Blood transfusion

Practical guide for doctors, nurses and other

health staff managing blood transfusion activities

Internal document
2019 edition
Lead author
Monique Guéguen

Editor
Elisabeth Le Saout

Contributors
Marie-Claude Bottineau, Philippe Calain, Anne-Sophie Coutin, Kelly Dilworth, Véronique
Grouzard, Judith Kendell, Cara Kosack, Elisabeth Le Saout, Claudine Maari, Miguel
Sanchez Murcia.
We would like to thank for their helpful advice: Jean-Pierre Allain, François-Xavier Daoudal,
Sophie Pilon, Jean Rigal, Micaela Serafini, Sebastian Spencer.

Translation coordinator
Carolina López Vázquez

Illustrations
Germain Péronne
Sarah Imani

Design and layout

Evelyne Laissu

Published by
Médecins sans Frontières

© Médecins sans Frontières, 2019

All rights reserved for all countries. No reproduction, translation and adaptation may be
done without the prior permission of the Copyright owner.

Médecins Sans Frontières. Blood transfusion. 2019 edition.

Preface

This guideline is intended for health professionals and support staff involved in supplying,
delivering and administering blood in resource-limited health facilities.
It provides practical answers to the main questions and problems faced by staff, drawing on
recommendations issued by reference organizations such as the World Health Organization
and the field experience of Médecins Sans Frontières. However, most countries have a
blood transfusion policy and national recommendations should be taken into account when
implementing blood transfusion activities.
Blood refers to whole blood and packed red blood cells. Fresh frozen plasma and platelet
concentrates are sometimes supplied by National Blood Services. Other blood components
that are rarely available, such as cryoprecipitates or specific coagulations factors are not
discussed.
The guideline is divided into four chapters:
– Blood transfusion safety (Chapter 1)
– From donor to qualified blood unit for transfusion (Chapter 2)
– Blood transfusion process (Chapter 3)
– Setting up and managing blood transfusion activities (Chapter 4)
Furthermore various practical tools, such as standard operating procedures and examples of
forms and registers, are presented in the appendices.
This guideline addresses the precautions required to ensure donor, recipient and staff safety.
Other techniques, such as detection of irregular antibodies, sensitive crossmatch procedures,
determination of Rhesus and Kell phenotypes or leukofiltration, exist. Being unavailable in
remote heath facilities –thus not developed in this manual– these techniques should be used
when available.
The authors would be grateful for any comments to ensure that this manual continues to
evolve and remains responsive to the reality of the field.
Comments are to be addressed to the laboratory referent of your MSF operational section.

3
Table of contents

Preface...................................................................................................................................... 3
Abbreviations and acronyms.................................................................................................... 5

Chapter 1: Blood transfusion safety

1. Introduction........................................................................................................................... 9
2. Immunological risks............................................................................................................. 10
3. Blood groups and compatibility........................................................................................... 12
4. Infectious risks..................................................................................................................... 17
5. Other risks........................................................................................................................... 20

Chapter 2: From donor to qualified blood unit for transfusion

1. Ethical aspects for blood donation...................................................................................... 25
2. Types of blood donation...................................................................................................... 28
3. Donor selection................................................................................................................... 31
4. Pre- or post-donation screening.......................................................................................... 34
5. Collection of blood donation............................................................................................... 36
6. Blood grouping and transfusion transmissible infections screening................................... 38
7. Possible preparations from whole blood............................................................................. 41
8. Registration and labelling ................................................................................................... 42
9. Decision trees...................................................................................................................... 44

Chapter 3: Blood transfusion process

1. Indications of red cells transfusion...................................................................................... 51
2. Prescription......................................................................................................................... 55
3. Delivery of blood units........................................................................................................ 61
4. Administration of a blood unit............................................................................................ 62
5. Management of transfusion-related complications............................................................ 66
6. Particular case of fresh frozen plasma................................................................................. 74

Chapter 4: Set up and management of transfusion activities

1. Setting up blood transfusion activities................................................................................ 79
2. Storage, transport and stock management of blood units.................................................. 82
3. Staff responsibilities............................................................................................................ 87
4. Hospital Transfusion Committee ........................................................................................ 89
5. Quality assurance in blood transfusion............................................................................... 90
6. Layout of premises.............................................................................................................. 92
7. Waste management............................................................................................................ 94

Appendices............................................................................................................................. 97

Glossary................................................................................................................................ 166

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Abbreviations and acronyms

ACT Activated cephalin time

CMV Cytomegalovirus

DIC Disseminated intravascular coagulation

EDTA Ethylen diamine tetraacetic acid

G6PD Glucose-6-phosphate dehydrogenase

GVHD Graft versus host disease

Hb Haemoglobin

HBV Hepatitis B virus

HCV Hepatitis C virus

HIV Human immunodeficiency virus

HTLV ½ Human T-cell lymphotropic virus ½

NBTS National blood transfusion service

NHFTR Non-haemolytic febrile transfusion reaction

PRBC Packed red blood cells

Rh Rhesus

TACO Transfusion associated circulatory overload

TRALI Transfusion-related acute lung injury

TT Thrombin time

TTI Transfusion transmissible infection

WHO World Health Organisation

5
Chapter 1:
Blood transfusion safety

1. Introduction.................................................................................................................. 9

2. Immunological risks.................................................................................................... 10

3. Blood groups and compatibility.................................................................................. 12

4. Infectious risks............................................................................................................ 17

5. Other risks.................................................................................................................. 20

References...................................................................................................................... 21
 Chapter 1: Blood transfusion safety

1. Introduction

Transfusion is an essential component of the management of life-threatening conditions such

as decompensated anaemia or major haemorrhage.
Transfusion always carries risks for the recipient, related either to the transfused blood itself or
to the patient’s underlying condition. In this chapter, these risks are classified into 3 categories:
immunological risks, infectious risks and other (non-immunological, non- infectious) risks.
In order to reduce as far as possible the potential complications of transfusion, specific
precautions have to be taken when selecting donors and collecting, testing, processing and
administering blood:
– Donor selection is essential to reduce infectious risks.
– ABO Rhesus D grouping and compatibility testing are mandatory.
– Blood must be systematically screened for transfusion transmissible infections (TTI).
Screening for HIV 1 and 2, hepatitis B, hepatitis C and syphilis is mandatory, even in an
emergency.
– Donors and recipients information must be correctly recorded.
– Blood donations and qualified blood units must be correctly labelled and recorded.
– Patients must be closely monitored by trained staff during and after transfusion.
Despite these precautions, transfusion is never totally risk-free. However, it may be detrimental
to the patient to avoid transfusion when it is indicated. Thus, it is the physician’s responsibility
to evaluate the potential risks and benefits of transfusion for each patient. Following clear
indications for transfusion helps prevent unnecessary transfusions. Transfusion, when
indicated, should be carried out without delay.
Transfusion safety is not limited to the above precautions. In addition, it must be ensured that:
– Transfusion is effective, i.e. the transfused blood has the required qualities to restore the
patient’s oxygen carrying capacity.
– All effective means to reduce or compensate blood loss (e.g. stop bleeding with mechanical
means such as compression, fluid resuscitation, tranexamic acid in trauma or post-partum
haemorrhage) are available at all times and used when indicated.
– Blood is used rationally to ensure that it will be available when needed. Unnecessary
transfusions may cause a shortage of blood for patients in real need.
– Medical and cold chain equipment, consumable items and quality laboratory reagents
are available to ensure that each step of the transfusion safety chain will be correctly
implemented.
As transfusion of safe blood is a complex procedure, and blood a scarce resource, all upstream
measures to reduce blood needs should be implemented (e.g. early management of anaemia,
severe malaria, trauma and complicated pregnancies).

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Chapter 1: Blood transfusion safety

2. Immunological risks

2.1 Immediate immune reactions (< 24 h)

2.1.1 Allergic reactions
About 2% of transfusions are complicated by mild allergic reactions. However, rare but severe
anaphylactic reactions may occur.

2.1.2 Non-haemolytic febrile transfusion reaction (NHFTR)

Leukocytes in transfused blood may be targeted by the recipient’s anti-HLA antibodies acquired
as a result of previous transfusions or pregnancies. Lysed leukocytes release pyrogens resulting
in a febrile reactiona.

2.1.3 Acute intravascular haemolytic transfusion reaction

Acute intravascular haemolytic reaction occurs when transfused red cells encounter natural
regular IgM antibodies in the recipient’s blood. The antigen-antibody reaction triggers the
intra-vascular lysis of transfused red cells. This is a severe potentially life-threatening reaction.
It may be associated with disseminated intravascular coagulopathy (DIC). The released
haemoglobin can cause acute renal failure.
Ninety percent of immediate acute intravascular haemolytic reactions are caused by transfusion
of ABO incompatible blood resulting from human error. The remaining ten percent are due to
irregular natural antibodies from other blood group systems (e.g. Lewis, P).

2.1.4 Transfusion-related acute lung injury (TRALI)

TRALI is a rareb post-transfusion acute respiratory distress syndrome. TRALI is typically associated
with plasma products such as fresh frozen plasma. However, it can occur in recipients of whole
blood and packed red blood cells (PRBC) due to the residual plasma present in PRBC units.

2.2 Delayed immune reactions

2.2.1 Extravascular haemolysis
Extravascular haemolysis occurs when red cells are trapped and lysed in the spleen. This
haemolysis is due to:
– The recipient’s acquired antibodies to Rhesus, Kell, Duffy or Kidd. In this event, the transfused
red cells are haemolysed.
or
– Hyper immune anti-A or anti-B antibodies (haemolysins) from “dangerous group O donors”c.
In this event, the recipient’s red cells are haemolysed.
Extravascular haemolysis occurs 5 to 10 days after transfusion.

a Leukofiltration, when available, reduces the frequency of NHFTR.

b Estimated at 1:5000 transfusions, however the true incidence of TRALI is not known.
c Some O donors (“dangerous O donors”) have acquired hyper immune anti-A and/or anti-B antibodies, called
haemolysins. These haemolysins, when highly concentrated, may induce haemolytic reaction after the
transfusion of only one unit of ABO compatible, non-identical blood (Chapter 1, Section 3.1).

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 Chapter 1: Blood transfusion safety

2.2.2 Post-transfusion purpura

Anti-platelet alloantibodies developed by multiparous recipients destroy both the transfused
platelets and the recipient’s platelets.
Post-transfusion purpura develops within 5 to 12 days after transfusion. This condition is rarely
life-threatening.

2.2.3 Graft-versus-host disease

Graft-versus-host diseases (GVHD) can occur in neonates and in severely immune compromised
patients. The T-lymphocytes in the transfused blood reject the recipient’s tissues. GVHD is rare
but fatal in half of all cases. The acute form (5 to 8 days post-transfusion) is always serious. The
chronic form (3 to 4 weeks post-transfusion) may be reversible over a 4 to 6 week period. The
risk of GVHDd is higher in intra-family donations, especially in mother-to-child transfusions. In
the event of direct blood donation, for neonates and severely immune compromised patients,
blood from a non-family donor or blood from a more distant relative than the mother (e.g.
aunt or uncle) is preferred whenever possible.

2.2.4 Alloimmunisation
As there are many different erythrocyte, leukocyte and platelet antigens, it is impossible to
transfuse immunologically identical blood. Transfused blood inevitably introduces antigens
that are foreign to the recipient. These antigens are called alloantigens. An alloantigen
prompts an immune response, including the production of specific antibodies to eliminate
this alloantigen. This phenomenon is alloimmunisation.
Alloimmunisation against red cells refers to the development of specific blood group
antibodies after the introduction of red cell antigens into a recipient who lacks these antigens.
In transfusion practice, the most important alloantigens are those of ABO, Rhesus, Kell, Duffy
and Kidd blood group systems, as they are the most immunogenic.
Alloimmunisation against leukocytes and platelets may also occur through the development
of anti-HLA antibodies or specific anti-platelet antibodies. This type of alloimmunisation is
relatively common in multi-transfused patients and multiparous women.
The clinical significance of alloimmunisation depends on the type and quantity of antigens
introduced, the rate of their introduction, and the recipient’s profile: sex (higher risk in women),
immune status (higher risk in immune competent patients), and associated pathology (e.g.
autoimmune disease).
Alloimmunisation may complicate possible future transfusions and/or pregnancies in recipients.
Prescription of “phenotyped blood”, terminology commonly used for full Rhesus and Kell group
determination, is the means to prevent most alloimmunisations in multi-transfused patients.

d Irradiating the blood is the only way to effectively prevent GVHD. Leukofiltration, when available, may reduce
the severity of the reaction.

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Chapter 1: Blood transfusion safety

3. Blood groups and compatibility

An individual’s blood group is defined by the presence of an antigen on the red cell membrane.
Individuals who possess the same antigen belong to the same blood group.
Individuals who do not express a given antigen may carry specific antibodies against the
antigen. If the antigen is introduced by blood transfusion into such a recipient, then mild or
severe haemolysis may occur. This defines blood incompatibility.
Patients to be transfused must only receive compatible blood, i.e. blood that will not carry the
risk of haemolytic transfusion reactions.
Testing the two most important groups –ABO and Rhesus– for compatibility is mandatory.

