r

ash,

rai

sed

red

whe

als

and

blac

kene

d ey

es.

Non

e.W

hen

mor

e th

an10

0mls

had

bee

ntr

ansf

used

.

Pre-

med

icat

ion

cove

r pr

ior

totr

ansf

usio

n.

Patie

nt r

ecov

ered

ful

ly w

ithin

24hr

s.W

ashe

d pl

atel

ets

have

bee

nre

com

men

ded

for

futu

re t

rans

fusi

ons.

AA

C

ase

16 *p

6 MO

ne u

nit

CM

Vne

gativ

e an

dirr

adia

ted

aphe

resi

spl

atel

etco

ncen

trat

e.

Plat

elet

coun

t9X

109 /L

Urt

icar

ia,

strid

or a

ndw

heez

e.Pr

evio

us Ig

A le

vels

norm

al.

Ten

min

utes

follo

win

gco

mpl

etio

n of

tran

sfus

ion.

Pre-

med

cov

er p

rior

to t

rans

fusi

onA

dren

alin

e an

dhy

droc

ortis

one

IVgi

ven

post

tran

sfus

ion

.

Reco

vere

d fu

lly w

ithin

min

utes

of

rece

ivin

g tr

eatm

ent.

W

ashe

d pl

atel

ets

have

bee

n re

com

men

ded

for

futu

retr

ansf

usio

ns.

Rea

ctio

ns

to r

ed c

ells

* In

clu

ded

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r


TAB

LE 2

1 (C

ON

TIN

UED

) A

NA

PHY

LAC

TOID

/AN

APH

YLA

CTI

C T

RA

NSF

USI

ON

REA

CTI

ON

(N

=23

)

Cas

e N

oA

ge

ye

ars

Gen

der

Co

mp

on

ent

Rea

son

fo

r Tr

ansf

usi

on

Sym

pto

ms

Inve

stig

atio

ns

Stag

e Tr

ansf

usi

on

R

eact

ion

d

evel

op

ed

Trea

tmen

tSe

qu

elae

/Rec

om

men

dat

ion

s fo

r fu

ture

tra

nsf

usi

on

AA

C

ase

17 *p

6 MO

ne u

nit

CM

Vne

gativ

e an

dirr

adia

ted

pool

edpl

atel

etco

ncen

trat

e

Plat

elet

coun

t12

x109 /L

Urt

icar

ia,

dysp

noea

,st

ridor

and

whe

eze.

Non

eIm

med

iate

lyfo

llow

ing

tran

sfus

ion.

Pre-

med

cov

erhy

droc

ortis

one

and

chlo

rphe

nira

min

e.O

2th

erap

yad

min

iste

red

and

hydr

ocor

tison

ere

peat

ed.

Patie

nt r

ecov

ered

with

in o

ne h

our

and

disc

harg

ed t

wo

hour

s la

ter.

Patie

nt r

ecei

ved

one

unit

of a

pher

esis

plat

elet

s fo

ur m

onth

s la

ter

unev

entf

ully,

but

had

sev

ere

anap

hyla

ctoi

d re

actio

n to

aph

eres

ispl

atel

ets

on a

sub

sequ

ent

tran

sfus

ion

Patie

nt t

o re

ceiv

e w

ashe

dco

mpo

nent

s in

fut

ure.

AA

Cas

e18

61 MO

ne u

nit

CM

V-ne

gativ

e an

dirr

adia

ted

pool

edpl

atel

etco

ncen

trat

e

Pre

plan

ned

inva

sive

proc

edur

ePl

atel

etco

unt

37x

109

/L

Urt

icar

ia a

ndhy

pert

ensi

on.

Uni

t an

d pa

tient

cultu

red

- ne

gativ

e.Ig

A le

vels

pos

ttr

ansf

usio

n no

rmal

.

Imm

edia

tely

follo

win

gtr

ansf

usio

n.

Chl

orph

enira

min

e.

Patie

nt r

ecov

ered

ful

ly im

med

iate

lyfo

llow

ing

trea

tmen

t. S

ubse

quen

ttr

ansf

usio

ns u

sing

aph

eres

is p

late

lets

have

bee

n un

even

tful

.

AA

C

ase

19 *

41

MO

ne u

nit

CM

V-ne

gativ

e an

dirr

adia

ted

pool

edpl

atel

etco

ncen

trat

e

Plat

elet

coun

t 25

x 1

09 /L

Urt

icar

ia,

hypo

tens

ion,

back

ache

and

nau

sea.

Uni

t cu

lture

dne

gativ

e. P

atie

nt n

otcu

lture

d.Ig

A le

vels

not

chec

ked.

Follo

win

g th

e fir

st50

-100

mls

of

tran

sfus

ion.

Chl

orph

enira

min

ean

d hy

droc

ortis

one.

Patie

nt r

ecov

ered

ful

ly im

med

iate

lyfo

llow

ing

trea

tmen

t.

Subs

eque

nttr

ansf

usio

ns u

sing

aph

eres

is p

late

lets

have

bee

n un

even

tful

.

Rea

ctio

ns

to r

ed c

ells

* In

dic

ated

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r


TAB

LE 2

1 (C

ON

TIN

UED

) A

NA

PHY

LAC

TOID

/AN

APH

YLA

CTI

C T

RA

NSF

USI

ON

REA

CTI

ON

(N

=23

)

Cas

e N

oA

ge

ye

ars

Gen

der

Co

mp

on

ent

Rea

son

fo

r Tr

ansf

usi

on

Sym

pto

ms

Inve

stig

atio

ns

Stag

e Tr

ansf

usi

on

R

eact

ion

d

evel

op

ed

Trea

tmen

tSe

qu

elae

/Rec

om

men

dat

ion

s fo

r fu

ture

tra

nsf

usi

on

AA

Cas

e20

82

MO

ne u

nit

pool

edpl

atel

etco

ncen

trat

e

Vent

ilate

dpo

st-

oper

ativ

ely.

Plat

elet

coun

t60

x109 /L

pr

e pl

anne

din

vasi

vepr

oced

ure.

Urt

icar

ia,

dysp

noea

,rig

ors,

hyp

erte

nsio

n an

dfa

lling

urin

e ou

tput

.(p

atie

nt a

lread

y on

dial

ysis

).

Uni

t cu

lture

dne

gativ

e.Pa

tient

not

cul

ture

d.Ig

A le

vels

pos

ttr

ansf

usio

n no

rmal

.

Imm

edia

tely

follo

win

gtr

ansf

usio

n.

Hyd

roco

rtis

one.

Vent

ilato

r su

ppor

tin

crea

sed.

Patie

nt s

ubse

quen

tly d

ied

from

unde

rlyin

g co

nditi

on.

AA

C

ase

21

27

MO

ne u

nit

CM

Vne

gativ

e an

dirr

adia

ted

pool

edpl

atel

etco

ncen

trat

e

Plat

elet

coun

t11

x109 /L

.

Urt

icar

ia,

hypo

tens

ion,

tach

ycar

dia

and

itch.

Uni

t cu

lture

dne

gativ

e. P

atie

nt n

otcu

lture

d.Ig

A le

vels

pre

tran

sfus

ion

norm

al.

Imm

edia

tely

follo

win

gtr

ansf

usio

n.

Pre-

med

of

chlo

rphe

nira

min

e.Po

st r

eact

ion

chlo

rphe

nira

min

ean

d hy

droc

ortis

one.

Patie

nt r

ecov

ered

ful

ly im

med

iate

lyfo

llow

ing

trea

tmen

t.

Subs

eque

nttr

ansf

usio

ns u

sing

was

hed

plat

elet

sha

ve b

een

unev

entf

ul.

AA

Cas

e22

*p

14

MO

ne u

nit

ofC

MV

nega

tive

and

irrad

iate

dpo

oled

plat

elet

s.

Kno

wn

Ast

hmat

icPl

atel

etco

unt

9X10

9/L

.

Feve

r >

1.5

0 C,

tach

ycar

dia,

itch

,ur

ticar

ial r

ash

and

whe

eze.

Uni

t cu

lture

d-ne

gativ

e.

Patie

nt n

ot c

ultu

red.

200m

ls t

rans

fuse

d.Sh

ould

hav

e re

ceiv

edpr

e m

ed o

f bo

thch

lorp

heni

ram

ine

and

hydr

ocor

tison

e-on

ly r

ecei

ved

chlo

rphe

nira

min

e.H

ydro

cort

isone

IVan

d sa

lbut

amol

nebu

liser

giv

en p

ost

actio

n.

Reco

vere

d fu

lly w

ithin

12

hour

s.W

ashe

d pl

atel

ets

have

bee

nre

com

men

ded

for

futu

re t

rans

fusi

ons.

Rea

ctio

ns

to r

ed c

ells

* In

clu

ded

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r


TAB

LE 2

1 (C

ON

TIN

UED

) A

NA

PHY

LAC

TOID

/AN

APH

YLA

CTI

C T

RA

NSF

USI

ON

REA

CTI

ON

(N

=23

)

Cas

e N

oA

ge

ye

ars

Gen

der

Co

mp

on

ent

Rea

son

fo

r Tr

ansf

usi

on

Sym

pto

ms

Inve

stig

atio

ns

Stag

e Tr

ansf

usi

on

R

eact

ion

d

evel

op

ed

Trea

tmen

tSe

qu

elae

/Rec

om

men

dat

ion

s fo

r fu

ture

tra

nsf

usi

on

AA

C

ase

545

M

SD P

lasm

aSD

Pla

sma

exch

ange

for

TTP.

Urt

icar

ia a

ssoc

iate

d w

ithbu

zzin

g an

d itc

hing

sens

atio

n in

bot

h ea

rs.

IgA

leve

ls w

ithin

norm

al li

mits

.Fo

llow

ing

nint

hun

it of

SD

pla

sma

durin

g pl

asm

aex

chan

gepr

oced

ure.

Proc

edur

eab

ando

ned.

Hyd

roco

rtis

one

and

chlo

rphe

nira

min

eA

lread

y on

red

ucin

gdo

ses

ofpr

edni

solo

ne.

Reco

vere

d w

ith n

o ill

eff

ects

, ha

ssi

nce

rece

ived

SD

pla

sma

durin

gpl

asm

a ex

chan

ge p

roce

dure

sun

even

tful

ly, w

ith p

re-m

ed.

cove

r.

Rea

ctio

ns

to p

lasm

a

* In

clu

ded

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r


Anaphylactoid/Anaphylactic TransfusionReaction (n=23)

Eight cases are described in detail in this chapter.A/A Cases 1, 11, 12, 13, 14, 15, 16, 17 & 22 aredetailed in the Paediatric chapter.

Reactions to red cells

AA Case 2 This patient developed a post-operative anaemia Hb6.6g/dl and required transfusion of one unit of redcells. During the first 20 minutes, following less than50mls of the transfusion, symptoms of dyspnoea,stridor, cyanosis and gastrointestinal discomfortdeveloped. The transfusion was discontinuedcompletely and IV chlorpheniramine 10 mgs andhydrocortisone 100mgs were given with relief ofsymptoms. Both patient and unit were cultured - noorganisms were isolated. The patient made a fullrecovery within four hours. IgA levels were not done.No further transfusion has been required to date.Oral iron therapy was commenced on discharge.

AA Case 3 This patient with a haematological disorder, requireda transfusion of one unit of CMV negative andirradiated red cells Hb 9.4g/dl. When 120mls of theunit had been transfused, the patient developedsymptoms of urticaria, dyspnoea, stridor andwheeze, restlessness, anxiety, dizziness, weaknessand a feeling of impending doom. The transfusionwas discontinued and hydrocortisone andchlorpheniramine were administered IV. The patientrecovered within a few hours without complications.IgA levels were normal. A HLA class 1 antibody wasfound. Further transfusions were administeredsuccessfully following premedication withchlorpheniramine

AA Case 4 This elderly patient, with a malignant haematologicaldisorder and a history of hypertension required atransfusion of one unit of red cells for anaemia Hb7g/dl. The transfusion was being infused through a

newly inserted peripheral line. When less than 50mlshad been transfused, the patient developedsymptoms of dyspnoea, pyrexia > 1.50C, rigors, chillsand orbital oedema. The transfusion wasdiscontinued. O2 was commenced andchlorpheniramine and hydrocortisone wereadministered IV. The patient recovered from thisincident within five hours without complications.ABO incompatibility was excluded. Culture of thepatient isolated no organisms but culture of the unitwas not performed. Further transfusions weresuccessfully administered without premedication.This patient had no past history of any type ofallergic reaction

AA Case 7This frail, elderly patient required a transfusion ofone unit of red cells post operatively Hb 9.2g/dl. Thepatient had received two units of red cellsintraoperatively uneventfully. Within an hour and ahalf, the patient became clammy and developedsymptoms of hypotension, dyspnoea, tachypnoeaand tachycardia. The fluid balance chart was missingand there was no written record of the volume thathad been transfused. Following medical review, thetransfusion was discontinued. No treatment ormedication was administered. There is no record ofthe length of time taken by the patient to recoverfully but it is documented in the nursing notes thatthe patient had ‘settled’ within seven hours. Nochest X ray was performed. The patient had nounderlying cardiac or respiratory disease and wasnot on regular diuretic medication. Neither thepatient nor the unit was cultured but ABOincompatibility was excluded. Although it is likelythat this reaction was related to the transfusion, ithas been difficult to clarify this due to the atypicalnature of the symptoms and the lack ofinvestigation post the reaction.

AA Case 10This patient with chronic iron deficiency anaemiawas prescribed three units red cell concentrate for aHb of 6.8g/dl. This transfusion was based onhaematology results taken ten days previously. Oral


iron therapy had also been prescribed but there is aquestion over patient compliance. The first two unitswere transfused uneventfully. However following<50mls of the third unit, the patient developedsymptoms of rigors and hypertension. Followingmedical review the transfusion was abandoned, notreatment or medication was necessary and thepatient recovered fully within minutes. IgA levelswere elevated probably due to underlying liverdisease. Following pre medication withhydrocortisone, the patient received a further twounits of red cells three days later uneventfully. Thesetransfusions were considered inappropriate as therewas no evidence of haemodynamic instability on theday of the first transfusion, or at the time of thesubsequent two-unit transfusion.

Reactions to Platelets

AA Cases 8 and 9 This female patient required one unit pooled plateletconcentrate for thrombocytopenia. Following lessthan 50mls of the unit, the patient developedsymptoms of urticaria, dyspnoea and chesttightness. The transfusion was discontinued andhydrocortisone and chlorpheniramine were givenwith relief of symptoms. This patient had a historyof medication allergies. As a result, she requiredroutine premedication prior to receiving certainmedications and was prescribed chlorpheniramineon an on-going basis. No premedication wasprescribed prior to this transfusion. Later that day,this patient was again prescribed one unit ofapheresis platelet concentrate. No pre medicationwas prescribed despite her earlier reaction.Following between 50 and 75mls of this unit, thepatient developed symptoms of urticaria, chills anditch. Medical review was again sought, thetransfusion was discontinued and hydrocortisoneand chlorpheniramine were given IV. The patientrecovered fully within minutes of treatment, withoutcomplications. Despite this patient’s history ofmedication allergies, routine prophylacticpremedication prescribed on an on-going basis andher transfusion reaction earlier that day, she received

no premedication cover prior to either transfusion.Subsequent platelet transfusions have been givenuneventfully using premedication cover ofhydrocortisone and chlorpheniramine.

AA Case 19 This male patient required transfusion of one unitCMV antibody negative and irradiated pooledplatelet concentrate for thrombocytopenia.Following infusion of between 50 –100mls of theunit, the patient developed symptoms of urticaria,hypotension, backache and nausea. Hydrocortisone100mgs and chlorpheniramine 10mgs were given IVand the patient’s symptoms resolved within minutes.The unit was cultured and no organisms wereisolated. The patient was not cultured. IgA levelswere not checked. Subsequent transfusions usingapheresis platelets have been given uneventfully.

AA Case 23 This patient required transfusion of two units of redcells for a postoperative blood loss of - 1140mls.Two units of red cells were issued and transfused.The first unit transfused uneventfully. Towards theend of the second unit symptoms of facial, bilateralhand and forearm oedema developed. Serologicalinvestigations post transfusion were normal. Thepatient suffered no complications as a result of thisepisode and no further transfusions were required.The case was initially reported as an unusualtransfusion reaction, however upon review, it wasdecided that this reaction should be included in theAA category.



Transfusion Associated Circulatory Overload

Transfusion Associated Circulatory Overload(TACO) is characterised by the development ofacute pulmonary oedema secondary tocongestive cardiac failure. Signs and symptomscan manifest during, or within some hours oftransfusion and can include any or all of thefollowing: dyspnoea, orthopnoea, cyanosis,tachycardia, hypertension and pulmonaryand/or pedal oedema. Chest auscultationreveals the presence of rales. (Popovsky, 2001).

TACO accounted for 14 (8%) of the incidentsreported during this reporting year. Pulmonarycomplications due to TACO or TRALI are nowamong the most frequent causes of life threateninghazards of transfusion. Unfortunately TACO is still anunder recognised and under appreciated problem intransfusion practice and can be fatal. It can strikepatients of any age and can be treated whenrecognised early. While adults over 60 and infantsare especially susceptible to fluid overload, notransfusion recipient is free from this risk (Popovsky,2002) and it can be associated with any type ofcomponent. Appendix 3 shows the average volumeof blood components issued.

Special care should be taken when transfusingpatients with diminished cardiac, respiratory or renalfunction and patients with severe chronic anaemia Hb <5g/dl. Where transfusion is considered essential,patients with significant chronic anaemia should betransfused slowly to avoid acute changes in bloodvolume, which may precipitate heart failure. (Stack etal, 1996). Transfusion should not be required in thevast majority of patients with chronic anaemia due tounderlying haematinic deficiencies of iron, B12 orfolate. These patients respond quickly to specificreplacement therapy. (Saxena et al, 2002).

Anaemia is common in patients with moderate tosevere heart failure and treatment with transfusioncan aggravate the condition. There is encouragingevidence that the anaemia of heart failure, not dueto other causes, may be improved by treatment witherythropoeitin and iron therapy, which may improvesymptoms and reduce the risk of hospitalisation forworsening heart failure. This is currently the subjectof a number of randomised control trials. (NHS,Clinical Guideline 5) (Silverberg et al, 2001).


Annual Report 2003

TACO causes increased central venous pressure,increased pulmonary blood volume and diminutionin lung compliance with resultant secondarycongestive failure and pulmonary oedema. (Mollisonet al., 1998) While the prevailing view is that therate of infusion is important in triggering thereaction, there is little data on this important point.(Popovsky, 2002)

The symptoms of TACO usually manifest within severalhours of transfusion. Signs and symptoms includedyspnoea, orthopnea, cyanosis, tachycardia, increasedblood pressure and pulmonary oedema. Non-specificmanifestations include headache, tightness in thechest and dry cough (Popovsky, 2001).

The incidence of TACO has been reported as varying from 1:1000 to 1:3000 red cells transfuseddepending on age and degree of monitoring of the patients. (Popovosky & Taswell 1996) However in a study of patients undergoing hip or kneearthroplasty, TACO was found in approximately1% of 382 patients. The underlying common

denominator was a positive fluid balance (mean2.5L) prior to the transfusion. The patients whodeveloped TACO were older (87 vs. 77 years) thanthose who did not develop this complication.(Popovsky & Taswell 1996, Popovsky 2002)

The incidence of TACO for this reporting year was 1:10,840 red cells and 1:22,171 units of plasma issued.

There has been a reduction in the incidence ofTACO associated with plasma transfusions since thefirst NHO report in 2000. This may be associatedwith increased education and the issuing of NHOinformation leaflets from the NHO on indications foruse, the associated risks and the recommended ratesof infusion. However, in the one case (Case 3)reported this year which was associated with plasmaused for warfarin reversal, the transfusioncontributed to mortality. This should prevent anycomplacency and also highlights the need forcontinuing education.

Additional evidence provided from a recent studydemonstrates that the management of patients withmarkedly prolonged INR values is safe and effective ifsmall doses of vitamin K are administered orally.Findings suggest this results in a more rapid return tosafe levels of anticoagulation and reduced risk ofbleeding as compared with simple warfarinwithdrawal alone. The findings suggest that a 2mgdose of oral vitamin K for patients with an INR valueof more than 10.0 is adequate. (Gunther et al 2004).

Findings

• 12 of the 14 cases (86%) were associated withthe transfusion of red cells.

• One case (Case 3) involved transfusion of eightunits of solvent detergent (SD) plasma. Althoughthe patient was very ill before the transfusion, it islikely that the transfusion contributed to mortality.

• One case in a patient with massive bleeding (Case6) involved a combination of blood products, redcells, pooled platelets, SD plasma andcryoprecipitate.

• Eleven cases (79%) involved elderly patients, themajority of whom were extremely ill pre-transfusion with multiple underlying conditionsincluding cardiovascular insufficiency, malignancyand renal decompensation. In one of these cases(Case 2), the anaemia was due to iron deficiency.

• Seven of the 14 patients did not have an intakeand output record for the 12 hours prior totransfusion. (In one of these cases, the case noteswere missing).

• Five cases (Cases 3, 4, 6, 7, 13) had a positivefluid balance prior to transfusion. In two of the sixcases where there was an intake and outputrecord, the chart was not filled in accurately.

