2004_haemo_annual report

National Haemovigilance Office
Annual Report
Foreword
The National Haemovigilance Office (NHO) is now firmly established in its role of collectingand analysing voluntary confidential information relating to adverse clinical reports fromblood transfusion. The first Annual Report of the NHO covered the relatively short periodfrom 1 October 1999 to 31 December 1999, but illustrated that transfusion of a bloodcomponent to the wrong patient was the most frequent problem, (44% of reports). Thisyear, the first complete year of reporting, the category of Incorrect blood componenttransfused (IBCT) again exceeds all others.
The Report’s findings illustrate that while blood transfusion therapy is a safe procedure,there is still a need to develop and perfect systems at hospital level to ensure safety andelimination of errors at all stages of the transfusion chain.
A considerable number of recommendations have ensued from the analysis of the reportsreceived and these are summarised at the beginning of this report and expanded uponwithin each appropriate chapter. Primary areas of concern are those incidents in thecategories of IBCT and transfusion associated circulatory overload (TACO) as theseincidents provide opportunities for improved practice.
In order to achieve improvements in transfusion safety - which is the ultimate goal of theNational Haemovigilance programme - the office has continued to extend its involvementwith hospital based Transfusion Surveillance Officers (TSO) in a pro-active way. Extensiveeducational visits, together with the development of in-service education programmes havecontinued. This aspect of the programme has been most rewarding, with a steady buildingof mutual trust and networking between the NHO staff, hospital based TSOs and othersworking in the area of transfusion throughout the country.
The NHO again wishes to acknowledge the support of Consultant Haematologists, Hospitalbased TSOs, Hospital Laboratory Technologists and Hospital Consultants in the manyhospitals who have participated and supported this programme. The continued feedbackfrom the wider ‘transfusion community’ is most encouraging. Thanks are also due to theMinister for Health and Children and his Department, Directors of Nursing, Chief ExecutiveOfficers and Hospital Administrative staff.
At this point I would like to mention the contribution of the Serious Hazards of Transfusion (SHOT), the UK haemovigilance reporting system. The structure anddevelopment of this report is based on that of SHOT and by using published SHOT reportsas references, the NHO has established a framework for our own report, and this has provedinvaluable.
A number of people have been involved in the continued development of the NationalHaemovigilance Programme. A multi-disciplinary National Steering Committee wasestablished to oversee and monitor the initial implementation of the scheme. The adviceand support of the Medical Director and staff of the Pharmacovigilance Department of theIrish Medicines Board (IMB) has also been invaluable. The work of the National Blood Users Group in researching best transfusion practice and inthe preparation of national guidelines for the use of blood components must be recognisedas a significant contribution to patient safety. Appreciation should also be extended to theConsultant Haematologists and the Management and Staff of the Irish Blood TransfusionService (IBTS).
On a personal level, I wish to mention Mr. Peter McDonnell and Mr. Gary Keany of theTraining Department at the IBTS who developed the induction-training sessions for newly National Haemovigilance Office
appointed TSOs. I also personally acknowledge, in a special way, the patience and efforts ofthe Staff of the NHO in compiling and drafting this report.
In the interest of improving the care and safety of patients requiring transfusion throughoutthe country, the NHO will continue to promote Haemovigilance in the year ahead byinitiating regional seminars and study days. The existing education programme will also bedeveloped further.
The excellent progress made in the first fifteen months of this programme has provided afirm foundation for these developments and augers well for the future.
Dr Emer Lawlor
Table of Contents
Hospital Transfusion Committees .
Education, Promotions and Developments .
"Near Miss" Pilot Scheme .
Definition of an Adverse Event/Reaction .
Incidents January – December 2000 .
Incorrect Blood Components Transfused .
Table 4 IBCT Minor Incidents .
IBCT Detailed Case Histories .
Severe Acute Anaphylaxis/Anaphylactoid Reactions .
Acute Haemolytic and Other Severe Acute Transfusion Reactions .
Transfusion Association Circulatory Overload .
Suspected Transfusion Transmitted Infection .
Delayed Haemolytic Transfusion Reaction .
Recommendations
◆ The importance of positive patient identification at the bedside using three minimum identifiers, i.e. full name, date of birth and unique hospital number, both at the time ofsampling and administration is highlighted. ◆ Should there be a discrepancy in any of the three minimum identifiers on the patient’s identity bracelet, the compatibility report form, the component issue label, theprescription or the clinical notes, the transfusion must not proceed and the laboratorymust be contacted.
◆ All stages of the transfusion process, from prescription, sample taking, cross matching in the laboratory to bedside administration require an uninterrupted workingenvironment, with adequate space.
◆ Whether using manual or a semi-automated systems, the laboratory must develop procedures to build in checks for all critical points in transfusion testing, e.g. preservingthe identity of samples during separation and processing.
◆ Computer software should be validated to ensure that it does not permit the allocation or release of ABO incompatible Red Cell Concentrate (RCC) units.
◆ It is recommended that hospitals put in place automated transfer systems of laboratory information to clinical areas to avoid communication errors.
◆ Computerised identification systems are available to ensure safe transfusion at the bedside. These systems must now be evaluated further with a view to their developmentwithin transfusion practice. Their potential value in areas other than the transfusionsetting, for example in reducing drug administration errors, should also be evaluated, asthis will improve their cost effectiveness.
◆ Satisfactory thawing of Fresh Frozen Plasma (FFP) is the responsibility of the hospital blood bank1. If frozen plasma is to be thawed outside the laboratory, staff carrying outthis procedure must be competent in doing so and a register of individual trainingrecords should be maintained.
◆ Immunocompromised patients have special transfusion requirements. The transfusion prescription and the request form must be accurately completed to include thesespecial requirements, i.e. cytomegalovirus (CMV) antibody negative and irradiatedcellular components. Through the provision of additional information such as diagnosis,provisional or otherwise, and past medical history on the transfusion prescription,Laboratory and Nursing staff may be prompted to intercept errors leading to omission ofspecial requirements for this patient group. ❖ Sharing care with tertiary care centres is becoming increasingly more common, especially in the Haematology/Oncology setting. A secure system to ensure thatpatients in shared care receive the appropriate blood components in theparticipating hospitals is recommended.
◆ It is recommended that vital signs relating to transfusion be recorded separately from routine vital signs and clearly dated to enable the information to be retrieved at a laterdate where necessary2.
◆ It is recommended that where a severe reaction occurs, the transfusion should be discontinued and not recommenced until a full documentation check, serologicalinvestigation and medical review has been undertaken. National Haemovigilance Office
◆ The causes of anaphylactoid/anaphylactic transfusion reactions are not always clear and may be linked to an allergy to plasma proteins. In some rare cases IgA deficiencies withanti-IgA antibodies have been described, therefore it is recommended that IgA levels bechecked when symptoms of anaphylactoid transfusion reactions develop, as thesereactions can be life threatening in patients with IgA deficiency. ❖ In cases of suspected allergic/anaphylactoid reactions, or in patients who have had difficulties with previous transfusions, it may be necessary to pre-medicate with anantihistamine before each transfusion episode3.
❖ If a patient has a history of repeated anaphylactic or severe anaphylactoid
transfusion reactions and IgA level is normal, the patient should receive washedcellular components if further transfusions are needed. Plasma transfusions shouldbe given cautiously after appropriate pre-medication4.
❖ Patients with IgA deficiency (<0.05mg/dL) should have anti-IgA antibodies checked and if positive will require special management, including the use of washed cellularcomponents, for future transfusions4. ◆ It is particularly important to fully investigate any severe acute symptoms occurring during the transfusion in an effort to identify the cause of the symptoms. In a number ofcases reported of anaphylactoid reactions, the diagnosis was not clear and fullserological/bacterial culture of patient and packs was not undertaken. A protocol forblood pack culture is available on request from the Quality Assurance/Quality ControlDepartment of the Irish Blood Transfusion Service (IBTS).
◆ Reports received indicate that transfusion associated circulatory overload (TACO) is associated with considerable morbidity. In one reported case with underlying cardiacdisease, it may have contributed to mortality. In response to these reports, particularlyassociated with the administration of FFP, the National Haemovigilance Office (NHO)issued an information leaflet on the use of FFP. (see Appendix 1) This included: ❖ Firm indications for the use of FFP❖ Suggested infusion rates ❖ Management of anticoagulation in the preoperative period❖ Conditional uses of FFP ◆ Careful attention should be paid to the patient’s fluid balance prior to transfusion of any blood component. In those patients considered to be at greater risk of developingcirculatory overload, the very small, elderly, cardiac or respiratory compromised patient,the transfusion should be administered slowly and the patient must be closelymonitored for early signs and symptoms5. In addition, the use of diuretic therapy shouldbe considered as a prophylactic measure in those patients considered to be at risk. ◆ The symptoms suffered during any transfusion reaction reinforce the need to transfuse
only where an alternative therapy does not exist.
◆ Because of the need to conserve supplies of Rhesus D negative blood for females of child bearing age, hospitals should have policies to cover switching patients fromRhesus D negative to Rhesus D positive blood when stocks are low or when massivebleeding is anticipated. ◆ Careful history taking in relation to transfusion and pregnancies by the requesting physician is important. However, up to 12% of patients do not realise that they havehad a transfusion6, so access to and checking of previous transfusion records areessential. Inter hospital computer access to laboratory transfusion records may need tobe evaluated for use in the future.
Annual Report 2000
◆ As antibodies can develop rapidly, patients being repeatedly transfused, depending on the interval between transfusions, should have a fresh sample submitted within 24-72hrs of a planned transfusion in accordance with British Committee for Standards inHaematology (BCSH) Guidelines7.