3.1 ABO system

The ABO blood group is defined by the presence or absence of A and/or B antigens on the
red cell surface. When either or both are absent from the red cell surface, the corresponding
antibody(ies) is (are) present in the plasmaa.
Individuals of group A have A antigen on their red cell membranes and naturally occurring
anti-B antibodies in their plasma.
Individuals of group B have B antigen on their red cell membranes and naturally occurring
anti-A antibodies in their plasma.
Individuals of group O have neither A antigen nor B antigen on their red cell membranes and
naturally occurring anti-A and anti-B antibodies in their plasma.
Individuals of group AB have A and B antigens on their red cell membranes and no naturally
occurring anti-A nor anti-B antibodies in their plasma.

ABO incompatibility reactions occur when the recipient’s naturally occurring antibodies
destroy the transfused red cells that express the corresponding antigen.
Individuals of group A may receive group A (identical) or group O (compatible) blood,
must not receive group B nor group AB (incompatible) blood.
Individuals of group B may receive group B (identical) or group O (compatible) blood,
must not receive group A nor group AB (incompatible) blood.
Individuals of group O may receive only group O (identical) blood,
must not receive group A nor group B nor group AB (incompatible)
blood.
Individuals of group AB may receive group AB (identical), or group A, or group B, or group O
(compatible) blood.
Thus, the rule is:
Transfuse only ABO compatible blood
AND
Prefer ABO identical blood

a Except in children under 3 months (because they have not yet developed natural antibodies).

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 Chapter 1: Blood transfusion safety

Table 1.1 - ABO compatibility rules for whole blood and red cells transfusion

Blood unit ABO group

Recipient
ABO group
1st choice 2nd choice 3rd choice 4th choice

O O

A A O

B B O

AB AB A B O

Group O donors are often called “universal donors”. The transfusion of group O blood to
any A, B or AB recipient is possible and will not induce acute ABO incompatibility accidents.
However, some donors may carry acquired anti A or anti B haemolysins of high titer, which can
induce delayed haemolysis when transfused to A, B or AB recipients. These donors are called
“dangerous O donors”. In the absence of detection of haemolysins to identify these dangerous
O donors, it is preferable to transfuse the least possible amount of non-ABO identical plasma
when it is not possible to transfuse ABO identical blood.
Transfusing O blood to non-O recipients must not be routine practice and should be considered
only when ABO identical blood is not available. In this event, preferably transfuse packed red
blood cells or the least amount of plasma possible.

3.2 Rhesus system

The Rhesus system (Rh) is the second most important system to consider when transfusing
patients. It is made up of 5 main antigens: RH1 (D), RH2 (C), RH3 (E), RH4 (c), RH5 (e).
Antigen D is the most immunogenic antigen of the Rhesus system. The presence of antigen
D defines Rhesus positive individuals. The absence of antigen D defines Rhesus negative
individuals.
There are no naturally occurring Rhesus antibodies. These antibodies are always acquired
through transfusion or during pregnancy and are developed by individuals who do not express
the corresponding antigen (i.e. an Rh D negative patient may develop anti-D antibodies).
Incompatibility reactions occur when the recipient’s acquired anti-D antibodies destroy the
Rh D positive transfused red cells. Rhesus antibodies often cause mild or moderate delayed
haemolysis, but rarely severe acute haemolytic reactionsb.

The rule is:

Prefer Rhesus D identical transfusion

b Rhesus antibodies can only be detected with laboratory screening and identification techniques that are
complex to implement.

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Chapter 1: Blood transfusion safety

If Rhesus D identical blood is not available:

Rh D negative blood to Rh D positive recipients
Rh D negative blood may be transfused to Rh D positive recipients without immunological
consequences, but only as second choice, since Rh D negative blood is rare and should be kept
for Rh D negative recipients.
Rh D positive blood to Rh D negative recipients
Under exceptional circumstances (absolute emergency), Rh D positive blood may be transfused
to Rh D negative recipients:
– There will be no immediate transfusion reaction in Rh D negative men and nulliparous
women who have never been transfused.
– Incompatibility reactions may occur if the recipient has developed acquired anti-D antibodies
through previous transfusion or pregnancy. Since the simple crossmatch method cannot
detect anti-D antibodies in the recipient, the risk of immediate transfusion reaction and
ineffective transfusion is unpredictable.
Therefore, the decision to transfuse Rh D positive blood to Rh D negative patients must be a
well-considered medical decision, taking into account not only the immediate risks but also
the potential consequences:
1. The recipient has a high likelihood (80% risk) of developing anti-D antibodies after a
transfusion with an incompatible Rh D blood unit: any future transfusions with Rh D positive
blood may cause adverse events.
2. Rh D negative women are likely to experience obstetrical complications if they subsequently
conceive Rh D positive children.
Table 1.2 - Rhesus compatibility rules for whole blood and red cells transfusion

Blood unit Rhesus

Recipient’s Rhesus
1st choice 2nd choice

Rh D positive Rh D positive Rh D negative

Rh D negative Rh D negative See above

Notes:
– It is pointless to administer anti-D immunoglobulin to prevent anti-D alloimmunisation to
an Rh D negative patient who has been transfused with Rh D positive blood. High doses of
anti-D immunoglobulin would be required to achieve effective prevention, and these could
even destroy the transfused Rh D positive red cells.
– Respecting Rh D compatibility rules does not exclude incompatibility reactions due to other
Rhesus antigens. The four other main Rhesus antigens: C, c, E and e are immunogenic, with
c and E the most immunogenic. In the event of repeated transfusions it may be important
to respect compatibility with these antigens and provide phenotyped Rhesus compatible
blood. In this event blood typing of the donor and recipient must be carried out for the
4 antisera (anti-C, anti-c, anti E and anti e).
Like anti-Rh D antibodies, anti-Rh C, anti-Rh c, anti-Rh E and anti-Rh e antibodies are acquired,
and undetectable by the simple crossmatch method. However, alloimmunisation caused by
Rhesus C, c, E and e antigens is usually not of clinical significance, except in multi-transfused
patients.

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 Chapter 1: Blood transfusion safety

3.3 Other blood group systems

Kell, Duffy and Kidd systems may be associated with severe transfusion reactions but cannot
be tested in contexts with limited resources.

3.3.1 Kell system

The Kell system consists of 2 main antigens: KEL 1 (K), KEL 2 (Cellano).
The antigen KEL 1 is a rare, very immunogenic antigen. The presence of antigen KEL 1 defines
Kell positive individuals. The absence of antigen KEL 1 defines Kell negative individuals. Kell
antibodies are acquired and found among multi-transfused patients and multiparous women.
Anti-KEL 1 antibodies are responsible for haemolytic reactions, often mild and delayed.
Since simple crossmatching cannot detect the recipient’s anti-KEL 1 antibodies, the risk of
transfusion reaction is unpredictable.

3.3.2 Duffy, Kidd and other systems

The Duffy system consists of 2 main antigens: FY1 (Fya) and FY2 (Fyb).
The Kidd system consists of 2 antigens: JK1 (Jka) and JK2 (Jkb).
Anti-Duffy and anti-Kidd are rare, acquired antibodies found among multi-transfused patients
and multiparous women.
Anti-Duffy and anti-Kidd antibodies may be responsible for very severe haemolytic reactions.
Since simple crossmatch procedures cannot detect these antibodies in the recipient, the risk
of severe, but rare, transfusion reaction is unpredictable.

3.4 Specific case of children under 4 months

Maternal IgG antibodies cross the placenta to the foetus. If the mother carries IgG anti-red cell
antibodies, these will be present in the child until they reach 4 months. This implies:
1. Transfused red blood cells must be compatible with the child’s and mother’s ABO blood
group.
2. If an irregular antibody test has been carried out on the mother’s blood (which is unlikely in
resource limited settings) and the result is positive, the transfused red blood cells must be
compatible with the mother’s antibodies.
3. If an irregular antibody test has not been carried out on the mother’s blood, the transfused
red blood cells must be compatible with the mother’s Rhesus phenotype, at least the Rh D
antigen.
Example: in the case of an O Rh D negative mother and an A Rh D positive child, transfuse O Rh
D negative blood to the child (Chapter 3, Section 2.5.2).

3.5 Blood grouping and crossmatch

3.5.1 ABO and Rh D grouping
Determination of ABO and Rh D groups (Appendix 16) is absolutely mandatory to ensure ABO
and Rh D compatibility, but does not exclude incompatibility reactions related to other non-
tested systems.

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Chapter 1: Blood transfusion safety

3.5.2 Crossmatching
Crossmatching is a means to reduce immunological complications. It is a laboratory procedure
that predicts if antigen-antibody conflict will occur during transfusion of a given blood unit.
The technique consists in placing the recipient’s plasma in contact with the red cells to be
transfused. A negative crossmatched blood unit means that there are no detectable antibodies
in the recipient’s plasma that may immediately destroy the red cells to be transfused.

Simple crossmatch method - Tile method (Appendix 26)

This aims to detect incompatibility between the patient’s plasma and the red cells from the
blood unit, due to agglutinating antibodies such as naturally occurring antibodies (anti-A,
anti-B) and also from other systems antibodies (anti-Lewis a, anti-P).

Other crossmatch methods

Women who have been pregnant and/or previously transfused patients should be targeted
for more sensitive crossmatch procedures (at 37 °C, in low ionic strength solutions, test with
antiglobulin, gel methods) to detect non-agglutinating antibodies including anti-Rhesus, anti-K,
anti-Duffy and anti-Kidd. These techniques may be available in some settings but, in general,
are complex to implement.

The rule is:

Transfuse only negative crossmatched blood units

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 Chapter 1: Blood transfusion safety

4. Infectious risks

Many pathogens present in donated blood can be transmitted to the recipient. In most cases,
the recipient is infected by receiving blood from an infected donor. These are transfusion
transmitted infections (TTI). The donor selection process (questionnaire and clinical
examination, see Chapter 2, Section 3.2 and Section 3.3) and the routine screening of blood for
infection markers can eliminate the vast majority of infected donations. The infections which
blood donors/donations should be systematically screened for are HIV, hepatitis B and C and
syphilis. However, despite these precautions, a residual risk of transfusing infected blood (e.g.
human error, window period, test performances, non-screened infections) persists.

4.1 Bacterial infections

Bacterial infections may result from:
– Contamination of blood during collection (error in asepsis is the most common case).
– Transfusion of blood from an infected donor that is asymptomatic at the time of blood
donation.
– Bacterial growth in the blood between collection and transfusion (mainly for platelet
concentrates because they are stored up to 5 days at 22 °C).
The severity of transfusion-acquired bacterial infection depends on the recipient’s underlying
condition, the type of bacteria, and the bacterial load, and may be life- threatening.

4.1.1 Septic complications

Bacteria found in blood units may be Gram-positive (e.g. S. epidermidis) or Gram- negative
(e.g. Klebsiella, Acinetobacter, P. aeruginosa, Y. enterolitica: the two latter are capable of
multiplying between +2 °C and +8 °C). Gram negative bacteria are considered to cause the
most severe septic complications, including septic shock.
To prevent septic complications, take measures to avoid contamination of blood during
collection and to prevent bacterial proliferation in the blood unita:
– Collect blood in a clean area, respecting hand hygiene and rigorous skin disinfection
techniques.
– Collect blood using blood bags with a diversion pouch (the first 35 mL of blood collected are
not transfused as they are the most likely to contain skin bacteria).
– Allow blood to sit for 2 to 4 hours between blood collection and refrigeration, if the
temperature can be kept between +18 °C and +24 °C. This enables white blood cells to carry
out their bactericidal effect (see Appendix 11).
– Maintain and closely monitor the storage temperature of blood units.
– Start transfusion within 30 minutes of removing the blood unit from the cold chain.
– Administer each blood unit within 4 hours maximum.

4.1.2 Syphilis
It is compulsory to routinely screen blood for syphilis (Treponema pallidum)1.

a Additional methods to reduce bacterial contamination exist, such as pre-storage leukocyte depletion filtration,
but are rarely available in resource-limited settings.

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Chapter 1: Blood transfusion safety

4.2 Viral infections

4.2.1 Human immunodeficiency virus (HIV)
Eighty to one hundred percent of recipients transfused with HIV-positive blood are later
found to be HIV infected, regardless of age, sex and type of component transfused. Therefore,
screening blood for HIV is compulsory2,3.

4.2.2 Hepatitis B virus

The risk of hepatitis B virus (HBV) transmission is very high and varies according to the stage of
infection in the donor. Screening donated blood for HBV surface Ag is mandatory.
In addition, it is recommended to offer hepatitis B vaccinationb to patients likely to receive
repeated transfusions4.

4.2.3 Hepatitis C virus

Hepatitis C virus (HCV) can cause severe life-limiting liver disease. Screening donated blood for
HCV is compulsory.

4.2.4 Other transfusion-transmissible viruses

Donated blood may also be screened for Human T- cell lymphotropic virus 1/2 (HTLV 1/2) and
cytomegalovirus (CMV), depending on the context:
– In endemic areas, such as the Caribbean, blood is routinely screened for HTLV 1/2 by national
blood transfusion services, using ELISA tests.
– While relatively harmless in immune competent patients, CMV is pathogenic in immune
compromised patients. Transmission rarely occurs if the blood has been stored refrigerated
over 72 hours. In settings where CMV testing is available, immune compromised patients
should receive CMV-negative blood.
– The Ebola virus may remain detectable in semen, maternal milk, aqueous humour and other
fluids or tissues several months after clinical cure. The isolation of viable virus in blood after
initial recovery still remains a rare observation. In the absence of internationally agreed
recommendations, as a matter of precaution, it is safer to exclude individuals clinically cured
of Ebola infection as potential blood donors5.