• In six cases (Cases 4, 5, 7, 8, 9 and 14), thepatients were receiving regular diuretic cover andin one of these cases (Case 7), the patient also



received a prophylactic diuretic prior totransfusion.

• In two cases (Cases 8 and 10), the patient hadreceived 100mls or less before displayingsymptoms of TACO.

• 12 of the 14 cases required supplemental diuretictherapy for relief of symptoms.

• In one case, (Case 8), there is a record ofsubsequent uneventful transfusions withprophylactic diuretic cover.

• In four cases, TRALI was considered but excluded.One case (Case 13) was submitted as a possibleTRALI but on review was moved to the TACOcategory. In another case, (Case 10), TRALI wasexcluded following a donor investigation in whichgranulocyte-specific and anti-lymphocyteantibodies were not detected. In the remaining twocases, (Cases 6 and 12), the possibility of TRALIwas considered but excluded on clinical grounds.

Recommendations

• All patients receiving blood components shouldbe assessed carefully but particular attentionshould be paid to the identification andmanagement 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.

• In susceptible patients, transfusions should beadministered slowly (1ml/kg of body weight/hour)(Popovosky, 2001). An accurate intake and outputrecord should be maintained. The risk ofoverloading the circulation can be minimised byadministering a prophylactic diuretic in addition tomaintenance diuretic therapy.

• 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.

• It may be prudent to transfuse only one unit in a24-hour period in high-risk patients. Somesubjects take as long as 24 hours to readjustblood volume and the effects of the transfusionof large amounts of blood must always becarefully monitored, particularly in those patientswhose venous pressure is already raised beforetransfusion had begun (Mollison et al 1998).

• In view of the need to observe the patient,transfusions should not normally be allowed tocontinue at night unless the patient has specialnursing care. (Mollison, 1998)

• Iron deficiency produces a chronic anaemia thatusually does not require immediate correction bytransfusion and for which a specific treatment(oral or parenteral iron) is available. Therefore,transfusion therapy in iron-deficient patientsshould be reserved for those patients who needcorrection of anaemia immediately. Transfusiontherapy should be administered only when theanaemia becomes physiologically destabilising.(Saxena et al, 1993).

• SD plasma or FFP is only required for the reversalof over anticoagulation in the presence of majorbleeding or emergency surgery as per informationleaflet issued by the NHO (Appendix 2).

94National Haemovigilance OfficeNational Haemovigilance Office

Annual Report 2003

TAB

LE 2

2 TR

AN

SFU

SIO

N A

SSO

CIA

TED

CIR

CU

LATO

RY O

VER

LOA

D (

N=

14)

Cas

e N

um

ber

Ag

eye

ars

Gen

der

Vo

lum

e Tr

ansf

use

dR

ate

of

Tran

sfu

sio

nPr

e-ex

isti

ng

Pro

ble

ms

Sym

pto

ms,

Sig

ns

& O

utc

om

eC

om

men

ts

TAC

OC

ase

1*

80

MO

ne u

nit

of r

ed c

ells

One

uni

t ov

er t

hree

hour

s.LV

F, h

yper

tens

ion

and

gout

.Sy

mpt

omat

ic a

naem

ia

Hb.

5g/

dl d

ue t

o a

GI

blee

d.

Dys

pnoe

a, c

hest

tig

htne

ss a

nd f

elt

clam

my.

Fru

sem

ide

adm

inis

tere

d w

ith a

good

diu

retic

res

pons

e. N

ebul

iser

adm

inis

tere

d. R

espo

nded

how

ever

rem

aine

d br

eath

less

for

thr

ee d

ays.

Inco

mpl

ete

fluid

bal

ance

rec

ord

pre-

tran

sfus

ion.

U

nit

pres

crib

ed o

ver

four

hrs

but

infu

sed

in t

hree

. P

oor

docu

men

tatio

n in

cha

rt.

TAC

OC

ase

2*

73 FO

ne u

nit

of r

ed c

ells

One

uni

t ov

er 4

hour

s an

d 20

min

utes

.

Hyp

erte

nsio

n, t

ype

2 D

M,

iron

defic

ienc

y an

aem

ia,

Hb

7.8

g/dl

.

Ten

min

utes

pos

t tr

ansf

usio

n an

d 20

min

s po

st o

ral d

iure

tic,

dysp

noea

,cy

anos

is,

pulm

onar

y oe

dem

a,hy

pert

ensi

on a

nd c

hest

tig

htne

ss,

tach

ycar

dia,

ral

es o

n ch

est

exam

. N

oC

XR

reco

rded

. T

reat

men

t IV

diu

retic

,cy

clim

orph

, an

d O

2, s

ympt

omat

ic r

elie

fw

ithin

few

hrs

.

No

docu

men

tatio

n of

res

pons

e to

diur

etic

.

TAC

OC

ase

4*

82

FO

ne u

nit

of r

ed c

ells

and

100m

ls o

f th

ese

cond

uni

t

One

uni

t ov

er f

our

hour

s.LV

F, c

hron

ic a

naem

ia a

ndch

roni

c re

nal i

mpa

irmen

t.O

n re

gula

r di

uret

ic.

Aft

er 1

00m

ls

2nd

unit,

tac

hyca

rdia

and

hype

rten

sion

. Tr

ansf

usio

n di

scon

tinue

d.N

o C

XR,

no

docu

men

tatio

n of

che

stau

scul

tatio

n.

No

furt

her

diur

etic

adm

inis

tere

d. R

ecov

ered

with

no

illef

fect

s.

Low

wei

ght

at r

isk

patie

nt.

* In

clu

ded

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r



TAB

LE 2

2 (C

ON

TIN

UED

) T

RA

NSF

USI

ON

ASS

OC

IATE

D C

IRC

ULA

TORY

OV

ERLO

AD

(N

=14

)

Cas

e N

um

ber

Ag

eye

ars

Gen

der

Vo

lum

e Tr

ansf

use

dR

ate

of

Tran

sfu

sio

nPr

e-ex

isti

ng

Pro

ble

ms

Sym

pto

ms,

Sig

ns

& O

utc

om

eC

om

men

ts

TAC

OC

ase

5*

85

FO

ne u

nit

of r

ed c

ells

and

135m

ls.

of t

hese

cond

uni

t

One

uni

t ov

er f

our

hour

s.Si

gnifi

cant

car

diac

his

tory

with

pre

viou

s M

I, PV

D,

rena

l im

pairm

ent,

ast

hma,

Post

-op

Hb

8.8

g/dl

. O

nre

gula

r di

uret

ic.

Aft

er 1

35m

ls o

f th

e 2n

d un

it,dy

spno

ea,

cyan

osis

, ta

chyc

ardi

a,hy

pert

ensi

on,

rale

s on

che

st e

xam

with

decr

ease

d O

2an

d in

crea

sed

pCO

2.C

XR

show

ed p

ulm

onar

y oe

dem

a.

IVfr

usem

ide

120

mg,

IV h

ydro

cort

ison

e,IV

cyc

limor

ph,

com

bive

nt n

ebul

iser

, O

2th

erap

y vi

a ve

nti m

ask

40%

and

gelo

fusi

ne 2

50m

ls a

dmin

iste

red.

Reco

vere

d w

ith n

o ill

eff

ects

with

in

24 h

ours

.

Low

wei

ght

at r

isk

patie

nt.

TAC

O

Cas

e 6

57

M

Nin

e un

it of

red

cel

lsFo

ur u

nits

poo

led

plat

elet

s16

uni

ts o

f SD

pla

sma

Two

units

of

cryo

-pre

cipi

tate

75m

ls p

er h

our

over

24-h

our

perio

d.H

epat

ic f

ailu

re,

liver

cirr

hosi

s, c

oagu

latio

ndi

sord

er,

non-

insu

linde

pend

ant

DM

. Bl

eedi

ng,

post

-live

r bi

opsy

.

Dys

pnoe

a, p

ulm

onar

y oe

dem

a.C

XR

show

ed p

ulm

onar

y ve

nous

hype

rten

sion

and

dec

reas

ed a

ir en

try

bila

tera

lly.

IV f

ruse

mid

e, O

280

%ad

min

iste

red.

Pat

ient

die

d of

und

erly

ing

cond

ition

.

TRA

LI c

onsi

dere

d bu

t ex

clud

ed.

TAC

OC

ase

7*

53

MO

ne u

nit

of r

ed c

ells

cells

Ove

r fo

ur h

ours

.Po

or r

espi

rato

ry f

unct

ion,

seps

is,

asci

tes,

CVA

,hy

pert

ensi

on,

mal

igna

ntha

emat

olog

ical

dis

orde

r,in

sulin

dep

enda

nt D

M,

post

-ope

rativ

e ab

dom

inal

surg

ery.

O

n re

gula

rdi

uret

ic.

Prem

ed IV

fru

sem

ide

with

goo

d di

ures

is.

Aft

er 5

0-10

0mls

, dy

spno

ea,

tach

ycar

dia,

pul

mon

ary

oede

ma,

fro

thy

sput

um,

rale

s, a

nd f

allin

g O

2sa

tura

tions

. N

o C

XR

perf

orm

ed,

tran

sfus

ion

disc

ontin

ued.

Fur

ther

dos

eIV

fru

sem

ide

with

goo

d ef

fect

. P

atie

ntdi

ed la

ter

unre

late

d to

tra

nsfu

sion

.

Hig

h-ris

k pa

tient

, re

ceiv

ed a

pro

phyl

actic

diur

etic

but

stil

l dev

elop

ed T

AC

O.

* In

clu

ded

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r


Annual Report 2003

TAB

LE 2

2 (C

ON

TIN

UED

) T

RA

NSF

USI

ON

ASS

OC

IATE

D C

IRC

ULA

TORY

OV

ERLO

AD

(N

=14

)

Cas

e N

um

ber

Ag

eye

ars

Gen

der

Vo

lum

e Tr

ansf

use

dR

ate

of

Tran

sfu

sio

nPr

e-ex

isti

ng

Pro

ble

ms

Sym

pto

ms,

Sig

ns

& O

utc

om

eC

om

men

ts

TAC

OC

ase

8*

78 FA

ppro

xim

atel

y 10

0mls

of r

ed c

ells

tra

nsfu

sed

over

one

hou

r an

d 15

min

utes

.

Ove

r fo

ur h

ours

.M

ultip

le m

edic

al p

robl

ems

incl

udin

g si

gnifi

cant

car

diac

dise

ase

with

LV

F, p

revi

ous

AA

A r

epai

r, re

nal

impa

irmen

t, h

yper

tens

ion,

CO

AD

. O

n di

uret

ic a

sne

cess

ary.

Dur

ing

first

50-

100m

ls,

dysp

noea

,ta

chyc

ardi

a, p

ulm

onar

y oe

dem

a.Tr

ansf

usio

n di

scon

tinue

d. IV

fru

sem

ide

adm

inst

ered

with

goo

d di

uret

ic e

ffec

t.

Hig

h-ris

k lo

w b

odyw

eigh

t (5

0 kg

).

TAC

OC

ase

9 81 M

One

uni

t of

red

cel

lsN

ephr

otic

syn

drom

e, L

VF.

Dys

pnoe

a.

Diu

retic

adm

inis

tere

d w

ithgo

od e

ffec

t.M

edic

al r

ecor

ds m

issi

ng.

TAC

O

Cas

e 10

*

83 M10

0mls

uni

t of

red

cells

48m

ls p

er h

our.

Car

diom

yopa

thy,

aor

ticst

enos

is,

AF,

CO

AD

,as

thm

a, D

M,

CVA

gas

triti

s,an

aem

ia.

On

regu

lar

diur

etic

.

Aft

er 1

00m

ls,

dysp

noea

, cy

anos

is,

tach

ycar

dia,

hyp

erte

nsio

n, f

allin

g O

2sa

tura

tions

, c

hest

tig

htne

ss,

bila

tera

lw

heez

e, c

onfu

sion

. Tr

ansf

usio

ndi

scon

tinue

d. IV

fru

sem

ide

hydr

ocor

tison

e, IV

chl

orph

enam

ine,

salb

utam

ol n

ebul

iser

,O2

via

mas

k 60

%ad

min

iste

red.

Diu

resi

s 70

0mls

over

nigh

t. S

ympt

oms

impr

oved

.

Hig

h-ris

k pa

tient

, ra

ised

JV

P an

d bi

late

ral

crep

itatio

ns o

n ad

mis

sion

. O

n da

ilydi

uret

ics.

No

extr

a di

uret

ic p

retr

ansf

usio

n.

Inve

stig

ated

for

TRA

LI b

utex

clud

ed.

TAC

OC

ase

11*

77

MO

ne u

nit

of r

ed c

ells

plus

100

mls

of

seco

nd u

nit

of r

edce

lls

71m

ls p

er h

our.

Car

diac

sur

gery

, m

alig

nant

haem

atol

ogic

al d

isor

der.

Firs

t un

it tr

ansf

used

une

vent

fully

. A

fter

100m

ls o

f th

e se

cond

uni

t, d

yspn

oea

and

ches

t tig

htne

ss.

Fru

sem

ide

and

O2

40%

ven

timas

k ad

min

iste

red.

Imm

edia

te s

ympt

om r

esol

utio

n.

Hig

h ris

k el

derly

com

prom

ised

pat

ient

.

* In

clu

ded

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r



TAB

LE 2

2 (C

ON

TIN

UED

) T

RA

NSF

USI

ON

ASS

OC

IATE

D C

IRC

ULA

TORY

OV

ERLO

AD

(N

=14

)

Cas

e N

um

ber

Ag

eye

ars

Gen

der

Vo

lum

e Tr

ansf

use

dR

ate

of

Tran

sfu

sio

nPr

e-ex

isti

ng

Pro

ble

ms

Sym

pto

ms

& O

utc

om

eC

om

men

ts

TAC

OC

ase

12*

70

FO

ne u

nit

of r

ed c

ells

Ove

r fo

ur h

ours

.A

cute

MI,

hype

rten

sion

,D

M.

Six

hour

s po

st t

rans

fusi

on,

tach

ycar

dia,

naus

ea,

hype

rten

sion

, fa

lling

O2

satu

ratio

ns,

whe

eze,

pyr

exia

, an

dbi

late

ral c

reps

, ap

preh

ensi

on.

Com

men

ced

nasa

l O2.

Tra

nsfe

rred

ITU

,be

cam

e hy

pote

nsiv

e. F

ruse

mid

e IV

,cy

clim

orph

, do

buta

min

e, is

orbi

dedi

nitr

ate

adm

inis

tere

d.

CX

R -

pulm

onar

y oe

dem

a, le

ft b

asal

eff

usio

n.Sy

mpt

oms

reso

lved

with

in 2

4 ho

urs.

Hig

h-ris

k, lo

w w

eigh

t pa

tient

, w

eigh

t56

.6 k

g. In

take

/out

put

reco

rd n

otm

aint

aine

d pr

e-tr

ansf

usio

n.N

o di

uret

icpr

e-tr

ansf

usio

n. T

RALI

con

side

red

but

excl

uded

.

TAC

OC

ase

13

*

53

M

Two

units

uni

t of

red

cells

(ha

d re

ceiv

edth

ree

units

the

prev

ious

day

)

Ove

r fo

ur h

ours

each

.Va

scul

ar d

isea

se,

insu

linde

pend

ant

DM

, as

thm

a,po

st-o

rtho

paed

ic s

urge

ry.

Aft

er t

wo

units

uni

ts, d

yspn

oea,

fal

ling

O2

satu

ratio

n. m

ild f

ever

, rai

sed

JVP

bila

tera

llo

wer

lim

b oe

dem

a. O

235

%, f

ruse

mid

ead

min

ister

ed, g

ood

diur

etic

resp

onse

.

Orig

inal

ly in

vest

igat

ed a

s TR

ALI

but

excl

uded

.

TAC

O

Cas

e 14

*

84

FTw

o un

it of

red

cel

ls

(had

rec

eive

d on

e un

itth

e pr

evio

us d

ay)

Ove

r fo

ur h

ours

each

.C

CF,

ren

al im

pairm

ent,

DM

,an

aem

ia u

nkno

wn

caus

e.O

n re

gula

r di

uret

ic.

Aft

er 1

00m

ls 2

nd u

nit,

dys

pnoe

a,w

heez

ing,

hyp

erte

nsio

n, s

wea

ting

ches

tpa

in.

IV h

ydro

cort

ison

e, n

ebul

iser

.

Patie

nt d

ied

two

to t

hree

wee

ks p

ost

tran

sfus

ion,

unr

elat

ed t

o tr

ansf

usio

n.

TAC

OC

ase

3*

83

MEi

ght

units

Oct

apla

sO

ver

eigh

t ho

urs.

Sign

ifica

nt c

ardi

ac d

isea

se,

hist

ory

of m

alig

nanc

y,se

psis

of

unkn

own

orig

inan

d im

paire

d re

nal

func

tion.

Rais

ed IN

R 11

.9.

No

reco

rd o

f ac

tive

blee

ding

. A

fter

5th

uni

t SD

pla

sma

O2

satu

ratio

n fe

ll.

Patie

nt d

ied

2 hr

sfo

llow

ing

com

plet

ion

of t

rans

fusi

on.

Posi

tive

fluid

bal

ance

180

0mls

in 2

4 hr

spr

e-tr

ansf

usio

n.

Patie

nt p

resc

ribed

8un

its S

D p

lasm

a. A

fter

fou

r un

its IN

R=4.

5bu

t a

furt

her

four

uni

ts in

fuse

d.

No

reco

rd o

f di

uret

ic t

hera

py,

poor

docu

men

tatio

n in

med

ical

rec

ords

.

* In

clu

ded

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r


Annual Report 2003

Transfusion Associated Circulatory Overload(n=14)

Cases Involving Red Cells

We describe 11 cases in detail in this section.

TACO Case 1 This elderly patient with a history of hypertensionand significant cardiac disease required a transfusionof red cells for a symptomatic anaemia (excessivefatigue) Hb 5g/dl. The patient was not on anyroutine diuretic therapy and did not receive anyprophylactic diuretics prior to transfusion. Five unitsof red cells were prescribed over four hours each.The first unit had been transfused over three hourswhen the patient became clammy and symptoms ofchest tightness and dyspnoea developed. The bloodpressure remained stable. While the patient hadbeen on an intake and output record, it had notbeen accurately completed. Frusemide and acombivent nebuliser was administered and a gooddiuresis of 800mls resulted. No chest x-ray wasrecorded. The patient recovered but remainedbreathless for three days following this event.

TACO Case 2 This elderly female was given a transfusion of oneunit of red cells for iron deficiency anaemia, Hb7.8g/dl. The patient had symptoms of tiredness,weakness, dizziness and intermittent back pain. Theunit was transfused was completed over four hourstwenty minutes and frusemide was administeredorally towards the end of the transfusion. Twentyminutes after receiving frusemide and ten minutespost transfusion, the patient developed symptoms ofdyspnoea, cyanosis, tachycardia, chest tightness andhypertension. There were audible rales on chestauscultation. The patient was reviewed andfrusemide and cyclomorph were administered IV. O2therapy at 60% was commenced. No chest x-raywas recorded and no documentation to theresponse to the diuretic but the patient made acomplete recovery within a few hours. The patient’sHb post transfusion was 9.2g/dl. The patient wasdischarged on oral iron supplements.

TACO Case 4.This small elderly patient with a significant cardiachistory, underlying hypertension, chronic renalimpairment and chronic haematological malignancywas transfused with two units of red cells forsymptomatic anaemia. Hb 8.1g/dl. The first unit wastransfused uneventfully over four hours. During thesecond unit, when less than 100mls had transfused,tachycardia and hypertension developed and thetransfusion was discontinued. The patient was on aregular diuretic and was prescribed further diureticmedication to be given following the second unit.However this diuretic was not administered becausethe patient was considered "dry" although apositive fluid balance of 230mls was recorded forthe twelve hours prior to the transfusions. A chest x-ray was not performed. The symptoms resolvedwithin one hour.

TACO Case 5 This small elderly female patient required a red celltransfusion for post-operative anaemia Hb 8.8 g/dl.This patient had a past medical history of ischaemicheart disease, peripheral vascular disease, asthmaand renal impairment. The patient was onmaintenance daily diuretic therapy. Twelve hours pretransfusion the patient had an intake of 1050mlsbut the output was not recorded accurately. Twounits of red cells were prescribed over two hourseach, but the actual administration rate oftransfusion was each unit over four hours. Overnightthe first unit was transfused uneventfully, but havingreceived 135mls of the second unit, the patientdeveloped symptoms of dyspnoea, cyanosis,tachycardia, pulmonary oedema and hypertension.The transfusion was immediately discontinued. IVfrusemide 80mgs was administered with a poorresponse. A further 40mgs of frusimide IV was givenwith effect. The patient also received IVhydrocortisone 100mgs, IV cyclimorph 5mgs,combivent nebuliser 2.5mls and O2 therapy via ventimask. The patient recovered from this event withoutcomplications within 24 hours.