Haemovigilance – an overview
Haemovigilance has been defined as:
" A set of surveillance procedures, from the collection of blood and its
components to the follow-up of recipients, to collect and assess information on
unexpected or undesirable effects resulting from the therapeutic use of labile
blood products, and to prevent their occurrence or recurrence"
The Scheme is an anonymised system similar to that in place for monitoring drug safety(Pharmacovigilance) and is dedicated to the improvement of practice within the transfusionchain at all stages from donor to recipient. Reporting of incidents is seen as part of theprofessional responsibility of all Health Care Professionals. The remit of the National Haemovigilance Office (NHO) is to: ◆ Receive, collate and follow up reports from hospitals and general practitioners of adverse reactions/events to transfusion of blood components/products and providefeedback information to reporters as appropriate. ◆ Advise on the follow-up action necessary, particularly with regard to suspected hazards. ◆ Report adverse reactions to the Irish Medicines Board (IMB) according to an agreed ◆ Provide ongoing support to hospital-based Transfusion Surveillance Officers (TSO) and as appropriate to medical, nursing and technical staff. ◆ Provide medical, scientific and nursing analysis of reports of adverse reactions. ◆ Advise on improvements in safe transfusion practice based on the data supplied by ◆ Support the development of clinical guidelines for hospitals in relation to the use of ◆ Support the audit function of hospitals in relation to transfusion practice. ◆ Promote the development of fully traceable transfusion records at hospital level.
◆ Report to the National Blood Users Group on a periodic basis with a view to developing A major part of the remit of the NHO is education and support in relation to besttransfusion practice at hospital level.
The NHO is located at the National Blood Centre, James’s St., Dublin 8 and functionsunder the directorship of a Consultant Haematologist with two Transfusion SurveillanceOfficers (TSO), an Office Administrator and Assistant Administrator.
Hospital Transfusion Committees
The NHO actively encourages and supports the development of multi-disciplinary HospitalTransfusion Committees to provide a forum for discussion and exchange of views at locallevel. It is also necessary to avoid assigning blame when an error is identified, but rather tofind the root causes of the error. Without an adequate understanding of the causes of error,there is little likelihood the error can be corrected and prevented in the future. It is essentialto look for and to eliminate situations that set up humans for failure8. An environment thatencourages organisations to identify errors, evaluate causes and take appropriate actions toimprove performance in the future can be developed through the establishment of a Hospital National Haemovigilance Office
Transfusion Committee9. The concept of local ‘ownership’ of issues in a ‘no blame culture’ isa fundamental element in supporting the role of the Hospital based TSO and also to theoverall success of the National Haemovigilance Programme.
National Blood Users Group
The National Blood Users Group was established by the Minister for Health and Children forthe purpose of preparing and disseminating guidelines for the use of blood products inIreland "A Guideline for Transfusion of Red Blood Cells in Surgical Patients" is the first in a seriesof planned National Blood Users Group publications, produced according to the principlesof evidence-based medicine. This document provides a valuable tool against which actualpractice may be audited and measured. Copies of this publication have been widelydistributed during 2001. Copies may also be downloaded and directly accessed on the IrishBlood Transfusion Service (IBTS) Website @ www.ibts.ie (Publications page). Education, Promotion and Developments
Improvements in hospital transfusion practices have been promoted and supported by anumber of different means. A vital part of the support structures for the NHO are thetraining and education programmes for nursing, medical and laboratory students. All newlyappointed Hospital based TSOs attend an induction programme, which includes anintroduction to Good Manufacturing Practice and an overview of the IBTS manufacturingprocesses in the National Blood Centre. The NHO has established an extensive network of contacts by personal visits, regularcorrespondence and telephone communication. The NHO Staff continue to take part ininterview panels when requested. Upon the appointment of the hospital based TSO,information packs, correspondence and induction days are arranged to encourageuniformity of practice and a free, open exchange of information. As the majority of TSO appointments were confined to the centres with a sizeable bloodusage, the NHO developed and provided a number of ‘in-service’ education sessions withinsmaller centres in an attempt to standardise care before, during and upon completion oftransfusions.
Information on Haemovigilance can be directly accessed on the IBTS Website @ www.ibts.ie.
NHO News
The first edition of NHO News, a quarterly newsletter for TSOs, was launched in June
2000. The aim of this newsletter is to provide news and helpful information in an informal
fashion to TSOs around the country. TSOs are encouraged to forward details of events that
may be of national interest, including results of audit trails, local education and training
initiatives, study days or incidents of interest that arise and may be of assistance or
relevance to work carried out by other TSOs. The newsletter also provides a forum for TSOs
to promote their efforts within their own hospital community.
NHO Audit Tool
Included in the remit of the NHO is the development of the audit function at hospital levelin relation to transfusion practice. As a result of feedback from TSOs around the country,NHO staff designed an audit tool to assist in identifying areas of transfusion practice wheredifficulties frequently arise. The document is loosely based on the NHO detailedquestionnaires and was designed for ease of completion both from observing practice andarchived patient records. Annual Report 2000
The initial audit trial permitted an overall assessment of the strength of the audit tool andallowed for modifications in future reviews. Re-audits will be carried out using the improvedaudit tool, to evaluate the efficacy of current guidelines in achieving quality care.
Resulting recommendations will be used to promote improvements in transfusion practiceby identifying areas of educational need and using the collated information for educationalpurposes. All participants in this project will receive feedback and analysis. ‘Near Miss’ Pilot Scheme
It is recognised that for every transfusion of wrong blood, despite there having been an errorat some point during the process, many other incidents are prevented by careful checkingprocedures. Adequate understanding of the causes of error is essential if the error is to becorrected and prevented in the future. It is vital to search for and eliminate faults within asystem that allow humans to make a mistake8.
In an effort to assess any problem areas that may be contributing factors to reportableincidents, a ‘Near Miss’ pilot scheme will be undertaken in the near future. The goal of thisproject will be:a) to raise the level of awareness of error detection and b) to evaluate, and put in place, systems which reduce the frequency of human failure.
The Near Miss scheme will have its own set of reporting forms, and it is anticipated thatevaluation of near miss incidents would greatly enhance the safety of transfusion andprevent such incidents occurring in the future.
Definition of Adverse Event/Reaction
Reported incidents are considered as adverse events if they fulfill the following criteria: Adverse Event:
Definition: An undesirable experience occurring following administration of a blood
Adverse Reaction:
Definition: A reaction which is harmful and unintended and which occurs following
transfusion of therapeutic volume of a blood component/product. Serious Adverse Reaction: These include adverse reactions, which fall into one or more of the following categories ◆ Permanently disabling or requiring treatment to prevent permanent damage or disability Reporting Forms
The NHO has the following set of forms in operation for the reporting of various types ofincidents, reactions and events: Incorrect Blood Component/Blood Product Transfused Acute Haemolytic or Other Severe Acute Transfusion Reaction National Haemovigilance Office
Severe Acute Anaphylaxis/Anaphylactoid Reactions Transfusion Associated Circulatory Overload Transfusion Associated Graft versus Host Disease Reports received by the NHO are also monitored for increased frequency of adverseevents/reactions to detect any problems which might be caused by changes in thecollecting and processing of blood components, e.g. increased incidences of anaphylactoidor unusual reactions. As this was the first full year of the scheme, the data collected thisyear may be useful as a baseline in future years, although it is recognised that increasedreporting may also reflect increased vigilance and awareness at hospital level.
‘Did Not Progress’
A total of 102 transfusion ‘incidents’ were reported to the NHO. Of these, 17 incidents didnot fulfill the criteria for a haemovigilance event. It was apparent upon further investigationthat these incidents were simple febrile or urticarial reactions or could be attributed to thepatient’s underlying condition, e.g. sepsis or malignancy. In one case, an initial report of suspected Transfusion Related Acute Lung Injury (TRALI)was determined to be due to pulmonary haemorrhage on investigation and has beenexcluded from further evaluation. Anonymised information regarding all these reportedincidents was retained, thus providing an important source of learning for the future.
‘Nil to Report’
To ascertain the percentage of hospitals participating in the NHO reporting scheme, a ‘Nilto Report’ form (see appendix 2) was sent through the TSO to all hospitals where blood istransfused (n=75). In the absence of a TSO at hospital level, the form was sent to thePathologist, Senior Laboratory Technologist or Senior Nursing staff. The receiver of the formwas asked if he/she had already reported incident(s) to the NHO during the period 1January – 31 December 2000. If no adverse event had been seen, he/she was asked toreturn the form as ‘nothing to report’.
Of the 75 hospitals eligible to participate, 28 (37.3%) submitted incident reports duringthe reporting year, 27 (96.4%) of which confirmed they had previously submitted a reportby returning the ‘Nil to Report’ form. A further 23 (30.6%) returned the form stating theyhad ‘nothing to report’. Combining these 23 hospitals with the 28 hospitals whichcontributed incident reports, participation in the scheme can be said to be 68% (51 of 75hospitals). These hospitals are responsible for transfusing approximately 70% of all bloodcomponents transfused.
The ‘Nil to Report’ form was also used to ascertain the number of units transfused in eachhospital in an effort to provide an accurate denominator against which transfusion risk canbe assessed. For this reason it was necessary to identify the returning hospitals and whendata was collated, reports were anonymised by removing all identifiers. Since 32% ofhospitals did not respond, it was decided that the number of units issued from the IBTSduring the reporting period would more accurately reflect the denominator.
Denominator:
In an effort to put the following data in context, an analysis of the number of units issued inthis period was also carried out. These figures do not account for units discarded or wasted.
See Table 1 over: Annual Report 2000
Table 1: Number of units issued by IBTS January – December 2000
Component
Total Issues
Combined total
Incidents January – December 2000
During the one-year period 1 January to 31 December 2000, there were 85 confirmedreports received and reviewed by the NHO which have been categorised as follows: Table 2 NHO-Confirmed Reports by Category
TACO TTI DHTR
Incidents
Incorrect Blood Component/Product Transfused. Severe Acute Anaphylactoid or Anaphylactic Reaction. AHOSTR Acute Haemolytic or Other Severe Acute Transfusion Reaction.
