Guidelines For The Administration of Blood and Blood Components

Guidelines for the
Administration
of Blood and
Blood Components
Issued by the National Blood Users Group
Page
Members of the National Blood Users Group 3
Abbreviations 4
Position statement 5
Introduction 7
1. Patient information 8, 18-20
2. Prescription 8
3. Positive patient identification 8
3.1 In-patients 8
3.2 Day patients/Out patients 8
3.3 Patients unable to identify themselves 8
4. Pre-transfusion sampling 8-9
5. The request for blood 9
5.1 The request form 9
5.2 The sample tube 9
5.3 Inadequately/incorrectly labelled samples 10
5.4 Emergency requests 10
5.5 Major emergency plan 10
5.6 Telephone requests 10
6. Pre-transfusion testing 10
6.1 Patients with special requirements 10
7. Issuing of blood 11
8. Storage of blood components 11-12
9. Collection of blood or components from the hospital transfusion laboratory 12
10. Pre-transfusion identification 12
10.1 Inspection of unit prior to administration 13
11. Administration of blood components 13
11.1 Optimal timing of transfusion 13
11.2 Infusion rates 13
12. Blood administration sets/equipment 13
12.1 Administration sets 13
12.2 Blood warmers 14
12.3 Handling and disposal of blood packs 14
13. Monitoring 14
13.1 In-patients 14
13.2 Unconscious patients 14
13.3 Day patients 14
14. Adverse events 14-15
14.1 Acute transfusion reactions 15, 21-26
14.2 Management and reporting of adverse events/errors 15, 21-26
14.3 Near miss incidents 15
15. Documentation and traceability 15-16
15.1 General points 15
15.2 Traceability of blood components 16
16. Developments in information technology 16
Guidelines for the Administration of Blood and Blood Components
1
17. The Transfusion Committee 16
18. Education and training programme 17
19. Hospital-based haemovigilance 17
20. The National Haemovigilance Office 17
Acknowledgement
Appendix 1 Blood Transfusion Information for Patients 18
Appendix 2 Post Transfusion Information leaflet for Day Patients 20
Appendix 3 Management of an Acute Transfusion Reaction 21
Appendix 4 Complications of Transfusion* 22-26
References 27
2
MEMBERS OF THE NATIONAL BLOOD USERS GROUP
Chairman: Professor John Bonnar, Emeritus Professor of Obstetrics and Gynaecology, Trinity College, Dublin.
Dr Paul Browne, Consultant Haematologist, St. Jamess Hospital, Dublin 8.
Dr Mary Cahill, Consultant Haematologist, Mid-Western Regional Hospital, Limerick.
Dr William Casey, Consultant Anaesthetist, Our Ladys Hospital for Sick Children, Crumlin, Dublin 12.
Ms Mary Edger, Haemovigilance Nursing Officer, Mater Misercordiae Hospital, Dublin 7.
Dr Freda Gorman, Consultant Neonatologist, National Maternity Hospital, Holles Street and Our Ladys Hospital for Sick
Children, Crumlin, Dublin 12.
Ms Deirdre Gough, Transfusion Surveillance Sister, St. Jamess Hospital, Dublin 8.
Mr Paul Keartland, Chief Perfusionist, Mater Misercordiae Hospital, Dublin 7.
Dr Barry Lyons, Consultant Anaesthetist, Mater Misercordiae Hospital, Dublin 7 and Cappagh Orthopaedic Hospital,
Dublin 11.
Dr Maire McCarroll, Consultant Anaesthetist, Mater Misercordiae Hospital, Dublin 7 and Cappagh Orthopaedic Hospital,
Dublin 11.
Ms Eilis McGovern, Consultant Cardiothoracic Surgeon, St. Jamess Hospital, Dublin 8.
Dr Corina McMahon, Consultant Haematologist, Temple Street Childrens Hospital, Dublin 1.
Dr William Murphy, National Medical Director, Irish Blood Transfusion Service, Jamess St., Dublin 8.
Dr Margaret Murray, Consultant Haematologist, University College Hospital, Galway.
Mr Paul OBrien, Chief Medical Scientist, St. Vincents Hospital, Elm Park, Dublin 4.
Dr Brian OCallaghan, Consultant Physician, Letterkenny General Hospital, Co. Donegal.
Mr Kevin OMalley, Consultant Surgeon, General and Vascular, Mater Misercordiae Hospital, Dublin 7.
Dr Joan ORiordan, Consultant Haematologist, Irish Blood Transfusion Service, Jamess St, Dublin 8 and St. Jamess
Hospital, Dublin 8.
Ms Hazel Reid, Senior Medical Scientist, Tralee General Hospital, Co. Kerry.
Dr Owen Smith, Consultant Haematologist, St. Jamess Hospital, Dublin 8 and Our Ladys Hospital for Sick Children,
Crumlin, Dublin 12.
Dr Barry White, Director, National Centre for Hereditary Coagulation Disorders (NCHCD), Dublin 8.
NATIONAL HAEMOVIGILANCE OFFICE STAFF
Dr Emer Lawlor, Director of National Haemovigilance Office, Irish Blood Transfusion Service, Dublin 8.
Ms Phil Keane-Egan, Transfusion Surveillance Officer, National Haemovigilance Office.
Ms Derval Lundy, Transfusion Surveillance Officer - Near Miss Project, National Haemovigilance Office.
Ms Siobhan OConnor, Transfusion Surveillance Officer, National Haemovigilance Office.
Ms. Cathy Scuffil, Administrator, National Haemovigilance Office.
ACKNOWLEDGEMENT
The National Blood Users Group acknowledges the efforts of Angie Corr and Maria Flanagan in preparing this
publication.