TACO Case 7This septic patient with multiple medical problemsand an underlying malignant haematologicaldisorder, required a post-operative transfusion ofone unit of red cells for a symptomatic anaemia -Hb.9.1g/dl. The patient’s condition was deterioratingand further surgery was scheduled. The patient hadongoing clinical problems with repeated episodes ofpulmonary oedema responsive to frusemide. Aclinical decision regarding a continuous frusemideinfusion was being considered. A record of theintake and output for the previous 24 hours showeda positive fluid balance of 1453mls. Prior totransfusion, a premedication of IV frusemide 40mgswas administered with an accompanying gooddiuresis. However, during the first 90 minutes when50-100mls had been transfused, the patientdeveloped symptoms of tachycardia, dyspnoea,falling O2 saturation, pulmonary oedema, frothysputum and rales on auscultation. The transfusionwas discontinued and a further dose of IV frusemide20mgs was administered. The cumulative diureticresponse to both doses of frusemide was 3720mls.The patient’s condition further deteriorated due tohis underlying disease and he subsequently diedsome days later unrelated to the transfusion.

TACO Case 8 This small elderly female patient with multiplemedical problems including ischaemic heart disease,chronic obstructive airways disease and renalimpairment was prescribed a transfusion of one unitof red cells over four hours for anaemia Hb 7.1g/dl.The patient was not on regular diuretic therapy, buton this admission, had been administered diureticsas required. After an hour and fifteen minutes whenapproximately 100mls of red cells had been infused,the patient developed symptoms of dyspnoea,tachycardia and pulmonary oedema. The transfusionwas immediately discontinued. IV frusemide 40mgswas administered with immediate effect. Recordeddaily weights were taken on this patient and on theday of transfusion was 0.9kg higher than theprevious day. The patient recovered with no illeffects. The patient received a further unit of red

cells two days later with premedication of frusemide40mg with no adverse effects.

TACO Case 10 This elderly male patient with an underlying historyof ischaemic cardiomyopathy, aortic stenosis, atrialfibrillation and chronic obstructive pulmonary diseasepresented with a raised JVP, pedal oedema andbilateral creps on auscultation. Chest x-ray onadmission showed gross cardiomegaly with fluidpresent. The patient was prescribed one unit of redcells for symptomatic anaemia Hb 9.3g/dl. He wastaking regular diuretic medication but did not receiveany extra diuretic prior to this transfusion. One unitof red cells was prescribed over a period of four tosix hours at a rate of 48mls/hour. Whenapproximately 100mls had been transfused, thepatient became confused and symptoms ofdyspnoea, cyanosis, tachycardia, hypertension, chesttightness, chest pain and bilateral wheeze developed.The O2 saturation fell and the transfusion wasdiscontinued completely. IV frusemide 40mg,hydrocortisone, chlorpheniramine, salbutamolnebuliser and 60% O2 were administered. Thepatient had a diuresis of 700mls overnight and thesymptoms improved but never completely resolveddue to his underlying cardiac disease. TRALI wasconsidered but excluded following a donorinvestigation in which granulocyte-specific and anti-lymphocyte antibodies were not detected.

TACO Case 11 This elderly male patient required a transfusion oftwo units of red cells for anaemia Hb 8.9g/dl. Thepatient had a history of cardiac surgery one yearearlier and an underlying haematologicalmalignancy. One unit of red cells was transfused asprescribed uneventfully at a rate of 71mls an hour.Having received 100mls of the second unit of redcells, the patient developed symptoms of dyspnoeaand chest tightness. The transfusion wasimmediately discontinued. O2 therapy and IVfrusemide 40mgs was administered with immediateeffect. The patient recovered with no complicationsfrom this event. An intake and output record which


Annual Report 2003

indicated a positive fluid balance of 682mls was onlymaintained from commencement of the transfusion.

TACO Case 12This small elderly female patient had a history ofdiabetes mellitus and hypertension and was onregular beta-blockers. She presented with asubendocardial myocardial infarct and required oneunit of red cells for a symptomatic anaemia Hb8.6g/dl, thought to be due to a leaking diverticulum.The unit was administered over four hours with nodiuretic prescribed pre transfusion; intake andoutput were not recorded. Six hours followingcompletion of the transfusion, the patient becamevery apprehensive, felt hot and cold and developedsymptoms of tachycardia, hypertension, falling O2saturations, nausea, wheeze and slight pyrexia,andwas commenced on O2. Bilateral creps were audibleon auscultation and a diagnosis of CCF was made.The patient was transferred into ITU for furthermanagement. On admission to ITU, her bloodpressure had fallen to 90/50. Frusemide, cyclimorph,dobutamine and isosorbide dinitrate wereadministered and betablockers were withheld. Therewas a moderate response to the diurectic. A portable chest x ray taken at the time of thereaction showed abnormal changes throughout bothlung fields with a diagnosis of pulmonary oedema.Two days following the reaction, the chest X rayshowed considerable improvement with a residualleft basal effusion. The patient’s condition continuedto improve and she was discharged from ITU to theward after two days. Ten days later the patient’schest x-ray was clear. The possibility of TRALI wasconsidered but excluded on clinical grounds.

TACO Case 13 This patient with a history of insulin dependentdiabetes and respiratory disease was admitted forelective orthopaedic surgery. He sustained moderateintra-operative blood loss and was transfused threeunits of red cells uneventfully Hb 6.9g/dl. Hesubsequently underwent an evacuation of a largehaematoma that developed post-operatively. Herequired a further two units of red cells. He was also

receiving fluid infusions including gelofusion and wasin a positive balance of 847mls. The red cellstransfused over four hours and following completionof the second unit, he developed a slight rise intemperature, dyspnoea, and falling O2 saturation82% on room air. He recovered quite quickly once hewas commenced on 35% O2 treatment. Reviewshowed a mildly elevated JVP, and bilateral lower limboedema.On examination he was found to havebilateral crepitations over his lung fields. He wasadministered intravenous diuretics and had a diuresisof more than 400mls with resolution of his symptoms.A chest x-ray 24 hours later showed mild interstitialoedema mainly in the lower lobes and someconsolidation medially in the right lower lobe whichwas thought to be due to localised alveolar oedema.This case was originally reported as a TRALI but thiswas excluded on the basis of the clinical findings.

TACO Case 14 This elderly patient with underlying renal failure,cardiac failure and anaemia of unknown causerequired red cells Hb. 7.9 g/dl. The patient was onregular diuretic therapy pre-transfusion. The intakeand output record had not been maintainedaccurately. One unit of red cells was transfusedwithout incident. On the following day, the patientwas prescribed two further units of red cells and adiuretic IV was prescribed for administrationfollowing the transfusion. The first unit wastransfused over three to four hours. Having received100 ml of the second unit the patient developedsymptoms of dyspnoea, wheezing, chest pain,sweating, hypertension and decreased O2saturation. It appears that IV frusemide 40 mg wasadministered twenty-five minutes prior to this unitbeing discontinued but there is no documentedresponse to the diuretic. IV hydrocortisone, anebuliser and O2 were administered. On O2, thesaturation improved from 84% to 93%. A chest x-ray was performed which showed a diffuseshadowing over both lung fields. The patientremained breathless following the transfusion anddied two weeks later due to the underlyingcondition unrelated to the transfusion.



Cases Involving Plasma

We describe the one case of TACO associated withplasma transfusion in detail.

TACO Case 3 This elderly patient with an underlying malignancy,sepsis, significant cardiac disease and impaired renalfunction was admitted with an INR of 11.9. Therewas no record of any active bleeding. Antibiotictherapy had been prescribed for the underlyingsepsis but the site of infection had not beendetermined. There was a positive fluid balance of1800mls over the 24-hour period pre transfusion.Eight units of SD plasma were prescribed and wereadministered in less than nine hours (177mls anhour). Following transfusion of four units, the INRwas 4.5 but a further four units were infused. TheO2 saturation dropped after the fifth unit and O2therapy was commenced at 40%. The patient wasnot on regular diuretic medication and did notreceive any diuretic prior to or during thetransfusion. This patient died two hours followingcompletion of the transfusion. The TSO discoveredthe incident during a routine retrospective audit oftransfusion practice.



Delayed Haemolytic Transfusion Reaction

Definition: Delayed haemolytic transfusionreactions are defined, for the purpose of thisreport, as those occurring more than 24 hoursfollowing the transfusion of a bloodcomponent. A haemolytic transfusion reactionoccurs when antigen-positive red blood cellsare transfused to a patient who develops analloantibody to that antigen. It results in thelysis or accelerated clearance of red blood cellsdue to immunologic incompatibility betweenthe blood donor and the recipient (Boehlen &Clemeston, 2001)

This category accounted for 5% of incidentsreported (9 of 180) Delayed haemolytic reactions,estimated to occur at a frequency of 1:400–1:700transfusions may be difficult to diagnose and may,therefore, have been underreported in the past. Asmany of these patients are already very ill, thediagnosis is often overlooked

Typically the picture is of falling Hb four to ten daysafter a transfusion. In some cases it may beassociated with jaundice and rarely renal impairment

although due to the underlying condition in many ofthese patients, the exact contribution of the delayedhaemolytic antibody reaction to the renalimpairment is difficult to evaluate.

The pre transfusion antibody screen sample is usuallynegative for the antibody responsible but theantibodies are subsequently detected on posttransfusion samples. These reactions occur whereantibodies present due to previous transfusion orpregnancy fall below the detection limits of the pretransfusion antibody screen but are rapidly boostedby a transfusion of red cells that express thecorresponding antigen leading to haemolysis ofthese cells. The antibodies involved typically are Kiddantibodies (Anti-Jka, Anti-Jkb) but other antibodiessuch as Rh and Kell may also be involved.

Findings

• There were nine cases reported and as of last yearwe have graded them by severity according to theSHOT criteria.

Annual Report 2003


Group 1 Asymptomatic with ‘antibody only’detected (with or without a positiveantiglobulin test (DAT) - Three cases (Cases1, 2 and 4) were classified as group 1reactions.

Group 2 Evidence of haemolysis measured by fallingHb and positive DAT.

Group 3 Falling Hb with jaundice with or without apositive DAT. There were four cases whichwere classified as group 3 reactions (Cases3, 7 8 and 9).

Group 4 As for group 3 but with renal impairment.There were two cases that were classifiedas group 4 (Case 5 and 6 ).

• The commonest antibodies implicated were Rh,Duffy and Kidd.

• There were no fatalities associated with thereactions.

• Case 8 demonstrates that in some cases it may benecessary, in an emergency, to transfuse beforethe antibody has been identified.

• Case 5 illustrates that in cases where there aremultiple antibodies it may not always be possibleto find fully compatible blood and it may benecessary to issue least incompatible blood.

• One of the group 1 cases (Case 1) represented areport of alloimmunisation after exposure to Rhpositive blood rather than a delayed haemolyticreaction.

Recommendations:

• These reactions, which are largely unavoidable,are likely to increase as our patient population,particularly the elderly, receive more transfusions.DHTR should be suspected when there is a fallingHb or jaundice some days post transfusion.

• Careful history taking in relation to transfusionand pregnancies by the requesting physician isimportant. However, up to 12% of patients donot realise that they have had a transfusion(Busch, 1991) therefore access to and checking ofprevious transfusion records is essential.

• Use of three cell screening panels, sensitiveantibody screening techniques and satisfactoryparticipation in external quality assuranceschemes such as the National External QualityAssurance Scheme (NEQAS), should minimisefailures to detect weak antibodies.

• As antibodies can develop rapidly, patientsrequiring repeated transfusions should have afresh sample submitted within 24-72 hours of aplanned transfusions (NBUG, 2002).

• When investigating a DHTR a serum sampleshould be used for antibody detection as someantibodies, particularly weakly complementbinding antibodies, not detectable in plasmaspecimens may be detected in serum samples(SHOT, 2003).

• A number of fatalities, which were reported inSHOT 2002, associated with DHTR were due todelays in transfusing suitable blood rather thandue to the DHTR itself. In the event that a patienthas a DHTR, specialist advice should be sought forcurrent management of the patient’s conditionand future transfusion requirements.

• Consideration should be given to issuing antibodycards to all patients with clinically significantantibodies (NBUG, 2002).

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


TABLE 23 DELAYED HAEMOLYTIC TRANSFUSION REACTION (DHTR) (N=9)

CaseNumber

AgeyearsGender

Pre-existingcondition

Intervalbetweentransfusion and onset ofsymptom/signs

Findings Outcome

DHTRCase 1

86M

GI bleed Hb 5.8g/dl. Transfusedwith nine units ofgroup O Rh Dpositive red cellsover five days dueto supply problems.

No symptoms. Six months posttransfusion of RhD positive redcells, patient wasre-crossmatchedand found tohave Anti-D andAnti-E.

Has not beentransfused since.

DHTRCase 2

71F

Recurrentpneumothorax andgeneral debility.

None Anti E detected6 days posttransfusion.

Subsequentlytransfused withantigen negativeblood uneventfully.

DHTRCase 4*

54F

Malignancy After 30mls ofblood hadinfused, fever>1.50CTransfusiondiscontinued.

DAT positive andAnti-C & -Edetected threedays posttransfusion.


DHTR Case 3

76 M

Post cardiacsurgery Hb 6.7g/dl.

Almostimmediately postoperatively.

Rising bilirubinand LDH, fallinghaemoglobin,Deterioratingrenal function.Anti-E detectedon day seven.

Died unrelated totransfusion.

DHTRCase 7*

78 F

Collapse, seizuresand anaemia.

Seven days. Falling Hb, risingbilirubin. Anti-c,Anti-E and Fyb

detected.

Recovered withoutcomplications.

Group 1

Group 3



TABLE 23 (CONTINUED) DELAYED HAEMOLYTIC TRANSFUSION REACTION(DHTR) (N=9)

CaseNumber

AgeyearsGender

Pre-existingcondition

Intervalbetweentransfusion and onset ofsymptom/signs

Findings Outcome

DHTRCase 8 *

75 M

Collapse, anaemiaprevious heartsurgery.

Eight days posttransfusion.

Falling Hb, risingbilirubin andLDH, requiredfurthertransfusion. Anti-C and Anti-E detected.


DHTRCase 9 *

60 M

Hypertension,intraoperativebleeding.Anti Fya detected.Fya negative cellstransfused

Four days. Jaundice,falling Hb, risingbilirubin, positiveDAT, anti-Jka

detected.

Patient recoveredcompletely withinfive days.

DHTRCase 5

50M

Oesophagealvarices GI bleed Cirrhosisof the liver.Congenital factordeficiency,Anti-D, anti- Jka ,Anti- S, Anti- Mantibodies present.D negative, JKa

negative, Snegative, M positivered cells transfusedin emergency

Two days. Falling Hb twodays laterRise in bilirubinand LDH 13 dayslater.Deterioratingrenal function.

Recovered withoutcomplications.

DHTRCase 6*

68M

Emergencyperioperativebleeding.

11 days posttransfusion.

Fallinghaemoglobinrising bilirubin.Rising LDH.Anti-c and Anti-Edetected. Deterioratingrenal function.

Died unrelated totransfusion.

Group 3

Group 4



Delayed Haemolytic Transfusion Reaction (n=9)

We describe five cases in detail. In one case (Case4), reported as a DHTR, the transfusion was stoppedas a result of pyrexia which may have been relatedto the underlying condition or to the presence of Rhantibodies detected three days later.

Group 1 DHTR Case 4 This patient was extremely ill with an underlyingmalignancy and required three units of red cells fora symptomatic anaemia. Three units of red cellswere transfused uneventfully. Within two weeks,three further units were again required for anaemiaas a result of continuous minor bleeding Hb 6.1g/dl.The pre transfusion antibody screen was negative.Following 30mls of the first crossmatched unit, thepatient’s temperature increased > 1.50C. Thetransfusion was stopped and the unit discarded. Thesuspected transfusion reaction was not reported tothe laboratory or the TSO. During routinehaemovigilance audit three days later, the TSOnoticed that only thirty mls had been transfused andthe two remaining units were quarantined forinvestigation. A fresh crossmatch specimen revealeda positive antibody screen with specificity for Anti-Cand Anti-E. The DAT was positive for IgG andC3b/C3d. The patient had three further units ofantigen negative red cells crossmatched and thesewere transfused uneventfully.

Group 3DHTR Case 7 This elderly female patient was admitted forinvestigation of anaemia associated with collapseand seizures. She had a history of multiple medicalproblems and had been previously transfused withfour units of red cells in 1998. Two units of red cellswere crossmatched and transfused. The pretransfusion antibody screen was negative. Sevendays post transfusion, the Hb began to fall with anassociated rise in bilirubin (10.5 to 30.5umol/l). Thepost transfusion antibody screen was positive with aspecificity of Anti-c, Anti-E and Anti-Fyb and the DAT

test was positive for IgG. Anti-c, Anti-E and Anti-Fyb

were identified on the eluate. The patient recoveredwithout complications.

DHTR Case 8 This elderly male patient was admitted followingcollapse associated with anaemia. He had a historyof surgery eight years previously but there was norecord of transfusion in this hospital. The pretransfusion antibody screen was negative and sixunits of blood were crossmatched. Only three ofthese were compatible and a specimen was sent tothe reference laboratory for further investigation.The three compatible units of red cells wereprescribed for emergency transfusion andadministered uneventfully. Testing of the pre-transfusion sample in the reference laboratoryrevealed Anti-C and an enzyme only Anti-E. Eightdays post transfusion, the Hb began to fall andthere was also a rise in serum bilirubin and LDH.Further transfusion was required. A new cross matchsample was sent to the reference laboratory forantibody screen and crossmatch. The antibodyscreen was found to be strongly positive for Anti-Cand Anti-E both strongly reacting in IAT. Twocompatible antigen negative units were issued tothe hospital and one was transfused. The patientrecovered from this reaction without compilcationsand required no further transfusions.

DHTR Case 9 This male patient with a history of hypertension andcardiac disease required four units of red cells for anintraoperative bleed. The patient had a previoustransfusion history of two units of autologous andone unit of allogeneic blood for elective surgeryseven years ago at a different hospital. The pretransfusion antibody screen was positive with Anti-Fya specificity and antigen negative units wereselected. These units were transfused uneventfully.However four days post transfusion the patientbecame jaundiced with falling Hb, a rise in serumbilirubin and a positive DAT. Retesting of the pretransfusion sample was performed with the sameresult. A new crossmatch specimen was requested


which showed presence of Anti-Jka in addition toAnti-Fya. No treatment was prescribed, the Hb andserum bilirubin returned to normal within five daysand the patient was discharged within the normalpostoperative timeframe.

Group 4DHTR Case 6 This male patient required an emergency transfusionof one unit of blood for a peri-operative bleed. Thepatient had been previously transfused but the pre-transfusion antibody screen was negative. Thepatient had a stormy postoperative period as a resultof his underlying condition. Eleven days posttransfusion it was noted by the laboratory staff thatthe bilirubin and LDH were raised and thehaemoglobin was falling with deteriorating renalfunction. There was also evidence of DIC which mayhave been related to the underlying condition ratherthan the transfusion. A repeat antibody screen waspositive with Anti-c and Anti-E specificity. The DATwas also positive for IgG. Anti-c and Anti-E wereidentified in the eluate. Retrospective testing of thepre transfusion antibody screen was negative. Thispatient remained extremely unwell post operativelyand died as a result of his underlying conditionunrelated to transfusion.


Annual Report 2003

Acute Haemolytic and Other Severe Acute Transfusion Reaction

Definition: Acute Transfusion Reactions aredefined as those occurring within twenty fourhours of transfusion. The major concern inevaluating these reactions is to excludebacterial contamination of the unit orhaemolysis due to incompatible red cells(Heddle & Kelton, 2001).

For the purpose of the NHO report, AcuteHaemolytic Transfusion Reactions occurring due toincorrect blood transfused are captured in the‘Incorrect Blood Component Transfused’ chapter.Anaphylaxis/Anaphylactoid transfusion reactions arealso reported within a separate chapter.

This category accounted for 4% of incidentsreported (8 of 180). As these reactions may reflectred cell incompatibility and particularly ABOincompatibility or bacterial infection of thecomponent, both of these possibilities must beexcluded. As noted in previous years the direct causeof all these reactions has not been fully established,and in some cases the symptoms were probablyrelated to the patient’s underlying condition.

Findings

All eight cases involved the transfusion of red cells.The reactions occurred during transfusion andalthough in all cases the patients recovered within24 hours without complications, one case (Case 7)involved a day case patient who requiredhospitalisation overnight.

• In three cases, the patient had irregular red cellantibodies detected. In two cases (Case 1 and 4)antibodies were detected prior to transfusion andantigen negative blood was selected. In Case 1 nopost transfusion serology investigation wasundertaken. In the second case (Case 4), red cellincompatibility was ruled out and the reaction wasprobably due to HLA antibodies. In the third case(Case 3), involving an elderly patient with noapparent previous transfusion history, a weak anti-Ka was detected in the post transfusion samplewhich had not been detected in the pre-transfusionsample. This was the likely cause of the reaction.

• Although all the reactions involved thedevelopment of a fever or rigors, in only fivecases (Cases 1, 4, 6, 7 and 8) where both the



patient and the unit were cultured and bacterialcontamination definitely excluded as the cause ofthe symptoms. In one case (Case 5), the reactionon investigation was found to be due to infectionin the patient’s Hickman line.