TACO Transfusion Associated Circulatory Overload. Transfusion Transmitted Infection. Delayed Haemolytic Transfusion Reaction Graph 1 NHO Incidents by Category
Number of Incidents = 85
No of Incidents
Category of Incidents
There were no reports received in the categories of: ◆ Post Transfusion Purpura, (PTP) ◆ Transfusion Related Acute Lung Injury (TRALI) ◆ Transfusion Associated Graft versus Host Disease (TAGvHD). Incorrect Blood
Component/Product Transfused
Definition: Incorrect blood component transfused is the transfusion
of a blood component/product which did not meet appropriate
requirements and/or was intended for another patient.
This category accounted for 37% of incidents reported (31 of 85).
Graph 2 - National Haemovigilance Office (NHO)
Incidents January-December 2000 (n= 85)
Incorrect Blood Component/Product Transfused. Severe Acute Anaphylactoid or Anaphylactic Reaction. Acute Haemolytic or Other Severe Transfusion Reaction. Transfusion Associated Circulatory Overload. Transfusion Transmitted Infection. Delayed Haemolytic Transfusion Reaction 1% (1) 2% (2)
SITE OF FIRST ERROR OF
IBCT INCIDENTS (n = 31)
Prescription &/or Request
Hosp Blood Bank
Administration
Site of Collection
Sampling
National Haemovigilance Office
FINDINGS
◆ The frequency of reports in this category highlights the need for attention to guidelines
and extreme care when sampling blood pre-transfusion and issuing/administering bloodcomponents/products. ◆ In three cases, patients received the wrong ABO/Rhesus group (IBCT Cases 1, 2 & 3). ❖ In one of these cases incorrect details were given to the porter and subsequently the incorrect pack was collected from storage. Bedside checking was inadequate andfailed to detect the error (IBCT Case 1). ❖ Due to distraction of the operator the computer warning was overridden and patient’s blood group was changed (IBCT Case 2).
❖ Rhesus D negative patient incorrectly transfused with Rhesus D positive blood due to incorrect blood grouping and failure to check historical records. (IBCT Case 3). ◆ In a further two cases involving transposition of ABO groups, no component was actually transfused, but as all checking procedures had been passed, it was decided to includethese as actual incidents rather than ‘near misses’ (IBCT Cases 4 & 5). ◆ In one case, a Rhesus D negative female received Rhesus D positive Fresh Frozen Plasma (FFP) when due to a transcription error she was incorrectly grouped as Rhesus Dpositive. (IBCT Case 16).
◆ In four cases, patients were transfused unnecessarily due to failure to communicate the correct results between laboratory and clinical staff (IBCT Cases 7, 8, 9 & 10). ❖ In one of these cases, the incorrect transfusion led to circulatory overload with major ◆ In one case it was unclear as to the site of first error where either the wrong component was ordered or the request was misinterpreted. However the error was not identified atthe bedside checking procedure pre-transfusion (IBCT Case 14). ◆ In two cases the error occurred at hospital blood bank site of collection and proceeded through to transfusion (IBCT Cases 17 & 18).
◆ In one case the error occurred at pre-transfusion sampling, the hospital number and date of birth were incorrectly transcribed. This error proceeded through to transfusiondespite multiple checking procedures (IBCT Case 12). ◆ In a further four cases, the original error occurred in the laboratory (IBCT Cases 6, 11, 13 & 15).
❖ In one of these cases the error was detected during the bedside checking procedure pre-transfusion. However, no action was taken and the unit was transfused (IBCTCase 13). ◆ In five cases there was a failure to request cytomegalovirus (CMV) antibody negative &/or Irradiated cellular components for immunocompromised patients. There were noclinical sequelae. (IBCT Cases 19-23).
◆ In one case FFP was thawed outside the laboratory by nursing staff. Following transfusion, deposits were seen in the pack, which may have been due to inadequatedefrosting. The reaction that occurred in the patient may or may not have been linked tothis. (IBCT Case 24).
◆ Seven incidents (IBCT Cases 25-31) could be classified as minor but were collected by the NHO as they reflect the necessity for careful monitoring of the transfusion process.
These incidents covered units expired, undetected changes in hospital digits andbedside administration errors - in some cases a series of errors.
Annual Report 2000
◆ The bedside checking procedure is vital in preventing transfusion error and is the last opportunity to detect an identification error. In twenty of the thirty-one IBCT cases (i.e.
64.5%) the bedside checking procedure failed. It is also important to note that thisfinal check will not necessarily detect errors of sampling or other errors, such as thoseoccurring in the transfusion laboratory10. RECOMMENDATIONS
◆ The importance of positive patient identification at the bedside using three minimum
identifiers, i.e. full name, date of birth and unique hospital number, both at the time ofsampling and administration is highlighted. ◆ Should there be a discrepancy in any of the three minimum identifiers on the patient’s identity bracelet, the compatibility report form, the component issue label, theprescription or the clinical notes, the transfusion must not proceed and the laboratorymust be contacted.
◆ All stages of the transfusion process, from prescription, sample taking, cross matching in the laboratory to bedside administration require an uninterrupted workingenvironment, with adequate space. ◆ Whether using a manual or a semi-automated system, the laboratory must develop procedures to build in checks for all critical points in transfusion testing, e.g. preservingthe identity of samples during separation and processing. ◆ Computer software should be validated to ensure that it does not permit the allocation or release of red cell ABO incompatible units. ◆ It is recommended that hospitals put in place automated transfer systems of laboratory information to clinical areas to avoid communication errors. ◆ Computerised identification systems are available to ensure safe transfusion at the bedside. These systems must now be evaluated further with a view to their developmentwithin transfusion practice. Their potential value in areas other than the transfusionsetting, for example in reducing drug administration errors, should also be evaluated, asthis will improve their cost effectiveness.
◆ Satisfactory thawing of FFP is the responsibility of the hospital blood bank1. If frozen plasma is to be thawed outside the laboratory, staff carrying out this procedure must becompetent in doing so and a register of individual training records should bemaintained.
◆ Immunocompromised patients have special transfusion requirements. The transfusion prescription and the request form must be accurately completed to include thesespecial requirements, eg. CMV antibody negative and irradiated cellular components.
Through the provision of additional information such as diagnosis, provisional orotherwise, and past medical history on the transfusion prescription, Laboratory andNursing staff may be prompted to intercept errors leading to omission of specialrequirements for this patient group. ❖ Sharing care with tertiary care centres is becoming increasingly more common, especially in the Haematology/Oncology setting. A secure system to ensure thatpatients in shared care receive the appropriate blood components in theparticipating hospitals is recommended.
◆ It is recommended that vital signs relating to transfusion be recorded separately from routine vital signs and clearly dated to enable the information to be retrieved at a laterdate where necessary2.
National Haemovigilance Office
Cause of Error
Rhesus D positive (mixed field), historical Remote checking of unit in the Nurses’ Station. Positive patient identification not confirmed. Error detected as unit was Remote checking of unit in the Nurses’ Station. Positive patient identification not confirmed. Error detected as unit was ransfused (IBCT)
Symptoms & Outcome
ransfused
olume of Incorrect
Table 3. Incorrect Blood Component T
Blood Component/
Product T
ABO & Rhesus
Group of IBCT
ABO & Rhesus
Annual Report 2000
Cause of Error
Incorrect haemoglobin result given verbally verbal report of haemoglobin result.
Symptoms & Outcome
ransfused
olume of Incorrect
V
Blood Component/
Product T
ABO & Rhesus
Group of IBCT
ABO & Rhesus
National Haemovigilance Office
Cause of Error
correct hopsital number and date of birth.
during the bedside checking procedure.
Pre-transfusion sample correctly labelled. serum tube was incorrectly transcribed in name and date of birth on issue label.
6 units of platelets were prescribed. It is unclear whether platelets or plasma were verbally requested by telephone. 6 units Symptoms & Outcome
ransfused
olume of Incorrect
V
Blood Component/
Product T
ABO & Rhesus
Group of IBCT
ABO & Rhesus
Annual Report 2000
Cause of Error
Group A Rhesus D positive platelets were not asked to identify self. Identity bracelet antibody negative and irradiated blood for antibody negative and irradiated blood for Symptoms & Outcome
ransfused
olume of Incorrect
V
Blood Component/
Product T
ABO & Rhesus
Group of IBCT
ABO & Rhesus
National Haemovigilance Office
Cause of Error
Symptoms & Outcome
ransfused
olume of Incorrect
V
Blood Component/
Product T
ABO & Rhesus
Group of IBCT
ABO & Rhesus
Annual Report 2000
Cause of Error
check of first unit. During bedside check out, identification bracelet missing.
One unit of Platelet concentrate pooled was delivered outside normal working hours. No facility available in this hospital for storage of platelets. Nursing staff decided to defer transfusion and store platelets overnight in satellite fridge without contacting the on- call medical or laboratory staff for advice.
The hospital blood bank issued two units ransfused (IBCT) - Minor Incidents
Symptoms & Outcome
ransfused
olume of Incorrect
V
Blood Component/
Product T
Table 4 Incorrect Blood Component T
ABO & Rhesus
Group of IBCT
ABO & Rhesus
National Haemovigilance Office
Cause of Error
Unit, which was due to expire at midnight, Bedside check failed to identify the error group O Rhesus D negative male patient.