4.3 Parasitic infections

In contrast to mandatory routine screening for HIV, hepatitis B and C and syphilis, screening for
parasitic infections is performed according to the epidemiological context.

4.3.1 Malaria
Plasmodia survive for at least 3 weeks in refrigerated blood6. Therefore, the risk of acquiring
malaria through transfusion of infected blood is high. Clinical symptoms depend on the malaria
immunological status of the recipient.
When malaria is highly prevalent, screening will detect many positive donors. Routine exclusion
of positive malaria blood (by rapid diagnostic test (RDT) or microscopy) may lead to blood
shortage. Furthermore, carriers with low level parasitemia may not be detected by microscopy
or RDT. The decision to screen donors’ blood or to give the recipient an empirical antimalarial
treatment depends on the epidemiological situation in the area (see Chapter 2, Section 6.2.4).

b Hepatitis B vaccination is also recommended for health staff at risk of blood exposure.

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 Chapter 1: Blood transfusion safety

4.3.2 Chagas disease

In endemic areas (Central and South America), the prevalence of Chagas disease has decreased
significantly over the past few years7. The possibility of transmission through transfusion exists.
Screening tests should be used in endemic countries.

4.3.3 Human African trypanosomiasis

This disease is endemic in certain parts of sub-Saharan Africa, often in specific localized areas.
Transmission by chronic asymptomatic carriers is possible, but rare8.

4.3.4 Visceral leishmaniasis

Visceral leishmaniasisis is endemic in numerous countries worldwide. However, the majority
of cases occur in north-eastern India, Bangladesh, Sudan, South Sudan, Ethiopia, and Brazil. In
other countries, the disease is found in relatively small and localized foci9.
The risk of infection through transfusion is low and only a few cases of transfusion- acquired
visceral lesihmaniasis have been reported.
However since there is a risk, although minimal, screening with a protein rK39 rapid test should
be performed in endemic areas.

4.3.5 Filarioses
The accidental transmission by transfusion of live microfilariae has no direct pathogenic power.
However, the destruction of transfused microfilariae by anti-helminthic drugs (which are also
microfilaricides) can sometimes provoke severe allergic accidents10.

4.3.6 Other infectious risks

Many other agents can be transmitted by transfusion but are not screened for, either because
their importance in blood safety is limited or unknown or because the necessary screening
tests are not available or not feasible in many contexts.

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Chapter 1: Blood transfusion safety

5. Other risks

5.1 Circulatory overload

Transfusion-associated circulatory overload (TACO) is a transfusion complication in which
cardiogenic pulmonary oedema develops due to high rates or high volume of transfusion.
Patients with cardiac or respiratory disease, elderly patients and children are at the highest
risk of developing circulatory overload.

5.2 Massive transfusion syndrome

Massive transfusion is defined as:
– The replacement of at least 50% of the total blood volume in less than 3 hours in adults and
children.
– Or the transfusion of over 3 units of whole blood or 4 units of PRBC within the first hour in
adults.
– Or the transfusion of over 15 mL/kg of PRBC within the first hour in children.
Massive transfusion syndrome is a combination of:
– Hypothermia (transfused refrigerated blood which has not been warmed before
administration).
– Hypoxemia (transfused stored red cells do not have immediate optimal oxygen carrying
capacity).
– Metabolic disorders: acidosis with hyperkalaemia due to potassium released by stored red
cells; hypocalcaemia due to citrate (i.e. the necessary anticoagulant present in blood bags).
– Bleeding disorders due to dilution of recipient’s coagulation factors and platelets, and lack
of coagulation factors and platelets in stored, i.e. “non-fresh”, blood.
In settings where calcium/potassium/coagulation/platelets monitoring is not feasible and
specific blood components for treating massive transfusion syndrome (i.e. fresh frozen plasma
and platelet concentrates) are not available, the only option to minimize the risk of massive
transfusion syndrome is to use fresh whole blood (that has not been refrigerated), or at least,
blood which has been collected within the past 2 days.

5.3 Ineffective transfusion

Transfused red cells can be damaged during storage (storage lesions) or destroyed prematurely
by antibodies (which have not been detected at the time of transfusion or may appear a few
days after transfusion), or by hypersplenism. In such cases, the benefit of transfusion may be
less than or may not last as long as expected.

5.4 Iron overload

Red blood cells contain ¾ of the body’s iron. This is why repeated transfusions lead to an
accumulation of iron or secondary hemochromatosis in polytransfused patients. This may lead
to heart, liver and/or endocrine organs failure.

For symptoms and management of transfusion-related complications, see Chapter 3, Section 5.

20
 Chapter 1: Blood transfusion safety

References Chapter 1

1. WHO 2012, Global Incidence and prevalence of selected curable sexually transmitted
infections.
http://www.who.int/reproductivehealth/publications/rtis/2008_STI_estimates.pdf

2. WHO, IFRC, 2010, Vers 100% de Dons de sang volontaires, cadre mondial d’action.
http://www.who.int/bloodsafety/publications/9789242599695.pdf?ua=1

3. Elizabeth Donegan, MD, University of California San Francisco, Transmission of HIV by Blood,
Blood products, Tissue transplantation, and artificial insemination, Hiv InSite Knowledge
Base Chapter, October 2003.
http://hivinsite.ucsf.edu/InSite?page=kb-07-02-09

4. WER, 2009, 40 (84):405– 420, Hepatitis B vaccines – WHO Position Paper.

http://www.who.int/wer/2009/wer8440.pdf

5. The Lancet, vol 388, August 13, 2016, Defining Interfering Genomes and Ebola virus
persistence, Philippe Calain.
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2816%2931272-7/
fulltext

6. Chattopadyay R, Majam VF, Kumar S, Survival of Plasmodium falciparum in human blood

during refrigeration, Transfusion, vol 51, Issue 3, pages 630–635, March 2011.
http://europepmc.org/abstract/MED/20849405

7. WER, 2015, 90, 33-44, Chagas Diseases in Latin America, an epidemiological update based
on 2010 estimates.
http://www.who.int/wer/2015/wer9006.pdf

8. WER, 2006, 81, 69-80, Trypanosomiasis (sleeping sickness), epidemiological update.

http://www.who.int/wer/2006/wer8108.pdf

9. WHO, Leishmaniasis, Epidemiological update 2015.

http://www.who.int/leishmaniasis/burden/en/

10. Dictionnaire médical de l’académie de médecine - version 2016, Filaires.

http://dictionnaire.academie-medecine.fr/?q=filaire

21
Chapter 2:
From donor to qualified blood unit for
transfusion

1. Ethical aspects for blood donation............................................................................. 25

2. Types of blood donation............................................................................................. 28

3. Donor selection.......................................................................................................... 31

4. Pre- or post-donation screening................................................................................. 34

5. Collection of blood donation...................................................................................... 36

6. Blood grouping and transfusion transmissible infections screening..........................38

7. Possible preparations from whole blood.................................................................... 41

8. Registration and labelling .......................................................................................... 42

9. Decision trees............................................................................................................. 44

References...................................................................................................................... 47
 Chapter 2: From donor to qualified blood unit for transfusion

1. Ethical aspects for blood donation

1.1 Protection of donor’s health

Donors’ health should not be put at risk by donating blood. A questionnaire and clinical
examination before blood donation are essential steps as they authorize, or not, the blood
collection (Chapter 2, Section 3.2). The objective of the questionnaire and clinical examination
are to detect potential problems that may contra-indicate a blood donation, either because
of the donor’s clinical status or medical history. Contra-indications should be respected
(Chapter 2, Section 3.4).
The frequency of blood donation should not exceed 3 donations per year for women and 4 for
men (to be checked with the national transfusion policy). If blood is donated more often, the
donor risks exhausting their iron reserves. The volume of blood collected at each donation
should not exceed 500 mL. An interval of at least 8 weeks must be respected between 2 blood
donations.
Hepatitis B vaccination should be offered to regular donors1.

1.2 Protection of recipient’s health

The safety of transfusion depends partly on the reliability of information provided by the donor
during the questionnaire. The donor should be informed that, in the interest of the recipient,
they may be excluded as a donor for reasons such as taking certain medications or having an
infection that can be transmitted through transfusion.

1.3 Informed consent

No one must be forced to donate blood.
Donors must be informed and agree that:
– They may be excluded at any stage of the selection process for various reasons, e.g. medical
history, high risk of exposure to transfusion-transmissible infections, positive or doubtful
screening tests, incompatibility with the recipient in the event of direct donation.
– Their blood will be screened to ensure that it is negative for at least HIV, hepatitis B and C
and syphilis (and other tests when indicated).
– Their blood will not necessarily be used for their relative in the event of replacement
donation but for another patient, depending on needs.
Generally, verbal consent is sufficient. Written consent is required in certain countries
(Appendix 5).

1.4 Non-remunerated blood donation

The International Society of Blood Transfusion, the International Federation of the Red Cross
and Red Crescent Societies, the World Health Organization (WHO) and other international
organizations recommend that blood services should be based on non-remunerated blood
donation, as remuneration carries the following risks2:
– Remuneration of blood favours excessive blood donation, especially in low-income
populations.

25
Chapter 2: From donor to qualified blood unit for transfusion

– Remunerated donors may be tempted not to reply truthfully to the questionnaire in order
to avoid exclusion from donation.
– Most studies show higher transfusion transmissible infection (TTI) prevalence rates among
remunerated donors compared to non-remunerated donors.
However, in certain countries, the national policy for blood donation is to provide donors
with allowances or in kind compensation. In such contexts, it is essential to ensure that the
incentive system does not lead to abuse (e.g. excessive donation, collection from donors that
would normally be refused) and that recruited donors are identified as low risk donors of TTI.

1.5 Anonymous blood donation

The identity of the donor should not be disclosed to the recipient or vice versa.
However, in the event of direct donation, the donor may be non-anonymous if the blood is
collected for the immediate needs of a patient in their entourage.

1.6 Confidentiality
Personal information disclosed by the donor and test results are confidential.
The donor’s name, occupation, address or phone number may be recorded in a blood donor
register for tracing purposes if required. This register must be kept in a safe place, under lock
and key.
The donor’s identifying information should neither be recorded in the blood donation register
nor in the blood stock/delivery register (Appendix 27 and Appendix 29). When feasible, in
order to improve confidentiality, the person who collects the blood donation should not be the
same as the person who tests it.

1.7 Disclosure of results to the blood donor

The main objective of routinely screening donor blood for TTI is to provide safe blood to the
recipient, not to diagnose infections in the donor.
Above all, the donor should be asked if they agree or not to receive their test results,
either during the questionnaire, or when signing the informed consent for blood donation
(Appendix 5). Test results cannot be forced on a donor who does not want to receive them.
However, if donors are not informed of unexpected positive results, the opportunity to treat a
disease and/or prevent its transmission is lost.
Disclosure of results is a sensitive issue that must be considered when implementing blood
transfusion activities. Check national blood policy on results disclosure. Disclosure of positive
results poses different problems depending on the test:
Informing the donor of positive results for syphilis or malaria does not usually raise major
problems: a single positive test is sufficient to offer treatment, these diseases are readily
curable and treatment is usually widely available.
Regarding HIV however, the screening strategy for selecting HIV negative blood differs from
that used for diagnosing HIV infection in an individual:
– In blood transfusion, a single HIV positive or doubtful test result is sufficient to exclude
a donor or a donation. When the result of the first test is clearly negative, a second test
is performed on the donated blood on the blood bag tubing. The second test is intended
to confirm that the blood to be transfused is HIV-negative. The donor has accepted that
their blood will be screened for the safety of the recipient and has been informed that HIV
diagnosis is not available through this testing process, as a positive test result that excludes
the donor/donation cannot be interpreted as reliable evidence of infection.

26
 Chapter 2: From donor to qualified blood unit for transfusion

– When diagnosing HIV infection in an individual, an HIV testing algorithm must be applied:
a first positive or doubtful HIV test is always followed by subsequent test(s) to confirm the
HIV serological status. The individual makes an informed choice to learn their HIV status,
is aware of potential consequences, and a positive diagnosis is disclosed only when 2 or
3 different tests, depending on local HIV prevalence, are clearly positive.
Thus, donors who donate blood in order to learn their HIV status should be referred to
HIV testing services intended to provide appropriate diagnosis, psychological support and
treatment, if needed.
For the diagnosis of hepatitis B or C infection, the donor should be referred to an appropriate
health facility to carry out further tests and, if needed, to provide clinical management and
follow-up of the patient. The donor may carry the virus in the acute, elimination or chronic
phase of the disease; or the initial positive test may not be confirmed.

When national policy is to notify the donor of abnormal results, ensure that there is an
appropriate process for notification and follow-up, i.e. the donor consents to disclosure before
donation and understands that more tests may be necessary.
A reliable diagnosis using appropriate algorithm is provided; the diagnosis of an infection
is disclosed only when the outcome of the testing process is unequivocal; confidentiality is
ensured at all stages; pre- and post-test counselling, as well as adequate treatment (if needed)
are available.