• Six of the cases (Cases 1-3 and 5-7) involvedtransfusions in patients with underlyingmalignancies. In some of these cases, where noother cause was discovered, the symptoms mayhave been due to the underlying disease ratherthan the transfusion.

• One case (Case 8) had been initially reported as aTACO in an elderly patient with underlying cardio-respiratory and chronic renal disease. While theremay have been an element of overload, it wasdecided to capture the reaction within theAHOSTR category on the basis of othersymptoms. Red cell incompatibility and bacterialinfection were ruled out.

Recommendations:

• Every patient should be carefully monitoredduring transfusion with special emphasis placedon the start of each new unit. Individual unitsshould be commenced slowly and the patientobserved closely for the first 15 minutes/50mls assevere reactions are most likely to occur withinthis time (BCSH, 1999).

• Each hospital must have a policy in place for themanagement of an acute transfusion reaction. Thisshould 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 an ABOincompatible transfusion has been excluded andthe blood has been re-crossmatched.

• Investigations should include: • Re-confirming the identification of the patient

and 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 cell incompatibletransfusion including a clotted sample forantibody identification using serum

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

and LDH (NBUG, 2003)

• If at all possible, further transfusions should bedelayed until completion of the transfusionreaction work-up.

• In the event of fever, both the patient and thetransfused unit(s) should be cultured to excludebacterial contamination of the unit

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

• A protocol for culturing of the blood componentis available by writing to the QA/QC Departmentof the IBTS. This protocol outlines the procedureto be followed when culturing a unit implicated ina febrile transfusion reaction.

• Where an antibody is detected in the posttransfusion sample taken within 24 hours of thetransfusion which was not detected in thepretransfusion sample, the pretransfusion sampleshould be tested by a different technique and/orreferred to a reference laboratory for investigation.It is likely that the antibody was presentpretransfusion but was not detected.

• Since the introduction of leucodepleted products,transfusion reactions associated with HLAantibodies in the patient have become lesscommon. However rarely severe reactions totransfusion may be caused by HLA antibodiesdespite leucodepletion of the product andparticularly in the case of repeated reactions, HLAantibody investigations should be undertaken.


Annual Report 2003Annual Report 2003

TAB

LE 2

4 A

CU

TE H

AEM

OLY

TIC

OR

OTH

ER S

EVER

E TR

AN

SFU

SIO

N R

EAC

TIO

N (

N=

8)

Cas

e N

oC

om

po

nen

t Pr

escr

ibed

Ag

e ye

ars

Gen

der

Un

der

lyin

g

con

dit

ion

V

olu

me

tran

sfu

sed

/on

set

Sym

pto

ms/

Sig

ns

Inve

stig

atio

ns

Trea

tmen

t &

Ou

tco

me

AH

OST

RC

ase

1* *p

One

uni

t of

antig

enne

gativ

e re

dce

lls.

14

FH

aem

atol

ogic

alm

alig

nanc

yA

nti-E

prio

r to

tran

sfus

ion.

< 2

00m

ls

Feve

r ris

e >

1.5

0 C,

chill

s/rig

ors

and

hypo

tens

ion.

Patie

nt a

nd u

nit

cultu

red–

nogr

owth

. R

ed c

ell i

ncom

patib

ility

not

excl

uded

.

Tran

sfus

ion

disc

ontin

ued

com

plet

ely

and

para

ceta

mol

giv

en w

ith e

ffec

t.Re

cove

red

with

no

ill e

ffec

ts.

AH

OST

RC

ase

2Tw

o un

its o

fre

d ce

lls.

45

MH

aem

atol

ogic

alm

alig

nanc

y.D

urin

g tr

ansf

usio

nof

the

sec

ond

unit.

Fe

ver

rise

> 1

.50 C

hypo

tens

ion.

Nei

ther

pat

ient

nor

uni

t cu

lture

d.Re

d ce

ll in

com

patib

ility

exc

lude

d.

Tran

sfus

ion

com

plet

ed.

Para

ceto

mol

and

frus

emid

e ad

min

iste

red.

No

furt

her

com

plic

atio

ns a

s a

resu

ltof

thi

s tr

ansf

usio

n. P

atie

nt d

ied

ofun

derly

ing

cond

ition

.

AH

OST

RC

ase

3*

One

uni

t re

dce

lls.

70

MIs

chae

mic

Hea

rtD

isea

se a

ndm

alig

nanc

y.

>10

0mls

Feve

r, ch

ills,

rig

ors

rest

less

ness

, an

xiet

y,fe

elin

g of

impe

ndin

gdo

om a

nd c

hest

pai

n.

Rais

ed b

iliru

bin,

pos

itive

DA

T, w

eak

anti

K d

etec

ted

post

tra

nsfu

sion

.

Tran

sfus

ion

disc

ontin

ued,

pa

race

tom

ol a

dmin

iste

red.

Reco

vere

d w

ith n

o ill

eff

ects

.

AH

OST

RC

ase

4*

Thre

e un

itsof

ant

igen

nega

tive

red

cells

.

65

FG

IT d

isea

seA

nti-E

and

ant

i-Lea .

Sym

ptom

sde

velo

ped

durin

gth

ird u

nit.

Feve

r ris

e >

1.50 C

, ch

ills,

rigor

s, d

yspn

oea

and

back

pain

.

Both

pat

ient

and

uni

t cu

lture

d –

no g

row

th.

DA

T po

sitiv

e po

st t

rans

fusi

on -

nore

d ce

ll in

com

patib

ility

det

ecte

d.

Tran

sfus

ion

disc

ontin

ued.

O2,

par

acet

amol

and

sal

buta

mol

nebu

liser

giv

en.

Reco

vere

d w

ith n

o ill

eff

ects

.

AH

OST

RC

ase

5 O

ne u

nit

ofre

d ce

lls.

27

MH

aem

atol

ogic

alm

alig

nanc

y.>

100

mls

Feve

r, ch

ills,

anx

iety

,hy

pert

ensi

on.

Uni

t cu

lture

d- n

o gr

owth

.G

ram

neg

ativ

e ba

cilli

isol

ated

fro

mH

ickm

an li

neRe

d ce

ll in

com

patib

ility

exc

lude

d.

Hyd

roco

rtis

one

and

chlo

rphe

nira

min

e.

Reco

vere

d w

ithno

ill e

ffec

ts.

* In

clu

ded

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r

111


TAB

LE 2

4 (C

ON

TIN

UED

) A

CU

TE H

AEM

OLY

TIC

OR

OTH

ER S

EVER

E TR

AN

SFU

SIO

N R

EAC

TIO

N (

N=

8)

Cas

e N

oC

om

po

nen

t Pr

escr

ibed

Ag

e ye

ars

Gen

der

Un

der

lyin

g

con

dit

ion

V

olu

me

tran

sfu

sed

/on

set

Sym

pto

ms/

Sig

ns

Inve

stig

atio

ns

Trea

tmen

t &

Ou

tco

me

AH

OST

R C

ase

6O

ne u

nit

of

Red

cells

83

FH

aem

atol

ogic

alm

alig

nanc

y.50

-99m

lsFe

ver

rise

>1.

50 C,

chill

s/rig

ors,

nau

sea

and

vom

iting

.

Patie

nt a

nd u

nit

cultu

red

- no

grow

th.

Red

cell

inco

mpa

tibili

ty e

xclu

ded.

Chl

orph

enira

min

e IV

hydr

ocor

tison

e 10

0mg

IVC

ycliz

ine

50m

g IV

Patie

nt r

ecov

ered

with

no

ill e

ffec

ts.

AH

OST

R C

ase

7Tw

o un

its o

fre

d ce

lls49

M

Susp

ecte

dm

alig

nanc

y.>

100m

ls.

Chi

lls/r

igor

s Pa

tient

and

uni

t cu

lture

d -n

ogr

owth

. R

ed c

ell i

ncom

patib

ility

excl

uded

.

Tran

sfus

ion

disc

ontin

ued

and

notr

eatm

ent

give

n. D

ay c

ase

patie

ntne

eded

ove

rnig

ht

adm

issi

on.

AH

OST

R C

ase

8*

Gro

up R

h D

Red

cells

84

C

hron

ic c

ardi

ore

spira

tory

dis

ease

and

chro

nic

rena

lfa

ilure

.

90m

ls

Dys

pnoe

a, h

yper

tens

ion,

falli

ng O

2sa

ts,

pyre

xia,

rigor

s an

d be

cam

eag

itate

d.

Patie

nt,

unit

and

perip

hera

l lin

ecu

lture

s ne

gativ

e.Re

d ce

ll in

com

patib

ility

exc

lude

d.

Frus

emid

e an

d IV

hyd

roco

rtis

one

adm

inis

tere

d.

Reco

vere

d w

ith n

o ill

effe

cts.

* In

clu

ded

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r



Acute Haemolytic or Other Severe TransfusionReactions (n=8)

We describe four cases in detail

AHOSTR Case 1 This young patient with a malignant haematologicaldisorder required one unit of red cells for anaemia Hb 7g/dl. The patient grouped as O Rh D positivewith an Anti E antibody and an autoantibodyreactive in enzyme only. The DAT was negative.Antigen negative blood was crossmatched andissued. When less than 200mls had been transfused,the patient developed fever with chills/rigors andhypotension. The transfusion was discontinuedcompletely and paracetamol was given. A fullrecovery was made within approximately 1-2 hours.The patient was cultured and no organisms wereisolated but no repeat serology was done posttransfusion reaction as per hospital policy. As a resultof this failure to complete reaction investigations,the management of adverse transfusion reactionshas been highlighted at existing educational sessionsand laboratory policy on the investigations ofadverse reactions to transfusion is being reviewed.

AHOSTR Case 3 This elderly male patient with a history of ischaemicheart disease and malignancy required a transfusionof one unit of red cells for anaemia Hb 8.3g/dl. Thispatient gave no previous history of transfusion andthe pre transfusion antibody screen was negative.Following transfusion of 100mls, the patientdeveloped symptoms of fever, chills, rigors,restlessness, anxiety, chest pain and feeling ofimpending doom. The transfusion was immediatelydiscontinued and paracetamol given. The patientrecovered uneventfully from the symptoms within 24hours and required no further transfusion. Posttransfusion investigations showed a weakly positiveDAT, a positive antibody screen and a raised bilirubin.

AHOSTR Case 4 This patient with anaemia secondary to GIT disease Hb 7.2 g/d required transfusion of three units of redcells. The patient’s serum contained Anti-E and Anti-Lea. Three units of antigen negative red cells wereissued. During the third unit, when 140mls hadtransfused, symptoms of fever (38.90C) chills, rigors,back pain and dyspnoea developed. The transfusion

was discontinued and O2, paracetamol andsalbutamol by nebuliser were given. The patientrecovered within one hour. Bacteriological culture ofthe patient and the third unit isolated no organisms.There was no evidence of red cell incompatibility onretesting of the pre and post transfusion samplesalthough the DAT result on the post transfusionclotted sample was positive (IgG). The serumbilirubin was not measured. There was no increasein Hb after transfusion of two and a half units of redcells but this was probably due to active bleeding.Strong HLA antibodies were subsequently detectedwhich may have been responsible for the symptoms,which subsided quickly. This patient wassubsequently managed by intravenous iron infusionsinstead of transfusion.

AHOSTR Case 8 This elderly male patient with underlying cardio-respiratory disease, chronic anaemia, and chronicrenal failure required a transfusion of one unit of redcells for a symptomatic anaemia Hb 10g/dl. Thepatient had been transfused with five units of redcells over the previous week uneventfully. Thepatient received his regular diuretic medication thatmorning but did not receive a premedication of adiuretic prior to the transfusion. The unit wasprescribed over 4 hours. The patient’s intake andoutput were not being recorded. Two hours into thetransfusion, having received 90mls, the patientdeveloped symptoms of dyspnoea, hypertension,falling O2 saturations, pyrexia (39.20C) rigors andagitation. The transfusion was discontinued andhydrocortisone and frusemide IV were administered.There is no record of the response to the diureticbut the patient’s symptoms resolved within threehours. The patient suffered no complications as aresult of this incident and has received furthertransfusions successfully. Investigations of thereaction excluded ABO incompatibility and the posttransfusion antibody screen was negative. Culturesof the patient, peripheral line and unit werenegative. This reaction may have been complicatedby transfusion overload but in view of the high feverand rigors it was decided to include the reaction inthe AHOSTR category.

Annual Report 2003


Definition: Transfusion Related Acute LungInjury (TRALI) is a clinical combination of acuterespiratory distress, hypotension, fever andrigors associated with bilateral pulmonaryoedema with no evidence of cardiac failure orfluid overload. Symptoms typically beginwithin 1-2 hours of transfusion and alwayswithin 6 hours (Popovsky, 2001)

Introduction

This category accounted for 1% (1 out of 180)incidents reported during this period. Two reportswere submitted and on analysis one fatal case wasconsidered to be definitely attributable to TRALI. In asecond case reported, the diagnosis of TRALI wasconsidered extremely unlikely and this case was re-categorised as a TACO incident.

It is very difficult to distinguish TRALI from othercauses of acute lung injury which also causedyspnoea, hypoxia and chest x-ray white out byinterstitial and alveolar infiltrates. Patients may alsopresent with hypo/hypertension. Symptoms generallybegin within six hours of transfusion and in the vastmajority the patient outcome is good. However, assystems are put in place to tackle fatal outcomesfrom other adverse events, TRALI is slowly coming toincreased prominence. In 2003 the most common

cause of transfusion related fatalities reported to theFDA in the USA was TRALI.

The true incidence is unknown and may range from1:5000 to 1:100,000 units of plasma containing bloodcomponents transfused. Under reporting and the lackof prospective data complicate the issue further.However, it is important to recognise that TACO ismuch more common than TRALI and where there isevidence of fluid overload or cardiac failure, thediagnosis is very unlikely to be TRALI (NHO, 2002).

The presence of white cell antibodies (including HLAclass I and II antibodies, granulocyte-specificantibodies and anti-monocyte antibodies) has beenreported to be associated in about 80% of casesand correspondence between the donor antibodyand patient antigen is found in up to 50% of these.There are, however, a number of cases where noantibody is found. It has been proposed that non-immunologic mechanisms may play a part in causingTRALI whereby two insults to the lung are necessary,the first one being a predisposing event such astrauma or sepsis and the second transfusion of abiologically active substance such as lipids found instored cellular blood products.

It is important that the condition is recognisedpromptly. Timely intervention with O2 or mechanical


Transfusion Related Acute Lung Injury

Incorrect Blood Component Transfused

Annual Report 2003

ventilation if necessary and other support measuresare fundamental to a successful outcome.

Findings

• There were two cases reported to the NHOthroughout this period. One involved thetransfusion of an apheresis platelet concentrateand one involved transfusion of a 16-day-old redcell concentrate.

• In Case 1, as was pointed out in the case history, itwas not possible to perform HLA typing of thepatient nor was cross-match carried out betweenthe patient’s cells and the donor’s serum. However,based on the close temporal association ofsymptom onset with the transfusion, the clinicalpicture and the post-mortem features, it was feltthat this fatality was very likely to be due to TRALI.The donor was found to have Class 1 HLA IgGantibodies and has been permanently deferred.

• The second case was notified as a TRALI onaccount of the temporal association of symptomonset with the transfusion and because thesymptoms resolved rapidly on commencing O2treatment. On review of the case however, therewas evidence of fluid overload, the JVP was foundto be mildly raised and the patient also hadbilateral lower limb oedema. A diagnosis of TRALIhas therefore been considered highly unlikely. Thiscase has been transferred to the TACO chapter asTACO Case 13.

Recommendations

• Whilst in both cases blood components weretransfused for appropriate reasons, it is importantto underline the need for vigilance in theappropriate use of blood, as transfusion relatedadverse reactions 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 NHO

information leaflet on differential diagnosis ofTRALI is included in Appendix 4

• The IBTS has put in place a number of measureswith a view to minimising the risk from TRALInamely avoiding the use of plasma from femaledonors both for suspension of pooled plateletsand as FFP and in early 2004 to defer new andlapsed female plateletpheresis donors with ahistory of pregnancy. As part of the vCJD Policy,SD Plasma has become the standard plasmaproduct. To date, SD treated plasma has not beenconvincingly implicated in TRALI.

Transfusion Related Acute Lung Injury (TRALI)(n=1)

TRALI Case 1An elderly male patient who was newly diagnosed witha malignant haematological disorder was admitted forhis first dose of chemotherapy. He had no previoushistory of cardiovascular disease; a physical examinationshowed no evidence of lower limb oedema or raisedJVP and his lung fields were normal. The ECG showednormal sinus rhythm. One hour after receiving hischemotherapy, (Daunorubicin and Vincristine) he wastransfused with one unit of platelets. 15 minutes afterthe transfusion he developed acute shortness ofbreath, vomiting, frothing, dizziness and clamminess.He became cyanotic, hypotensive (60/48mmHg)tachycardic, and tachypnoeic with O2 saturation onroom air 74%. He suffered a cardiac arrest andresuscitation was attempted but was unsuccessful. Theautopsy showed a normal heart with no evidence offibrosis or recent ischaemia. It also showed severepulmonary oedema bilaterally. Petechial haemorrhageswere present on the surface of the lungs and there wasno evidence of pulmonary embolism. There was focalinfiltration of the lungs by the malignanthaematological cells. Blood samples from the donor ofthe implicated apheresis platelet concentrate showedthe presence of HLA Class 1 IgG antibodies and on thisbasis the donor has been permanently deferred. It wasnot possible to perform HLA typing on the patient norwas it possible to perform cross-match between thepatient’s white cells and the donor’s.

Annual Report 2003115


TAB

LE 2

5 TR

AN

SFU

SIO

N R

ELA

TED

AC

UTE

LU

NG

INJU

RY (

TRA

LI)

(N=

1)

Cas

e N

um

ber

Ag

e ye

ars

Gen

der

Co

mp

on

ent

and

nu

mb

er

of

un

its

tran

sfu

sed

Rea

son

fo

rtr

ansf

usi

on

Sym

pto

ms

Pati

ent

Inve

stig

atio

ns

Trea

tmen

tD

on

or

Inve

stig

atio

ns

Co

mm

ents

TRA

LIC

ase

1 77

M

One

uni

t of

aphe

resi

spl

atel

etco

ncen

trat

e

Thro

mbo

cyto

peni

ase

cond

ary

tom

alig

nant

haem

atol

ogic

aldi

sord

er.

Prof

ound

hypo

tens

ion,

dysp

noea

, cy

anos

isan

d fa

lling

O2

satu

ratio

n.

O2

satu

ratio

n 74

%.

No

ches

t x-

ray

perf

orm

ed.

Elec

troc

ardi

ogra

phno

rmal

sin

us r

hyth

m.

100%

nas

al O

2an

din

trav

enou

sad

rena

line.

One

don

or in

volv

edH

LA c

lass

1 a

ntib

ody

dete

cted

.

Patie

nt d

ied

two

hour

sfo

llow

ing

the

com

plet

ion

oftr

ansf

usio

n.


This category accounted for 2% of incidentsreported (4 of 180) 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.Viral infections which are not covered by mandatorytesting, e.g. Hepatitis A virus, CMV and Parvovirus,but are reported to the NHO and suspected to beassociated with a blood transfusion during thecurrent reporting year will be recorded as an NHOincident and investigated appropriately. The NHOalso collects and investigates reports of transfusion-transmitted bacterial and parasitic infections.

The onset of symptoms related to a transfusion-transmitted viral infection may occur several weeksto years 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 are

not 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 needto investigate other possible sources (SHOT, 1999).Such investigations may involve microbiologicaltesting of many donors and may take many monthsto complete.

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

Suspected Transfusion Transmitted Infection


• The recipient had evidence of infection followingthe transfusion, with no evidence of infectionprior to the transfusion

and, either

• A donor who had evidence of the sametransmissible infection donated at least onecomponent received by the infected recipient

or

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

Much concern has been voiced in recent yearsregarding the risk of transfusion-transmittedinfection and much quality assurance effort hasbeen directed towards appropriate testing andhandling of blood after collection. There is verygood evidence that with continuous improvementsin the donor selection/testing procedures andmanufacturing processes used in Ireland, the risk oftransfusion-transmitted infection is very small.The current estimated risk for HIV and HCV is lessthan 1:4,000,000 components transfused,(O’Riordan, 1999). These residual risk estimates arebased on serological testing and nucleic acidamplification testing (NAT) for HCV and HIV.

Even prior to the introduction of NAT testing the riskfor Hepatitis C for screened blood was 1:500,000 which is estimated to be less than therisk of infection from nosocominal sources. (Ross etal, 2000, Gerberding et al, 2003).

The risk for HBV has been estimated atapproximately 1:200,000 since the introduction oftesting for antibody to Hepatitis B core in January2002 (O’Riordan 2002 personal communication).Hepatitis B infection is not uncommon in thecommunity and in up to 40% of cases no risk suchas sexual exposure, intravenous drug abuse ortransfusion is present. Evidence of past cleared

infection in blood donors, a highly selected populationwas found in 0.17% i.e. 17 in 10,000 donors in thefirst year of testing. In many of these cases,nosocomial risks in the past may be responsible. Suchcleared infection does not pose a risk to recipients andin a number of countries, such individuals areacceptable as donors. In Ireland, we introduced coreantibody testing in 2002 to reduce the possible risk ofdonors donating before HBV infection was fullycleared i.e. in the second window period when HbsAgis no longer detectable in blood but before anadequate (>100miu/l) antiHbs antibody is found.Because hepatitis B core antibodies are a mandatorytest, donors with cleared infection found reactive forthe 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 offeredtesting before therapy and at regular intervals withstorage of samples wherever possible for furthertesting if necessary.