3
ABBREVIATIONS
AIDS Acquired immune deficiency syndrome
BP Blood pressure
CJD Creutzfeldt Jakob disease
CMV Cytomegalovirus
CVP Central venous pressure
CXR Chest x-ray
DCT Direct Coombs test
DIC Disseminated intravascular coagulation
FBC Full blood count
HBV Hepatitis B virus
HCV Hepatitis C virus
HIV Human immunodeficiency virus
HPA Human platelet antigen
HTLV Human T-cell lymphotropic virus
IBTS Irish Blood Transfusion Service
ID Band Identity band
IgA Immunoglobulin A
IgG Immunoglobulin G
IV Intravenous
IM Intramuscular
JVP Jugular venous pressure
LFT Liver function test
LVF Left ventricular failure
NBUG National Blood Users Group
NCHCD National Centre for Hereditary Coagulation Disorders
NHO National Haemovigilance Office
RBCs Red blood cells
PTP Post transfusion purpura
Rh D Rhesus D
SD plasma Solvent detergent plasma
SOPs Standard Operating Procedures
TACO Transfusion associated circulatory overload
TA-GVHD Transfusion associated graft-versus-host disease
TRALI Transfusion related acute lung injury
TSO Transfusion surveillance officer
vCJD variant Creutzfeldt Jakob disease
4
POSITION STATEMENT
Important steps in the administration of blood components start with the correct identification of the patient and
crossmatch sample and end with the collection and infusion of the right blood to the right patient at the right time. Each
step is important and must be subject to written procedures and quality management. Processes must be in place to
ensure that all steps are adhered to and any divergence from standard procedure is corrected. All staff must be trained
and be familiar with procedures which should be regularly updated. Any breakdown in procedures should be investigated
and corrected even if the recipient of the transfusion is unharmed.
1
Blood Transfusion can be fatal if incorrectly administered
Errors occur most frequently in:
Patient identification.
Sampling/labelling of the pre-transfusion specimen.
Removal of blood from the blood fridge before transfusion.
Checking the identification of both the patient and the blood component at the bedside.
Written policies/protocols must exist
Staff training to implement these policies is critical
Each institution should have or participate in a local transfusion committee
National Blood Users Group
January 2004
5
6
7
INTRODUCTION
The administration of blood and blood components involves more than 70 steps and each of these may be subject to
error.
2
Standard protocols for the administration of blood are essential to minimise the potential for error. These
protocols should be in place in each institution and should conform to standard practice as outlined in these guidelines.
A quality management system should exist in each institution.
3
This should include an active transfusion committee, a
process to correct protocols and practice when deficiencies are identified, participation in local and regional audit and
in the national haemovigilance programme.
The recommendations that follow deal with specific areas and should be adapted to the local institution. Guidelines
cannot cover every situation, however they may reduce the wide variation in transfusion practice.
3
Specific advice can
be obtained from consultant haematologists, transfusion surveillance officers (TSO), transfusion scientists, the National
Haemovigilance Office (NHO) or from the Irish Blood Transfusion Service (IBTS).
1 PATIENT INFORMATION
Except in emergencies, the risks, benefits and alternatives to blood transfusion should be discussed with the patient and
documented in their medical records. The provision of a blood transfusion information leaflet for patients is
recommended
4
and an example of one such leaflet currently in use in Ireland is provided in Appendix 1.
2. PRESCRIPTION
The patients hospital medical records should contain the indication for the blood transfusion and the number of units
required.
5
All blood and blood components for transfusion should be prescribed by a medical practitioner, preferably on
a unit by unit basis.
6
Specialist advice may be needed on the need for cytomegalovirus (CMV) seronegative or gamma
irradiated components. Individuals responsible for the prescription and request of blood components must be familiar
with the special needs of their patients. These special requirements should form part of the prescription and should be
flagged on the clinical and laboratory records.
7-14
Any medication to be given in conjunction with the transfusion must
be prescribed on the drug chart. No other infusions, solutions or drugs should be added to any blood component as
they may result in haemolysis or clotting.
15
3. POSITIVE PATIENT IDENTIFICATION
Hospital policy should address the training of staff in the identification of the patient. This procedure should include
asking the patient to state his/her full name and date of birth e.g. patient should be asked what is your name not are
you Mr/Mrs Murphy? The information given by the patient must be identical to that on the patients identity band (ID
band).
16
ID bands should preferably be printed: hand-written bands can be difficult to read, contain varying information
and may be subject to overwriting. In the event of removal of ID bands e.g. to access the radial artery, it is the
responsibility of the person who removes the ID band to ensure it is reapplied.
4
A standard procedure should exist for
positively identifying the patient and any blood or blood components being transfused during transfer between clinical
areas.
3.1 In-patients
A secure patient identification procedure should be in place in all hospitals and the ID band should be worn at all
times. All patients should be allocated a unique identification number on admission to hospital, which should
remain unchanged for the duration of hospitalisation and should be used in subsequent hospital admissions.
15
This ID band should record the patients full name, date of birth and a unique identification number.
3.2 Day patients/Out patients
Patient ID bands should be positioned before the pre-transfusion sampling procedure and worn until the
transfusion is completed. Where the pre-transfusion sample is taken and the patient is readmitted at a later date
for transfusion, policies should be in place for reapplying the original, or a new ID band, before the transfusion is
commenced.
3.3 Patients unable to identify themselves
This includes patients who are undergoing general anaesthesia, unconscious or confused patients, young children
or patients whose first language is not English. To ensure continuing accurate positive identification, we
recommend that these patients should have two ID bands applied e.g. wrist and ankle bands.