Symptoms & Outcome
ransfused
olume of Incorrect
V
Blood Component/
Product T
ABO & Rhesus
Group of IBCT
ABO & Rhesus
Annual Report 2000
Incorrect Blood Component Transfused – Detailed Case Histories
IBCT Case 1
This was a non-emergency transfusion of RCC outside normal working hours to a patient for
anaemia of malignancy. Patient X was grouped as group O Rhesus D positive. Patient Y had
a similar name and was on the same ward. Both patients had blood available for them. The
porter who had been asked to collect the blood for Patient X, was given Patient Y’s
addressograph label by ward staff and so collected the incorrect unit for this patient. Two
qualified nurses checked the unit in the office – not at the bedside - against Patient Y’s
chart and documentation. At the bedside, Patient X – although conscious - was not asked to
state his name or date of birth, neither was his identity bracelet checked –which was legible
and correct. The error was noted when laboratory staff recognised that the incorrect unit
had been removed from storage, by which time 50-100 mls. of group B Rhesus D positive
blood had been transfused. Patient X developed symptoms of fever, rigors and vomiting and
the transfusion was discontinued completely. The patient recovered within 24 hours with no
ill effects.
IBCT Case 2
This young patient had received a non-emergency transfusion of two units of RCC
for anaemia of malignancy in an in-patient setting. Patient details on the sample were
hand-written, correct and labelled at the bedside. Due to distraction, a laboratory
technician overrode a warning on the computer system, and in error, changed patient’s
blood group from A to B and the patient received a unit of group B Rhesus D positive blood.
This error was identified one week later when cross-matching was repeated. Due to
underlying condition, the patient had no anti-B detectable. There was no observable
morbidity.
IBCT Case 3
An elderly male patient grouped as O Rhesus D negative and required multiple transfusions
perioperatively. A decision was made to change over from negative to positive components
to maintain Rhesus D negative supply. Two weeks later a further transfusion of two units of
RCC was prescribed. The cross-match was performed outside normal working hours and the
patient grouped as O Rhesus D positive with mixed field. No Rhesus D antibodies were
detected on pre-transfusion antibody screen. Historical records were not checked so two
units of group O Rhesus D positive RCC were issued and transfused. The error was
recognised the following day in the laboratory during routine checking and retrospective
antibody screen showed anti D in enzyme only. There were no features of haemolysis. The
patient developed no adverse effects as a result of this transfusion, but died 24 hours later
from underlying disease.
IBCT Case 4
A transfusion of RCC was to be administered to a patient in a day care setting. Two nurses
checked the unit in the nurses’ station – not at the bedside - and one nurse then proceeded
to the bedside, where the identity bracelet was not checked. Positive identification was not
sought from the patient. A unit of RCC group A Rhesus D positive was placed on the
intravenous stand at the patient’s bedside to be commenced when a platelet transfusion
was completed. The error was detected when the staff nurse was informed that the patient’s
blood group was O Rhesus D positive. The unit had not been connected to the patient.
IBCT Case 5
A transfusion of RCC was to be administered to a patient in a day care setting. The patient’s
blood group was A Rhesus D positive Two nurses checked the unit in the nurses’ station –
not at the bedside - and one nurse then proceeded to the bedside, where the identity band
was not checked. Positive identification was not sought from the patient. The nurse
connected a unit of O Rhesus D positive RCC to the patient’s central venous line. The error
was detected when the transposition error in another transfusion on the same ward was
National Haemovigilance Office
made known to the nurse involved. (see IBCT 4 above) The roller clamp on the bloodadministration set had not been unclamped and so no blood was infused.
IBCT Case 6
Four units of RCC were transfused following an intraoperative bleed. No transfusion history
was recorded on the transfusion request forms. This patient had previously been transfused
and had an anti Jka. Pre-transfusion antibody screen performed but due to an inconclusive
result, was to be repeated. However, staff changeover due to illness led to the issue of four
units of RCC without confirming the result. The patient was asymptomatic and suffered no
sequelae. Laboratory staff detected this error when extra units were requested post-
operatively.
IBCT Case 7
An error occurred in communication between medical staff regarding this transfusion which
resulted in the patient being transfused unnecessarily with two units of RCC. The patient
developed no adverse effects as a result of this transfusion.
IBCT Case 8
An elderly patient was transfused with two units of RCC following elective surgery. This
incident occurred following a change of staff who assumed that the verbal report of a
haemoglobin of 7.5 gm/dl referred to a post transfusion sample result and a further two units
were transfused (actual haemoglobin 9.5gm/dl). The patient had an underlying chronic renal
impairment with associated cardiac problems. During transfusion symptoms of circulatory
overload developed with no response to intravenous diuretics. This patient required renal
dialysis, and continues on maintenance dialysis. There was a significant medication history,
which included long-term use of non-steroidal anti-inflammatories and analgesics – known to
be associated with renal dysfunction. The error was discovered when the computer-generated
report stating the correct haemoglobin result was found following the transfusion.
IBCT Case 9
This non-emergency transfusion took place in an in-patient setting. One unit of RCC was
prescribed for an elderly patient with a haemoglobin of 8.1 gm/dl, which had been reported
verbally and recorded as such in the medical notes. Error was identified by the Transfusion
Surveillance Officer (TSO) during routine auditing of transfusions when the haemoglobin
was found in fact to be 9.6 gm/dl. The patient developed no adverse effects as a result of
this transfusion.
IBCT Case 10
This elderly patient had suspected gastro-intestinal bleed with associated anaemia.
Laboratory staff telephoned a haemoglobin result of 6.7 g/dl. This result was however two
days old and the anaemia had been appropriately treated. The ward staff assumed that this
result was the most recent haemoglobin and based on this inaccurate information, four
units of RCC were requested and issued. As the first unit was completed the computer-
generated result was then viewed and the actual haemoglobin was found to be 10.8gm/dl.
No further units were transfused. The patient developed no adverse effects as a result of
this transfusion.
IBCT Case 11
This elderly patient was transfused for anaemia in a non-emergency setting. In the
laboratory, due to distraction, the computer-generated issue label with patient details was
placed inadvertently on a unit of RCC, which was of the correct group, but had not been
cross-matched for this patient. The pre-transfusion bedside check failed to recognise that
the donation number on the issue label on the back of the pack did not match the donation
number on the Irish Blood Transfusion Service (IBTS) label on the front of the pack. The
patient developed no adverse effects as a result of this transfusion. The error was
discovered the following day by laboratory staff during a routine stock check.
Annual Report 2000
IBCT Case 12
An elderly patient requiring five units of RCC following elective surgery was transfused
between the Operating Theatre, Recovery Unit and the ward. The pre-transfusion sample
was hand-written but incorrectly labelled by the phlebotomist – the surname was incorrectly
spelled which in effect created a new surname. This error continued throughout the
transfusion chain process. Subsequently the surname on the pack issue label was also
incorrect. Two nurses and an anesthetist checked the units as correct, without reference to
the patient, who was conscious and able to identify him/herself. The identity bracelet was
correct in all details, but was not included in the checking process. There were no
complications relating to this transfusion. The error was discovered by laboratory staff one
week later when repeat cross matching was requested with correct details written on sample
tube and on request form.
IBCT Case 13
This patient was group A Rhesus D negative and was transfused during the night with two
units of group O Rhesus D negative RCC. The pre-transfusion sample was labelled using only
two patient identifiers, as the Hospital Number was not available because the Admissions
Office was closed. Two units of RCC were issued and transfused uneventfully. During the
night, two further units were requested over the telephone for an emergency transfusion. The
laboratory staff generated the request form using patient details from the separated serum
sample tube but transcribed these details incorrectly. A further transcription error arose when
inputting data into the computer and the surname was incorrectly spelled. Hence two units
of RCC were issued with the incorrect date of birth and incorrect surname. The discrepancy
in date of birth was noted, however, the incorrect surname was not noted and the unit was
transfused without consulting laboratory staff. The patient developed no adverse effects as a
result of this transfusion. The TSO noted the error during routine surveillance.
IBCT Case 14
A patient was prescribed 6 units of single donor platelets (1 adult dose) prior to an invasive
procedure, but 6 units of FFP were issued instead, based on a telephone request where
either the wrong component was ordered or the order was misinterpreted. The bedside
checking process did not detect the error. During the 4th unit the patient arrested. This
patient died of underlying disease, but an element of circulatory overload cannot be
outruled and may have been a contributing factor, as the volume of four units of plasma
(approximately 880 mls) is considerably greater than that of platelets (approximately
300mls). The event was reported to the TSO as a reaction to platelets and the error was
identified during the investigation.
IBCT Case 15
FFP was administered in an emergency to the intended patient but ascribed on hospital
computer for another patient of the same name. This arose because the chart was
unavailable immediately and only name and date of birth were recorded on the pre-
transfusion sample tube label. The unique hospital number was not recorded. The
laboratory selected another patient of same name but different date of birth from computer
screen, changed the details on the sample tube to match and issued four units of FFP to
that patient. The discrepancies were noted at the bedside but the transfusion proceeded
without contacting laboratory staff. The patient developed no adverse effects as a result of
this transfusion. The TSO was informed of the event some days later.
IBCT Case 16
An elderly Rhesus D negative woman was incorrectly grouped as Rhesus D positive due to
transcription error. Historical records were not found as she had been transfused under a
different medical record number previously. Seven units of Rhesus D positive FFP were
issued and transfused. Subsequent transfusion two months later identified error, showing
incorrect group had been issued on this occasion. The patient developed no adverse effects
as a result of this transfusion.
National Haemovigilance Office
IBCT Case 17
One pool of unlabelled group O Rhesus D positive platelets were collected in error and
transfused to a group A Rhesus D positive patient, while group A Rhesus D positive platelets
were already labelled and available in the hospital blood bank for this patient. The bedside
checking procedure failed to identify the error. Laboratory staff detected the error during a
routine stock check. The patient developed no adverse effects as a result of this transfusion.