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)

One case (Case 1–2002) of Hepatitis B remainsoutstanding from NHO Annual Report 2002 where ithas not been yet been possible to undertake viralsequence investigations.


Annual Report 2003

Findings

• Four incidents, which fit the criteria of suspectedtransfusion-transmitted infection, were reportedto the NHO during this reporting year.

• There were two reports of suspected HBVinfection, one of HCV and one of HIV.

• In all cases, transfusion was excluded as the likely cause.

We report the details on the four suspected cases.

TTI Case 1This patient was found to have chronic HBV infectionin May 2003 having had a number of transfusionsbetween March 2002 and May 2003 all of whichscreened negative for Hepatitis B surface antigen andanti Hepatitis B core antibody. The patient had notbeen previously tested for hepatitis B but a storedsample from December 2002 was tested and showedsimilar findings. Investigation of the nine donorswhose units had been transfused between Marchand December 2002 were investigated. Eight of thedonors had returned or were recalled and testednegative for HBV markers of infection. The finaldonor could not be contacted but the archive sampleof the implicated donation was tested for hepatitis BDNA and anti-Hb core antibody and was found to benegative. It is therefore very unlikely that transfusionwas the cause of the patient’s chronic hepatitis B

TTI Case 2 This patient, a EU non-national, had had transfusionin their country of origin prior to coming to Ireland.The patient had three units of blood in Irelandbetween July 2002 and April 2003. She was foundto be HIV positive in July 2003 not having beenpreviously tested. The three donors wereinvestigated and found to HIV negative on repeattesting, and have been excluded as the cause of thepatients HIV.

TTI Case 3This patient who had four units of blood in 1994was tested and found to have evidence of hepatitisC in 2003. She had not been previously been tested.The four donors have retested and had been foundto be negative.

TTI Case 4This patient with a haematological malignancyreceived a total of 41 blood components betweenMay 2001 and October 2001. He was found to haveevidence of chronic Hepatitis B in October 2003. Asample for Hepatitis B surface antigen was negativein June 2001 before therapy but full hepatitis Bmarkers had been not been done and the samplewas no longer available for retesting. All but one donor has either returned to donate orbeen recalled. One donor was found on recall tohave evidence of past cleared hepatitis B infection(core antibody positive and surface antibody level>1000 miu/L). Testing of an archive of a donation in1999 prior to the implicated transfusion showedcore antibody and the same high surface antibodylevels of > 1000miu/l indicating that the infectionhad been cleared prior to the implicated transfusionin 2001. It is therefore very unlikely that this donorwas the cause of the patient’s Hepatitis B infection.The final donor who did not return was tested onan archive for HBV DNA and anti Hepatitis B coreantibody and found to be negative. It is thereforevery unlikely that transfusion was the cause.




TABLE 26 SUSPECTED TRANSFUSION TRANSMITTED INFECTION (TTI) (N=4)

CaseNumber

Gender Year of Transfusion

Adult or Child

Viral Market No. ofdonors

Outcome

TTI Case 1*

F 2002 Adult Suspected HBV 9 Transfusion excluded asthe source of theinfection.

TTI Case 2*

F 2001-2003 Child Suspected HIV 3 Transfusion excluded asthe source of theinfection.

TTICase 3*

F 1994 Adult Suspected HCV 4 Transfusion excluded asthe source of theinfection.

TTI Case 4*

M 2001/2002 Adult Suspected HBV 41 Transfusion excluded asthe source of theinfection.



Pre-Deposit Autologous Donor Incidents

Definition: An adverse or unforeseen eventwhich is experienced by the donor during orfollowing a pre-deposit autologous donationprocedure. (SHOT, 2001)

Adverse incidents or reactions during the donationprocedure are collected in this section. Incidentsoccurring during the transfusion of autologousblood are captured elsewhere in this report underthe relevant category.

These adverse reactions account for 3% of the totalincidents reported (6 out of 180).

Autologous blood transfusion is an option forsuitable patients where transfusion is anticipatedduring surgery (BCSH, 1993). Pre-deposit autologousdonation (PAD) involves the collection and storageof up to five units of autologous blood during thepre-operative period. The technique increased inpopularity during the 1980s as a result of publicconcern regarding transfusion safety.

One popular area of application for PAD has been inthe field of elective orthopedic surgery. Ten yearsago, the average estimated blood loss for total hipreplacement (THR) averaged between 900 and1800mls. Today the average blood loss has beenreduced to 500ml (Billotte et al, 2002). Thusadvancements in anaesthesia and surgical technique,in addition to appropriate pre-operative assessmentand reduced transfusion thresholds, have reducedthe need for transfusion in such patients. Billote etal (2002) showed that pre-operative autologousdonation increased the likelihood of transfusion atthe time of surgery or led to wastage.

Most donors tolerate the donation procedurewithout incident, but adverse reactions occuroccasionally (Brecher et al, 2002). The mostcommon reaction is vasovagal in nature. (Yomtovianand Praprotnik, 2001). However, severe reactions areup to 12 times more likely in autologous donorsthan in allogenic donors. (Popovsky et al, 1995). The benefits to the patient of autologoustransfusion include elimination of the risk oftransmission of infectious diseases, alloimmunization

Annual Report 2003


and other adverse immunological effects ofallogeneic transfusion (Politis and Richardson, 2001).However Linden and Kruskall (1997) point out thatwhile 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).

The use of PAD blood has declined with theincreasing safety of blood transfusion for the maintransfusion transmitted viruses HIV, Hepatitis B & C.However other transfusion transmitted infectionagents are emerging including West Nile Virus andvCJD. Although for a long time considered atheoretical risk, a case of vCJD in a transfusionrecipient was reported in the UK in late 2003(Llewelyn et al. 2004). The patient had received atransfusion from a donor who subsequentlydeveloped vCJD. Although this patient could alsohave acquired vCJD from dietary exposure, thefindings strongly suggest that vCJD is transmissibleby blood. The reported finding of abnormal prionsat post mortem in the spleen of a second recipientwho died of unrelated causes but who had receiveda unit of blood from a donor who developed vCJDsupports the likely transmission of vCJD throughtransfusion (Peden et al, 2004).

These cases may lead to the re-evaluation of theneed to provide autologous transfusion. Howeverthe disadvantages associated with PAD such as thenecessity for a definite date for surgery, increasedlikelihood of receiving a transfusion, additional costand the fact that it is still open to the risk of error,volume overload and bacterial contaminationsuggests that other forms of autologous transfusionin particular intraoperative cell salvage may be moreuseful. Increased usage of such systems can helpreduce the requirement for allogeneic transfusion.(BCSH, 1993). Guidelines for perioperativehaemodilution and cell salvage have been issued bythe BCSH in 1997.

Regulatory aspects

Hospitals that collect pre-deposit autologous bloodwill now be considered blood establishments1 and assuch subject to the same scrutiny as a bloodtransfusion service under Article 29 of the newEuropean Directive 2002/98/EC due to come intoeffect on 8th February 2005.

More detailed requirements covering autologousdonations are listed in Commission Directive2004/33/EC which addresses technical requirementsfor blood donors including autologous donors. Itcovers information to be given to donors, andstorage, transport and distribution requirements.

In particular Article 7.2 states that autologousdonations must be clearly identified and keptseparate from allogeneic donations.

The information, which must be given to autologousdonors, is covered in Annex II. These Directives canbe downloaded from http://europa.eu.int.

Findings:

• Four of the six incidents involved PAD fororthopaedic surgery, two of which were total hipreplacement revisions. The remaining twoincidents were associated with PAD prior to plasticsurgery.

• Symptoms reported were vasovagal in nature andranged from feeling sleepy, light headed, ornauseous, to actually fainting. Onset of symptomsvaried from during donation to up to five hourspost donation.

• All of the donations took place in an outpatientsetting. All but one of the incidents occurred to donors donating for the first time. Theremaining donor had donated a unit previouslywithout incident.

1 Blood establishment has been defined: "Any structure or body that is responsible for any aspect of thecollection and testing of human blood or blood components, whatever their intended purpose and theirprocessing, storage and distribution when intended for transfusion.


• The donors involved in these incidents had nounderlying medical conditions that wouldcontraindicate PAD. All were female and fourwere below the age of 40. All weighed over50kg. The predonation Hb level was over 12g/dlin all cases

• Simultaneous volume replacement did not takeplace during any of the donations. However intwo cases, IV fluids were transfused to twodonors who experienced symptoms during orshortly after donation while still in the clinic.

• All donors recovered without complications orhospitalisation but none went on to donate again.

• After the adverse reaction had resolved in twocases, the donors admitted to having a fear of "needles".

• The blood collected was transfused in only twoout of the six cases. In one case (Case 3) wherethe adverse reaction occurred on the seconddonation, neither unit was transfused. In anothercase, the unit was not transfused as the plannedsurgery was cancelled.

Recommendations

• PAD clinics must have in place procedures to dealwith donor reactions. All serious reactions shouldbe documented and reported to the NHO.

• Particular attention at pre-donation assessmentshould be paid to first time donors, as these aremore likely to have reactions. Popovsky et al(1995) also identified an increased risk of adversereactions in low weight female donors. At pre-donation assessment, attention should also bepaid to psychological factors such as fear ofneedles which may predispose the donor to anadverse reaction.

• It is important PAD is only used for procedureswhere blood transfusion is likely to be needed.Hospitals should have up to date MaximumSurgical Blood Ordering Schedules (MSBOS) toidentify procedures likely to require transfusionand the decision to take an autologous unitshould be based on this. Donors should not beexposed to the risks of donation if the blood isunlikely to be required.

• Patients in a PAD programme, particularly thosepatients who donate more than one unit, may bemore likely to require transfusion intra- or post-operatively. This increased likelihood brings with itincreased risks, as autologous transfusion holdsthe same risks as allogeneic transfusion in termsof errors at the time of administration. (Goldmanet al, 2002).


TAB

LE 2

7 PR

E-D

EPO

SIT

AU

TOLO

GO

US

DO

NA

TIO

N (

N=

6)

Cas

e N

um

ber

Ag

eye

ars

Gen

der

Wei

gh

tK

gs

Hb

g

/dl

Pro

ced

ure

Cu

rren

t m

edic

atio

nN

o.

do

nat

ion

sp

lan

ned

Rea

ctio

n/

do

nat

ion

his

tory

Co

mp

licat

ion

Co

mm

ents

PAD

un

ittr

ansf

use

d

PAD

C

ase

1*

39 F70

14.3

Brea

stre

duct

ion.

Non

e1

On

1st

Brad

ycar

dia,

hyp

oten

sion

,te

mpo

rary

loss

of

cons

ciou

snes

sat

end

of

dona

tion.

Past

his

tory

of

fain

ting.

Reco

vere

d w

ith n

oco

mpl

icat

ions

.

No

PAD

Cas

e 2

*

17 F59

13

.8Pe

riace

tabu

lar

oste

otom

y.N

one

1O

n 1s

t N

ause

a, li

ght-

head

edne

ssim

med

iate

ly p

ost

dona

tion.

Past

his

tory

of

fain

ting

witn

essi

ng in

ject

ion,

nee

dle

phob

ia.

Reco

vere

d w

ith n

oco

mpl

icat

ions

.

No

PAD

Cas

e 3

*

52 F>

5014

.1Re

visi

on T

HR.

Ora

lan

alge

sia

2O

n 2n

d,

1st

unev

entf

ul

Nau

sea

light

-hea

dedn

ess,

fain

ting

five

hrs

post

don

atio

n.Fa

ult

occu

rred

on

a ho

tcr

owde

d tr

ain.

Rec

over

edw

ith n

o co

mpl

icat

ions

.

No

PAD

Cas

e 4

*

34 F>

5013

.6Re

visi

on T

HR.

Ora

l iro

n2

On

1st

Hyp

oten

sion

, fa

tigue

, 20

min

spo

st d

onat

ion.

500m

ls IV

Flu

ids

adm

inis

tere

d. R

ecov

ered

with

no

com

plic

atio

ns.

No

(sur

gery

canc

elle

d)

PAD

Cas

e 5

*

17 F>

5012

.2Se

cond

sta

gesp

inal

fus

ion.

Ora

l iro

n3

On

1st

Del

ayed

fai

ntin

g 2

hrs.

45

min

spo

st d

onat

ion.

Reco

vere

d w

ith n

oco

mpl

icat

ions

.Ye

s

PAD

Cas

e 6

*

62

F60

13.2

Brea

stRe

cons

truc

tion.

Ora

l iro

n2

On

1st

Pallo

r, lig

ht-h

eade

dnes

s, n

ause

a,fo

ur m

ins

into

don

atio

n.

1L IV

flu

ids

adm

inis

tere

d.Re

cove

red

with

no

com

plic

atio

ns.

Yes

(par

tial

unit)

* In

clu

ded

as

full

case

his

tory

*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

Pae

dia

tric

Ch

apte

r


Pre-Deposit Autologous Donation Incident(PAD) (n=6)

PAD Case 1 This female patient was pre-donating one unit ofblood for elective plastic surgery. She was not on anymedication and had never donated blood previously.Between 400-450mls of blood were collected.Towards the end of the donation, she developedsymptoms of bradycardia, hypotension andexperienced a temporary loss of consciousness.Following medical review and a rest period of 50minutes, she was discharged. Further questioningrevealed that she was frightened of needles andprone to fainting. Although this was covered by thepre assessment questionnaire, she did not alert thenurse to this fact until the procedure had begun. Nofurther attempt at pre-deposit donation was made.The autologous unit was suitable for transfusion,however, the patient’s haemoglobin postoperativelydid not warrant blood. The estimated blood loss forthis procedure is between 500-700mls.

PAD Case 2 This young female patient was pre-donating oneunit of blood for elective orthopaedic surgery. Shewas not on any medication and had no record ofprevious donations. The amount collected was537mls. Immediately following donation, shedeveloped symptoms of nausea and light-headedness. Following medical review and a restperiod of 30 minutes, she was discharged. Furtherquestioning revealed that she was "frightened ofneedles" and had fainted while witnessing aninjection previously. She had been asked about this,but the nurse undertaking the procedure was notalerted to this until after the event. No furtherattempt at pre-deposit donation was made. Theautologous unit was suitable for transfusion, butwas not required.

PAD Case 3 This female patient attended a pre-donation clinic topre deposit her second unit of blood prior to electivesurgery. She was on oral analgesia twice daily.Although she had a past history of bronchitis, she wasfit at the time of donation. Five hundred and forty onemls of blood were collected. She left the donationsuite following a rest period of 30 minutes. Shesubsequently had a long train journey during very

warm weather and the train was very crowded.Approximately five and a half hours followingdonation, she became light-headed, nauseated andfainted despite taking frequent fluid as recommended.Both donated units were suitable for transfusion butneither was required at the time of surgery.

PAD Case 4This female patient was scheduled to pre-donatetwo autologous units of blood for elective surgery.The amount of blood collected was 543mls. Twentyminutes following donation, she becamehypotensive and complained of fatigue. Followingmedical assessment, 500mls of normal saline wasadministered. After this, she recovered and wasdischarged. She did not donate again. Although theunit was suitable for donation, it was not used asthe planned surgery was cancelled.

PAD Case 5This young female patient was scheduled to pre-donate three units of blood prior to elective surgery.The first donation took place uneventfully and 450mlsof whole blood were collected. She rested for 30minutes following donation and left the hospital. Twohours and forty-five minutes later, she fainted. It wasan extremely hot day and she had not taken anyfluids since she left the clinic. The symptoms resolvedfollowing oral fluids and a further rest period oftwenty minutes. No further attempts were made atdonation. The patient received one unit of autologousblood immediately post operatively and did notrequire allogeneic transfusion. The haemoglobin priorto discharge was -10.4g/dl.

PAD Case 6 This elderly female patient was scheduled to pre-donate two units of blood prior to elective surgery.She had no significant previous medical history. Fourminutes into the donation when 355mls had beencollected, she felt faint with symptoms of light-headedness, nausea and appeared pale. Thedonation procedure was discontinued at this point.She received one litre of IV fluids and recovered withno ill effects after a rest period of one hour at thedonation clinic. The second pre-donation episodewas cancelled. Post operatively the patient’s Hb was7.5gm/dl and she received the pre-donated unit. Noallogeneic units were required. Prior to dischargehome her Hb was 9.8gm/dl.


Paediatric Incidents

Paediatric patients form an important sub-group oftransfusion patients. We have therefore summarisedthe findings of the 26 paediatric cases in Tables 28-32. We have collected all the individual casehistories in the AA and AHOSTR categories in thissection and the IBCT incidents of particular relevanceto paediatric rather than general hospital practice.The remaining incidents are described in theirrespective chapters. For the purpose of this year’sreport, we have raised the age to which thedefinition of paediatric refers to from 15 to 18 years.

Findings

IBCTThere were 13 incidents reported in the IBCTcategory. The types of errors were similar to thosefound in the adult patients involving all parts of thetransfusion chain.

There were five level 1 cases (Cases 13, 23, 27, 37and 52).

• Four of these cases (Cases 13, 27, 37 and 52)involved failure to prescribe or issue the correctproduct.

• In two cases of these cases, Uniplas* was issuedinstead of group specific SD plasma (Case 13 and 27).

• In one case, the crossmatched label was put onthe wrong pack and blood issued wasuncrossmatched (Case 23).

• One case involved collection of blood componentswhere the wrong component was collected fromthe satellite fridge (Case 37).

• The final case involved the wrong RecombinantConcentrate prescribed (Case 52).

There were seven level 2 incidents (Cases 1, 8, 44,65, 35, 89 and 110).

• Three cases involved failure to prescribe CMVnegative and/or irradiated product (Cases 1, 8and 44). In two of these, (Cases 1 and 8) patientshad congenital immunodeficiencies and shouldhave received irradiated products.

• Two cases involved problems with medical devicesinvolving an infusion pump in one case (Case 65)


Annual Report 2003

and a syringe used without a filter in the second.(Case 35)

• In one case, a unit was left out of storage for overone hour before being returned to the fridge andthen removed and transfused (Case 89).

• One case (Case 110) involved an inappropriatelylarge dose of platelets.

• The one level 3 incident (Case 61) involved unitstransferred between hospitals.


Reactions

• The most common reaction reported was in theA/A category with nine cases.

• Seven of these involved platelet concentrates andtwo involved red cells.

• In one case (case 13), the patient who had beentransfused in a day care ward had a reaction athome and required overnight admission.

• Further transfusion was managed bypremedication in one case (Case 13) and bypremedication and platelet apheresis in a secondcase (Case 11).

• In one case (Case 17), however, the patientsuffered a reaction despite having receivedpremedication cover and platelet apheresis.

• Seven cases required/will require washedcomponents for further transfusions. (Case 1, 12,14, 15, 16, 17 and 22). All but one (Case 12)had a history of previous reactions.

• There was one AHOSTR where the patient had ared cell antibody pre-transfusion but no postreaction investigation was undertaken. (AHOSTRCase 1).

• Two cases (PAD Cases 2 and 5) involved reactionsassociated with pre-autologous donations. Thesecases are described in the PAD chapter.

• One case (TTI case 4) was an investigation forSuspected Transfusion Transmitted Infection which was excluded. This case is described in the TTI chapter.

Recommendations:

• On call staff not routinely working in thetransfusion laboratory must receive on-goingtraining on the correct products to be issued for neonates.

• It is important to ensure that the patient has apatent IV cannula and that all documentation iscorrect prior to collection of the unit. Shouldthere be a delay in the commencement of thetransfusion, it is necessary to return the unit tocontrolled storage within thirty minutes andinform the laboratory to insure the unit is beingreturned to the appropriate fridge.

• 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.

• 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 forpatients with a history of transfusion reactions topooled products, apheresis platelets (which areassociated with a lower rate of reactions) withpremedication cover should be tried first.



TABLE 28 IBCT PAEDIATRIC INCIDENTS:

Level Case Number

Age years

Volume of Incorrect BloodComponent or Product Transfused

Symptoms& Outcome

Cause of Error

1 IBCT Case 13*p

2 wks 18mls of Uniplasgiven.


Wrong component issued oncall. Medical scientist thoughtUniplas was the product ofchoice for neonates.

1 IBCT Case 27*p

1day

Less than 50mls ofUniplas


Medical scientist thoughtUniplas was the product ofchoice for neonates.

1 IBCT Case 37*p

3 days 32mls of red cells No complicationsas a result of thistransfusion.

Emergency uncrossmatchedgroup O Rh D negative red cellsfor adult use collected fromsatellite fridge and transfusedinstead of group O Rh Dnegative paedipack foremergency neonatal use.

1 IBCT Case 23 *

9mths


Label for crossmatched unitattached in error to anuncrossmatched but groupcompatible unit. Error identifiedby laboratory staff whenchecking stock and noted that aunit which was logged out ofthe fridge as transfused was infact still in stock.