4. PRE-TRANSFUSION SAMPLING
Hospital policy should address the training needs of staff who undertake pre-transfusion sampling and provide detailed
instructions on venepuncture and on the identification of patient and sample.
5
Correct blood sampling techniques are
8
9
vital to avoid haemodiluted samples being processed which may lead to incorrect clinical management/inappropriate
transfusion.
12-14
The pre-transfusion blood sample must be taken by trained individuals e.g. phlebotomists, nurses or
doctors. Instruction on pre-transfusion sampling should form part of induction programmes. A record of this instruction
should be maintained. Personnel responsible for taking samples for blood grouping and cross-matching must strictly
follow hospital procedures at all times to avoid errors in patient sampling and patient identification. The person taking
the sample must sign the sample tube confirming the patients identity.
17
5. THE REQUEST FOR BLOOD
Each request for blood must be documented on a laboratory request form and submitted to the laboratory with the blood
sample for compatibility testing. The hospital transfusion laboratory should have a policy for documenting telephone
requests. The identity of the person making the request and the person receiving it should both be recorded. The
following information should be provided: patients surname, first name, unique identification number, date of birth,
location, the number and type of blood components required (including any special requirements), the reason for the
request and the time and date the blood components are required.
4
5.1 The request form
The request form must contain the following minimum information:
15
Surname and first name.
Unique identification number.
Date of birth.
Gender.
The request form should also contain:
Blood component required.
Number of units required.
Date, time and the location where required.
Indications for request.
Patient diagnosis.
Any special requirements e.g. CMV seronegative, gamma irradiated.
Previous transfusions, obstetric history, red cell antibodies or any adverse reactions.
Name and signature of requesting person.
For the unconscious / unidentified patient, the minimum information necessary on the request form is a unique
identification number and gender of the patient.
5.2 The sample tube
The sample tube must contain the following minimum information:
Surname and first name.
Date of birth.
Signature of person drawing the sample (the signature is required to confirm that they have verified the
patients identity).
Date and time sample was drawn.
Sample tubes should be hand-written and labelled immediately after sampling at the patients side. Electronically
generated bar-coded labels are being developed and are under evaluation. For the present, until the automated systems
are available, identification procedures must be strictly adhered to at the bedside to reduce sample errors. The use of
addressograph labels or the pre-labelling of blood sample tubes is specifically prohibited.
5
5.3 Inadequately/incorrectly labelled samples
Hospital policy addressing inadequately/incorrectly labelled samples, should be agreed by both the Hospital Transfusion
Committee and the Risk Management Department. Hospital transfusion laboratory staff are acting correctly in
refusing to accept a request for compatibility testing when either the request form or the sample is
inadequately labelled.
15
5.4 Emergency requests
Each institution must have a fast tracking procedure for dealing with emergency requests. This should be in keeping with
protocols for dealing with massive haemorrhage and with the hospitals major emergency plan:- See A Guideline for the
Use of Blood and Blood Components in the Management of Massive Haemorrhage.
18
Wherever possible the senior
doctor managing the clinical situation should state the degree of urgency of the transfusion requirement so that the
laboratory can decide what blood should be selected. When several patients require transfusion, one person on the
Accident and Emergency team should be delegated to communicate with the hospital transfusion laboratory. This avoids
confusion with duplicate orders and incorrect information.
5.5 Major emergency plan
Hospitals should have a major emergency plan in place to cover major accidents/incidents, which should include
transfusion provision.
5.6 Telephone requests
Telephone requests should be documented by the laboratory and in the patients medical records by the requesting
doctor.
16
The following minimum information must be given and confirmed:
(i) Surname.
(ii) First name.
(iii) Hospital/accident and emergency number/trauma number.
(iv) Location.
(v) Number/volume and type of component.
(vi) Reason for request.
(vii) Date and time required.
13
6. PRE-TRANSFUSION TESTING
Each hospital transfusion laboratory should follow standard operating procedures (SOPs). All laboratories
crossmatching blood should participate in external quality control. The hospital transfusion laboratory should verify the
patients ABO and Rhesus D (Rh D) group against previous records for the patient; any discrepancies should be
resolved before blood components are issued.
4
Where there is an urgent requirement for transfusion, group O Rh D
negative blood should be issued until the discrepancy is resolved. Hospital transfusion laboratory practices should
comply with the guidelines for blood bank computing.
19
6.1 Patients with special requirements
The transfusion laboratory should have a record of patients special requirements eg CMV seronegative or gamma
irradiation, and these components should be selected. Patients with significant red cell antibodies should be issued with
antigen negative blood. Consideration should be given to issuing antibody cards to all patients with clinically significant
red cell antibodies.
10
When the care of patients with haematological or other disorders requiring transfusion support is
shared, there is a risk that not all pertinent transfusion history will be available to both sites. In the absence of networked
10
pathology information systems, it is essential that local procedures are devised for adequate communication between
laboratories as well as clinical teams.
10
7. ISSUING OF BLOOD
Computer generated self-adhesive compatibility labels are recommended. Efforts to standardise these labels nationally
should continue for consistency between hospitals and to minimise checking errors. The hospital transfusion laboratory
should also provide a blood compatibility report form with the blood component issued.
The compatibility label on each unit should show:
15
Surname and first name of patient.
Date of birth.
Gender.
ABO group and Rh D group of the patient.
ABO group and Rh D group of the unit.
Donation number.
Expiry date of unit.
Time when blood is required.
Location of patient.
The compatibility report form should contain the following information:
Surname and first name of the patient.
Date of birth.
Gender.
ABO group and Rh D group of the patient.
ABO group and Rh D group of the unit.
Donation number.
Expiry date of unit.