IBCT Case 18
This patient was transfused with one unit of apheresed platelets for acute haemorrhage
associated with coagulopathy in Intensive Therapy Unit (ITU). He was group A Rhesus D
positive. One pack of apheresed platelet concentrate group O Rhesus D negative, intended
for another patient in ITU was collected from the blood bank and placed at the bedside of
this patient. Two people checked the component at the bedside but the patient, although
conscious was not asked to confirm positive identification. There was no patient identity
bracelet in place. The error was detected when the empty pack with the other patient
details on it was found at the bedside of this patient. The patient developed no adverse
effects as a result of this transfusion.
Failure to administer CMV antibody negative and irradiated products
IBCT Case 19
A new patient with an underlying haematological disorder requiring CMV antibody negative
and irradiated cellular blood components received 4 units of RCC which were not CMV
antibody negative or irradiated when transfused in a general hospital before transfer to a
specialist Haematology centre. The patient suffered no sequelae. The TSO identified this
error during routine surveillance.
IBCT Case 20
An anaemic baby required emergency transfusion as an in-patient. Care was being shared
with a tertiary centre and patient required CMV antibody negative and irradiated cellular
components as per tertiary centre’s instructions. Request form was hand-written omitting
this detail. Prescribing doctor later verbally requested CMV antibody negative and irradiated
component but did not change the prescription accordingly. The component issued was not
irradiated. Two nurses checked unit and patient identity at bedside. This case highlights
the need to prescribe components needing special requirements on prescription sheet. The
patient suffered no sequelae.
IBCT Case 21
Patient scheduled for peripheral blood stem cell (PBSC) collection was transfused with
non-irradiated, non-CMV antibody negative platelets twenty-four hours prior to procedure.
The component had been requested verbally when the laboratory already knew the patient’s
group, but the requesting doctor failed to mention the special requirements needed for this
transfusion. The component had been correctly prescribed on the transfusion prescription
form, but the bedside check failed to identify that special requirements were not met.
Laboratory staff discovered the error when subsequent transfusion of CMV antibody
negative and irradiated component was ordered. The patient suffered no sequelae.
IBCT Case 22
A potential bone marrow transplant patient was transfused with non-irradiated, non-CMV
antibody negative pooled platelet concentrate in a day ward setting. The component had
been requested verbally when the laboratory already knew the patient’s group, but the
requesting doctor failed to mention the special requirements needed for this transfusion.
The component had been correctly prescribed on the transfusion prescription form but the
bedside check failed to identify that special requirements were not met. Laboratory staff
discovered the error when subsequent transfusion of CMV antibody negative and irradiated
component was ordered. The patient suffered no sequelae.
Annual Report 2000
IBCT Case 23
A patient due to undergo PBSC harvest received non- irradiated, non-CMV antibody
negative unit of platelet concentrate apheresis. Component had been requested verbally
when the laboratory already knew the patient’s group, but requesting doctor failed to
mention the special requirements for this transfusion. The component had been correctly
prescribed on the transfusion prescription form but the bedside check failed to identify that
special requirements were not met. The TSO discovered error when reviewing pre bone
marrow/PBSC transplant patients. The patient suffered no sequelae.
Failure to defrost Plasma correctly
IBCT Case 24
FFP was collected from laboratory freezer and defrosted at ward level by nursing staff. The
patient, who already had an underlying petechial rash due to meningococcal sepsis,
developed an urticarial ‘nettle sting’ type rash during transfusion. On examination,
following transfusion, deposits were seen in remaining plasma, which may have been due to
inadequate defrosting. The patient recovered without sequelae.
Incorrect Blood Component Transfused - Minor Incidents
Seven incidents (IBCT 25-31) could be classified as minor but were collected by the NHOas they reflect the necessity for careful monitoring of the transfusion process. Theseincidents covered units expired, undetected changes in hospital digits and bedsideadministration errors, - in some cases a series of errors. As there are a number ofsimilarities in all of these cases, for reporting purposes, one case is included in detail. IBCT Case 27
This elderly patient was transfused for anaemia with one unit of RCC, as an in-patient in a
non-emergency setting. The hospital number was transcribed onto the sample tube
incorrectly at time of sampling. In the laboratory, transfusion records were not checked and
the discrepancy was not detected. This incorrect number was transcribed onto the issue
label and the issue report form. The name and date of birth were correct on all
documentation but the hospital number had a digit discrepancy. The unit was not formally
checked for identity at time of collection from storage. Remote checking of the unit in the
Nurses’ Station failed to identify the error prior to transfusing the first unit. The patient’s
identity bracelet was missing, thus positive patient identification was not confirmed. Staff
checking the second unit discovered the error and contacted the laboratory. The patient
developed no adverse effects as a result of this transfusion.
Severe Acute Anaphylactoid
or Anaphylactic Reaction
Definition: Allergic, anaphylactoid and anaphylactic transfusion reactions span
a range of symptoms of varying severity. The symptoms encompass simple
allergic-type reactions such as urticaria/pruritis or urticaria/pruritis associated
with gastrointestinal discomfort, to more severe reactions such as stridor,
wheeze, bronchospasm, laryngeal oedema and hypotension. The onset of
intractable hypotension or shock with loss of consciousness is commonly
designated as an anaphylactic reaction. In its severest form
anaphylaxis can be life threatening4.
This category accounted for 26% of incidents reported (i.e. 22 of 85).
In most cases symptoms described were not severe and patients recovered withoutsequelae. All incidents were included in the overall review for the purposes of this Report and where recommendations re future transfusions were given by thereporting hospitals, these have also been included. A number of cases with more severesymptoms or those that illustrate the requirement of pre-medication have been described inmore detail. FINDINGS AND RECOMMENDATIONS:
◆ The occurrence of anaphylactoid reactions particularly with Fresh Frozen Plasma (FFP)
emphasises the need to only use FFP when clinically indicated. The NationalHaemovigilance Office (NHO) issued an information leaflet to hospitals drawingparticular attention to this, a copy of which is attached (see Appendix 1) ◆ It is particularly important to fully investigate any severe acute symptoms occurring during the transfusion in an effort to identify the cause of the symptoms. In a number ofanaphylactoid reactions reported the diagnosis was not clear and fullserological/bacterial culture of patient and packs was not undertaken. A protocol forblood pack culture is available on request from the Quality Assurance/Quality ControlDepartment of the Irish Blood Transfusion Service (IBTS).
◆ The causes of anaphylactoid/anaphylactic transfusion reactions are not always clear and may be linked to an allergy to plasma proteins. In some rare cases IgA deficiencies withanti-IgA antibodies have been described, therefore it is recommended that IgA levels arechecked when symptoms of anaphylactoid transfusion reactions develop, as thesereactions can be life threatening in patients with IgA deficiency. ❖ In cases of suspected allergic/anaphylactoid reactions or in patients who have had difficulties with previous transfusions, it may be necessary to pre-medicate with anantihistamine before each transfusion episode3.
❖ If a patient has a history of repeated anaphylactic or severe anaphylactoid
transfusion reactions and IgA level is normal, the patient should receive washedcellular components if further transfusions are needed. Plasma transfusions shouldbe given cautiously after appropriate pre-medication4. ❖ Patients with IgA deficiency (<0.05mg/dL) should have anti-IgA antibodies checked and if positive will require special management, including the use of washed cellularcomponents for future transfusions4. National Haemovigilance Office
transfusions
Sequelae/
reatment
T
ransfusion Recommendations
Reaction future
developed
Investigations
*Included in this report as a full case review Symptoms
Table 5 Severe Acute Anaphylaxis/Anaphylactoid Reaction (AA) -
Reason for
transfusion
Component
Annual Report 2000
transfusions
Sequelae/
reatment
ransfusion Recommendations
Reaction future
developed
Investigations
Symptoms
Reason for
transfusion
Component
National Haemovigilance Office
transfusions
Sequelae/
reatment
ransfusion Recommendations
Reaction future
developed
Investigations
Symptoms
Reason for
transfusion
Component
Annual Report 2000
transfusions
Sequelae/
reatment
ransfusion Recommendations
Reaction future
developed
Investigations
Symptoms
Reason for
transfusion
Component
National Haemovigilance Office
transfusions
Sequelae/
reatment
T
ransfusion Recommendations
Reaction future
developed
Investigations
Symptoms
Reason for
transfusion
Component
Annual Report 2000
Severe Acute Anaphylactoid or Anaphylactic Reaction –
Detailed Case Histories
Six cases displaying more severe symptoms are described in greater detail.
AA Case 3
This elderly patient had a history of flushing, weakness and breathlessness when previously
transfused. During the first 15 minutes (100 mls) of l unit of RCC, symptoms of dyspnoea,
restlessness and flushing again developed. The transfusion was discontinued and
Hydrocortisone, Piriton and nasal oxygen were administered. The pack cultured negative.
IgA levels were checked and found to be deficient (<0.05mg/dL) but anti IgA antibodies
were not performed. This patient recovered with no sequelae but subsequently died from
unrelated causes.
AA Case 11
This patient with an underlying malignancy was receiving transfusions as supportive therapy
in a non-emergency setting and had been premedicated with Piriton. This patient also had
asthma and was taking a Ventolin inhaler as needed. During the second unit of saline
washed platelet concentrate, the patient developed urticaria and chest pain. The
transfusion was discontinued immediately, and following immediate review Dexamethasone
was administered intravenously. IgA levels were normal. It was recommended that the
patient receive antihistamine and steroid cover 1 hour prior to future transfusions and
saline washed cellular components be used.
AA Case 15
This elderly patient was admitted for an elective procedure with coagulopathy secondary to
liver cirrhosis. The patient had a previous uneventful transfusion history. 11/2 hours into
transfusion of the 3rd unit of FFP the patient became dyspnoeic and developed urticaria
and hypertension. Following immediate review the patient was successfully treated with
Piriton, Hydrocortisone and salbutamol nebuliser. IgA levels were normal and the patient
recovered with no ill effects.