2 IBCT Case 1*p

2mths

Three units of SAG-Mred cells. Sevenaliquots of paedipackred cells


Failure to request and/orprescribe irradiated cellularcomponents for this patient.

2 IBCT Case 8*p

7 days Three units of SAG-Mred cells. Two units ofplatelet concentrateapheresis and fivealiquots of paedipackred cells


Failure to request and/orprescribe irradiated cellularcomponents for this patient.

* Included in this chapter*p Included as full case history in appropriate Chapters


Annual Report 2003

TABLE 28 (CONTINUED) IBCT PAEDIATRIC INCIDENTS:

Level Case Number

Age years

Volume of Incorrect BloodComponent or Product

TransfusedSymptoms& Outcome

Cause of Error

2 IBCT Case 35*

1 day 11mls red cells No complications as aresult of this transfusion.

Transfusion given via a syringewithout integral 170-260micron filter in place.

2 IBCT Case 44*p

1 day 45mls red cells No complications as aresult of this transfusion.

CMV negative red cells notselected although available inlaboratory.

2 IBCT Case 65*p

5mths

One unit ofplatelets forneonatal use.

No incremental risefollowing transfusion.Infant required furthertransfusion to increaseplatelet count toacceptable levels.

Platelet transfusion given via anelectronic infusion device,contravening hospital policy.

2 IBCT Case 89 *p

6 One unit ofCMV negativeand irradiatedred cells.

No complications as aresult of this transfusion.

Unit out of fridge for one hourthen returned to fridge fortwenty minutes then removedand transfused.

2 IBCTCase 110*p

4 Two units ofCMV negativeand irradiatedapheresisplatelets.

No complications as aresult of this transfusion.

300mls of platelets prescribedpre-operatively platelet count 19 X 109/L Platelet count posttransfusion of 200mls unit was118 X 109/L but patient wastransfused with a further unit ofplatelets. Platelet count 155 X109/L.

3 IBCTCase 61*

17 Two units of redcells.

There were nocomplications to thistransfusion.

Two units transfused came froma different hospital and hadaccompanied the patient ontransfer.

1 IBCT Case 52*p

16 8000 iu ofRefacto

No complications to thisincorrect administrationof Refacto.

Refacto was prescribed instead ofRecombinate for a patient withhigh responding inhibitors. Itwas highlighted on the computersystem that this patient normallyreceives Recombinate orNovoseven. Laboratory staffquestioned request but wereasked to issue the product.

* Included in this chapter*p Included as full case history in appropriate Chapters



TAB

LE 2

9 A

/A P

AED

IATR

IC IN

CID

ENTS

:

Cas

e N

um

ber

Ag

e ye

ars

Gen

der

Co

mp

on

ent

Rea

son

fo

r Tr

ansf

usi

on

Sym

pto

ms

Stag

e Tr

ansf

usi

on

R

eact

ion

d

evel

op

ed

Inve

stig

atio

ns

Trea

tmen

tSe

qu

elae

/Rec

om

men

dat

ion

sFo

r fu

ture

tra

nsf

usi

on

AA

Cas

e 1

*p

16

MO

ne u

nit

ofre

d ce

lls.

Ana

emia

H

b 8.

7g/d

lU

rtic

aria

,hy

pote

nsio

n,dy

spno

ea,

rest

less

ness

,an

xiet

y,pe

riorb

ital,

oede

ma

&w

heal

s on

bod

y.

Follo

win

g th

e fir

st50

mls

.Ig

A le

vels

nor

mal

.Tr

ansf

usio

nin

com

patib

ility

excl

uded

.

Hyd

roco

rtis

one

and

chlo

rphe

nira

min

e.Re

cove

red

fully

late

r th

at d

ay.

Ther

e w

ere

no c

ompl

icat

ions

to

this

tra

nsfu

sion

. F

urth

ertr

ansf

usio

n w

ill r

equi

re p

re m

ed.

of IV

chl

orph

enira

min

e an

dw

ashe

d ce

llula

r co

mpo

nent

s.

AA

C

ase

11

*p

17

MO

ne u

nit

ofap

here

sis

plat

elet

conc

entr

ate.

Plat

elet

coun

t10

X10

9/L

Hyp

oten

sion

,ta

chyc

ardi

a,ur

ticar

ia,

ches

ttig

htne

ss,

coug

hing

and

falli

ng O

2sa

tura

tion.

Whe

n 85

mls

of

plat

elet

s ha

d be

entr

ansf

used

.

IgA

leve

ls p

ost

tran

sfus

ion

low

-0.

37g/

L (r

elat

ed t

oim

mun

osup

pres

sant

ther

apy

rece

ived

).

Hyd

roco

rtis

one

and

chlo

rphe

nira

min

e.

Patie

nt r

ecov

ered

with

in n

inet

ym

inut

es w

ithou

t co

mpl

icat

ions

.Su

bseq

uent

tra

nsfu

sion

s us

ing

aphe

resi

s pl

atel

ets

and

pre-

med

cove

r ha

ve b

een

unev

entf

ul.

AA

C

ase

12

*p

6 M12

0mls

CM

Vne

gativ

e an

dirr

adia

ted

aphe

resi

spl

atel

etco

ncen

trat

e.

Plat

elet

coun

t11

X10

9 /L

Itchi

ng,

hype

rten

sion

,dy

spno

eare

stle

ssne

ssw

heez

e, n

ause

aan

d ab

dom

inal

cram

ps.

Follo

win

g 12

0mls

.30

–35

min

s.

Aft

erco

mm

enci

ngtr

ansf

usio

n.

IgA

leve

ls n

orm

al.

Pre-

med

. co

ver

ofhy

droc

ortis

one

&ch

lorp

heni

ram

ine

give

n.Tr

ansf

usio

n te

mpo

raril

yst

oppe

d, s

albu

tam

olne

bulis

er g

iven

& r

emai

nder

of u

nit

then

tra

nsfu

sed.

Shor

tnes

s of

bre

ath

reso

lved

with

in m

inut

es a

nd r

ash

reso

lved

late

r th

at e

veni

ng.

Was

hed

prod

ucts

wer

e re

com

men

ded

for

futu

re t

rans

fusi

ons

and

thes

eha

ve b

een

tran

sfus

edun

even

tful

ly.

AA

C

ase

13

*p

10

M40

0mls

of

CM

V-ne

gativ

e an

dirr

adia

ted

red

cells

.

Hb

6.9g

/dl

Seve

re u

rtic

aria

lbo

dy r

ash

with

wee

ping

rai

sed

whe

als.

Four

hou

rsfo

llow

ing

tran

sfus

ion

whe

npa

tient

was

at

hom

e.

Non

eC

hlor

phen

iram

ine.

A

dmitt

ed t

o ho

spita

l ove

rnig

ht.

Reco

vere

d fu

lly w

ithin

24h

rs.

Subs

eque

nt t

rans

fusi

ons

wer

eun

even

tful

fol

low

ing

pre-

med

.co

ver

with

chl

orph

enira

min

e.


*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

th

is C

hap

ters

Annual Report 2003

TAB

LE 2

9 (C

ON

TIN

UED

) A

/A P

AED

IATR

IC IN

CID

ENTS

:

Cas

e N

um

ber

Ag

e ye

ars

Gen

der

Co

mp

on

ent

Rea

son

fo

r Tr

ansf

usi

on

Sym

pto

ms

Stag

e Tr

ansf

usi

on

R

eact

ion

d

evel

op

ed

Inve

stig

atio

ns

Trea

tmen

tSe

qu

elae

/Rec

om

men

dat

ion

s Fo

rfu

ture

tra

nsf

usi

on

AA

C

ase

14.

*p

2 MO

ne u

nit

ofC

MV

neg

ativ

ean

d irr

adia

ted

pool

edpl

atel

etco

ncen

trat

e.

Plat

elet

coun

t 9

X 1

09 /L

Urt

icar

ia,

strid

or,

whe

eze

and

seve

re f

acia

lw

heal

s.

With

in t

wo

hour

sof

sta

rtin

gtr

ansf

usio

n.

Non

ePr

e-m

ed.

cove

r of

hyd

roco

rtis

one

& c

hlor

phen

iram

ine

give

n.C

hlor

phen

iram

ine

IV a

ndsa

lbut

amol

neb

ulis

ers

adm

inis

tere

d.

Subs

eque

nt t

rans

fusi

ons

with

was

hed

plat

elet

s ha

ve b

een

give

nun

even

tful

ly.

AA

C

ase

15.

*p

6 FO

ne u

nit

ofC

MV

neg

ativ

ean

d irr

adia

ted

aphe

resi

spl

atel

etco

ncen

trat

e

Plat

elet

coun

t 8

X 1

09 /L

Urt

icar

ial r

ash,

rais

ed r

edw

heal

s an

dbl

acke

ned

eyes

.

Whe

n m

ore

than

100m

ls h

ad b

een

tran

sfus

ed.

Non

eN

o tr

eatm

ent.

Pre

-med

. co

ver

ofhy

droc

ortis

one

&ch

lorp

heni

ram

ine

give

n

Patie

nt r

ecov

ered

ful

ly w

ithin

24h

rs.

Was

hed

plat

elet

s re

quire

d fo

r fu

ture

tran

sfus

ions

.

AA

C

ase

16*p

6 MO

ne u

nit

CM

V n

egat

ive

and

irrad

iate

dap

here

sis

plat

elet

conc

entr

ate.

Plat

elet

coun

t9X

109 /L

Urt

icar

ia,

strid

oran

d w

heez

e.Te

n m

inut

esfo

llow

ing

com

plet

ion

oftr

ansf

usio

n.

Prev

ious

IgA

leve

ls n

orm

al.

Pre-

med

cov

er p

rior

totr

ansf

usio

n. A

dren

alin

e an

dhy

droc

ortis

one

IV g

iven

pos

tre

actio

n.

Reco

vere

d fu

lly w

ithin

min

utes

of

rece

ivin

g tr

eatm

ent.

W

ashe

dpl

atel

ets

reco

mm

ende

d fo

r fu

ture

tran

sfus

ions

.

AA

C

ase

17*p

6 MO

ne u

nit

pool

edpl

atel

etco

ncen

trat

e.

Plat

elet

coun

t12

x109 /L

Urt

icar

ia,

dysp

noea

,st

ridor

and

whe

eze.

Imm

edia

tely

follo

win

gtr

ansf

usio

n.

Non

ePr

e-m

ed.

cove

r of

hyd

roco

rtis

one

and

chlo

rphe

nira

min

e gi

ven.

O2

ther

apy

adm

inis

tere

d an

dhy

droc

ortis

one

50m

gs IV

repe

ated

.

Patie

nt r

ecov

ered

with

in o

ne h

our,

disc

harg

ed h

ome

two

hour

s la

ter.

Patie

nt w

ent

on t

o re

ceiv

e ap

here

sis

plat

elet

s fo

ur m

onth

s la

ter

unev

entf

ully

but

exp

erie

nced

ase

vere

ana

phyl

actic

rea

ctio

n to

aphe

resi

s pl

atel

ets

subs

eque

ntly.

Was

hed

com

pone

nts

reco

mm

ende

dfo

r fu

rthe

r tr

ansf

usio

ns.


*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

th

is C

hap

ters


TAB

LE 2

9 (C

ON

TIN

UED

) A

/A P

AED

IATR

IC IN

CID

ENTS

:

Cas

e N

um

ber

Ag

e ye

ars

Gen

der

Co

mp

on

ent

Rea

son

fo

r Tr

ansf

usi

on

Sym

pto

ms

Stag

e Tr

ansf

usi

on

R

eact

ion

d

evel

op

ed

Inve

stig

atio

ns

Trea

tmen

tSe

qu

elae

/Rec

om

men

dat

ion

sFo

r fu

ture

tra

nsf

usi

on

AA

Cas

e22

.*p

14

MO

ne u

nit

ofC

MV

nega

tive

and

irrad

iate

dpo

oled

plat

elet

s.

Kno

wn

Ast

hmat

ic.

Plat

elet

coun

t 9X

109 /L

Feve

r >

1.5

0 C,

tach

ycar

dia,

itch,

urt

icar

ial

rash

and

whe

eze.

Whe

n 20

0mls

. ha

dbe

en t

rans

fuse

d.U

nit

cultu

red

- no

orga

nism

isol

ated

. Pa

tient

not

cul

ture

d.Ig

A le

vels

not

chec

ked.

Shou

ld h

ave

rece

ived

pre

med

. of

bot

hch

lorp

heni

ram

ine

and

hydr

ocor

tison

e bu

t on

lyre

ceiv

ed c

hlor

phen

iram

ine.

Hyd

roco

rtis

one

IV &

salb

utam

ol n

ebul

iser

giv

enpo

st r

eact

ion

Reco

vere

d fu

lly w

ithin

12h

rs.

Was

hed

plat

elet

s r

ecom

men

ded

for

futu

re t

rans

fusi

ons.

TAB

LE 3

0 A

HO

STR

PA

EDIA

TRIC

INC

IDEN

TS

Cas

e N

um

ber

Ag

e ye

ars

Gen

der

Co

mp

on

ent

Pres

crib

edV

olu

me

Tran

sfu

sed

Sym

pto

ms

Inve

stig

atio

ns

Trea

tmen

t &

Ou

tco

me

AH

OST

RC

ase

1*p

14

FO

ne u

nit

of a

ntig

enne

gativ

e re

d ce

lls f

oran

aem

ia o

f m

alig

nanc

y.A

nti-E

prio

r to

tra

nsfu

sion

.

Less

tha

n20

0mls

of

red

cells

.

Feve

r ris

e of

> 1

.50 C

,ch

ills/

rigor

s an

dhy

pote

nsio

n.

Patie

nt c

ultu

red

– no

gro

wth

. U

nit

cultu

red

–no

gro

wth

. Re

d ce

ll in

com

patib

ility

exc

lude

d.Tr

ansf

usio

n di

scon

tinue

d.

Para

ceta

mol

giv

en.

Rec

over

ed w

ith

no il

l eff

ects

.

TAB

LE 3

1 T

TI P

AED

IATR

IC IN

CID

ENTS

:

Cas

e N

um

ber

Gen

der

Year

of

Tran

sfu

sio

nV

iral

Mar

ker

Nu

mb

ero

f d

on

ors

Ou

tco

me

TTI

Cas

e 2

*

F20

01,

2003

Susp

ecte

d H

IV3

Tran

sfus

ion

excl

uded

.


*p

Incl

ud

ed a

s fu

ll ca

se h

isto

ry in

th

is C

hap

ter

* In

clu

ded

as

case

his

tory

in T

TI c

hap

ter

Annual Report 2003

TAB

LE 3

2 PA

D P

AED

IATR

IC IN

CID

ENTS

Cas

e N

um

ber

Ag

e ye

ars

Gen

der

Wei

gh

tH

b L

evel

Pro

ced

ure

Cu

rren

t m

edic

atio

nN

um

ber

of

do

nat

ion

s p

lan

ned

His

tory

of

do

nat

ion

sC

om

plic

atio

nC

om

men

ts

PAD

Cas

e 2

*

17

F59

kgs

13.8

g/dl

Peria

ceta

bula

ros

teot

omy.

Non

e.1

1st.

Nau

sea

and

light

he

aded

imm

edia

tely

fol

low

ing

dona

tion.

Don

or h

ad p

revi

ous

hist

ory

of f

aint

ing

witn

essi

ng a

n in

ject

ion

and

a fe

ar o

fne

edle

s.

Uni

t no

t tr

ansf

used

.

PAD

Cas

e 5

*

17

F>

50kg

s12

.2g/

dl.

Seco

nd s

tage

spin

al f

usio

n.O

ral i

ron

daily

31s

tD

elay

ed f

aint

2 h

ours

and

45

min

saf

ter

leav

ing

the

dona

tion

sess

ion.

Ther

e w

ere

no c

ompl

icat

ions

to

this

tran

sfus

ion.

U

nit

tran

sfus

ed


* In

clu

ded

as

full

case

his

tory

in P

AD

ch

apte

r


IBCT Paediatric Incidents 2003 (n=13)

We describe a number of these cases in detail

Wrong component issued

Uniplas issued instead of group specific SDplasma

Level 1 IBCT Case 13 This infant, with an abnormal coagulation screenunresponsive to vitamin K, required a transfusion ofSD treated plasma. Eighteen mls of SD plasma wasprescribed (weight 1.17 kg). A medical scientistwho does not regularly work in the transfusionlaboratory processed the request on call. Uniplaswas issued although the baby’s group was knownand group specific SD plasma was available. Thescientist thought Uniplas was the product of choicefor neonates. The error was not identified duringthe pre-transfusion checking procedure. The errorwas discovered by the TSO during retrospectiveaudit of blood component/product usage.

Level 1 IBCT Case 27This premature baby with an abnormal coagulationscreen – APTT 77.1 seconds - required an emergencytransfusion of solvent detergent (SD) plasma. Thepre-transfusion sample was processed on call. Inerror, Uniplas was issued to this baby although thebaby was known to be group A. The historicalgrouping record was checked confirming the groupof the baby, but the medical scientist issuing theproduct, who normally works in the transfusionlaboratory, thought Uniplas was the product ofchoice for neonates. The error was identified duringroutine retrospective audit by the TSO.

Failure to transfuse red cells suitable forneonatal use

Level 1 IBCT Case 37 This group A Rh D positive baby, with a pulmonaryhaemorrhage required an emergency transfusion inthe neonatal intensive care unit Hb 9.2 g/dl. Thirty

two mls of group O Rh D negative emergency redcells, in paedipack form for neonatal use, wererequired. One unit of group O Rh D negative redcells for adult use was collected from the satellitefridge in error and 32mls were transfused from thispack. Transfusion laboratory staff identified theerror when checking stock in satellite fridge. Theuse of emergency adult red cells was theninvestigated. In this hospital, emergency group O RhD negative red cells for adult use are always CMVnegative. However the donor would not havefulfilled the screening criteria for neonataltransfusion.

Label on uncrossmatched unit

Level 1 IBCT Case 23 This case is reported in the IBCT chapter

Failure to provide irradiated or CMV negativeproduct

Level 2 IBCT Case 1 This infant with a congenital immune deficiencyrequired a transfusion peri-operatively with threeunits of SAG-M red cells, seven aliquots of apaedipack and two units of apheresis plateletconcentrate. All neonatal blood used in this hospitalis CMV negative, but the prescription and requestdid not state the need for irradiated cellularcomponents. The error was not identified eitherduring laboratory processing or during the bedsidechecking procedures. The laboratory staffdiscovered the error when subsequent post-operative requests for blood stated the need forirradiated cellular components.

Level 2 IBCT Case 8The infant, with a congenital immune deficiency,was transfused with three units of SAG-M red cells,five aliquots of a paedipack and two units of plateletconcentrate during the peri-operative period.Transfusion policy within this hospital states that allneonatal blood is CMV negative, but theprescription and request did not state the need for


Annual Report 2003

irradiated cellular components. The error was notidentified either during laboratory processing or thebedside checking procedures. The TSO discoveredthe error during routine surveillance.

Level 2 IBCT Case 44 This day-old group B Rh D negative male infantsuffered a haemorrhage post delivery, Hb 14.4g/dl.One unit of CMV negative red cell concentrate wasprescribed. The on call medical scientist informed theprescribing paediatrician that there were no groupcompatible CMV negative red cells available in thelaboratory and that they would need to be orderedfrom the IBTS. The paediatrician wished to transfusewithout delay resulting in an emergency transfusionof 45mls of non-CMV negative O Rh D negative redcells. The on call medical scientist did not regularlywork in the transfusion laboratory. The following dayduring a routine audit, transfusion staff discoveredthat Group B, Rh D negative CMV negative red cellshad been available in the blood fridge.

Problems with infusion pump

Level 2 IBCT Case 65 This septic baby required a platelet transfusion forthrombocytopenia – platelet count 21x109/L. Theunit was transfused via a blood administration setusing an electronic infusion device which was notsuitable for platelets. The error was discovered whenthe laboratory staff questioned the lack of a plateletincrement. The baby required a further unit ofplatelets. As there was underlying sepsis the failureof the platelet count to rise may have been due tothis rather than the use of the infusion pump.

Level 2 IBCT Case 35 As this case occurred in an adult centre it is reportedin the IBCT chapter.

Unnecessary Component Transfused

Level 2 Case 110 IBCT This young child with an underlying malignancyrequired a transfusion of CMV negative irradiated

platelets pre operatively for a platelet count of 19X109/L. The prescription for platelets was calculatedusing a hospital guideline of 10-20ml/kg. The childweighed 16 kg and 300mls of apheresis plateletswere prescribed. However the first unit of plateletscontained only 198ml and a second unit of plateletswas then administered. The child’s platelet countpost transfusion of the first unit was 118X 109/L anda decision was made by the clinical team totransfuse a second unit. Following transfusion of thesecond unit the platelet count was 155X 109/L. Thiswas discovered during a routine haemovigilanceaudit the following day. Following discussion withthe consultant haematologist, it was felt that thesecond unit exposed the child unnecessarily to asecond donor. As a result of this incident, changeshave been made within the hospital policy so thatwhere greater than 200ml transfusion is required, arepeat platelet count post transfusion may showthat a single unit of platelets is adequate.