If not recorded elsewhere, eg prescription sheet, space for signature of persons checking and administering
the unit.
Time when blood is required.
Location of patient.
The ABO group, Rh D group and unit number must be identical on the Irish Blood Transfusion Service Label, Hospital
Compatibility Report Form and the Compatibility Label on the blood pack. Occasionally the ABO group and Rh D group
issued for a patient may be of a different group
15
, usually due to a shortage of a particular group. In these circumstances,
the hospital transfusion laboratory should inform the patients doctor and include the information on the compatibility
report form.
8. STORAGE OF BLOOD COMPONENTS
Red blood cells and whole blood should only be stored in a designated controlled blood refrigerator.
15
Plasma is stored frozen and thawed in the laboratory immediately before use.
Platelets are stored at room temperature on a controlled agitator to avoid clumping, and should never be
stored in a refrigerator.
The time of removal of all components from the controlled storage should be logged ideally electronically,
or failing that, manually.
11
Once a unit of blood has been removed from controlled storage the transfusion should be commenced
immediately on delivery to the clinical area. If the transfusion cannot be initiated promptly, the blood should
be returned to the hospital transfusion laboratory for storage, unless the transfusion to the intended
recipient can be completed within 4 hours. Blood should be returned to the hospital transfusion laboratory
for documented disposal if out of controlled storage for more than 30 minutes.
16
The transfusion of plasma and platelets should be commenced as soon as possible following issue from the
laboratory and must not be stored outside the laboratory.
The use of validated blood transport containers is recommended.
9. COLLECTION OF BLOOD OR COMPONENTS FROM THE HOSPITAL TRANSFUSION LABORATORY
Written requests for the release and collection of blood components are recommended and should contain the patients
full name, date of birth, unique identification number and location of patient. If a telephone request is given to a porter
or other member of staff to collect blood, the person must be given the above patient identification details so that he/she
can write them down and bring them to the storage area when removing the blood component.
4
The removal of a blood
component from storage must be recorded manually or electronically. This area is identified as a critical area for human
error.
7-11
Hospital policy should dictate who is trained and certified to collect the blood component.
4
The person
requesting the collection of the blood component must ensure the patient has a patent intravenous cannula before the
blood component is removed from storage.
10. PRE-TRANSFUSION IDENTIFICATION
Hospital blood administration policy should include detailed instruction on the procedure for pre-transfusion identification
of both the intended recipient and the blood component to be transfused. This procedure must be performed by two
persons and both must sign the prescription sheet or the compatibility report form.
4
Persons authorised to perform pre-
transfusion identification include: a registered nurse, doctor or perfusionist. Before starting the transfusion, the following
checks are essential at the patients bedside or wherever the patient is to be transfused (See Table 1). The checks
should never be performed remote from the patient or at the nurses station or in a side room.
Table 1.
Bedside Checklist
4,15
Are the patient identification details identical on:
- the patients identity band?
- the compatibility label on the blood component pack?
- the compatibility report form sent with the blood component from the hospital transfusion laboratory?
- the patients medical record?
- the prescription chart?
Do these details match who the patient says he/she is?
- Patients who can communicate must be asked to state their surname, first name and date of birth.
Are the ABO and Rh D group and donation number all identical on:
- the IBTS label on the blood component pack?
- the compatibility label on the blood component pack?
- the compatibility report form sent with the blood component from the hospital transfusion laboratory?
Do the details of the pack, compatibility form and prescription form, match any special
requirements for special types of blood components e.g. CMV seronegative, gamma-irradiated etc?
12
If there are any discrepancies, the unit must not be transfused. The hospital transfusion laboratory should be informed
immediately. Generally it will be necessary to return the unit and compatibility form to the laboratory.
10.1 Inspection of unit prior to administration
Check that the pack is in date and shows no sign of leakage, unusual colour or haemolysis.
Check that the platelet packs do not show clumping or appear unusually cloudy, as this may be a sign of
bacterial contamination.
If a defect is suspected, contact the hospital transfusion laboratory for advice.
If in doubt, do not transfuse.
15
11. ADMINISTRATION OF BLOOD COMPONENTS
11.1 Optimal timing of transfusion
Elective transfusions and transfusion for transfusion-dependent anaemia should normally be carried out
during the day.
11.2 Infusion rates
In the non-haemorrhaging patient, rates depend on the clinical context, age and cardiac status. Except in
the massive transfusion setting, transfusion rates for blood should not exceed 2-4 mls/kg/hr.
20
From starting the infusion (puncturing the blood pack with the infusion set) to completion, infusion of the
pack should take a maximum of 4 hours.
Each unit of solvent detergent (SD) plasma should be transfused to the uncompromised adult over 30-60
minutes. Patients should be examined clinically for evidence of volume overload.
12-13
A single adult dose of apheresis platelets contains an average of 230-300mls and pooled platelets contain
an average of 320-340mls. Each dose of platelets should be transfused over a period of 30-60 minutes.
12. BLOOD ADMINISTRATION SETS/EQUIPMENT
12.1 Administration sets
Cannula size depends on vein size and rate of infusion required.
16
For whole blood, red cells, platelets, plasma and cryoprecipitate, an infusion set containing an integral filter
(170-200 microns)
17
must be used. This is a standard clot screen filter. Bedside white cell filters are no
longer required as all blood components are now leucodepleted pre-storage by the IBTS.
Blood administration sets should normally be changed after a maximum of 6 hours.
17
In the massive
transfusion setting the blood administration set may be changed at the discretion of the nurse or doctor
administering the blood i.e. if they become blocked or have been used to transfuse multiple units.
For efficient use, blood administration sets should be primed with the blood component, fully wetting the
filter.