27
Chapter 2: From donor to qualified blood unit for transfusion

2. Types of blood donation

The type of donation varies according to transfusion needs, capacity to store blood and the
willingness of the population to donate blood. Health facilities can be supplied by direct
donation and/or national blood services and/or replacement donors and/or locally recruited
voluntary donors.
A country is capable of supplying blood for all patients needing a transfusion when an unpaid,
voluntary system of blood donation exists and functions correctly in the whole country.
Countries which manage to set up a system exclusively made up of voluntary donors have a
higher proportion of regular donors2. In countries where access to health care and diagnostic
and treatment are limited, the main indications for transfusion are for pregnancies and
complicated deliveries, severe anaemia in children (in particular in areas with high prevalence
of malaria), haemoglobinopathies (e.g. thalassemia, sickle cell disease) and trauma. If there is
a need for regular transfusion activity in these contexts, but the supply of blood is not ensured
at national level, the provision of transfusion services directly at health facility level should be
considered (Chapter 4).

2.1 Direct donation

Direct donation is an option in health facilities where it is not possible to store blood, either
because the medical authorities do not allow it, or because a cold chain has not been or cannot
be set up. Blood from a voluntary donor is collected for a particular patient in immediate
need. Blood is collected only if the donor’s group is compatible with the recipient’s group,
the donor’s blood screens negative for TTI and the crossmatch is negative. Once the donor is
approved, blood is collected and transfused immediately to the patient.
Direct donation is typically used in small health facilities where blood transfusions are not
regularly performed. Direct donation is not recommended if a health facility that carries out
more than 2 to 3 transfusions a day.
Direct blood donation should be considered as a temporary type of blood donation until the
storage of the blood is possible.

2.2 Replacement donation

This is still the most frequent type of blood donation in peripheral health facilities in resource
limited countries. Relatives of patients transfused with blood are asked if they themselves
would like to donate blood.
Bear in mind that:
– Replacement donation can only be envisaged in medical facilities where blood can be stored.
– No one must be forced to donate blood. People often feel obliged to donate when a family
member is concerned: family donors tend not to answer the questionnaire truthfully for
fear of not being eligible to donate blood. If families feel under pressure to donate blood,
they may seek “professional donors”a. This is strongly discouraged given the higher risk of
TTI in this type of donor.

a Or remunerated donors.

28
 Chapter 2: From donor to qualified blood unit for transfusion

– Although donors are not openly paid for replacement donations, it is important to watch out
for possible hidden financing systems.
– Replacement donation should gradually evolve towards voluntary blood donation if
conditions allow.

2.3 Voluntary donation

Blood is collected from voluntary donors who go to donation centres or mobile collection
sites on their own initiative, and who may become regular donors. Collected blood is grouped,
screened for TTI and stored in a special refrigerator for blood. Blood units are then supplied
to wards or to external health facilities according to needs. The donor receives no financial
compensation or incentive. A blood donor card can be issued for regular donors, with
information concerning the blood group, donation dates and haemoglobin levels.
This type of donation is usually implemented by blood transfusion services that supply blood
to central/peripheral health facilities.
Voluntary donation is to be preferred over other types of blood donation and should be set up
at health facility level as soon as the operational context allows. It is important to understand
the beliefs and attitudes of the population towards blood donation in order to deliver the right
messages. Simple surveys on knowledge, attitudes and practices can indicate factors that may
influence blood donation3,4. The young educated age group is the most susceptible to adhere
to blood donation promotion messages. Voluntary blood donors receive health information
and, in turn, can be effective recruiters and promoters of blood donation.
Regular donors are the safest source of blood. Recruitment and development of a pool of
regular donors require regular public blood donation promotion campaigns. Their influence
is one of the most effective strategies to enlist new donors. The recruitment and retention of
donors require specific strategies to target donors that are particularly available. Local radio
stations can play an important role in promoting blood donation messages. These donors are
the means of ensuring a constant blood supply.
Recruitment of donors among health staff is not recommended in their own health facility:
– It is particularly difficult to ensure the confidentiality of sensitive information, e.g. reasons
for exclusion or tests results.
– The risk of stigmatization of those who do not want or are unable to donate blood is high.
– It is difficult to ensure that the staff member will not be over solicited.
– Donation by a member of the health staff, since it is not anonymous, may be prejudicial in
the event of a complication/death after transfusion. The recipient’s family may well sue the
donor, even if the complication is not attributable to transfused blood.
If a member of staff wants to donate blood, they should be directed to another facility, with no
connections to the facility where they are employed, in order to guarantee confidentiality of
information and donor anonymity.
June 14th is world blood donor day. This is an opportunity to organize an event and activities
on blood donation, highlight messages, motivate blood donors and recruit new ones.

Mobile blood collection (mobile drives)

Mobile blood collection is a way to reach out to potential donors who cannot travel for various
reasons (e.g. time, transport, social reasons, etc.) and to reach out to people who, due to lack
of adequate information, do not know why blood donation is useful or do not know how to
give blood in practice.

29
Chapter 2: From donor to qualified blood unit for transfusion

Mobile blood donation can be carried out in different types of places (e.g. heath centres, high
schools, markets, offices of a religious or secular organisation, etc.) as long as the environment
is suitable in terms of space and hygiene, can ensure confidentiality and is welcoming. The
mobile collection site must be evaluated before blood collection takes place. It must have
access to water and sufficient sanitation to guarantee hygiene and safety standards for donors
as well as for health staff. The opening hours of blood collection sites should take into account
when the largest number of people can attend.
Mobile blood collection sessions attract new donors if the place is well chosen. There will be
even more new donors if local partners or organizations, particularly high schools, universities
and community organizations, participate actively and promote the effort. Mobile collections
at regular intervals in the same place increase donor retention.
It is important to consider the cost/effectiveness of mobile blood collection. During the planning
of mobile blood collections, the locations chosen should be those where the participation and
number of blood donations were highest during previous sessions.
For a blood mobile collection session to be successful, the key points to consider are:
– Choice of place and date
– Participation of partner organizations, especially during preparation of the event
– Organization and rigorous planning of logistics, including cold chain
– The preparation of premises
– Availability of all necessary staff

2.4 “Walking blood bank”

Blood is collected from a registered pool of pre-identified, low risk, voluntary donors. Donors
are called on demand, either because they have a rare blood group (e.g. O Rh D negative) or
when there is a sudden increase in the need for blood or because a recipient needs fresh non-
refrigerated whole blood.
A “walking blood bank” can be a temporary solution until a transfusion service with blood
storage capacity is available instead of or in addition to direct donation. It can also complement
a conventional blood transfusion service.

30
 Chapter 2: From donor to qualified blood unit for transfusion

3. Donor selection

The aims of donor selection are to provide blood that is as safe as possible for the recipient
and to ensure that blood donation does not harm the donor’s health.

3.1 Pre-selection process

The pre-selection process aims to protect the donor. Pre-selection criteria include age, weight,
time since last donation, number of donations over the past year, haemoglobin (Hb) level, and
for women, pregnancy and lactation (Chapter 2, Section 3.4).

3.2 Pre-donation questionnaire5,6

The questionnaire may help identify high-risk donors, thus minimizing the risk of collecting
infected blood. Well conducted questionnaires can lead to excluding a quarter of potential
donors in certain contexts.
The interview should take place in an area where auditory and visual privacy is ensured. The
donor’s name should not be recorded on the questionnaire. Answers are also confidential.
This must be clearly explained to the donor to encourage them to answer truthfully.
Staff must ensure that the donor understands the questions and why they are being asked. It
is important to mention to the donor that they can self-exclude themselves any time if they do
not wish to answer the questions.
The questionnaire should not be skipped in an emergency situation or due to concern that the
potential donor will change their mind if asked questions about their personal life.
Sensitive questions related to the risk of TTI must be asked and be formulated according to
the social and cultural context and local beliefs. Questions regarding high-risk exposure (e.g.
unprotected casual sex, multiple partners, men to men sex, IV drug use) must be asked with a
non-judgemental attitude.
If at the end of the questionnaire the donor is excluded, the reason for the exclusion must be
communicated to the donor if requested.

3.3 Physical examination

All donors should be in good physical condition.
The physical examination is brief:
– Measure temperature, pulse and blood pressure.
– Look for:
• Jaundice (conjunctiva)
• Cervical, axillary and inguinal lymph nodes
• Skin rash
• Oral thrush
The physical examination can be performed by a health care worker other than a physician
provided that they have been specifically trained for this task, are supervised by a physician and
if the national policy allows it. The potential donor must be referred to the physician in the event
of abnormality during the clinical examination.
Note: mobile blood collection must use the same pre-selection criteria (including Hb level),
and the questionnaire is still required but can be simplified.

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Chapter 2: From donor to qualified blood unit for transfusion

3.4 Contraindications for blood donation

Table 2.1 - Absolute and relative contraindications for blood donations
ABSOLUTE RELATIVE
Age < 15 years and > 65 years
Weight < 45 kg If 45 to 50 kg, collect a smaller volume
(150 or 250 mL)
Pregnancy During pregnancy and up to
6 months after delivery or
PRE-SELECTION

miscarriage
Breastfeeding Exclusive breastfeeding Mixed feeding: collect blood if child is
> 1 year
Last blood donation < 2 months If < 3 months, collect a smaller
Men: max. 4 blood donations/ volume (150 or 250 mL)
year if Hb > 13.5 g/dL;
Women: max. 3 blood donations/
year if Hb > 12.5 g/dL
Hb level < 11 g/dL If < 12.5 g/dL, collect a smaller
volume (150 or 250 mL)
Occupation Sex workers Military, drivers, itinerant workers or
people separated from their family
(for any reason)
Chronic illness HIV, hepatitis, severe asthma, Refer to the physician if other chronic
haemopathy including illnesses (e.g. pulmonary, cardiac).
haemoglobinopathy, epilepsy,
insulin dependent diabetes,
cancer
Current treatment Contraindication if rabies Antibiotics, anticoagulants,
vaccination after rabies exposure cardiovascular drugs (ß-blockers, anti-
arrhythmics, etc.), insulin.
Live attenuated vaccinesa within the
last 4 weeks.
Refer to the physician.
History of
– Dental procedure 1 day if simple dental care
HISTORY

(e.g. carries, dental descaling),

1 week if other dental care (root
treatment, extraction)
– Recent fever Refer to the physician if fever within
the 3 last weeks.
– Confirmed malaria Within the 3 last weeks Positive malaria testb
– Jaundice Unexplained jaundice, regardless If the cause is known, refer to the
of when it occurred physician.
– Cutaneous wound Until wound has healed
(infected wound, ulcers...)
– History of AAR, TB, Until 2 years after cure
Q fever, osteomyelitis
– History of dengue Until 6 months after cure

– History of cured Ebola Definitive exclusionc

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 Chapter 2: From donor to qualified blood unit for transfusion

ABSOLUTE RELATIVE
History of STId < 4 months after cure > 4 months after cure
For syphilis, 1 year after cure
Blood transfusion Definitive contraindication if
history of past transfusion
Surgery or endoscopy < 6 months if major surgery or
HISTORY

endoscopy
1 week if minor surgery
High risk exposure In the last 6 months: unprotected
casual sex (not with regular
partner), multiple partners, rape,
IV drug use, scarification,
tattoo, piercing - including
earlobes
Temperature > 37.5 °C axillarye
Pulse < 50 or > 100 or irregular
SIGNS

Systolic BP < 100 or > 180 mmHg

Conjunctiva Jaundice
Others Swollen lymph nodes, oral thrush,
skin rash: refer to the physician.

a Main live attenuated vaccines: yellow fever, oral polio, measles, rubella, mumps, BCG, varicella.
b Refer to malaria screening, Chapter 2, Section 6.2.4.
c See Chapter 1, Section 4.2.4.
d STI: sexually transmitted infection. A previous STI such as chlamydial infection, gonorrhoea or syphilis are risk
factors for HIV and hepatitis acquisition and transmission.
e Screen for malaria in an endemic area. Whatever the cause of the fever, exclude the donor or postpone the
donation and refer to the physician.

When there is an identified problem such as low Hb level or abnormal blood pressure etc., the
donor will be referred to a health facility to be managed.

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Chapter 2: From donor to qualified blood unit for transfusion

4. Pre- or post-donation screening

In direct donation, screening for TTI is always performed before blood collection as it is
pointless to collect the blood donation if any result is positive.
In mobile blood collection sessions, or in case of unexpected massive influx of donors in a
health facility, screening for TTI is always performed after blood donation, in the laboratory
due to organizational constraints.
For voluntary and replacement donations, the screening strategy should be carefully
considered before setting up blood transfusion activities as each strategy has advantages and
disadvantages.

Table 2.2 - Pre or post-donation screening: advantages and disadvantages

Advantages Disadvantages

Screening Safer for staff handling blood (e.g. Harder to guarantee confidentiality.
the donor collection, grouping, disposal).
before blood Use of blood donation as screening
donation In the laboratory, no risk of for HIV.
confusion between infected and
safe blood units. Risk of stigmatization in the event
of exclusion.
Less waste (blood, bags, etc.) and
less waste to dispose of. Requires that staff has time and is
able to communicate with donors
Enables to immediately explain clearly and respectfully.
the reasons for exclusion, prompt
treatment of the donor if the blood
is positive for syphilis or malaria,
and immediate referral for other
TTI.