Red cells out of controlled storage

Level 2 IBCT Case 89This young child required a transfusion of one unitof CMV negative irradiated red cells for anaemiaassociated with a malignant haematological disorder.One unit of red cells was collected by the porter andbrought to the ward for transfusion. During thefinal bedside check, it was noted that the patient’sunique blood transfusion sticker in use in thishospital was missing from the hospital ID band. This transfusion sticker serves as an additional checkin conjunction with the other three identifiers. Asper hospital policy the transfusion was abandoned.As the child was being nursed in isolation the staffspent considerable time searching for the sticker. The porter was then notified by clinical staff toreturn the unit of blood to the fridge. By the timethis occurred, the unit had been out of controlledstorage for over one hour. The unique ID transfusionsticker was subsequently located by nursing staffand reapplied to the patient’s hospital ID band. (Thiswould not be normal practice but the other threeidentifiers were correct and the child was being



nursed in isolation). The child who was a bitmischievous admitted to removing the stickerhimself. The porter was then contacted again tocollect the unit of red cells from the laboratoryfridge and the transfusion commenced, ninetyminutes from the time the unit was initially removedfrom the fridge. The unit was transfuseduneventfully. The event was discovered during aroutine audit of transfusions at this hospital.

Units transfused crossmatched elsewhere

Level 3 IBCT Case 61 This case is reported in the IBCT chapter.

Wrong Factor Concentrate

Level 1 IBCT Case 52This young man with Factor VIII deficiency and highresponding inhibitors required factor concentrate fortwo consecutive days over a weekend. He normallyreceived Recombinate but in error a member of thehaematology team prescribed Refacto. The on calllaboratory scientist processing the request waswarned by the computer system that this patientnormally received Recombinate and questioned themedical team. As the primary care team hadprescribed the product and the on-call medical officerwas not a member of this team, he/she decided toproceed with the administration of the incorrectproduct. The error was discovered following reviewof all on-call work on the next normal working day.The hospital plans to introduce stickers which can beplaced on the front of each patient’s chart indicatingthe clotting factor deficiency and which factorconcentrate the patient is to receive.

AA Paediatric Reaction Incidents (N=9)

AA Case 1 This teenage patient with a haematological disorderrequired one unit of red cells for Hb of 8.7/dl in theday ward. The patient had a history of urticarialreaction to red cells within the previous few months.IgA levels were normal. On this occasion,

desferroxamine was administered alongside thetransfusion, of red cells. Following the first 50mls oftransfusion the patient developed symptoms ofurticaria, hypotension, dyspnoea, restlessness,anxiety, periorbital oedema and wheals on body.The transfusion was discontinued andchlorpheniramine and hydrocortisone were given IV.The patient recovered fully within hours and wasdischarged home later that day. Future transfusionswill be managed with chlorpheniraminepremedication and washed cellular components.

AA Case 11 This adolescent patient suffered a relapse of amalignant haematological disorder and requiredone unit of apheresed platelets forthrombocytopenia. When approximately 85mls ofplatelets had been transfused, the patient developedsymptoms of hypotension, urticaria, chest tightness,coughing and falling O2 saturation. The transfusionwas discontinued immediately. Chlorpheniramineand hydrocortisone were administered and thepatient recovered from this episode within 90minutes. IgA levels were performed, but althoughthe result was low - 0.37g/L, this related to theimmunosupressant therapy rather than a true IgAdeficiency. Further transfusions were administereduneventfully following premedication withchlorpheniramine and the use of apheresed platelets.

AA Case 12 This young child who was receiving shared care for amalignant haematological disorder, required one unitof CMV negative irradiated apheresis platelets forthrombocytopenia. Premedication cover ofhydrocortisone and chlorpheniramine was givenprior to transfusion. Following 120mls of plateletsover 30-35 minutes, the child developed symptomsof itching, hypertension, dyspnoea, restlessness,wheeze, abdominal cramps and nausea. Thetransfusion was discontinued temporarily and asalbutamol nebuliser was administered. The child’srespiratory symptoms resolved within minutes andthe remainder of the transfusion was then givenuneventfully. IgA levels were within normal limits.



The rash resolved completely later that evening. The child’s primary care centre was contacted andfollowing specialist advice, it was decided thatwashed products should be used for futuretransfusions. Subsequent transfusions using washedproducts have been uneventful.

AA Case 13 This young child required a transfusion of CMVnegative irradiated red cells for anaemia ofmalignancy. Previous transfusions had beenuneventful. The transfusion was completed in theday ward and the child discharged home. Fourhours later, the child returned to the hospital withan all over urticarial rash and weeping, raised redwheals. Chlorpheniramine was administered PO.The child remained in hospital overnight and hadrecovered fully by the following day. Premedicationcover of chlorpheniramine was recommended priorto future transfusions. Subsequent transfusionsfollowing this regime have been successful.

AA Case 14 This male infant required CMV negative irradiatedplatelets for thrombocytopenia associated with amalignant haematological condition. The child had ahistory of one previous reaction to platelets. As aresult, he was receiving a premedication ofchlorpheniramine prior to each transfusion. Withintwo hours of commencing the transfusion, hedeveloped symptoms of an urticarial rash includingsevere facial hives associated with stridor andwheeze. The transfusion was discontinued.Chlorpheniramine IV and salbutamol nebuliser wereadministered and he recovered from this incidentwithin 24 hours. Subsequent transfusions usingwashed platelets have been uneventful.

AA Case 15 This young child required CMV negative irradiatedapheresed platelets for thrombocytopenia associatedwith malignancy. She had a history of two previousreactions to platelets and one reaction to red cells.Premedication of chlorpheniramine andhydircortisone was administered prior to thistransfusion. However, within 20 minutes of

commencing the transfusion when greater than100mls had been transfused, she developedsymptoms of an urticarial rash with raised redwheals and blackened eyes. The transfusion wasdiscontinued completely. No medication ortreatment was administered and the child recoveredfrom this incident within 24 hours. This patient willreceive washed platelets for any future transfusions.

AA Case 16 This young child required a transfusion of apheresedCMV negative irradiated platelets forthrombocytopenia associated with a malignanthaematological disorder. He had a history of threeprevious reactions to pooled platelets. As a result,apheresed platelets were prescribed andpremedication of chlorpheniramine andhydrocortisone was administered prior to thistransfusion. Within 10 minutes of completing thetransfusion, the child developed symptoms ofurticaria, stridor and wheeze. Adrenaline andhydrocortisone were administered IV and the childrecovered immediately. Future transfusions will becarried out using washed platelets.

AA Case 17 This young male child required platelet transfusionfor thrombocytopenia secondary to a malignanthaematological disorder. As a result of a previousallergic reaction to platelets, premedication ofhydrocortisone and chlorpheniramine was given.Immediately following transfusion of one unitpooled platelet concentrate, he developedsymptoms of urticaria, dyspnoea, stridor andwheeze. O2 therapy was commenced and a furtherdose of hydrocortisone 50mgs was given. Thepatient recovered fully within one hour and wasdischarged home two hours later. A subsequenttransfusion four months later using apheresisplatelets and premedication cover was uneventful.However, this patient went on to experience ananaphylactic reaction following his most recentplatelet transfusion, despite pre-medication coverand the use of apheresis platelets. If this patentrequires any further transfusion, washedcomponents will be prescribed.

Annual Report 2003


AA Case 22 This young male patient required transfusion of oneunit of CMV negative irradiated pooled plateletconcentrate. He had previously experienced areaction to platelets. He was also a knownasthmatic and as a result, should have receivedpremedication of hydrocortisone andchlorpheniramine prior to transfusion. Howeverchlorpheniramine only was given pre transfusion.Following infusion of 200mls of this unit, the patientdeveloped symptoms of tachycardia, itch, urticarialrash, wheeze and an associated temperature rise of>1.50C. The transfusion was abandoned andhydrocortisone IV and salbutamol nebuliser weregiven. The patient recovered fully within 12hrs.Bacteriological culture of the pack was negative.Following discussion between the supply centre andthe patient’s consultant, a decision has been madeto use washed products for future transfusions.

AHOSTR Paediatric Incidents (N=1)

AHOSTR Case 1 This case is also reported in the AHOSTR chapterThis young patient with a malignant haematologicaldisorder required one unit of red cells for anaemia -Hb 7g/dl. The patient grouped as O Rh D positivewith an Anti E antibody and an autoantibodyreactive in enzyme only. The DAT was negative.Antigen negative blood was crossmatched andissued. During transfusion, when less than 200mlshad been transfused, the patient developedsymptoms of fever >1.50C with chills/rigors andhypotension. The transfusion was discontinuedcompletely and paracetamol was given. A fullrecovery was made within approximately 1-2 hours.The patient was cultured and no organisms wereisolated but no repeat serology was done posttransfusion reaction as per hospital policy. As aresult of this failure to complete reactioninvestigations, the management of adversetransfusion reactions has been highlighted atexisting educational sessions and laboratory policyon the investigations of transfusion reactions isbeing reviewed.

PAD (N=2)/TTI (N=1) Paediatric Incidents

The PAD Paediatric incidents (Cases 2 and 5) and TTIPaediatric Incident (Case 2) are reported in theirrespective chapters.



The Near Miss Project

Definition of a Transfusion Related Near MissEvent: "Any error which might have occurred,but didn’t, because it was detected andcorrected before administration took place"Adapted by NHO 2002

A three-year research project looking at Near MissEvents in transfusion commenced in November2002. During the first year, most of the focus hasbeen on setting up the project and carrying outtraining in all of the ten sites involved.

The first fully trained site commenced ‘live’ reportingin May 2003, with seven sites joining on a site-by-site basis between May and December 2003. Theremaining two sites completed training and went‘live’ with reporting from January 2004.

The events are being processed and analysed usingthe Medical Event Reporting System for TransfusionMedicine (MERS-TM)

The MERS-TM system analyses events slightlydifferently to the way the NHO analyses actual errors

or reactions. The main focus is the Root CauseAnalysis (RCA). MERS-TM breaks down root causesinto either System (both organisational andmanagerial) or Human failures. It can highlight toeach individual site trends in error, high-risk steps inthe work process and high-risk areas. This allowsthe focus for improvement and resources to beconcentrated in these particular areas first.

The reporting is anonymised and confidential witheach site contributing data under unique hospitalcodes. The establishment of a ‘non punitive’reporting culture which has full support of bothmanagement and stakeholders along with theenthusiasm and hard work of the TSOs from eachsite have been key factors in the successfulimplementation of the project.

The following data analysis is based on a relativelysmall number of events as the project is still in itsinfancy. However, there are some areas wheretrends are already significant and should bemonitored carefully.

Annual Report 2003


Step in the Work Process Where Near Miss Events are First OccurringSample Collection is the step in the work process most frequently associated with Near Miss eventsoccurring, with 64 events (48%) first occurring at this step. This is followed by the Prescription/ Requeststep, where 19 events (15%) first occurred.

The following is aggregate data for 2003 from thesites that have contributed to the project to date.Each site is given individual feedback on their dataanalysis by the project co-ordinator as definite trendsor high-risk events/areas emerge.

There were 84 low risk events, 31 medium riskevents and 15 high-risk events reported in 2003.

Findings

Total Number of Near Miss Events ReportedMay – December 2003A total of 130 Near Miss Events were reportedbetween May and December 2003. A further tenreports were received but could not be processeddue to either insufficient information provided onthe form, or the event did not fit the criteria for aNear Miss Event according to the NHO definition.

Sample Collection49% (64)

Order Entry1% (1) Unit Manipulation

1% (1)Misc. 14% (18)

Check-in 2% (3) Selection 2% (3)

Sample Handling 1.5% (2) Testing 1.5% (2)

Bedside admin.7% (9)

Issue6% (8)

Pres./Request15% (19)

Figure 4 Occurence Information (First Site of Error) N=130


Distribution of Events by Clinical areaThe majority of Near Miss Events 66 (51%) occurred in wards. Laboratory and Accident and Emergency Departments were also areas which featured significantly in events reported.

Ward50% (66)

Laboratory16% (21)

A&E13% (17)

Labour Ward6% (8)

OPD5% (6)

ICU5% (6)

Misc.5% (6)

Figure 5 Areas where Events are Occuring (N-130)

Medical Staff47% (70)

Nursing Staff23% (35)

Laboratory Staff15% (22)

Other(Porter/Phlebotomy)15% (22)

Figure 6 Who is Involved in Near Miss Events

Who Is Involved in Near Miss Events?Medical staff were most frequently involved in Near Miss events - 70 events (47%). This was followed bynursing staff who were involved in 35 events (23%). Laboratory and other grades of staff (phlebotomy andportering) were involved in 22 events (15%) each. It should be noted that many events involved errors by morethan one grade of staff.


Patients Requiring Repeat Samples as a Resultof Near Miss Events

Of the 130 events reported, 77 (59%) required thepatient to be re-sampled. Where delays occur in re-sampling, the patient’s transfusion can be delayed.In addition, patients (including neonates andchildren) have to be sampled twice, often causingdistress and leading to extra workload for both thesampler and the laboratory.

ROOT CAUSES - WHAT DO THEYMEAN?

Where root cause analysis is carried out on an eventusing MERS-TM the root cause/causes will be shownas either ‘system’ or ‘human’ failure or acombination of both. Most events involve morethan one type of failure and therefore will havemore than one root cause.

Following root cause analysis of the 130reported events, the most frequent root causesseen involve ‘Human Failures‘ (human error).

Human Failures

Human slips were the most common type of humanerror seen. The main reasons sited for these slipswere tiredness, distraction and / or busy workload.Examples of events involving human slips wereerrors relating to unique identifiers on samples,transcription errors and forgetting to complete tasks.

The second most significant root cause seen wasfailure to adhere to policies/procedures and/or failureto verify patient/product details.Examples of events involving these root causes arefailure to check patient’s ID band or productinformation, remote or pre labelling of samples orrequests and failure to adhere to SOPs correctly.

Lack of knowledge by all grades of staff involved inthe transfusion chain and failure to communicateeffectively were also root causes seen in a smaller

number of events. Although these root causes wereseen far less frequently than other types of humanfailures, they were significant, as a lack ofknowledge about either policies/procedures orclinical issues and poor communication werefrequently associated with high risk events.

System Failures

The most frequent system failure seen was poorlydesigned or absent policies/procedures within anorganisation. Examples of events involving this rootcause are absence of policies such as laboratorysample acceptance/rejection policies, maximumsurgical blood ordering schedules (MSBOS) andpolicies / procedures which are flawed, out of dateor confusing.

System failures at management level were also asignificant root cause. These events relate toinadequate staffing levels, cross call cover in thelaboratories and lack of training for new orinexperienced staff. Organisational/professionalculture was also found to be a root cause in somecases. Examples found involving these types ofevents were the reluctance of medical staff to attendhaemovigilance training as it was not seen assignificant to their work, portering staff who werereluctant to use newly introduced collection slipsand unwritten rules being applied to work practices.

Technical design faults were also found to havecontributed to some events. These were faults suchas hospital computer systems not being fully linkedto laboratory computer systems, which led to afailure to carry any updated information across fromone system to the other. In other cases, poorlydesigned systems allowed warnings be overriddentoo easily where special requirements such as CMVnegative and irradiated products were required.Also highlighted, were faults in technical equipmentsuch as label printers.

There were also a small number of events, caused bymaterial defects such as poorly designed labels or

National Haemovigilance Office142

143Annual Report 2003Annual Report 2003

forms which led to staff using them incorrectly andpoor quality of materials i.e. adhesive failuresleading to stickers falling off or becoming smudgedand illegible.

Other Root Causes

In some cases the failures, either system or human,were beyond the control of the investigatingorganisation. This would include events such aserrors made involving the blood supplier or errorsmade by another centre, which were picked up inthe reporting site.

A further category of root cause, which has beenseen in small numbers, is ‘patient related factors’.These types of events involve errors made due to thepatient giving false or wrong information to ahospital i.e. in relation to their name or date of birthor patients who remove their own ID bands.


Acknowledgements

The NHO would like to thank a number of peoplefor their contributions to this report.

Dr Stefan Laspina, IBTS for the TRALI chapter and DrJoan Fitzgerald for her contribution to the Anti-Dchapter.

Dr Joan O’Riordan and Dr Louise Pomeroy for herhelpful discussion and donor virology statistics forthe TTI chapter.

Dr William Murphy for permission to reproduce hisletter of 17/8/04 to all medical practitioners.Mr Don Mullahy, IBTS for advice on serological issues.

Ms Bernie Quirke and the staff of the VirologyLaboratory, Carmel Sheridan, Recipient Tracing Unitand Pauline Coakley QA Manager IBTS and MrGeoff O’Connell and staff in the Virus ReferenceLaboratory, University College Dublin for their helpin suspected transfusion transmitted donorinvestigations.

Mr Geoff Lucas and staff at the International BloodGroup Reference Laboratory, National Blood GroupReference Laboratory, National Blood Service, Bristolfor granulocyte and lymphocyte antibodyinvestigations in donors involved in suspected TRALIreactions.

Dr Joan Gilvarry, Dr Helena Daly, Ms Niamh Arthur,Mr John Lynch and Mr Patrick Costello in the IrishMedicines Board, Dublin for helpful discussion andsuggestions.



Dr. Emer Lawlor FRCPath, FRCPIConsultant HaematologistDirector

Transfusion Surveillance OfficersMs. Phil Keane-Egan RGN RM BNS (Hons)Transfusion Surveillance Officere-mail [email protected]: (01) 432 2891

Ms. Donna Harkin RGN RM DSMTransfusion Surveillance Officer e-mail [email protected]: (01) 432 2890

Ms. Marcia Kirwin RGN RM MSc Ed & Training MgtTransfusion Surveillance Officer, e-mail [email protected]

Ms. Mairead Sheahan RGN DSMTransfusion Surveillance Officere-mail [email protected]: (01) 4322891

Near Miss ProjectMs. Derval Lundy RGNTransfusion Surveillance Officer e-mail [email protected]: (01) 432 2825

Ms. Gillian Horgan Dip PRAdministrator – Near Miss Projecte-mail [email protected]: (01) 432 2854

NHO AdministrationMs. Cathy Scuffil Dip Mgmt, CISMProgramme Administrator e-mail [email protected]: (01) 432 2894

Ms. Caroline O’Neill BSc (Hons) Dip Mgmt, CIPDActing Programme Administratore-mail [email protected]: (01) 432 2894

Ms. Paula Bolger BA (Hons) HumanitiesAssistant Administratore-mail [email protected]: (01) 432 2854

NationalHaemovigilanceOfficeTeam


AABB (2003) Standards for Blood Banks andTransfusion Services. 22nd Edition. AmericanAssociation of Blood Banks.

Bilotte, D, Glisson, S, Green, D, and Wiyson, R.(2002) A Prospective Autologous Donation for HipReplacement Surgery. The Journal of Bone and JointSurgery Incorporated. 84 (8) 1299-1304

Boehlen, F. and Clemetson, K.J. (2001) Plateletchemokines and their receptors: what is theirrelevance to platelet storage and transfusionpractice. Transfusion Medicine (11) 403-417.

Brecher, M.E, Combs, M.R, Drew, M.J. et al (2002)American Association of Blood Banks TechnicalManual. 14th Edition. Bethesda, AABB Press.

British Committee for Standards in Haematology(BCSH) Blood Transfusion Task Force (1999) Theadministration of blood and blood components andthe management of transfused patients. TransfusionMedicine. 9, 227-238.

British Committee for Standards in Haematology(BCSH) Blood Transfusion Task Force (1993) Guidelinesfor Autologous Transfusion Pre-operative AutologousDonation. Transfusion Medicine, 3, 307-316.

British Committee for Standards in Haematology(BCSH) Blood Transfusion Task Force (2004)Guidelines for the use of Fresh Frozen Plasma,Cryoprecipate and Cryosupernatant.

British Committee for Standards in Haematology(BCSH) Blood Transfusion Task Force (1997)Guidelines for autologous transfusion. II.Perioperative haemodilution and cell salvage.

British Journal of Anaesthesia, 78, 768-771.Busch, M.P. (1991) Lets look at humanimmunodeficiency virus look-back before leaping intohepatitis C virus look-back. Transfusion. 31,655-661.

Directive 2002/98/EC of the European Parliamentand of the Council of 27 January 2003 settingstandards for the collection, testing, processing,storage and distribution of human blood and bloodcomponents and amending Directive 2001/83/EC.

Gerberding, J.L, Snider, D.E, Stroup, D.F. et al (2003)Transmission of Hepatitis B and C Viruses inOutpatient Settings – New York, Oklahoma andNebraska, 2000-2002. Morbidity and MortalityWeekly Report (MMWR) 52, 901-904.

Goldman, M. and Blajchman, M.A. (2001) BacterialContamination: In: Popvosky, Transfusion Reactions.2nd Edition. Maryland, AABB Press, 29-149.GoldmaN, M, Savard, R, Long, A, Gelinas, S. andGermain, M. (2002) Declining value of preoperativeautologous donation. Transfusion. 42 (7), 819-823.

Guide to the preparation, use and Quality Assuranceof Blood Components, (2001) Council of EuropePublishing, Strasbourg, 7th Edition, 70.

References


Gunther K, E., Conway G., Leibach L., Crowther M,A. (2004) Low-dose oral vitamin K is safe andeffective for outpatient management of patients withan INR >10. Thrombosis Research. 113, 205-209.