16
Multiple blood components administered sequentially through the same set should be ABO
compatible. After a red cell component or plasma transfusion, a new blood administration set should be
used to transfuse platelets. Blood component administration sets should not be used for subsequent
infusions post transfusion as the intravenous fluid may be incompatible with blood in the line.
21
Transfusion can take place through one lumen of a multi-lumen central catheter while the other lumen or
lumina are in use.
22
No other infusion solutions or drugs should be added to any blood component as they
may result in haemolysis or clotting.
15
13
12.2 Blood warmers
Routine warming of blood is not indicated. Patients who will benefit from warmed blood include adults and children
receiving massive transfusion,
18
infants requiring exchange transfusion and patients with clinically significant high-titre
cold agglutinins active in vitro at 37C.
15
Blood warmers must be subject to regular servicing and used in accordance
with the manufacturers instructions.
Red blood cells and plasma exposed to temperatures over 40C may cause severe transfusion reactions.
Blood components must NOT be warmed by improvisations such as putting the pack into hot water, in a
microwave, or on a radiator, as uncontrolled heating can damage the contents of the pack.
15
12.3 Handling and disposal of blood packs
Hospital policy should cover the use of gloves, trays, bags, accidental spills/damage and disposal. Unless the patient
has an acute transfusion reaction, used blood packs should be disposed of after the transfusion in an appropriate
designated container i.e. a rigid spill proof bin with yellow lid. If more than 100mls remains in the pack, disposal should
be in a spill proof container in accordance with local hospital policy.
13. MONITORING
13.1 In-patients
Severe reactions are most likely to occur within the first 15 minutes/50mls of each unit and patients should be closely
observed during this period.
16,21,23
Temperature, pulse, respirations and blood pressure should be measured and
recorded before the transfusion commences and when the transfusion of each unit is completed. Temperature and pulse
should be measured 15 minutes after the start of each individual unit.
21
Additional observations are discretionary and the
patient should be monitored as his/her condition warrants, or if there are signs of a transfusion reaction. The patient who
is elderly, or who has compromised cardio-respiratory function requires additional monitoring. Patients with chronic
anaemia are usually normovolaemic or hypervolaemic and may have signs of cardiac failure before any fluid is infused. If
such a patient must be transfused, each unit should be given slowly with a diuretic (e.g. frusemide 20mg) and the patient
closely observed. Restricting transfusion to one unit of red blood cells in each 12 hour period should reduce the risk of
left ventricular failure (LVF).
15
13.2 Unconscious patients
These patients require continuous observation and monitoring. A transfusion reaction should be considered in the event
of any deterioration in the patients condition during or immediately following a transfusion.
15
13.3 Day patients
Day patients discharged from hospital following a blood transfusion should be issued with an information card indicating
the symptoms and signs of transfusion reactions and given advice on when to contact the hospital (See Appendix 2).
14. Adverse events
Patients should be observed closely during the initial 15 mins/50mls of a transfusion.
16,21,23
Any symptoms, which may
indicate a transfusion reaction including distress, pain at or near the transfusion site, loin pain, backache, fever, or
dyspnoea, must be investigated as they could indicate a serious reaction. The transfusion must be stopped and the
cause of the symptoms investigated immediately. Serious or life-threatening acute reactions are very rare. However, new
14
symptoms or signs that arise during a transfusion must be taken seriously, as they may be the first warning of a serious
reaction.
15
It is important to realise that signs and symptoms are not necessarily specific to a given type of
reaction (See Appendix 3). The commonest problem associated with transfusion is a rise in temperature. This can
be a result of the transfusion itself or the underlying illness and can occur at any time during the transfusion. Each patient
should be assessed individually, but in general a temperature rise of 1.5C above normal should result in the cessation
of the transfusion and investigation of a possible transfusion reaction. In the case of simple, urticarial-type reactions with
no other symptoms or signs, the patient can be given antihistamines and the transfusion may be continued at a slower
rate. (See Appendix 3).
14.1 Acute transfusion reactions
Acute transfusion reactions can be associated with significant morbidity and rarely with mortality (See Appendix 4).
Prompt recognition and management is essential. All suspected transfusion reactions should be reported immediately to
the hospital transfusion laboratory. Immediate reporting is particularly important if an incorrect unit of blood has been
transfused in case blood packs have been transposed and another patient is put at risk.
15
Protocols should be in place to detect, investigate, and where possible prevent adverse reactions.
16
Adverse reactions
should be reported to the hospital transfusion laboratory and TSO.
14.2 Management and reporting of adverse events/errors
Failure to adhere to policies and procedures should be dealt with by the local TSO in association with the local Hospital
Transfusion Committee. Serious adverse events/errors should be reported to the NHO. Article 15 of the Directive
2002/98/EC of the European Parliament and of the Council of 27 January 2003, which will come into effect in 2005,
requires mandatory reporting of serious adverse events (accidents and errors) relating to the collection, testing,
processing, storage and distribution of blood and blood components which may have an influence on their quality and
safety, as well as any serious adverse reactions observed during or after transfusion which may be attributed to the quality
and the safety of blood and blood components.
24
14.3 Near miss incidents
Near miss incidents are defined as Any error, which if undetected, could result in the determination of a wrong blood
group, or issue, collection, or administration of an incorrect, inappropriate or unsuitable component but which was
recognised before the transfusion took place.
11
Near miss incidents should be reported to the local TSO. Hospitals
should have a system of recording, evaluating and learning from near miss events as these are more frequent than real
errors, but often have the same root causes.
7-11
Local audit and education should be used to close the loop on near miss
incidents to prevent recurrence.