Screening Easier to guarantee confidentiality. Risk of handling infected blood.

the donated
blood after Donors are less likely to use blood In the laboratory, risk of confusion
donation donation as a means of obtaining between infected and safe blood
their HIV status. donations.
Unnecessary blood donations and
waste of supplies.
More waste to dispose of (blood
bags etc.).
Missed opportunity to treat an
infected donor for syphilis or
malaria and missed opportunity to
refer for others TTI.

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 Chapter 2: From donor to qualified blood unit for transfusion

If at least 5% of blood donations are rejected due to TTI, the recommendation is to screen
before blood collection.

If screening is performed before donation:

– Draw a blood sample in an EDTAa tube.
– Perform the first blood grouping, the first HIV testb, and the test for hepatitis B, C and syphilisc
on the EDTA tube.
– Exclude the donor if any of the TTI test result is positive or doubtful.
– If all TTI tests are clearly negative: collect the blood donation, and then perform the second
blood grouping and the second HIV testd on the blood in the distal segment of the bag
tubing.

If screening is performed after donation:

– Collect the blood donation.
– At the end of collection, fill an EDTA tube, or in the event of a blood bag with a diversion
pouch (sampling arm), fill the EDTA tube as soon as the diversion pouch is full.
– Perform the first blood grouping, the first HIV test and the tests for hepatitis B, C and syphilis
using the EDTA tube one by one or in batchese.
– Discard the blood donation if any of the TTI test result is positive or doubtful.
– If all TTI tests are clearly negative, perform the second blood grouping and the 2nd HIV test
on the blood of the distal segment of the bag tubing.

In both cases:
If the second HIV test is clearly negative: the blood donation is qualified.
If the second HIV test is positive or doubtful: the blood donation is excluded.

All blood donations with any positive or doubtful test results must be discarded (Chapter 4,
Section 7).

For blood collection procedure, see Appendix 11.

When an HIV, hepatitis B or C test is detected positive and the donor wants to know their
results, they are referred to an appropriate health facility (Chapter 2, Section 1.7).

a EDTA: Ethylen Diamine Tetraacetic Acid

b First HIV test: HIV 1/2 Determine® is currently the most sensitive test available. It is recommended for blood
safety when Elisa tests are not available.
c For syphilis, see also Chapter 2, Section 6.2.3.
d Second HIV test: HIV Stat Pak® or HIV 1/2Uni-Gold®.
e In the event of a high workload, performing the tests in batches will save time but the risk of errors is higher.

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Chapter 2: From donor to qualified blood unit for transfusion

5. Collection of blood donation

5.1 Premises, furniture and equipment

The premises where donors’ blood is collected must be welcoming and comfortable for both
donors as well as staff, and separate from the laboratory. The premises should comply with the
following characteristics:
– Registration area
– Waiting room with enough seats
– Room that is well lit and ventilated (or air-conditioned).
– Water point nearby or in the room (to wash hands and forearms)
– Spacious enough for circulation of staff
– Rest room after blood donation: the donor must be in staff’s view at all times.
Suitable, regularly cleaned furniture:
– Sufficiently high donor chairs or beds
– Trolleys
– Work surface with sink
– Cupboard to store materials away from sunlight
Staff must be continuously present throughout the entire blood donation process. Nurses,
laboratory technicians or assistants, if local legislation allows, are authorized to collect blood.
They are trained to respect strict aseptic procedures and how to avoid blood exposure
accidents. Staff is always supervised by a physician.
In the event of many donations (over 5 blood donations per day), the presence of many blood
donors at the same time, or mobile blood collection, additional equipment may be useful:
– Blood collection monitors that in particular allow one staff member to collect blood from
several donors at the same time.
– A blood bag tube sealer.

5.2 Blood collection process

In order to prepare donors and create a positive memory experience which will encourage
them to return and make future donations:
– Thank them for their availability and reassure them if needed.
– Check when they last ate and drank. Certain donors may have travelled a considerable
distance and have walked a long way.
– Provide a drink to rehydrate if necessary and even something to eat before they donate blood.
– Demonstrate professionalism: have equipment ready and organised, dress smartly, wear a
clean medical coat, demonstrate a composed attitude and confident actions etc.
– Check the donor’s identity.
– Explain all stages of the procedure before starting to collect blood.
See Appendix 11 and Appendix 34.

5.3. Possible incidents during or after blood collection

– The blood flow is slow or the blood flow stops:
• Ensure the blood bag is lower than the venipuncture site.
• Ask the donor to pump their fist in order to increase the flow.
• Loosen and retighten the tourniquet in order to improve the flow.
• Move the needle gently.

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 Chapter 2: From donor to qualified blood unit for transfusion

– The blood flow stops before the minimum volume is reached:

The collected blood cannot be used for transfusion. Discard the bag.
Each blood bag contains a specific amount of anticoagulant solution for a determined
quantity of blood and should be filled appropriately to ensure the correct ratio blood/
anticoagulant.
If the donor agrees, attempt another collection on the other arm using a new bag. The blood
bag size for the second collection should be chosen taking into account the volume already
withdrawn from the donor, in order not to exceed the maximum amount per donation (e.g.
if 150 mL were withdrawn during the first attempt, use a bag of 250 mL for a second blood
collection when the donor is eligible for collection of 450 mL).
– In the event of vasovagal reaction:
Vasovagal reaction occurs during or after collection in up to 5% of blood donors.
It is frequently triggered by anxiety or can happen when the donor gets up too quickly.
The donor feels unwell with symptoms such as light-headedness, profuse sweating, pallor,
blurred vision, transient alteration of consciousness.
In case of loss of consciousness, stop the blood collection. Position the donor on their back
with their feet elevated. Once recovered, ensure that the donor is properly hydrated.
– In the event of accidental exposure to blood:
Follow the recommendations for post-exposure prophylaxis, following the recognized
protocol in the country.

37
Chapter 2: From donor to qualified blood unit for transfusion

6. Blood grouping and transfusion transmissible

infections screening

6.1. Donor’s blood grouping

For safety reasons, blood grouping must be performed twice:
– Firstly: on the donor’s blood, before or after donation.
– Secondly: on the blood donation, using the distal segment of the blood bag tubing.
The tile method is recommended as it is less prone to handling errors than the tube method
(Appendix 16).
When blood units are supplied by an external source e.g. a regional/national blood transfusion
centre or another hospital, the unit’s blood group must be checked and tested again for all TTI7
using blood from the distal segment of the blood bag tubing, unless the external source has
been validated by a competent medical professional (Chapter 4, Section 1.1.2).

6.2 Transfusion transmissible infection (TTI) screening

Donated blood must be routinely screened for HIV, hepatitis B, hepatitis C and syphilis. Other
screening tests (e.g. malaria, Chagas’ disease) are performed according to the epidemiological
context (Chapter 1).
Screening tests have to combine:
– High sensitivity in order to correctly detect as soon as possible after contamination infected
blood and to avoid false negative test results.
– High specificity to avoid rejecting blood with false positive test results.
Tests must be stable under field conditions (e.g. transport, temperature, humidity) and results
must be rapidly available.
Performing the full battery of tests is preferred as it provides more complete and accurate
information on the positivity rate of each infection among donors/donations. Sequential
testing (according to local epidemiology of infections) is more cost effective and less time
consuming, but the positivity rates are not representative of real TTI prevalence rates of the
donor population as they are based on different denominators.
See Appendices 19 to 25.3.

6.2.1 HIV
The objective of screening blood for HIV is to provide safe blood for the recipient, not to
diagnose HIV infection in the donor. Therefore, the blood safety testing strategy differs from
the individual testing algorithm used for HIV infection diagnosis.
The WHO considers the use of one single highly sensitive and specific HIV 1/2 test sufficient to
ensure transfusion safety regarding HIV transmission.

38
 Chapter 2: From donor to qualified blood unit for transfusion

However, to improve screening reliability, it is prudent to perform 2 different tests on 2 different

blood samples because rapid tests have inherent limitations and because human error (e.g.
in handling or storing tests, labelling tubes, bags and test devices) may result in inaccurate
results.
The two HIV tests results must be clearly negative. In the event of a doubtful or positive result
in the first test, the donor or the blood donation must be excluded.
Nevertheless, a negative HIV test does not prevent HIV transmission through transfusion if
the donor has been infected within the previous 3 to 4 weeks, which is the usual period for
detection of HIV antibodies using highly sensitive rapid tests in immune competent individuals.
The pre-donation questionnaire and physical examination are therefore essential to select low
risk donors and exclude those who may have been infected recently.

6.2.2 Hepatitis B and C

In the event of doubtful or positive results, the donor or the blood donation must be excluded.
The average period for hepatitis B surface antigen (HBs Ag) detection is 30 days (7 - 63 days)
and 82 days (54 - 192 days) for HCV antibody using rapid tests.

6.2.3 Syphilis
Screening should be performed using a rapid Treponema-specific test (e.g. Syphilis 3.0 SD
Bioline®). RPRa is no longer recommended as it is neither sensitive nor specific enough.
Syphilis positive blood should not be transfused as it may be infected by Treponema pallidumb.
Furthermore, syphilis positive donors are at higher risk of having acquired other STIs, including
HIV infection.
However, under exceptional circumstances (blood shortage, life-threatening emergency), the
use of syphilis positive blood can be justified after 5 days of storage at 4 °C, provided the
recipient is simultaneously treated for syphilis.
Table 2.3 - Management of syphilis positive test c

If the donor’s test is positive If the blood unit is positive

(screening before donation) (screening after donation)

• Collect blood only in the event of an • Label the blood unit as syphilis-positive
emergency if no other donor is available. and store it separately from the other
• Treat the donor AND the recipient for units in the refrigerator for 5 days before
syphilis. usec.
• Use this unit only if there is no alternative.
• If the blood is transfused, treat the
recipient for syphilis.

a RPR : Rapid Plasma Reagin : non- treponemic test

b A positive syphilis test does not indicate whether the donor has been infected recently or in the past, nor
whether they are still infectious. The test can remain positive even after successful treatment.
c Treponema pallidum is sensitive to cold. Infectivity decreases when blood is refrigerated (between 2 °C and
8 °C) and blood is no longer infectious after a period of 120 hours (5 days).

39
Chapter 2: From donor to qualified blood unit for transfusion

First choice treatment is benzathine benzylpenicillin IM: 2.4 MIU as a single dose. Alternative
treatment is doxycycline PO: 100 mg 2 times daily for 14 days if benzathine benzylpenicillin
is not available or in penicillin allergic patients. It is contraindicated in pregnant and lactating
women.

6.2.4 Malaria
In low endemic areas or areas of seasonal transmission
Malaria screening should be performed, using an RDT. Despite a negative test, malaria can still
be transmitted when the donor’s parasitaemia is too low to be detected. Thus, during donor
selection, donors with fever or history of recent fever or recent malaria infection should be
excluded.
Donors with a positive malaria test will receive a full, effective antimalarial treatment.
Blood should not be collected, unless transfusion is needed urgently and no other donor
is available. In that case, treat all recipients of malaria positive blood with a full, effective
antimalarial treatment.
All neonates should receive a full course of anti-malarial treatment when they receive a blood
transfusion. This is regardless of the malaria RDT test result.

In highly endemic areas with stable transmission8

The decision to screen for malaria or not should take into consideration the prevalence of the
disease, the laboratory capacity to perform the tests and national recommendations.
Depending on the context, 2 options are possible:
– Option 1: donors are not screened for malaria and an effective antimalarial treatment is
routinely administered to all recipients.
– Option 2: screening is routinely performed but positive blood is not necessarily excluded.
It can be drawn then labelled as malaria-positive and stored separately. When the blood is
transfused, the recipient receives concomitantly an effective antimalarial treatment. Malaria
RDT positive blood units must be transfused only to malaria positive adult recipients while
systematically giving them antimalarial treatment.
All neonates should receive a full course of anti-malarial treatment when they receive a blood
transfusion. This is regardless of the malaria RDT test result.

6.3 Qualified blood unit

A blood unit is qualified for transfusion when a blood donation, or the components issued
from it, fulfils all the criteria required for blood safety, i.e.:
– Undamaged bag (no leaks)
– Correct colour of contents
– Minimum length of blood bag tubing, with at least 3 segments
– Tubing correctly closed (tight knots or correct seals)
– Adequate weight
– Negative TTI tests results
– Blood grouping tested twice and concordant
– Clear and complete labelling

40
 Chapter 2: From donor to qualified blood unit for transfusion

7. Possible preparations from whole blood

7.1 Packed red blood cells prepared by sedimentation from a single blood bag
of whole blood
See Appendix 12 for procedure.
Packed red blood cells (PRBC) are to be favoured:
– In the event of anaemia without hypovolaemia.
– In patients at risk of circulatory overload, including children.
– In patients transfused with non-identical ABO blood.
The blood unit must not be shaken during transfer to the ward nor during the transfusion, in
order to avoid mixing the sedimented red blood cells with the plasma.
The transfusion must be stopped when the plasma reaches the bottom of the blood bag or
when the prescribed volume has been administered.

7.2 Preparation of paediatric whole blood units from a penta bag system
See Appendix 13 for procedure.
The penta bag system is a closed system consisting of a 450 mL primary bag containing the
CPDA-1 anticoagulant/preservative solution, connected to 4 satellite 100 mL bags that do not
contain anticoagulant.
This system allows transfer of the whole blood in the primary bag into the 4 satellite bags for
paediatric needs.
The satellite bags must only be filled once the blood donation is qualified for transfusion.