Heddle, N.M., and Kelton J.G. (2001) FebrileNonhaemolytic Transfusion Reactions In: Popovsky,Transfusion Reactions. 2nd Edition. Maryland, AABBPress, 45-82.

Jeffrey, Carson P. (2002) Anaemia and red blood celltransfusion In: Rossi E.C., Simon T, Dzik W. et al,Principles of transfusion medicine. 3nd Edition,Philadelphia: Lippincot Williams & Wilkins, 149-164.

Kaplan, H.S., Callum, J.L., Eastman, B.R., Markley,L.L. (2002) The Medical Event Report System forTransfusion Medicine: Will it Help Get the RightBlood to the Right Patient? Transfusion MedicineRevieww, 16 (2).

Linden, J.V., and KruskalL, M.S.(1997) Autologousblood: always safer? Transfusion. 37, 455-456.

Llewelyn, C.A., Hewitt, P.E., Knight, R.S.G. et al(2004) Possible transmission of variant Creutzfeldt-Jakob disease by blood transfusion. The Lancet, 363,417-421.

Love, E., Soldan, K., Cohen, H., et al (2001) SeriousHazards of Transfusion (SHOT) Annual Report 1999-2000. Manchester, SHOT Office.

Mc Clelland, D.B.L. (2001) Handbook of TransfusionMedicine, 3rd Edition, London, The Stationery Office.

Mollison, P.L,, Engelfriet, C.P., and Contreras, M.(1997) Blood Transfusion in Clinical Medicine. 10thedition, London, Blackwell Science.

Mollison P.L., Engelfriet C.P., Contreras M., (1998)Blood Transfusion in Clinical Medicine. 10th Edition,Oxford, Blackwell Scientific Publications, 304-7.

National Blood Users Group (NBUG) (2001) AGuideline for Transfusion of Red Blood Cells in SurgicalPatients. Dublin, Department of Health and Children.

National Blood Users Group (NBUG) (2002) Guidelinesfor the use of Blood and Blood Components in theManagement of Massive Haemmorrhage. Dublin,Department of Health and Children.

National Blood Users Group (NBUG) (2004)Guidelines for the Administration of Blood andBlood Components. Dublin, Department of Healthand Children.

National Haemovigilance Office (2000) NationalHaemovigilance Office Annual Report Dublin, TheNational Haemovigilance Office.

National Haemovigilance Office (2001) NationalHaemovigilance Office Annual Report. Dublin, TheNational Haemovigilance Office.

National Haemovigilance Office (2002) NationalHaemovigilance Office Annual Report. Dublin, TheNational Haemovigilance Office.

National Institute for Clinical Excellence for theNational Collaborating Centre for ChronicConditions, July 2003. Management of chronicheart failure in adults in primary and secondary care.Clinical Guideline 5. UK; NHS.

Octapharma Limited (2002) Octaplas: Summary ofProduct Characteristics. Republic of Ireland Specific,Octapharma Limited.

O’Riordan, J. (2002) National Blood StrategyImplementation Group Audit (Unpublished, personalcommunication).

O’Riordan, J. (2003) Personal communication with.As per Schreibner S.H, Busch, G.B., Kleinman, S etal. The risk of Transfusion Transmitted Viral Infection1993-1996, New England Journal of Medicine.1996: 334, 1685-1690.

Peden A.H, Head M.W, Ritchie D.L, et al (2004)Preclinical vCJD after blood transfusion in a PRNPcodon 129 heterozygous patient. The Lancet, 364,527-529.

Petz, L.D., Blood Transfusion in Acquired HemolyticAnaemias In: Petz, LD, Swisher, SN., Kleinman, S.,Spence, RK., and Strauss, RG. Clinical Practice ofTransfusion Medicine 3rd Edition. New York,Churchill Livingstone.

Politis, C and Richardson, C. (2001) Autologousblood donation and transfusion in Europe. VoxSanguinis. 81, 119-123.


Popovsky, M.A. (2001) Transfusion Related AcuteLung Injury (TRALI). In: Popovsky M.A. TransfusionReactions. 2nd Edition, Maryland, AABB Press.

Popovsky, M.A. (2001) Circulatory Overload. In:Popovsky, M.A. 2nd Edition. Transfusion Reactions.2nd Edition, Maryland, AABB Press, 255-260.

Popovsky, M.A. (2002) Breathlessness and Blood a Combustible Combination, Vox Sang, 83 (1) , 147-150.

Popovsky M.A, Taswell HF. (1996) Transfusionassociated circulatory overload in orthopaedicsurgery patients: a multi-institutional study.Immunohaematology. 12 (2); 87 –9.

Popovsky, M.A, Whitaker, B. and Arnold, N.L. (1995)Severe outcomes of allogeneic and autologousblood donation: frequency and characterization.Transfusion. 35, 734-737.

Popovsky, M.A. and Hayley, N.R. (2000) Furthercharacterisation of Transfusion Related Acute LungInjury: demographics, clinical and laboratory featuresand morbidity. Immunohaematology. 16: 157-159.

Rizk, A., Gorson, K.C., Kenney, L and Weinsteim, R.(2001) Transfusion Related Acute Lung Injury afterthe Infusion of IVIG. Transfusion. 41: 264-267.

Ross, S., Viazov, S., Roggendorf, M. (2002)) Risk ofHepatitus C Transmission from Medical Staff toPatients. Archives of Internal Medicine. 160, 2313-2316.

Saxena, S, Rabinowitz, A.P, Johnson, C, Shulman,I.A, Iron - Deficiency Anaemia :a Medically TreatableChronic Anaemia as a model for TransfusionOveruse. The American Journal of Medicine 1993,vol 94, 120-124.

Serious Hazards of Transfusion (1998) SeriousHazards of Transfusion (SHOT) Annual Report 1996-1997. Manchester, SHOT Office.

Serious Hazards of Transfusion (1999) SeriousHazards of Transfusion (SHOT) Annual Report 1997-1998, Manchester, SHOT Office.





Silverberg D.S., Wexler D., Sheps D., et al (2001) Theeffect of correction of mild anaemia in severeresistant congestive heart failure using subcutaneouserythropoietin and intravenous iron: a randomisedcontrolled study. Journal of the American College ofCardiology. 37(7), 1775-1780.

Stack, G., Judge, J.V. and Snyder, E.L. (1996) Febrilenon-immune transfusion reactions. In: Rossi, E.C.,Simon, T.L., Moss, G.S. and Gould, S.A. Principles ofTransfusion Medicine. 2nd Edition, Baltimore,Williams and Wilkins.

Turner C.L., Casbard, A.C and Murphy, M.F. (2003)Barcode technology: its role in increasing the safetyof blood transfusion. Transfusion. 43:1200-1209.

Vamvakas, E.C. and Pineda, A.A. (2001) Allergic andAnaphylactic Reactions. In: Popvosky, M.A.Transfusion Reactions. 2nd Edition, Maryland, AABBPress, 83-120.

Working Group of the British Blood TransfusionSociety and the Royal College of Obstetricians andGynaecologists (Convenor: Lee, D.) (1999).Recommendations for the use of anti-Dimmunoglobulin for Rh prophylaxis. TransfusionMedicine, 9, 93-97.

Yomtovian, R and Praprotnik, D. (2001) AdverseConsequences of Autologous Transfusion Practice. InPopovsky MA. Transfusion Reactions. 2nd Edition,Maryland, AABB Press, 261-302.


Solvent Detergent (SD) Plasma

This leaflet is an up-date of the FFP informationleaflet issued in March 2000. We wish to remindyou that there remains a risk of TransfusionAssociated Circulatory Overload following theadministration of Solvent Detergent Plasma.

Points to note

• In 2001, the National Haemovigilance Office(NHO) received 16 (11%) reports of TransfusionAssociated Circulatory Overload (TACO). Six(37.5%) of these were associated with FreshFrozen Plasma (FFP).

• Occasional severe anaphylactoid reactions havebeen reported in association with FFP, especiallywith rapid infusion rates. During 2001 the NHOreceived 35 reports of severe acute anaphylactoidreactions, 11 (30.5%) of which were associatedwith FFP. Anaphylactic or anaphylactoid reactionsdue to hypersensitivity to infused plasma proteinsor anti-IgA following the transfusion of SolventDetergent Plasma (SDP) are rare (<1: 1000),1 andare likely to be of the same order as for FFP.

• The dosage of SDP depends upon the clinicalsituation and underlying disorder, but 12-15mls/Kg

is a generally accepted starting dose. It is importantto monitor the response both clinically and withmeasurement of prothrombin time (PT), partialthromboplastin time (PTT) or specific factor assays.2

• The statement on both the label and the productinsert recommends that ‘the thawed productshould be used immediately’. This must beinterpreted in such a way as to minimise the risk ofvolume overload. The infusion of SDP shouldbegin as soon as clinical circumstances permit afterthawing. British guidelines recommend that eachunit of plasma be transfused to an uncompromisedadult over 30 minutes.3 Generally, the thawedproduct should be transfused within four hours ofthawing. Coagulation factor replacement in themassively haemorrhaging patient may require fasterinfusion rates.

• The patient who is elderly, very small and/orcardiac or respiratory compromised deservesspecial mention. There is a significant risk ofvolume overload leading to respiratory distresswith severe morbidity/mortality especially usingrapid infusion rates. In the non-bleedingsituation, transfusion rates for this group ofpatients should not exceed 2-4mls/kg per hour.4

Appendix 2


• Each unit of SDP contains a standard volume of200mls, in contrast to a unit of FFP, whichcontains 220-300mls. This smaller volume mayneed to be considered when calculating doses.

Table 1. Suggested times for infusion in thenon-bleeding patient.In general SDP can be considered as equivalent,volume for volume, to FFP. If a slower transfusionrate is needed, the plasma can be thawed in divided doses.

Firm indications for giving plasma5: Plasma therapy should only be given where there isa clear clinical indication and where the expectedbenefit outweighs the inherent risks. Firm indicationsfor giving plasma include:

• The correction of haemostatic disorders where noother more suitable therapy exists or is available

• Emergency warfarin reversal whereprothrombin complex concentrates areunavailable (As in Table 2)

• Haemostatic failure associated with majorblood loss

• Liver disease, either in the presence ofhaemorrhage, or prior to an elective procedure

• Acute Disseminated Intravascular Coagulation

• Replacement of single factor plasmadeficiencies where no licensed virally-inactivated or recombinant single factorconcentrate is available e.g. factor V deficiency(currently) and acetyl cholinesterase deficiency

• The treatment of choice in thromboticthrombocytopenic purpura (TTP) in conjunctionwith plasma exchange

SDP is only required for the reversal of overanticoagulation in the presence of major bleeding.Generally it should not be used in patientsscheduled for elective invasive procedures as thesesituations are best managed using Vitamin K andwithdrawal of Warfarin.

PatientWeight

Units Required

Rate of Transfusion per hr

20 kg 1 unit 40mls – 80mls

30 kg 2 units 60mls – 120mls




Table 2. Recommendations for management of bleeding and excessive anticoagulation6

INR* 3 - 6 ( target INR 2.5)INR 4-6 ( target INR 3.5) no bleeding or minor bleeding

1. Reduce warfarin dose or stop2. Restart warfarin when INR < 5.0

INR 6 - 8; no bleeding or minor bleeding 1. Stop warfarin2. Restart when INR < 5.0

INR > 8.0, no bleeding or minor bleeding 1. Stop warfarin2. Restart warfarin when INR < 5.03. If other risk factors for bleeding exist**, give 1-2.5 mg of

vitamin K IV or orally

Life threatening bleeding 1. Stop warfarin2. Give 5mg of vitamin K IV 3. Give prothrombin complex concentrate*** 25- 50 iu/kg or

SDP 12-15mls/kg

Notes: *INR = International Normalised Ratio **Age of patient > 70 and/or Previous history of bleeding ***Unlicensed product


Managing Anticoagulation in the PerioperativePeriod

Elective invasive procedure: Stop anticoagulantfor three days prior to surgeryEmergency invasive procedure: Where surgerycannot be postponed, reverse anticoagulant withlow dose Vitamin K as above.6

In emergency situations, Vitamin K should be givenIV, which will reduce the INR within 4 hours, withcomplete reversal to the therapeutic range within24hours. In less urgent situations, it can be givenorally. As Vitamin K tablets are only available as 10mgs, the intravenous solution of Vitamin K can begiven orally and is effective. Only 1mg is required toreduce the INR from >4.5 to a target of 2.0-3.07within 24 hrs .6, 8, 9

SD Plasma is not indicated in treatment of:

• Hypovolaemic shock• Selected nutritional deficiencies• Correction of immunodeficiency• Replacement fluid in plasmapheresis with the

exception of TTP

References

Octapharma Limited, (2002) Octaplas®: Summary ofProduct Characteristics, Republic of Ireland Specific,Octapharma Limited.

BCSH Blood Transfusion Task Force (1992)Guidelines for the use of fresh frozen plasma,Transfusion Medicine, 2, 57-63.

BCSH Blood Transfusion Task Force (1999) Theadministration of blood and blood components andthe management of transfused patients. TransfusionMedicine, 9, 227-238.

Vamvakas, E.C. & Pineda, A.A. (2001) Allergic andAnaphylactic Reactions. In: Popovsky, M.A, ed.Transfusion Reactions, 2nd Edition Bethesda. MD:AABB Press.

Contreras, M. ed. (1998) ABC of Transfusion, 3rdedition, London, BM J Books.

BCSH Haemostasis and Thrombosis Task Force(1998) Guidelines on Oral Anticoagulation BritishJournal of Haematology 101, 374-387.

Watson, H.G., Baglin, T, Laidlaw, S, Makris, M, andPreston, F. (2001) A comparison of the efficacy andrate of response to oral and intravenous Vitamin Kin reversal of over-anticoagulation with warfarin.British Journal of Haemotology. 115, 145-149

Shetty, H, Backhouse, G, Bentley, D, andRouteledge, P. (1992) Effective reversal of warfarin-induced excessive anticoagulation with low dosevitamin K Thrombosis and Haemostasis. 67, 13-15.

Crowther, M.A, Julian, J, McCarthy, D, Douketis, J,Kovacs, M, Biagoni, L, Schnurr, T, McGinnis, J, Gent,M, Hirsh, J, and Ginsberg, J. (2000) Treatment ofwarfarin-associated coagulopathy with oral vitaminK: a randomised controlled trial. The Lancet. 356:1551-1553


Appendix 3

AVERAGE VOLUME OF BLOOD / COMPONENTS ISSUED IBTS 2003

Product Average Volume Issued

Red cell concentrate 284mls.

Solvent detergent (SD) Plasma 200mls.

Fresh Frozen Plasma 260mls.

Platelets Pooled 330mls.

Platelets Apheresis 240mls.


Transfusion-Related Acute Lung Injury (TRALI)

As we have recently received some reports of seriousadverse transfusion reactions, which were suspectedto be TRALI, we are forwarding some up-datedinformation for your notice board.

Presentation

TRALI generally manifests itself as acute respiratorydistress, fever, and hypotension (hypertension ispresent in 15% of cases) during or after transfusionwith associated bilateral pulmonary oedema, andwith no evidence of cardiac compromise or acutevolume overload. Symptoms typically begin within 1-2 hours of transfusion and are usually present by 4-6hours. Chest X-rays classically demonstrate white-out by interstitial and alveolar infiltrates, but in thefirst few hours a patchy pattern may be observed.The incidence of TRALI is about 1:5000 transfusions,but this may be significantly under diagnosed.

Implicated Products

TRALI has been more frequently described intransfusions containing significant amounts of plasmai.e. fresh frozen plasma (FFP) and platelets, but it hasalso been associated with cryoprecipitate, red celltransfusions and intravenous immunoglobulin.

Solvent detergent plasma (SD plasma) has not beenimplicated in TRALI probably because of the poolingprocess involved during manufacture.

Pathophysiology

TRALI is thought to result from the presence of anti-HLA and/or anti-granulocyte antibodies mainly in theplasma of multiparous female donors, or lesscommonly in the plasma of donors who have receivedprevious transfusions. One or both of these antibodytypes have been found in 89% of TRALI cases,although there have been documented cases wherethere were no associated antibodies. It has beenhypothesised that white cell–antibody interactioncauses activation and sequestration of white cells inthe pulmonary microvasculature. The granulocytemetabolic products released give rise to endothelialinjury, leading to increased endothelial permeabilityand consequent exudation of fluid and protein.

National Haemovigilance Office (NHO) AnnualReport 2001

During 2001, the NHO received three reports ofsuspected TRALI. Two of these reports, which involvedthe transfusion of red cells, have been confirmed asTRALI. The third, which is still under investigation, isrelated to the transfusion of two units of FFP.

Appendix 4


Differential Diagnosis

• The symptoms of transfusion associatedcirculatory overload usually begin within severalhours of the transfusion of any type ofcomponent or product. There may be othersymptoms of cardiac insufficiency. Often there ispre-existing cardiovascular or respiratory disease.

• The respiratory distress and cyanosis ofanaphylactic transfusion reactions is related tobronchospasm and laryngeal oedema, not topulmonary oedema. Furthermore, cutaneousmanifestations are common and typically involvethe trunk, face and neck. Fever, generally, is not amanifestation of anaphylactic transfusion reactions.

• While fever and hypotension are frequentsymptoms of bacterial contamination, respiratorydistress is not as frequently observed. The onsetof symptoms is usually within 1-2 hours ofcommencing the transfusion. Although plateletsare most frequently implicated due to theirambient storage conditions, red cell transfusionsmay also be associated with this complication.

• TRALI is clinically indistinguishable from acuterespiratory distress syndrome (ARDS). ARDSshould be considered if the presentation is over12 hours post transfusion, or if the condition failsto resolve within 72 - 96 hours. This should alsobe considered in patients with clinical disordersassociated with ARDS e.g. pneumonia, sepsis,aspiration of gastric contents and severe trauma.

Treatment

TRALI is associated with significant patient morbidityand the mortality rate may be as high as 25%.Generally patients will require O2 support, withapproximately 70% requiring mechanical ventilation.In about 80 percent of cases the pulmonaryinfiltrates evident on radiography resolve almostcompletely within 96 hours and arterial blood gasesreturn to baseline values during this period. It isgenerally agreed that ventilatory assistance (O2 andin severe cases mechanical ventilation) and fluidreplacement (0.9% NaCl) are indicated for thetreatment of TRALI. Diuretics are contraindicated.Pressor agents are occasionally required to controlfluid replacement resistant hypotension. Nosignificant role has been determined, as yet, for theuse of corticosteroids.

Recommendations

1. Be alert that any respiratory distress occurringduring, or within six hours following, blood orblood component transfusion could potentially beTRALI. Discontinue the transfusion immediately,begin O2 and supportive therapy.

2. Patient samples required for follow-upinvestigations include: 10mls in EDTA tube and10mls in plain tube. Please contact the NHO foradvice re same.

3. Notify the Blood Centre that supplied the bloodcomponent of the unit numbers of thecomponents used.

4. Report TRALI as a serious adverse reaction totransfusion to the NHO.


DIFFERENTIAL DIAGNOSIS

Fever BP Pulse Clinical features Onset Investigation

TRALI s st t Bilateral PulmonaryOedema

During / up to 1-6hours after

Granulocyte serology

CirculatoryOverload

- s s Cardiac FailurePulmonary OedemaPositive FluidBalance

During/after ECG, cardiacenzymes, ECHO

Anaphyactoidreaction

- tt s RashDysponea

Immediateoccurring up to 2hours

IgA Levels

Bacterialinfection

s tt s Endotoxic Shock During or 1-4hours after

Blood cultures ofpatient and bloodcomponent

ARDS s st s Bilateral PulmonaryOedema

Consider if onsetlater than 6 hours

Investigations forunderlying conditions

Bibliography

1. Popovsky, M.A. and Moore, S.B. (1985)Diagnostic and pathogenetic considerations intransfusion-related acute lung injury. Transfusion,25:573-577.

2. Popovsky, M.A. (2001) Transfusion-Related AcuteLung Injury (TRALI) In: Popovsky, M.A. (ed.)Transfusion Reactions 2nd edition, Bethesda, MD:AABB Press.

3. Rizk A, Gorson K, Kenny L. and Weinstein R.(2001) Transfusion-related acute lung injury afterthe infusion of IVIG. Transfusion; 41:264-268.

4. Popovsky, M.A. (2000) Transfusion-related acutelung injury. Curr Opinion Haem; 7:402-407.

5. Engelfriet, C.P. and Reesink, H.W. (2001)Transfusion-related acute lung injury (TRALI). VoxSang; 81:269-283.

6. Serious Hazards of Transfusion (SHOT) AnnualReport 2000-2001 Love, E. et al

For further information contact:National Haemovigilance Office at the NBC,James’s St, Dublin 8.

NationalHaemovigilanceOffice

Annual Report 2003

National Haemovigilance OfficeNational Blood Centre James’s Street Dublin 8.Tel: 01 432 2894Fax: 01 432 2930

Natio

nal H

aemo

vigilan

ce Office

An

nu

al Rep

ort 2003

designed byw

ww

.redd

og

.ie

national haemovigilance office · jvp jugular venous pressure ldh lactate dehydrogenase lvf left...

Documents