15. DOCUMENTATION AND TRACEABILITY
15.1 General points
A medical practitioner must record the prescription of blood and blood components. Each hospital must have a system
in place to ensure full traceability through maintaining patient and laboratory transfusion records. These records must be
stored safely and be available for future look-back and audit exercises. Procedures and policies for each part of the
record keeping system must be established and documented. Records may be held in a manual, computerised, or
microfilm format or a combination thereof. Records must be protected from inadvertent or unauthorised destruction or
modification. Procedures for tracing of blood components in any future look-back should be included in hospital
transfusion laboratory SOPs.
16
15
15.2 Traceability of blood components
The Council of Europe defines traceability as the ability to identify the actual recipients, of every component released
and, conversely, the ability to identify all blood donors involved in the transfusion of a given patient. Retrospective analysis
has shown that traceability is not achieved by the simple knowledge of the patient to whom the blood component was
initially distributed. Active return of information from the clinical area to the blood transfusion service after the transfusion
act is necessary to provide complete and reliable information about the fate of a given blood component. Traceability
documents may include information on the existence of immediate adverse reaction.
17
Article 14 of the EC Blood
Directive 2002/98/EC mandates full traceability of all blood components.
24
Data needed for full traceability in
accordance with this article must be retained for at least 30 years.
24
Donation numbers for blood and blood components (whole blood, red cells, platelets, cryoprecipitate and cryo-poor
plasma) and batch numbers for pooled blood products (Octaplas and Uniplas, clotting factor concentrates, albumin, anti-
D, intravenous immunoglobulin), must be specifically recorded on the transfusion record sheet and filed in the patients
medical record and in the hospital transfusion laboratory or pharmacy. Recording practices such as the use of peelable
labels containing batch numbers are encouraged to reduce the possibility of transcription error. Standardisation of
documentation throughout the country is recommended, as is the maximum use of computerised and electronic data.
16. DEVELOPMENTS IN INFORMATION TECHNOLOGY
Computer systems should be used in the transfusion process as they reduce the risk of transfusion error and facilitate
full traceability and audit. These systems are used in hospital transfusion laboratories, but as sampling and administration
have been identified as problem areas in the transfusion chain, extension of the use of such systems to the clinical area
to ensure correct patient identification at sampling and administration is recommended.
7-11
Use of computerised request
forms should be adopted. There is evidence that stimulating awareness of, and compliance with, best practice by
computer generated reminders at the point of care is effective.
25
Computerised request programmes with pre-
established algorithms can guide the clinician to comply with accepted guidelines and ask for additional clinical reasons
when overriding the guidelines. They also provide an effective means of online documentation.
3
Computerisation is known to reduce human error in the many steps involved in the administration of blood. We
recommend that hospital authorities should evaluate the use of computerised systems for the whole transfusion process
from pre-transfusion patient sampling through to the administration of the transfusion of blood to the recipient. This will
be essential for full traceability.
17. THE TRANSFUSION COMMITTEE
The hospital executive or health board has the responsibility to establish the hospital transfusion committee. The
committee should be supported and resourced by hospital management which should also be represented.
3
The
membership of a hospital transfusion committee should be multidisciplinary representing the main users of blood and
should include a consultant haematologist, transfusion scientist and TSO in a hospital or region. The committee should
meet regularly and adopt a preventative/corrective approach to transfusion problems. Adverse events and near misses
should be examined. The committee should review and audit the use of blood and blood components and make
recommendations on appropriate use. The committees recommendations should be conveyed to the hospital executive
in regular reports.
16
18. EDUCATION AND TRAINING PROGRAMME
The TSO, or another identifiable member of staff, should be responsible for ensuring that all staff involved in the
transfusion process receive adequate education and training relevant to their role within that process. This programme
should be documented and subject to regular review.
19. HOSPITAL-BASED HAEMOVIGILANCE
Haemovigilance should be under the direction of the consultant haematologist and is the responsibility of all persons
involved in the transfusion process.
Haemovigilance should include:
Promoting the appropriate use of blood and blood components/products.
Provision and organisation of education and training relevant to staff involved in the transfusion process.
Co-ordination, collection and reporting to the NHO of serious adverse reactions/events relating to blood
transfusion.
The tracing and recall of blood and blood components as requested by the IBTS.
Participation in an active hospital transfusion committee.
Review and audit of all aspects of the transfusion process.
20. THE NATIONAL HAEMOVIGILANCE OFFICE
The NHO receives and follows-up confidential reports from hospitals and medical practitioners of serious adverse
events/reactions to blood components following transfusion. Feedback is provided as appropriate. The reports are
analysed, the findings are then disseminated and published in the form of an Annual Report, which makes
recommendations for future practice.
The NHO recognises the progress that has already been made in the area of administration of blood and blood
components. This programme has been co-ordinated through the efforts of local TSO and their teams.
The National Haemovigilance Office can be contacted at:
Irish Blood Transfusion Service,
National Blood Centre,
James Street,
Dublin 8.
Tel: 01 432 2894/2854
Fax: 01 432 2999
Website: www.ibts.ie (Haemovigilance pages)
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APPENDIX 1 BLOOD TRANSFUSION INFORMATION FOR PATIENTS (PAGE 1)
What is a blood transfusion?
Giving a patient red blood cells, platelets or plasma is a blood transfusion. Blood is stored in a plastic bag and given
through a tube, which is connected to a needle usually inserted in the arm. The transfusion should not be painful but
having a needle in your arm may be slightly uncomfortable. Each unit of blood is generally transfused over two to four
hours.
Why do patients need blood transfusions?
Blood components
1
are used to correct abnormalities in the blood, which cannot be corrected by any other means.