7.3 Preparation of paediatric PRBC units by sedimentation from the penta bag
system
The 450 mL primary bag is put to sediment according to the procedure described in Appendix 12,
but with the transfusion outlets pointing up.
The remaining procedure is described in Appendix 14.
The plasma is transferred into one of the satellite bags, and discarded because it does not
qualify as fresh frozen plasma: it is ordinary plasma of no therapeutic use.
The concentrated red blood cells are distributed:
– Into the other 3 satellite bags to obtain 3 paediatric units of PRBC,
– Or into the other 3 satellite bags and the primary bag to obtain 4 paediatric units of PRBC.

41
Chapter 2: From donor to qualified blood unit for transfusion

8. Registration and labelling

8.1 Blood donors register

The donor’s name, occupation, address and phone number may be kept in a blood donors
register. This register must be kept in a safe place, under lock and key.
The blood donors register is the only document where the link between the donation number
and the donor’s identity can be found. This link allows tracing back of donors when:
– There is a pool of regular donors including donors called on demand.
– The national transfusion policy may recommend tracing blood donors, e.g. when a serious
transfusion complication is to be investigated or in the event of abnormal screening test
results.
The results of TTI screening must not be reported in the blood donors register.

8.2 Blood donations register

Information pertaining to the donation (date of donation, donation number, blood grouping
and TTI screening results) should be recorded in a blood donations register (see Appendix 27).
The blood donation is identified by a single identification number attributed when the blood
donor is declared eligible for blood donation. The donation number remains the same during
the qualification and preparation process and all components prepared from this donation
keep the same number. The donor’s name, age, address or any other identifying information
must not be recorded in the blood donations register.
In the event of mobile blood collection, ensure blood is collected using a different donation
number series from that used to identify blood collected in the health facility, in order to avoid
confusion with blood collected at the facility on the same day.

8.3 Blood unit labelling

Before collection, the empty blood bag is labelled using a permanent marker recording the:
– Donation number
– Blood collection date
– Expiry date
The blood group is only added AFTER the second blood group determination.
On the qualified blood unit, are also clearly marked:
– Tests results, including possible positive test results for malaria and syphilis,
– Type of blood component,
– Volume.
Given that this information is manually written, it is recommended to adopt a convention
(decided by the team) to write each piece of information in a given section of the label (e.g.
the blood group in the top right corner of the label) whatever the type or brand of the blood
bag; this is to facilitate looking for blood units in the fridge and checking them on the wards.

42
 Chapter 2: From donor to qualified blood unit for transfusion

Figure 2.1
Information to be recorded on each blood unit

8.4 Blood stock/delivery register

A blood stock/delivery register is needed to track the use of blood units. It combines information
on the qualified blood units and on the recipient (Appendix 29).
The register, divided into 4 sections (one for each ABO blood group), is used to facilitate the
search for the needed blood unit. When transfusion activity is high, one register per blood
group can be used.
Each blood unit, once qualified for transfusion, should be immediately entered in the register
recording the following information: blood unit number, date of collection, blood group ABO
Rh D, type of component, volume and expiry date, on the left side of the register.
Once the blood unit is issued, information on the recipient is entered in the register (date, name,
age, sex, blood group and Hb level, reason for transfusion, ward, patient file number, cross-match
result, time of delivery), on the right side of the register.
If a blood unit is returned without being transfused, it can be re-entered into the stock and issued
for another patient, only if it has remained in the cold chain.

8.5 Transfused patients register = recipients register

See Appendix 30.
Each blood unit delivered is recorded in this register. The entries on the left side of the register
record the blood unit delivery date, recipient information and on the right of the register
information on the blood unit(s) delivered.
Note: in a health facility with low transfusion activity (few blood units per week) and therefore
a small stock, a transfused patients’ register is sufficient instead of keeping both a stock register
and a transfused patients register.

43
Chapter 2: From donor to qualified blood unit for transfusion

9. Decision trees
Voluntary donation and replacement donation
If screening is performed BEFORE donation

Donor
Age, weight, sex, pregnancy, lactation, date of last donation?

Exclude. Look for YES Exclusion criteria?

another donor
NO

Collect capillary blood for Hb

(+ malaria screening if indicated)

Exclude. Look for NO Hb ≥ 11 g/dL?

another donor
YES

Questionnaire and physical examination

Exclude. Look for YES Exclusion criteria?

another donor
NO

Collect a blood sample in an EDTA tube

First ABO Rh D group and

first HIV(1) test and HBV, HCV and syphilis(2) tests

Exclude. Look for NO All clearly negative?

another donor
YES

Collect the blood donation

2nd ABO Rh D group and 2nd HIV test (3)

(on blood bag tubing)

Exclude. Look for NO 2nd HIV test clearly negative?

another donor
YES

Label the blood unit

Blood unit qualified for transfusion

Store in cold chain if not needed immediately

(1) HIV 1/2 Determine®

(2) Refer to Chapter 2, Section 6 in the event of positive syphilis or malaria screening.
(3) Stat Pak® or Uni-Gold®
Note : in case of high workload, batch testing on EDTA tubes is possible. However, the 2nd HIV test and the
2nd blood group must be performed one by one using the blood bag tubing.

44
 Chapter 2: From donor to qualified blood unit for transfusion

Voluntary donation and replacement donation

If screening is performed AFTER donation

Donor
Age, weight, sex, pregnancy, lactation, date of
the last donation?

Exclude. Look for YES Exclusion criteria?

another donor
NO

Collect capillary blood for Hb

(+ malaria screening if indicated)

Exclude. Look for NO Hb ≥ 11 g/dL?

another donor
YES

Questionnaire and physical examination

Exclude. Look for YES Exclusion criteria?

another donor
NO

Collect the blood donation and an EDTA tube

EDTA tube

First ABO Rh D group

and first HIV test(1)
and HBV, HCV and syphilis(2) tests

YES
2nd ABO Rh D group and 2nd HIV test(3)
All clearly negative?
(on blood bag tubing)
NO

NO
Discard blood donation 2nd HIV test clearly negative?

YES

Label the blood unit

Blood unit qualified for transfusion

Store in cold chain if not needed immediately

(1) HIV 1/2 Determine®

(2) Refer to Chapter 2, Section 6 in the event of positive syphilis or malaria screening.
(3) Stat Pak® or Uni-Gold®
Note : in case of high workload, batch testing on EDTA tubes is possible. However, the 2nd HIV test and the
2nd blood group must be performed one by one using the blood bag tubing.

45
Chapter 2: From donor to qualified blood unit for transfusion

Direct donation

Donor
Age, weight, sex, pregnancy, lactation, date of the last donation?

Exclude. Look for YES Exclusion criteria?

another donor
NO

Collect capillary blood for Hb,

first ABO Rh D group
(+ malaria screening if indicated)

Exclude. Look for NO Hb ≥ 11 g/dL?

another donor
YES

Exclude. Look for NO Compatible blood group?

another donor
YES

Questionnaire and physical examination

Exclude. Look for YES Exclusion criteria?

another donor
NO

Collect a blood sample into an EDTA tube

First HIV test(1) and HBV HBC and syphilis(2) test

Exclude. Look for NO All clearly negative?

another donor
YES

Collect the blood donation

2nd ABO Rh D group and 2nd HIV test(3)

(on blood bag tubing)

Exclude. Look for NO 2nd HIV test clearly negative?

another donor
YES

Label the blood unit

Blood unit qualified for direct transfusion

(1) HIV 1/2 Determine®

(2) Refer to Chapter 2, Section 6 in the event of positive syphilis or malaria screening.
(3) Stat Pak® or Uni-Gold®

46
 Chapter 2: From donor to qualified blood unit for transfusion

References Chapter 2

1. WER, 40 (84): 405– 420, Hepatitis B vaccines – WHO Position Paper

http://www.who.int/wer/2009/wer8440.pdf

2. WHO et IFRC. Vers 100% de Dons de sang volontaires, cadre mondial d’action. WHO et
IFRC, 2010.
http://www.who.int/bloodsafety/publications/9789242599695.pdf?ua=1

3. Methodological guidelines for socio-cultural studies on issues related to blood donation.

http://www1.paho.org/hq/dmdocuments/2009/F4942Method%20GuideTEXT.pdf

4. IFRC. Making a difference : recruiting voluntary non remunerated blood donors.

http://www.ifrc.org/PageFiles/53503/1226403-IFRC%20Health%20Corporate%20
Folder%202012-EN-7-Blood-donation-LR.pdf

5. Bruno Danic, Pierre Gallian, Dominique Legrand, Bertrand Pelletier, Le don de sang en
France : les grands principes du don, son organisation, ses contre-indications médicales et
les modalités de dépistage, BHE 39-40, 2012.
http://opac.invs.sante.fr/doc_num.php?explnum_id=8539

6. Arrêté du 5 avril 2016 fixant les critères de sélection des donneurs de sang, JORF n°0085
du 10 avril 2016, texte n°8.
https://www.legifrance.gouv.fr/eli/arrete/2016/4/5/AFSP1608360A/jo/texte

7. WHO. Screening Donated Blood for Transfusion-Transmission Infection, recommendations.

WHO, 2009.
http://www.who.int/bloodsafety/ScreeningTTI.pdf

8. Alex K. Owusu-Ofori Christopher Parry Imelda Bates, Transfusion-Transmitted Malaria in

Countries Where Malaria Is Endemic: A Review of the Literature from Sub-Saharan Africa,
Clinical Infectious Diseases, Volume 51, Issue 10, 15 November 2010, Pages 1192–1198.
https://academic.oup.com/cid/article/51/10/1192/393419/Transfusion-Transmitted-
Malaria-in-Countries-Where

47
Chapter 3:
Blood transfusion process

1. Indications of red cells transfusion............................................................................. 51

2. Prescription................................................................................................................ 55

3. Delivery of blood units............................................................................................... 61

4. Administration of a blood unit................................................................................... 62

5. Management of transfusion-related complications...................................................66

6. Particular case of fresh frozen plasma........................................................................ 74

References...................................................................................................................... 76
 Chapter 3: Blood transfusion process

1. Indications of red cells transfusion

Transfusion of red blood cells improves oxygen transport in patients with clinical symptoms of
anaemia. Transfusion is indicated to relieve clinical symptoms of decompensation of anaemia
or prevent further decompensation in patients at risk. It is not indicated to normalize the
patient’s Hb level.

1.1 Severe anaemia

Anaemia is defined by a Hb level below reference values for age, sex and for pregnant woman,
pregnancy state (see Appendix 1). It results in a decrease in blood oxygen-carrying capacity.
However, low Hb levels may be well tolerated. Clinical tolerance is related to the rate at which
it develops and the patient’s underlying condition.
– The more rapidly anaemia develops, the more likely compensatory mechanisms to maintain
the transport and transfer of oxygen to tissues will be overwhelmed, especially in patients
with impaired cardiopulmonary function.
– Conversely, slow-onset chronic anaemia is usually well tolerated (except in patients with
pre-existing cardiopulmonary disorders) since long-term mechanisms will have developed
over weeks or months.
– However, many factors such as fever, infection, haemorrhage or haemolysis can precipitate
the decompensation of well-tolerated anaemia.
– Decompensation signs of anemia are: respiratory distress, tachycardia, altered mental
status, cardiac failure, coronary failure, shock.
Anaemia is considered severe when Hb level falls below critical values (or transfusion
thresholds), even if there are no signs of decompensation and/or clinical symptoms. In an
episode of severe malaria, Hb level can drop by 2 g/dL per day. In children, the risk of death
rapidly increases when Hb level drops below 4 g/dL.1 Therefore close monitoring of Hb is
essential in adults and children with severe malaria and transfusion should be considered
when the Hb is approaching transfusion trigger levels.
Note: transfusion thresholds are the Hb values at which transfusion is imperative (except in
the event of hereditary anaemia, see Chapter 3, Section 1.4.1).

Table 3.1 - Hb transfusion thresholds

Premature Hb < 7 g/dL
Transfusion is indicated if Hb < 10 g/dL
neonate
AND
There are signs of decompensation
Full-term neonate Hb < 8 g/dL

Children Hb < 4 g/dL Transfusion is indicated if Hb is between 4 and 6 g/dL

AND
There are signs of decompensation, sickle cell, severe
malaria, severe bacterial infection or pre-existing heart
disease

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Chapter 3: Blood transfusion process

Table 3.1 - Hb transfusion thresholds (continued)

Pregnant women Hb ≤ 5 g/dL Transfusion is indicated if Hb < 7 g/dL
< 36 weeks AND
There are signs of decompensation, sickle cell, severe malaria,
severe bacterial infection or pre-existing heart disease.

Pregnant women Hb ≤ 6 g/dL Transfusion is indicated if Hb < 8 g/dL

≥ 36 weeks AND
There are signs of decompensation, sickle cell, severe malaria,
severe bacterial infection or pre-existing heart.

Adults Hb < 7 g/dL

Consider earlier transfusion in patients with signs of decompensation, sickle
cell, severe malaria, severe bacterial infection or pre-existing heart disease.