AA Case 16
This patient, with a malignant haematological disorder, required platelet transfusion
for thrombocytopenia with active bleeding. Following 200 mls of pooled platelet
concentrate symptoms of dyspnoea, anxiety, fever, hypertension and falling oxygen
saturation developed. Transfusion was discontinued completely. Piriton and Hydrocortisone
given intravenously, with nasal oxygen and paracetamol also given. Pack was not cultured.
Patient was cultured with no growth. IgA levels not done. Patient recovered with no ill
effects.
AA Case 19
This patient with malignant disease, required platelet transfusion for thrombocytopaemia
post-chemotherapy. Following transfusion of approximately 140 mls of pooled platelet
concentrate, symptoms of rash and hypotension developed. Patient also became verbally
unresponsive for 40 seconds. Transfusion was discontinued completely. Hydrocortisone and
Piriton were given intravenously. Patient and pack cultured – no growth. IgA levels were
normal. Patient recovered with no ill effects.
AA Case 22
This patient required transfusion of 6 units of FFP prior to emergency surgery for repair of
an abdominal aortic aneurysm with an associated coagulopathy. Previous transfusions had
been administered uneventfully. Within 1 hour of completion of the transfusion, the patient
developed dyspnoea, urticaria, shivering, bronchospasm, backpain and headache.
Hydrocortisone and Piriton were administered intravenously with effect. This patient went
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to theatre immediately following the reaction and suffered repeat bronchospasm there. IgAlevels were not measured. After a period in ICU for an underlying condition, this patientrecovered with no ill effects. Acute Haemolytic and Other Severe
Acute Transfusion Reaction
Definition: Acute Transfusion Reactions are defined as those occurring
within twenty four hours of transfusion. The major concern in evaluating
these reactions is to exclude bacterial contamination of the unit
or haemolysis due to incompatible red cells11.
For the purpose of this report Acute Haemolytic Transfusion
Reactions occurring due to incorrect blood transfused are captured
in the ‘Incorrect Blood Component Transfused’ chapter.
Anaphylaxis/Anaphylactoid transfusion reactions are also reported
within a separate chapter.
This category accounted for 17% of incidents reported (i.e. 14 of 85).
In most cases the cause of these reactions was not fully clarified, but it is likely thatimmune reactions between the recipient and donor white cells and/or plasma proteins was responsible. Although all red cell and platelet concentrates are leucodepletedprestorage by the Irish Blood Transfusion Service (IBTS) since November 1999, theoccurrence of the described reactions suggest that prestorage leucodepletion may reduce,but not abolish, severe non-haemolytic acute transfusion reactions.
FINDINGS AND RECOMMENDATIONS
◆ None of the cases reported showed evidence of haemolysis due to red cell
incompatibility or evidence of bacterial contamination. The reactions described in thiscategory are likely to represent cases of severe non haemolytic transfusion reactions.
◆ Symptoms of chest pain, back pain and in one case, pain along the vein into which the transfusion was being infused, often described in association with haemolysis, werefound in four patients.
◆ In three cases, dyspnoea and fever were features, raising the possibility of Transfusion Related Acute Lung Injury (TRALI) as a diagnosis. TRALI also shares some of thefeatures of febrile non-haemolytic transfusion reactions such as fever and dyspnoea,and can be difficult to distinguish. However, the fact that clinical symptoms resolvedrapidly on Paracetamol therapy alone in two cases and the absence of X-ray changes -characteristic of TRALI - in the third, made diagnosis of TRALI unlikely.
Other causes of respiratory distress and fever must be evaluated and donor and/orrecipient serum investigated for the presence of Human Lymphocyte Antigen (HLA) orgranulocyte-specific antibodies in order to outrule TRALI. These cases highlight theneed to further investigate atypical transfusion reactions. ◆ In some cases clinical features can be related to the patient’s underlying condition, making it difficult to determine the cause of symptoms and signs which may/or may notbe transfusion related.
◆ It is of interest that two reactions occurred in association with antibodies, which are not considered to be of clinical significance – anti-Bg and anti-c detected by enzymeonly.
❖ A third occurred in a patient without detectable antibodies who developed anti-K National Haemovigilance Office
◆ One reaction occurred in a patient, in whom an indication for transfusion did not exist, The symptoms suffered during any transfusion reaction reinforce the need to treat
appropriately and only transfuse where an alternative therapy does not exist.
◆ It is recommended that where a severe transfusion reaction occurs, the transfusion should be discontinued and not recommenced until a full documentation/serologicalinvestigation and medical review has been undertaken.
◆ In a number of cases, full serological/bacterial culture of patient and packs was not undertaken. It is particularly important to fully investigate severe acute symptomsoccurring during the transfusion in an effort to identify the cause of the symptoms. Aprotocol for blood pack culture is available by writing to the Quality Assurance /QualityControl Department of the IBTS. Annual Report 2000
ransfused
reatment
& Outcome
ransfusion Reactions (AHOSTR)
Investigations
Symptoms
Table 6 Acute Haemolytic and other Severe Acute T
ransfused
Component
National Haemovigilance Office
ransfused
reatment
& Outcome
Investigations
Symptoms
ransfused
Component
Annual Report 2000
ransfused
reatment
& Outcome
Investigations
Symptoms
ransfused
Component
National Haemovigilance Office
ransfused
reatment
& Outcome
Investigations
Table 7 AHOSTR Cases
was a causative factor in symptom development. Symptoms
In the following cases it was difficult to confirm whether the transfusion ransfused
Component
Annual Report 2000
Nine cases of Acute Haemolytic or Other Severe Acute Transfusion Reaction displaying
features of special interest are described in more detail.
AHOSTR Case 2
Following 100 mls of transfusion of RCC, the patient developed fever, dyspnoea and the
transfusion was discontinued. The patient responded to Paracetomol and recovered with no
ill effects. However, as the patient had asymptomatic iron deficiency anemia, this
transfusion did not meet clinical criteria for transfusion.
AHOSTR Case 8
This patient required ongoing transfusion support for anemia secondary to a bone marrow
failure syndrome. During the first unit of RCC, after approximately 2 hours, the patient
developed fever, rigors and backpain. Following review the transfusion was discontinued
temporarily. Piriton and Hydrocortisone were given intravenously. and Paracetomol orally.
The patient recovered with no ill effects and the transfusion was recommenced and
completed uneventfully. Subsequently, serological studies confirmed no incompatibility.
In the following four cases the patient either had antibodies which are not considered to be
of clinical significance or developed clinically significant antibodies subsequent to the
transfusion.
AHOSTR Case 3
This patient had a previous transfusion history and required a transfusion postoperatively.
Following less than 100 mls of RCC symptoms of fever, chills, hypotension, tachycardia,
nausea and vomiting developed. The transfusion was discontinued and Paracetemol given.
The patient recovered with no ill effects. Anti-Bg antibodies were detected in this patient prior
to transfusion. Anti-Bg antibodies which are directed against certain leucocyte antigens and
expressed to a variable degree on red cells are considered not to be of clinical significance
and are not routinely screened for in pre-transfusion testing although they may give rise to
problems in identification in the cross-match. The reaction in this patient may have been
associated with the presence of Bg antibodies or the patient may have developed additional
HLA antibodies as a result of previous transfusions that may account for this reaction.
AHOSTR Case 9
This patient was being transfused with RCC for a haemoglobin of 7.8 g/dl following surgery.
Following 50-90 mls of the transfusion, the patient developed dyspnoea, vomiting and
rigors. The transfusion was discontinued and the patient required 60% oxygen for 24 hours.
Pre-transfusion the antibody screen was negative and DAT positive. Retrospective testing of
the pre-transfusion sample and a repeat post-transfusion sample showed anti-c by enzyme
testing only. There were no new changes on chest x-ray. IgA levels were normal and HLA
antibodies negative.
AHOSTR Case 10
This elderly patient, with a history of falls and angina exacerbated by anaemia was
transfused. During the transfusion, the patient became pyrexial, the transfusion was
discontinued and Paracetomol was given. When the temperature returned to the baseline,
the transfusion was recommenced but the temperature increased again, and the transfusion
was discontinued completely. Investigations post transfusion showed the antibody screen as
negative. Four months later, the patient was regrouped and crossmatched and the antibody
screen showed anti-Kell. On this admission the patient was transfused with Kell negative
blood without symptoms.
AHOSTR Case 11
This patient required the discontinuation of a unit of RCC following the transfusion of
50mls., having received 2 units uneventfully. During the third unit symptoms of
restlessness, gastrointestinal cramps and flushing with associated lightheadedness
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developed. Symptoms resolved without medication. The reaction was not reported to theTSO and hence was not investigated. Twelve days later the patient was having a repeatcrossmatch pre-operatively, at this time anti-Bg antibodies were identified. The reaction inthis patient may have been associated with the presence of Bg antibodies or other HLAantibodies as a result of previous transfusions.
The following cases are more probably attributable to the patients’ underlying medical
condition, thus highlighting the difficulties in determining whether the symptoms were
associated with the transfusion.
AHOSTR Case 12
A patient with a malignant haematological disorder required one unit of pooled platelets.
Fifteen minutes after commencement, the patient developed rigors, tachycardia and
hypertension. Following medical review the transfusion was discontinued. The pack
cultured negative. The patient’s medical condition deteriorated and he died from his
underlying disease.
AHOSTR Case 13
A patient required 3 units of RCC for haemoglobin of 6.8 g/dl associated with haemorrhage.
After 50 mls of the third unit, symptoms of dyspnoea, fever of 38°C, hypertension, chills,
rigor, tachycardia and Premature Ventricular Contractions (PVC) developed. Transfusion was
discontinued immediately and the patient was reviewed with no medication prescribed.
ABO and Rhesus D incompatibility was ruled out and the unit cultured negative.