Common reasons for blood transfusions are,
Blood lost because of an accident or surgery,
Anaemia
2
Bleeding or clotting disorders.
If you lose a significant amount of blood during an operation or an accident your doctor will want to replace the blood
loss with a blood transfusion immediately so that you do not suffer the serious effects of your blood loss.
If you have anaemia, your body does not have enough red cells to carry the oxygen you need and you may feel tired or
breathless. Many cases of anaemia may be treated with medication, however not all cases respond and blood transfusion
may be required. Your medical team will best explain details about why you may need blood.
Steps taken to ensure that the blood is safe?
The Irish Blood Transfusion Service have many safeguards on our national blood supply. All the donors are voluntary and
unpaid as such donors are the safest source of blood. Before giving blood, donors must answer detailed questions about
their health and risk factors for diseases to ensure that they are in good health. Every unit is tested for infections which
can be transmitted through blood, i.e. Hepatitis B and Hepatitis C, HIV I and 2 (the cause of AIDS), Syphilis and HTLV I
and II.
Are there risks involved when having a blood transfusion?
The serious risks of having a blood transfusion are rare and must be balanced against the risk to your health of not having
a transfusion. Many hundreds of lives are saved each year by blood transfusions. Investigations and operations can be
performed because blood is available. When a blood transfusion is needed the risk of not receiving blood far outweigh
the risks of a transfusion. The serious risks are reactions to the blood or the transmission of infections. These risks are
minimised by the careful selection of donors, testing and handling of the blood.
Infections and Viruses
A great deal of publicity has been given to the potential risk of getting AIDS or Hepatitis from blood transfusions. All
blood transfused in Ireland is tested for these viruses. When you consider the risks of transfusion, it is important to realise
that the risk of infection from a blood transfusion is very low. Daily activities such as road travel are associated with much
greater risks than the risks of a blood transfusion when you need it. The estimated risks in Ireland for known viruses are:
HIV 1 possibility in 4 million units of blood transfused
Hepatitis C 1 possibility in 4 million units of blood transfused
Hepatitis B 1 possibility in 200,000 units of blood transfused
The careful collection and storage of the blood reduces the risk of bacterial infection, which is rare but can be fatal.
Variant Creutzfeldt Jacob Disease (vCJD), a degenerative neurological disease, was first recognised in 1996 and is
caused by eating BSE contaminated meat. Over 150 cases have occurred to date, the vast majority in UK patients or
in patients who have lived in the UK for extended periods of time. vCJD is a new disease and the risks of transmission
through blood transfusion have been of concern to blood services since its discovery. One case where vCJD has
probably been transmitted by transfusion has been identified in the UK. The donor was well at the time of donation but
later developed vCJD. The recipient developed vCJD 6 years after the transfusion and it is thought that this was much
more likely to have been caused by the transfusion than by eating beef. The predicted incidence of vCJD due to eating
infected beef in Ireland is calculated to be very small due to the much lower amount of BSE infected meat consumed in
Ireland. To reduce the risks of possible transmission of vCJD through transfusion from a donor who might have become
infected with vCJD, the IBTS has introduced a number of precautionary measures since 1999. These include the
removal of white cells (believed to contain much of the infectious agent, the prion), the deferral of donors who have lived
for a number of years in the UK or who have a history of transfusion outside Ireland and the importation of virally safe
plasma from outside of Europe. It is important to realise that the risks of not having a necessary blood transfusion
exceeds the extremely low risk of vCJD transmission by transfusion.
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APPENDIX 1 BLOOD TRANSFUSION INFORMATION FOR PATIENTS (PAGE 2)
Matching Blood
A harmful reaction to the blood transfusion can be caused by the transfusion of blood, which is not matched to the
patients blood. This is prevented by matching the donated blood with a carefully identified sample from the patient. At
the bedside, before the transfusion is started both you and the unit of blood will be carefully identified. This is the reason
why the nurse, doctor or phlebotomist asks you to state your name when taking a blood sample and prior to transfusion.
Reactions
Your nurse will observe you carefully during transfusion particularly at the beginning. Tell your nurse immediately if you
feel unwell or experience fever or chills during or after the transfusion. Even if you have a reaction to blood it does not
mean that there is cause for concern. As a precaution your nurse will stop the transfusion and call a doctor, your
symptoms will be treated and the reason for the reaction investigated. All significant reactions are reported to the
National Haemovigilance Office at the Irish Blood Transfusion Service.
Transfusions after a reaction
If a patient develops a reaction to the blood transfusion, medication given prior to the next transfusion or giving a different
blood product may prevent a further reaction.
The most important blood groups, the ABO and Rh D groups, are matched prior to transfusion. However a match of the
patients blood against the donors can never be perfect. Rarely some months after a transfusion, patients may develop
antibodies to the transfused red cells. These antibodies will not usually make the person ill, but will be important for future
transfusions or in pregnancy. They will be discovered when the blood is tested and this test will also help decide what
blood should be given next time around.
Are there alternatives to having a blood transfusion?
Some blood loss can be replaced by other fluids and your body will then make new red cells over the next few weeks.
The following is a brief outline of the alternatives, which can be offered to some patients. The availability of these
alternatives generally depends on your underlying illness and your general health. If you would like more information ask
your doctor for advice.
Fit persons undergoing a planned surgery may be able to donate their own blood a number of weeks before their surgery.
This is called autologous donation. In other circumstances, blood lost during or immediately after an operation can be
collected and transfused back to the patient. Medication can, in some instances, be administered to reduce or prevent
bleeding.
Using your own blood will prevent the rare transmission of viral infections but will not avoid the rare risks of bacterial
infection or the transfusion of an incorrect unit of blood.