Adapted from the WHO CD Rom, Clinical use of blood, 2005.2

1.2 Acute haemorrhage

Acute haemorrhage is associated with hypovolaemia and reduced circulating haemoglobin.
Acute haemorrhage causes haemodynamic instability, with reduced tissue perfusion and
oxygen delivery. The priorities of management are to control bleeding and restore circulating
volume, while maintaining oxygenation. Patients with ongoing, massive bleeding may benefit
from limited fluid resuscitation and toleration of moderate hypotension until haemorrhage
has been controlled.
Crystalloid solutions should be used for initial correction of hypovolaemia (Ringer Lactate or
0.9% sodium chloride). There is no evidence that colloids (Haemaccel®, Plasmion®, Gelofusin®)
are more effective than crystalloids for fluid resuscitation and may be associated with increased
adverse effects. Blood should not be used to correct hypovolaemia.
Blood loss equivalent to 30% total blood volume (ACSa Class I and II Acute Haemorrhage)
can normally be tolerated without blood transfusion, provided that volume replacement is
adequate.
The decision to transfuse is based on clinical criteria. Transfusion is indicated when
haemodynamic instability and tissue hypoxia persist despite adequate volume resuscitation. It
is usually necessary when blood loss exceeds 30-40% total blood volume (ACS Class III and IV).
However, earlier transfusion may be necessary if the patient’s underlying condition prevents
effective compensation of acute anaemia.
At birth, an acute haemorrhage can present with pallor (without jaundice), tachypnea (or
gasping respiration), tachycardia and symptoms of hypovolaemia ranging from decreased
peripheral perfusion (10% loss of blood volume) to hypovolaemic shock (20-25% loss of blood
volume).3

1.3 Coagulation disorders

Stored (non-fresh) blood is not effective in correcting haemorrhage secondary to coagulation
disorders as it contains neither coagulation factors V and VIII nor functional platelets.

a ACS: American College of Surgeons

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 Chapter 3: Blood transfusion process

1.3.1 Acquired disorders

Early trauma induced coagulopathy is due to release of inflammatory mediators from
damaged tissue, dilution of blood with crystalloids, acidosis associated with tissue hypoxia
and hypothermia.
Disseminated intravascular coagulation (DIC) is mainly seen in obstetric complications (e.g.
abruptio placentae, retained dead foetus), snake envenomation (viperids, crotalids) and
severe infections (e.g. meningococcal and other bacterial septicaemia, malaria). Management
consists essentially of treating the primary cause of early trauma induced coagulopathy and
DIC and restoring platelets and coagulation factors by the transfusion of fresh whole blood
(never refrigerated) or specific blood components, such as fresh frozen plasma and platelet
concentrates, if they are available.

1.3.2 Congenital disorders

Patients with congenital disorders of platelets or coagulation factors are at risk of severe
bleeding during trauma, delivery or surgery and need specific blood components (e.g.
cryoprecipitates, platelet concentrates) to correct their deficiency. They should be referred to
a centre where these components are available.
In the event of haemorrhage, if referral is not feasible, transfusion of fresh whole blood may
provide adequate clotting factors and platelets to control haemorrhage if the coagulation
disorder is mild to moderate.

1.4. Specific considerations

1.4.1. Hemoglobinopathies
Sickle cell disease
Transfusion is indicated in:
– Acute severe haemolysis: if Hb ≤ 5 g/dL or drop of 2 g/dL below the patient’s baseline.
Target a Hb level of 9 g/dL.
– Splenic sequestration with Hb ≤ 5 g/dL (the objective is to reach 7-8 g/dL maximum).
– Stroke: if Hb ≤ 9 g/dL; target Hb of 10 g/dL.
– Acute chest syndrome: if symptoms are unresponsive to antibiotics and Hb < 9 g/dL.
– Pregnant woman ≥ 36 weeks with Hb < 8 g/dL.
– Pregnant woman < 36 weeks with Hb < 7 g/dL

Thalassaemia major
Thalassaemia major is a severe, transfusion-dependent anaemia.
The Hb target should be 10 to 12 g/dL.
Administration of iron chelating agents is essential for the treatment of chronic iron overload
secondary to frequent transfusions. Patients with thalassaemia intermedia do not usually
require regular transfusions.

Glucose-6-phosphate-dehydrogenase (G6PD) deficiency

G6PD deficiency can cause acute or chronic haemolysis during severe viral and bacterial
infections, or ingestion of certain foods (e.g. fava beans) or exposure to various drugs
(e.g. dapsone, nitrofurantoin, primaquine, sulfonamides, aspirin, chloroquine, quinine,
chloramphenicol). Transfusion is not required in most cases but is indicated in severe
haemolysis.

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Chapter 3: Blood transfusion process

1.4.2. Severely malnourished children

In the absence of other explanations, a drop in Hb level within a few days following the
admission in nutritional centre suggests the correction of a pre-existing haemoconcentration
(increase in plasma volume following oral or IV rehydration) and in itself is not an indication
for transfusion.
According to the WHO, children with kwashiorkor may have redistribution of fluid leading to
low Hb (related to haemodilution) which does not necessarily require transfusion.

1.4.3. Obstetrics
During delivery, normal blood loss is approximately 500 mL (for vaginal delivery and for
caesarean section). If blood loss is not greater than normal and the Hb level was ≥ 8 g/dL
before delivery, blood transfusion is rarely necessary.
In the event of elective caesarean section, if the preoperative Hb level is < 8 g/dL prepare two
compatible and cross-matched blood units and have them ready for immediate use but do not
perform preventive transfusion.

1.4.4. Surgery
In healthy patients, the pre-operative decision for a transfusion depends on the patient’s clinical
tolerance of anaemia. However, be prepared for transfusion if Hb is < 7 g/dL in a healthy adult
undergoing major surgery or surgery with significant blood loss. Have blood units ready for
immediate use (compatible and crossmatched), but do not perform preventive transfusion. All
patients who undergo elective surgery, even if minor, must have a blood group determination
performed.
In adults with low cardiopulmonary reserve (e.g. heart failure, coronary disease, chronic
respiratory disease) or in elderly patients, an Hb threshold of 8-9 g/dL is usually recommended
before surgery.
Notes:
– When a patient is referred to a surgical facility for elective surgery, certain facilities may
organise that a compatible and negatively crossmatched donor selected from the patient’s
entourage accompanies them in case the patient requires a transfusion.
– Blood recovered from a large, closed haemothorax via an intercostal drain may be re-
infused as an alternative to transfusion of donor blood. This must only be undertaken by
experienced staff using adequate sterile equipment.

1.4.5 Severe burns

Burns initially do not bleed. In the absence of comorbidity, such as trauma or profound pre-
existing anaemia, burns alone do not call for a blood transfusion.
However, surgical interventions on burns, such as excision-grafting, may cause copious
bleeding and therefore require preparation for possible transfusion. Extensive burns cause an
inflammatory syndrome that prevents haematopoiesis. It is therefore essential to constantly
monitor the Hb level throughout the wound healing process. Furthermore, anaemia delays
wound healing.

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 Chapter 3: Blood transfusion process

2. Prescription

Only a physician or an anaesthetist nurse (if local legislation allows) can prescribe a blood
transfusion. They are responsible for the following steps:

2.1. Request the patient’s Hb level and determine the transfusion indication
The decision to transfuse a patient is based on several parameters:
– Clinical tolerance of anaemia
– Underlying conditions (cardiovascular and pulmonary disease disease, etc.)
– Severity, rate and history of blood loss or of red cell destruction
– Haemoglobin levela
When transfusion is indicated, it should be carried out without delay.

2.2. Inform the patient about the need for a transfusion and obtain written
consent
Once the decision to transfuse has been taken, the patient or legal representative must be
informed about the benefits/risks of transfusion.
The patient (or legal guardian) MUST give written consent for transfusion. (Appendix 6).
If it is not possible to obtain consent, the transfusion can be administered if the physician
considers it is in the best interest of the patient. In this event, the patient must be informed
later that they have received a transfusion.
An adult or a legal representative of a child, who is able to give informed consent, may refuse
transfusion. In such cases, it is important to understand the reason for the refusal and to
explain the benefits of the transfusion. In the event of continued refusal, inform the patient of
the consequences of this decision. Any refusal of transfusion must be recorded in the patient’s
file.

2.3. Request the patient’s blood group determination

Even if the patient knows what blood group they are, the blood group must still be determined.
The patient’s blood group should be determined twice. The first determination can be done
on admission (on capillary blood if venous sampling fails) and the second determination when
blood is prescribed (Appendix 16 and Appendix 26).
Notes:
– An EDTA tube is necessary for crossmatching and is drawn when the transfusion is prescribed.
– All blood samples must be labelled with the patient’s identity and the date of collection.
– The ABO bedside compatibility test should not be confused with blood group determination.

a Recommended equipment for Hb measurement includes point-of-care analysers (HemoCue Hb 301®) or

automated haematology analysers.

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Chapter 3: Blood transfusion process

2.4. In the event of direct donation, ask for identification of a compatible blood
donor
See Chapter 2.

2.5. Prescribe the blood product, the volume needed, and the transfusion rate;
indicate the urgency of transfusion
2.5.1 Choice of blood component
In most cases, the choice is limited to whole blood or packed red blood cells (PRBC).

Stored whole blood

The stored whole blood (i.e. kept refrigerated) is the most commonly transfused component
and mainly indicated in severe anaemia with hypovolaemia (e.g. trauma, haemorrhage) or in
some aetiologies of shock.
In stored blood, red blood cells keep their qualities (oxygen carrying capacity, deformability)
but platelets irreversibly self-aggregate at temperatures below 16 °C and thermo-labile
coagulation factors deteriorate within 72 hours when stored at 4 °C.

Fresh whole blood

When it is necessary to provide platelets and/or clotting factors, and if specific components
are not available:
– Massive haemorrhages in surgical, obstetric and trauma patients: if the volume of blood
transfused within 12 hours reaches 50% of the total blood volume, stop transfusing stored
whole blood and administer fresh whole blood (blood collected less than 4 hours before
transfusion, that has never been refrigerated).
– DIC: if possible transfuse fresh whole blood from the outset.

PRBC
PRBC are preferred:
– For patients with severe anaemia without hypovolaemia (e.g. haemolysis)
– For patients at risk of circulatory overload, i.e. those with cardiac or respiratory disease,
elderly patients, and children.
– In the event of transfusion with non-ABO identical blood (Chapter 1, Section 3).
PRBC are either:
– Supplied by the national blood transfusion service.
– Prepared from multiple bags after sedimentation and separation into satellite bags.
– In the absence of multiple bags, whole blood units can be stored vertically with the
transfusion outlets pointing down, and then carefully transported to the ward so as to
not mix the red cells back into the plasma. Only the sedimented red blood cells must be
transfused (Appendix 12).

2.5.2 Compatibility rules

Adults & children above 4 months
Use ABO Rh identical blood whenever possible.
If identical ABO Rh D blood is not available, compatible ABO Rh D blood may be transfused
only with the prescribing doctor’s agreement according to the compatibility rules mentioned
in the table 3.2.

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 Chapter 3: Blood transfusion process

Table 3.2 - Compatibility rules for red cells transfusion for adults and children above 4 months

Recipient Blood unit ABO group

ABO group 1st choice 2nd choice 3rd choice 4th choice
O O
A A O
B B O
AB AB A B O

Blood unit Rhesus

Recipient’s Rhesus
1st choice 2nd choice
Rh D positive Rh D positive Rh D negative
Rh D negative Rh D negative See Chapter 1, Section 3.2

Neonates up to 4 months
The blood must be compatible with both the mother’s and child’s blood according to the
table 3.3. Do not use blood from the mother. For more information, see Chapter 1, Section 3.4.

Table 3.3 - Compatibility rules for red cells transfusion for neonates up to 4 months

Neonates
Mother Blood to transfuse Comments
up to 4 months
O A, B or O O
A or AB A (or O)
A
B or O O
B or AB B (or O) If mother’s blood group
B unknown:
A or O O give O group blood
AB AB, A, B (or O)
AB A A (or O)
B B (or O)
Rh + Rh +
Rh -
Rh +
Rh - If Direct Coombs test
negative in child, If mother’s Rh unknown:
possible to give Rh + give Rh - blood
Rh + Rh -
Rh -
Rh - Rh -

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Chapter 3: Blood transfusion process

Notes:
– In all cases, prefer ABO identical blood transfusion when possible.
– When O blood is to be transfused to a non O child, transfuse PRBC, or the least possible
amount of plasma.
– Secure Rh negative blood for Rh negative recipients.

2.5.3 Volume to be transfused

Children up to 20 kg including severely malnourished children
The volume to be administered is:
– For whole blood: 20 mL/kg
– For PRBC: 15 mL/kg
See Appendix 7.
To reduce the risk of circulatory overload, preferably use PRBC to reduce the volume to be
transfused.
Close and regular monitoring during and after transfusion is critical as an increase in blood
volume can precipitate or aggravate heart failure. The physician must be immediately informed
of any anomaly.
Notes:
– Transfusion set tubing holds a dead volume of around 15-18 mL; the doctor must take this
volume into account when calculating the volume of blood to be ordered.
– If PRBC are prescribed but whole blood is delivered, red cells will start spontaneously
sedimenting during the transfusion. Warn the staff and the care giver that this is normal. Do
not homogenise. Stop the transfusion when the prescribed volume has been administered
or when there is only plasma left in the bag.