This patient had a similar episode the following night when no blood transfusion was beingadministered, both episodes occurring approximately 20 minutes following repositioning ofpatient. Subsequently the patient’s blood cultures grew gram-positive organisms. It is likelythat the reaction was not related to the blood transfusion but associated with sepsis andpossibly with concomitant severe anxiety.
AHOSTR Case 14
This patient required a transfusion of RCC for anemia secondary to haemorrhage and
developed chills, backpain, pain around intravenous site, fever and hypotension during the
first unit. The patient was re-grouped and crossmatched and went on to react against a
further 2 units which were abandoned. The patient was restless and monitored in HDU
during transfusion and had episodes of extreme anxiety. Blood cultures were negative. On
pre and post transfusion serology no antibodies were detected. IgA levels were normal.
Following further review and specialist consultation an additional 4 units were administered
without further adverse reactions.
TRANSFUSION ASSOCIATED
CIRCULATORY OVERLOAD
Definition: Large volume/rapid transfusion of blood and blood components can
lead to circulatory overload. This is particularly the case in the elderly, the very
small or the patient with cardiac compromise in the non-bleeding situation,
where rapid transfusion of blood or blood components can quickly lead to
circulatory overload with congestive cardiac failure5.
This category accounted for 9.5% of incidents reported (i.e. 8 of 85)
FINDINGS AND RECOMMENDATIONS
◆ Reports received indicate that transfusion associated circulatory overload is associated
with considerable morbidity. In one reported case with underlying cardiac disease, itmay have contributed to mortality. In response to these reports, particularly associatedwith the administration of Fresh Frozen Plasma (FFP), the National HaemovigilanceOffice (NHO) issued an information leaflet on the use of FFP (see Appendix 1). Thisincluded: ❖ Firm indications for the use of FFP❖ Suggested infusion times ❖ Management of anticoagulation in the preoperative period❖ Conditional uses of FFP ◆ The risk of volume overload and ensuing respiratory distress is increased with the very small, elderly, cardiac or respiratory compromised patient.
◆ Careful attention should be paid to the patient’s fluid balance prior to transfusion of any blood component. In those patients considered to be at greater risk of developingcirculatory overload, the transfusion should be administered slowly and the patient mustbe closely monitored for early signs and symptoms5. In addition, the use of diuretictherapy should be considered as a prophylactic measure in those patients considered tobe at risk. National Haemovigilance Office
Pre-existing Problems
ACO)
Symptoms & Outcome
diuretics, Betaloc and nasal oxygen.
* included as a full case history review ransfusion Associated Circulatory Overload (T
ransfusion
Table 8 T
ransfused
Age/Gender
of Patient
Annual Report 2000
Pre-existing Problems
Symptoms & Outcome
ransfusion
ransfused
Age/Gender
of Patient
National Haemovigilance Office
Three cases Of Transfusion Associated Circulatory Overload displaying points or features of
special interest are described in more detail.
Case No. 4
A 63-year-old patient, with an INR of 8.8 and evidence of bruising due to over-
anticoagulation, required a transfusion of FFP. The patient had underlying ischaemic heart
disease, with left ventricular failure and chronic obstructive pulmonary disease. Four units
of FFP were prescribed. The rate of administration was not prescribed. The first two units
were transfused over 30-40 minutes and following completion of the second unit, the
patient developed symptoms of dyspnoea, tachycardia, falling oxygen saturation and
increasing pCO2 levels. The transfusion was discontinued and the patient received
intravenous Frusemide, Hydrocortisone and Piriton. This patient subsequently died as a
result of underlying medical condition, however circulatory overload may have contributed
to mortality.
Case No. 5
This 75-year-old patient with severe haematemesis was transfused with 2 units of RCC.
There was an underlying history of myocardial infarction and mitral stenosis with left
ventricular failure. This patient was on routine diuretic therapy at home, which was
discontinued on admission due to hypovolaemia. The first unit was transfused uneventfully
over 4 hours. During the second unit (1
dyspnoea, hypertension, tachycardia and falling oxygen saturation developed. There werewidespread crepitations on chest auscultation. The transfusion was discontinued andintravenous Frusemide and Cyclimorph and nasal oxygen were given with good response.
The patient made a full recovery.
Case No. 6
A 59-year-old patient with atrial fibrillation/flutter following Coronary Artery Bypass Graft
presented for cardioversion with an INR of 10 due to over-anticoagulation. The patient was
on routine oral diuretic prior to transfusion. Three units of FFP were prescribed. The rate of
administration was not prescribed but the first two units were administered over 1 hour.
Patient observations were not recorded. Towards the end of the second unit the patient
developed symptoms of hypertension, dyspnoea, tachycardia, rigors and vomiting. He
became cold and sweaty, pO2 fell and pCO2 began to rise. He became cyanosed and there
was a falling urinary output. A wheeze was audible on auscultation and frothy sputum was
produced. A diagnosis of pulmonary oedema was made which responded to intravenous
diuretics, Hydrocortisone, Piriton, Aminophylline and Maxolon. The patient was ventilated
for 24 hours and recovered with no ill effects.
Suspected Transfusion Transmitted Infection
This category accounted for 8% of incidents reported (i.e. 7 of 85).
To date none of these incidents have been confirmed, see Table 8 for details.
The National Haemovigilance Office (NHO) collects reports of all transfusion-transmitted bacterial and parasitic infections, and suspected transfusion-transmitted viral infections.
There were no incidents of bacterial or parasitic transfusion-transmitted infections reportedduring this reporting year. The onset of symptoms related to a transfusion-transmitted viral infection may occurseveral weeks to years after the date of transfusion. Therefore, reports received within thiscategory are not necessarily the result of components transfused during this reportingperiod. Infections presenting weeks, months or years after a transfusion are termed post-transfusion infections (PTI). These may indeed be due to the transfusion of an infected orcontaminated unit, but equally, infection may have been acquired from another source.
Investigation of markers of infection in an implicated donation, or in subsequent samplesfrom the donors of implicated donations, can confirm transfusion as the probable cause ofinfection, or identify the need to investigate other possible sources12. Such investigationsmay involve microbiological testing of many donors and may take several months tocomplete. A post transfusion infection is confirmed as transfusion-transmitted onceinvestigations are complete and the following criteria are fulfilled: ◆ the recipient had evidence of infection following the transfusion, with no evidence of ◆ at least one component received by the infected recipient was donated by a donor who had evidence of the same transmissible infection ◆ at least one component received by the infected recipient was shown to have been contaminated with the same infectious agent12.
Much concern has been voiced in recent years regarding the risk of transfusion-transmittedinfection, and much quality assurance effort has been directed toward appropriate testingand handling of blood after collection13. There is very good evidence that with continuousimprovements in the donor selection, testing procedures and manufacturing processes usedin Ireland the risk of transfusion-transmitted infection is very small. The current estimatedrisk for Human Immunodeficiency Virus (HIV) is less than 1 per 3.3 million componentstransfused and for Hepatitis B Virus (HBV) it is approximately 1 per 100,000 componentstransfused14. Up to November 1999 the estimated risk for Hepatitis C (HCV) was less than 1 per500,000 components transfused14, however, with the introduction of Nucleic AcidAmplification Testing for HCV since then, it is estimated that the risk of transfusion-transmitted HCV has been reduced to 1 per two million components transfused. The risk of receiving an incorrect blood component is in fact greater than the risk ofreceiving a transfusion transmitted infection. Over the 4 year period since the UnitedKingdom Serious Hazards of Transfusion (SHOT) began reporting, confirmed reports ofTransfusion Transmitted Infection accounted for 2.5% of incidents in comparison to theIncorrect Blood Component Transfused which accounted for almost 60%10,12,15 & 16. National Haemovigilance Office
This report reflects similar findings in this country with a greater incidence of reportedIncorrect Blood Component Transfused (37%) compared with reports of suspectedTransfusion Transmitted Infection (8%). A total of nine incidents were reported to the NHO during this reporting period, of whichtwo did not progress as subsequent investigation showed no evidence of infection in therecipient. Of the remaining seven incidents, three were HCV, two were HBV and one wasHIV. The remaining incident was a co-infection with HCV/HBV.
◆ In four of the seven cases, (two HCV, one HBV and one HIV) transfusion has been definitively excluded as the cause of the infection.
◆ In one case of Hepatitis B infection could not be definitively excluded as one donor could not be traced. However, there were other risk factors in the recipient.
◆ In the case of co-infection with both Hepatitis B and Hepatitis C, the patient, who has required multiple transfusions, had also received transfusions and initial hospitaltreatment outside this country. This is considered to be the likely source of theinfection, but investigations into the Irish Blood Transfusion Service (IBTS) donors areon-going. To date the transfusions have been excluded as the source of Hepatitis C,further tests are awaited on donor blood to exclude HBV.
◆ In the remaining case, a case of Hepatitis C infection reported as relating to a transfusion in 1993, investigations are ongoing at time of reporting.
Annual Report 2000
ransfusion excluded as cause of infection.
ransfusion excluded as cause of infection.
ransfusion excluded as cause of infection.
infection. Recipient has other existing risk factors.
Investigations ongoing. Previously treated outside this country with blood components/products.
Three donors excluded. Investigations ongoing. ransmitted Infection (TTI)
of donors
ransfusion T
Table 9 Suspected T
ransfusion
Delayed Haemolytic Transfusion Reaction
Definition: Delayed haemolytic transfusion reactions are defined,
for the purpose of this report, as those occurring more than 24 hours
following the transfusion of a blood component. A haemolytic transfusion
reaction occurs when antigen-positive red blood cells are transfused to a
patient who develops an alloantibody to that antigen. It results in the
lysis or accelerated clearance of red blood cells due to immunologic
incompatibility between the blood donor and the recipient17.