Some illnesses or dietary deficiencies, which cause anaemia, may be treated with medications including iron or vitamins.
Can my relatives or friends donate blood for me?
When relatives or friends donate blood it is called directed donation. Research has shown that such transfusions are not
any safer than carefully selected voluntary donations. Directed donations are not available in Ireland, the UK or in most
European countries.
Further information
You can discuss any worries you have about the blood transfusion with your doctor. If you would like any additional
information contact the Department of Transfusion Medicine here in the hospital.
Glossary
1. Blood components
Unit of blood: A unit of donated blood can be separated into a number of individual components principally a red
cell preparation, platelets and plasma.
Platelets: Platelets are small blood cells. They are essential to enable blood to clot properly.
Plasma: Plasma is used to correct deficiencies in patients blood clotting.
2. Anaemia: Anaemia refers to a lower than normal red blood count.
January 2004
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APPENDIX 2 POST TRANSFUSION INFORMATION LEAFLET FOR DAY PATIENTS
You have been transfused with a blood transfusion as prescribed by your doctor here today.
Occasionally during or after a blood transfusion you may feel unwell; this is referred to as a reaction. Indeed
reactions can occur up to several weeks after a transfusion. The symptoms of a transfusion reaction may include:
Apprehension/Faintness/Weakness.
Nausea/Vomiting.
Breathlessness/Chest pain/Back pain.
Hives/Rash/Itch/Flushing.
Fever/Rigors/Chills.
Jaundice/ Dark or Red Urine.
A reaction may not always be a cause for concern but it is important to inform your nurse or doctor immediately if
you experience any unexplained worsening of your symptoms.
Rarely you may develop a reaction after the transfusion therefore if you experience any worsening of your
symptoms it is important to contact a member of your Medical Team.
Contact __________________ during clinic hours or _______________ out of hours and during the weekend.
Adapted from leaflet issued by Blood Bank and Nursing Staff, University of Michigan Hospitals and Health Centres,
Patient Post Transfusion Discharge Instructions, February 2000
20
21
Wrong unit and/or ABO
incompatible transfusion
Remove unit and giving set.
Leave cannula in place and put up new
administration set.
Start IV saline infusion.
Inform the transfusion laboratory
immediately as another patient may
be at risk of receiving an
incompatible unit.
Return unit intact to hospital
transfusion laboratory.
If ABO incompatible see below for
investigation and management as for
acute haemolysis and seek expert
haematological/ medical advice .
Febrile non haemolytic reaction
Temperature rise <1.5C. Patient
otherwise well and observations stable.
Give paracetamol and restart transfusion
at slower rate.
Observe more frequently.
Acute haemolysis/bacterial
contamination
Remove unit and administration set.
Leave cannula in place and put up a
new administration set.
Start IV saline infusion.
Take blood cultures and samples for
repeat group/crossmatch/DCT, FBC,
coagulation studies, biochemistry.
Check for haemoglobinuria and
monitor urine output.
Maintain urine output at >100mls/hr.
Start IV antibiotics immediately if
suspected bacterial transmission.
Return unit with all used/unused units
to hospital transfusion laboratory
Inform transfusion laboratory and seek
expert haematological/medical advice.
Mild allergic reaction
Urticaria/rash only.
Give 10mg chlorpheniramine slowly IV
and restart infusion at slower rate.
Severe allergic/anaphylaxis
reaction
Tachycardia, dyspnoea and cough,
wheezing, malaise, angioedema (often
of the lips, eyes or tongue)
Stop transfusion.
Call for medical assistance.
Give oxygen.
Give chlorpheniramine 10mg slowly IV
and hydrocortisone 100-200mg IV.
If respiratory symptoms or history of
asthma give salbutamol nebuliser.
If anaphylactic shock: hypotension,
sub-sternal or abdominal pain, worsening
symptoms, laryngeal oedema, respiratory
obstruction, collapse.
Give adrenaline (epinephrine) 1:1000
solution 0.5mL (500 micrograms) IM
into anterior aspect of mid thigh.
Repeat once after 5 minutes if no clinical
improvement or deterioration.
Seek expert medical advice as soon as
possible.
Investigation
Send sample for IgA level.
Transfusion Related Acute Lung
injury (TRALI)
Clinical features of acute non
cardiogenic pulmonary odema.
Stop transfusion.
Give oxygen and ventilate if required.
Contact anaesthetist for further
management and investigation.
Fluid overload/acute pulmonary
oedema
Stop transfusion.
Give oxygen and frusemide 40-80mg
IV.
Symptons/Signs of Acute Transfusion Reaction
Fever, chills, tachycardia, flushing, urticaria, bone/muscle/chest/abdominal pain, nausea, dyspnoea, collapse, hypo/hypertension, dark urine or patient generally unwell.
Seek Haematological advice where severe acute reactions occur
APPENDIX 3. MANAGEMENT OF AN ACUTE TRANSFUSION REACTION
Temporarily stop the transfusion and call the doctor
Check temperature, pulse, BP, respiratory rate, oxygen saturation. Check that the identity of the recipient, details on the unit and documentation match.
Is this the
wrong unit
and/or is it ABO
incompatible?
Reaction
involves
mild fever or
urticarial
rash only?
Severe allergic
reaction/anaphylaxis?
Fever >1.5 C
and/or rigors,
hypotension,
back pain
Persists or patient
becomes unwell
Other severe
reaction-non
respiratory?
Symptoms
mainly
respiratory/
dyspnoea/cough
No
No
No
Or
Yes
Yes
Yes
Yes
Yes
Yes
Normal
CVP/JVP
Raised CVP/JVP
Urticaria
Mild Fever
Or
22
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27
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