This category accounted for 2% of incidents reported (i.e. 2 of 85)
FINDINGS AND RECOMMENDATIONS
◆ The need to conserve supplies of Rhesus D negative blood for pre-menopausal females
and difficulties with provision of adequate amounts of Rhesus D negative blood arelikely to lead to an increase in the development of anti-D antibodies and the possibilityof increased incidents of delayed haemolytic transfusion reactions in the future.
◆ Because of the need to conserve supplies of Rhesus D negative blood hospitals should have policies to cover switching patients from Rhesus D negative to Rhesus D positiveblood when stocks are low or when massive bleeding is anticipated.
◆ Careful history taking in relation to transfusion and pregnancies by the requesting physician is important. However, up to 12% of patients do not realise that they havehad a transfusion6, therefore access to and checking of previous transfusion records areessential.
◆ As antibodies can develop rapidly, patients being repeatedly transfused, depending on the interval between transfusions should have a fresh sample submitted within 24-72hrs of a planned transfusion in accordance with British Committee for Standards inHaematology (BCSH) Guidelines7.
National Haemovigilance Office
reatment
T
Signs/Symptoms
Interval
transfusion
& onset of
symptoms
Pre-existing
condition
ransfusion Reactions (DHTR)
Clinical
Age &
Table 10 Delayed Haemolytic T
ABO &
component
transfused
ABO &
Rhesus Rhesus Gender
Component
Annual Report 2000
The following are details of the Delayed Haemolytic Transfusion Reaction cases reported to
the National Haemovigilance Office
DHTR Case 1
This elderly female patient with an underlying malignancy was Rhesus D negative with anti-
C + D antibodies. She required an unexpected massive transfusion intraoperatively needing
a total of 22 units of Rhesus D negative RCC. Further massive haemorrhage occurred, and
following discussion with the Consultant Haematologist, as the antibodies were no longer
detectable, it was decided to switch to Rhesus D positive blood to avoid further depleting
the Rhesus D negative supply. The patient was then transfused with Rhesus D positive RCC
as a life saving measure and bleeding subsequently was controlled. Six days later a rising
bilirubin and raised LDH developed but there was no associated fall in haemoglobin or
evidence of renal dysfunction. The patient subsequently died from her underlying
condition.
DHTR Case 2
This elderly male Rhesus D negative patient had received 11 units of Rhesus D negative
blood three months previously. On this occasion, the patient presented with haemorrhage
and a haemoglobin of 5.1g/dl. requiring repeat transfusion. The pre-transfusion antibody
screen was negative. To conserve Rhesus D negative blood, it was necessary to transfuse 8
units of Rhesus D positive RCC. Twenty-four days later the patient developed jaundice with
a falling haemoglobin, rising bilirubin, rising LDH, haemoglobinuria and evidence of
deteriorating renal function. There was no evidence of DIC. The DAT was positive and
antibody screen at this time showed anti-C+D+E antibodies. The patient recovered with no
ill effects and subsequently had an uneventful transfusion of Rhesus D negative blood.
Unusual Transfusion Reactions
Definition: These transfusion reactions include those that did not fit
criteria for any other category, but which were serious and of
significance to the Haemovigilance programme.
This category accounted for 1% of incidents reported, (i.e. 1 of 85).
The patient reported the unusual symptom of joint pain associated with a febriletransfusion reaction. Unusual Case 1
This patient was transfusion dependent, and on this occasion the transfusion of two units of
Red Cell Concentrate (RCC) was completed uneventfully in a day ward setting. Later that
evening at home, the patient developed dyspnoea, fever and joint pain. The patient
contacted the hospital and returned for review the following day. The pack had been
discarded following the patient’s discharge and was unavailable for laboratory
investigations. The patient recovered with no ill effects.
References
British Committee for Standards in Haematology (BCSH) Blood Transfusion Task
Force. Guidelines on product liability for the hospital blood bank. Clinical Laboratory
Haematology, 1990, 12, 329-344.
British Committee for Standards in Haematology (BCSH) Blood Transfusion Task
Force. The administration of blood and blood components and the management of
transfused patients. Transfusion Medicine 1999, 9, 227-238.
Jenner P.W & Holland P.V. Diagnosis and Management of Transfusion Reactions. In:Petz L.D, Swisher S.N, Kleinman S, Spence R.K & Strauss R.G. eds. Clinical Practiceof Transfusion Medicine 3rd edition, New York: Churchill Livingstone, 1996.
Vamvakas E.C & Pineda A.A. Allergic and Anaphylactic Reactions. In: Popovsky M.A.
ed. Transfusion Reactions Bethesda, MD: AABB Press, 1996.
Popovsky M.A. Circulatory Overload In: Popovsky M.A. ed. Transfusion ReactionsBethesda, MD: AABB Press, 1996.
Busch M.P. Let’s look at human immunodeficiency virus look-back before leaping into
hepatitis C virus look-back. Transfusion, 1991, 31, (7), 655-659.
British Committee for Standards in Haematology (BCSH) Blood Transfusion Task
Force. Guidelines for pre-transfusion compatibility procedures in blood transfusion
laboratories. Transfusion Medicine, 1996, 6, 273-283.
Kaplan H.S & Battles J.B. Managing Error for System Improvement. In: Linden J.V & Bianco C. eds. Blood Safety and Surveillance New York: Marcel Dekker, Inc.,2001.
Kohn LT, Corrigan JM. & Donaldson MS. eds. To Err is Human: Building a SaferHealth System. Washington, D.C: National Academy Press, 2000.
Williamson L.M, Lowe S, Love E, Cohen H, Soldan K, McClelland D.B.L, Skacel P. &Barbara J.A.J. Serious Hazards of Transfusions (SHOT) Annual Report 1998-1999,Manchester: SHOT Office, Manchester Blood Centre, 2000.
11. Heddle N.M. & Kelton J.G. Febrile Nonhaemolytic Transfusion Reactions In: Popovsky M.A. ed. Transfusion Reactions Bethesda, MD: AABB Press, 1996.
12. Williamson L.M, Lowe S, Love E, Cohen H, Soldan K, McClelland D.B.L, Skacel P & Barbara J.A.J. Serious Hazards of Transfusion (SHOT) Annual Report 1996-1997Manchester: SHOT Office, Manchester Blood Centre, 1998.
13. Linden J.V, Paul B. & Dressler K.P. A report of 104 transfusion errors in New York State Transfusion, 1992, 32, (7), 601-606.
Handbook of Transfusion Medicine Republic of Ireland Edition, London, The Stationery Office, 1999.
15. Williamson L.M, Lowe S, Love E, Cohen H, Soldan K, McClelland D.B.L, Skacel P & Barbara J.A.J. Serious Hazards of Transfusion (SHOT) Annual Report 1997-1998,Manchester: SHOT Office, Manchester Blood Centre, 1999.
National Haemovigilance Office
16. Williamson L.M, Lowe S, Love E, Cohen H, Soldan K, McClelland D.B.L, Skacel P & Barbara J.A.J. Serious Hazards of Transfusion (SHOT) Annual Report 1999-2000,Manchester: SHOT Office, Manchester Blood Centre, 2001.
17. Davenport R.D. Haemolytic Transfusion Reactions In: Popovsky M.A. ed. Transfusion Reactions Bethesda, MD: AABB Press, 1996.
NATIONAL HAEMOVIGILANCE OFFICE (NHO)
Contacts:
e-mail [email protected]: (01) 432 2891 Information on the National Haemovigilance Office may be accessed through the IrishBlood Transfusion Service Web site @ www.ibts.ie NATIONAL HAEMOVIGILANCE OFFICE (NHO)
National Blood Centre
James’s Street
Tel: (01) 432 2800
Fax: (01) 432 2930
Appendix 1
National Haemovigilance Office
As we have recently had some reports of serious adverse events associated
with the transfusion of Fresh Frozen Plasma (FFP), here is some
updated information for your notice board.
Points to note
◆ Risk of volume overload leading to respiratory distress with severe morbidity/mortality
especially using rapid infusion rates with very small and/or elderly recipients ◆ Occasional severe Anaphylactoid reactions especially with rapid infusion rates.
◆ Dosage of FFP generally depends upon the clinical situation and underlying disorder but 12-15 mls/Kg is a generally accepted starting dose. It is important to monitor theresponse both clinically and with measurement of prothrombin time (PT), partialthromboplastin time (PTT) or specific factor assays. 1 ◆ The recent British guidelines recommend infusion of a unit of plasma to an ◆ Coagulation factor replacement in the massively haemorrhaging patient may require ◆ In the elderly, the very small or the patient with cardiac compromise in the non-bleeding situation, transfusion rates for plasma should not exceed 2-4 mls/kg per hour. 3*If a slower transfusion rate is needed, the plasma can be thawed in divided doses asonce thawed a unit of plasma should be transfused within 4 hours. TABLE 1 SUGGESTED TIMES FOR INFUSION IN THE NON-BLEEDING PATIENT:
Rate of Transfusion
Duration of Transfusion
Required
Firm indications for giving FFP include4
◆ Replacement of clotting factors where there is evidence of critical deficiency and where there is no specific factor concentrate available.
◆ To correct depletion of coagulation factors in bleeding associated with thrombolytic ◆ For reversal of the effects of oral anticoagulation associated with serious bleeding if prothrombin complex and factor VII concentrates are not available. ◆ Used in Thrombotic Thrombocytopenic Purpura (TTP) as the treatment of choice in National Haemovigilance Office
Fresh Frozen Plasma is not routinely necessary in the management of over anticoagulationwith Warfarin, but only in selected cases as set out in Table 2. Table 2 Recommendations for management of bleeding and excessive anticoagulation5
2. Restart warfarin when INR < 5.03. If other risk factors for bleeding, 1. Stop warfarin2. Give prothrombin complex concentrate *Age > 70, patients with previous history of bleeding, patients with epistaxis.

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