Adults
For an average-size adult, one unit of 450 mL of whole blood or one unit of adult PRBC increases
the Hb level by 1 to 2 g/dL.
Important notes:
– Fever, even if high, is not a contraindication for transfusion.
– The patient does not need to have an empty stomach; if the patient needs to eat at the
beginning of the transfusion, wait 15 minutes after the start of the transfusion.
– Routine administration of furosemide prior to transfusion in order to prevent cardiac failure
or pulmonary oedema is not recommended. The decision to administer furosemide (Child:
0.5 to 1 mg/kg/injection; Adult: 20 to 40 mg/injection, by slow IV injection) should be made
on a case-by-case basis, according to the patient’s clinical condition.

2.5.4 Transfusion rate

Blood units should not be exposed to ambient temperature more than 4 hours and a half
(30 minutes for blood delivery and 4 hours for administration) to limit bacterial proliferation.
Fast infusion rates increase the risk of circulatory overload in patients with cardiac or respiratory
disease, elderly patients, and children.
In children without hypovolemia and/or shock, the recommended transfusion rate is
5 mL/kg/hour for PRBC and whole blood (Appendix 7).
In the event of haemorrhagic shock, insert the blood unit into an inflatable cuff or a pressure
cuff to increase the flow rate without exceeding a pressure of 300 mm Hg. Ensure further
venous access is available in case it is needed.

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 Chapter 3: Blood transfusion process

2.5.5 Urgency of transfusion

In urgent cases, blood is needed within 1 hour or lessb.
In life-threatening emergencies, when the patient’s blood group is unknown, the transfusion
department can issue O Rh D negative blood (Chapter 1, Section 3.1).

2.5.6. Massive transfusion protocol

A transfusion is defined as massive if:
– In children and adults: over 50% of the total blood volume is replaced by blood components
in less than 3 hours (total blood volume is 70 mL/kg in men, 60 mL/kg in women, 80 mL/kg
in children and 85-90 mL/kg in neonates).
– Or in adults: 3 whole blood units or 4 PRBC units are transfused in the first hour and further
blood components are expected to be needed.
– Or in children: the transfusion of over 15 mL/kg of PRBC in the first hour.

Management in adults
– Hb level, urgent blood group determination and a blood EDTA tube for the crossmatch.
– If available, ask for platelet count, thrombin time (TT) and activated cephalin time (ACT),
calcium and potassium.
– If there is no blood stock, identify and test potential compatible blood donors and/or warn
the blood transfusion department that a massive transfusion protocol has been activated.
– Order and transfuse according to the protocol below based on the availability of components:
Step 1
• 2 whole blood units (the most recent units)
• Or 2 fresh whole blood units
• Or 2 whole blood units + 2 FFP
• Or 2 PRBC + 2 FFP
• Tranexamic Acid (Exacyl®)4 is indicated in massive haemorrhage due to trauma and in
massive obstetric haemorrhage. The first dose must be given as soon as possible and within
three hours after the onset of bleeding (administration of the first dose of tranexamic acid
after three hours may be associated with increased risk of mortality).
• Protocol: inject tranexamic acid 1 g by slow IV bolus in 10 minutes.
• If bleeding continues, a second bolus of tranexamic acid 1 g slow IV (10 minutes) may be
given 3 hours after the first bolus.
• Systematically add calcium gluconate: 1 g by slow IV in a separate IV line from the blood
components. The first dose of calcium gluconate should be given AFTER these two units
of blood.
If the patient is still haemodynamically unstable, or if bleeding persists, continue as follows:
Step 2
• 4 fresh whole blood units
• Or 4 whole blood units (the most recent units) + 1 adult pool of platelets if available
• Or 4 whole blood units + 4 FFP + 1 adult pool of platelets if available
• Or 4 PRBC + 4 FFP + 1 adult pool of platelets if available
• Subsequent doses of calcium gluconate should ideally be based on the serum calcium
level.

b The minimum time required for a direct blood donation, including donor selection (questionnaire, blood
grouping, TTI screening), blood collection and crossmatching, is approximately 60 minutes when performed
by experienced staff.

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If the patient is still haemodynamically unstable, or if bleeding persists, continue as follows:

• Repeat either half or all of step 2
• Or according to laboratory test results if available:
Hb < 7 g/dL: transfuse 2 additional PRBC units.
TT or ACT > 1.5 the reference value: transfuse 4 additional FFP units.
Platelets < 75 x 10⁹/L: transfuse 1 additional adult pool of platelets.
Ionized calcium < 1 mmol/L: transfuse 10 mL of calcium gluconate by slow IV (10 minutes).
Other measures include: stop/limit the bleeding; maintain a permissive hypotension (SBP
of 80-90 mmHg, do not let SBP exceed 90 mmHg except in head or medulla trauma where
the SPB can be up to 120 mmHg); prevent or treat hypoxia (SpO2 > 95%); prevent or correct
hypothermia (> 35° C, using a “fluid warmer” for infusions and for all blood components, and
an emergency/warming blanket); avoid excess crystalloid infusion; prevent or correct acidosis
(pH > 7.38).
Stop massive transfusion protocol when the following criteria have been reached: absence
of haemorrhage or DIC, haemodynamic stability, adequate results for Hb (>7 g/dL), platelets
(> 75 x 10⁹/L), and coagulation tests (TT or ACT < 1.5 the reference value).
The massive transfusion protocol should not be continued if the patient’s condition deteriorates
to the point that survival is unlikely and further transfusions become futile.

Management in children
Transfuse 20 mL/kg of fresh whole blood.
Or 20 mL/kg of whole blood (the most recent units) and if available 10 mL/kg of FFP et 10 mL/
kg of platelets.
Or 15 mL/kg of PRBC and if available 10 mL/kg of FFP et 10 mL/kg of platelets.
Inject tranexamic acid (Exacyl®): 15 mg/kg bolus by slow IV (10 minutes) in the first hour then
a second bolus 3 hours after the first bolus if needed (only in case of trauma haemorrhage).
There is no indication for giving calcium gluconate with the first 15 mL/kg of PRBC or 20 mL/kg
of whole blood, but if more blood is needed, then inject calcium gluconate by slow IV: up
to 10 kg: 0.5 mL/kg and from 11 to 45 kg: 0.3 mL/kg (in a separate IV line from the blood
components).
If necessary, repeat the transfusion of the blood components as above according to clinical
criteria and/or laboratory results (same parameters as for adults).

2.6. Record all relevant information in the patient’s file

Record the reason for transfusion and the patient’s Hb level. The patient’s blood group indicated
on the blood group result form (Appendix 17) is recorded in the patient’s medical file.
Record the prescription: type of component, prescribed volume, administered volume, rate,
urgency, etc. Record that written consent for transfusion has been obtained (Appendix 6).

2.7. Fill in a blood request and delivery form

The blood request form should provide all required information (Appendix 31). It is sent to the
blood transfusion department in duplicate (using NCRc duplicate order pads or carbon papers),
along with the labelled EDTA tube for crossmatching and the 2nd blood group determination.

c NCR: No carbon required

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3. Delivery of blood units

The laboratory technician or the person in charge of delivering blood is responsible for the
following steps:

3.1. Check the stock register for availability of ABO Rh D identical blood
In case of non-identical blood, the prescriber’s agreement is necessary for delivering ABO Rh D
non-identical compatible blood.

3.2. Check the blood unit

Check the blood unit for any abnormality. The blood unit and tubing should be intact with no
visible leaks. The red cells should be dark red and the plasma bright yellow. Do not deliver
units with visible clots, black brown or purplish red cells, pink or pale plasma.

3.3. Crossmatch the selected blood unit with the patient’s plasma
For procedure, see Appendix 26.
Only negatively crossmatched units may be delivered, whatever the type of donation.
Information on crossmatch (date, blood unit number, patient identification, result) should be
recorded in the blood stock/delivery register (Appendix 29).
If there is no laboratory staff available, the crossmatch can be performed at the patient’s
bedside by placing in contact the recipient’s capillary blood and the blood to be transfused
using a tile.

3.4. Deliver the blood unit

The blood unit is delivered together with:
– The full request/delivery form, completed with information on the blood unit (Appendix 31).
A copy is kept in the blood transfusion department.
– A card for the bedside verification of ABO compatibility (Appendix 18.1 and Appendix 18.2)
together with its accessories.
If it takes more than 10 minutes to deliver the blood unit from the transfusion department to
the ward or if the blood unit is not to be used immediately but within two hours, place it:
– In a vaccine carrier,
– With 5 pre-conditioneda ice packs (one at the bottom and one on all 4 sides),
– Protect the blood unit from direct contact with the ice packs by placing insulation material
(e.g. bubble wrap, cardboard) between the blood unit and the ice packs.
If the blood unit is to be used more than two hours later, the reserved blood unit should stay
stored in the blood refrigerator (where the temperature control is more precise than in a
vaccine carrier).
The transfused patients register (Appendix 30) is filled out at the time of delivery.

a Pre-conditioned ice-pack: ice pack frozen at – 20 °C and partially defrosted under running water so that when
placed vertically 5 cm of liquid water is visible at the bottom of the ice-pack.

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4. Administration of a blood unit

The prescribing physician is responsible for the entire transfusion process.

The nurse is responsible for the following steps 4.1 to 4.6:

4.1. Take delivery of, and inspect, the blood unit

– Check on the delivery form the time the blood unit was issued from the transfusion
department. Return the blood unit to the transfusion department if it has been out of cold
chain for over 10 minutes.
– Inspect the blood unit for any abnormality. The blood bag and tubing should be intact with
no visible leaks. The red cells should be dark red and the plasma bright yellow.
– Return the blood unit to the blood transfusion department if: clots are visible; red cells are
black, brown or purplish; plasma is pink or pale, or if any other abnormality is observed.
– Check the expiry date of the blood unit.
Notes:
– If the blood reaches the ward within 10 minutes and is to be immediately transfused, there
is no need to transport the blood unit in a vaccine carrier.
– If the blood is to be transfused within two hours, it should be transported and kept in a
vaccine carrier.
– If the blood is to be transfused more than 2 hours later, it should be kept in the blood
refrigerator.

4.2. Check the identity of the patient and match it with the prescription and the
delivered blood unit
The most frequent cause of transfusion accidents is the transfusion of a blood unit that was
intended for another patient.
In order to prevent these accidents, at the bedside:
– Check the patient’s identity by asking open questions: what is your name? Can you spell it
please? What is your date of birth? Where were you born? A double identity check (i.e. by 2
different people) is recommended.
– If the patient is a child or is unconscious, ask a care giver to identify the patient. A double
identity check (i.e. by 2 different people) is recommended.
Patients who are unconscious or undergoing surgery and children should be identifiable,
e.g. wearing a wristband with their last name, first name, age or date and place of birth.
– Compare the patient’s identity with the prescription and the blood delivery form to ensure
the right patient gets the right blood unit.
– Check that the blood group indicated on the blood unit and on the delivery form are the
same and corresponds to the patient’s blood group.
– Check that the number of the blood unit corresponds to the number on the delivery form.

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4.3. Perform last verification of ABO compatibility at bedside

Even if blood grouping has been performed on both the patient’s blood and the blood unit, ABO
incompatibility accidents may still occur. These accidents are due to human error, including
blood specimens drawn from the wrong patient, blood units given to the wrong patient or
labelling errors on tubes/blood units.
The bedside verification of ABO compatibility is performed just before transfusion (i.e. before
connecting the transfusion set to the blood unit). It is intended to verify one last time, at
the patient’s bedside, that the recipient’s blood and the blood to be transfused are ABO
compatible. It is the responsibility of the health staff that carries the transfusion to perform
this verification. The interpretation of ABO card must be doubtless.
In case of any doubt, repeat the ABO compatibility procedure and call the doctor. See
Appendix 18.1 and Appendix 18.2.
Keep the bedside testing card in the patient’s file.

4.4. Carry out the transfusion

Prepare a monitoring form and assess the patient’s vital signs (Appendix 8).
Procedure for transfusion process is described in the Appendix 4.
Other monitoring parameters may be added according to the patients: glucose level for
neonates and children, particularly in malaria patients.
Check all basic resuscitation drugs and materials in case of adverse reactions are at
hand.

Notes:
– The blood and its components must imperatively be filtered by means of a blood
administration set fitted with a 170/200 micron filter.
– If venous cannulation is impossible, the intraosseous route can be used (Appendix 3).
– The use of infusion/blood warmer is indicated ONLY in the event of rapid transfusion (for an
adult, rate of over 25-30 mL/kg/hour and for a child rate of over 15 mL/kg/hour).
– Paediatric administration sets (blood burette) are used to ensure the transfusion of the
precise volume prescribed. For very small volumes of blood transfusion, the rate in drops/
minutes is very low and impossible to adjust manually with precision. In the absence of an
infusion pump or electric syringe, blood boluses can be administered every 15, 20 or 30
minutes while injecting a saline solution between the boluses to keep the vein open using a
3 way connector.
– A drip assist is an electronic droplet counter which displays the infusion rate in number of
drops per minute and the total volume administered since the start of the transfusion.
– An infusion pump is another means to ensure the exact volume and rate of transfusion are
respected as prescribed (caution: a specific transfusion set compatible with the infusion
pump is required). Infusion pumps cannot be used to transfuse neonates.
– An electric syringe may be used: the 50 mL syringe is filled with blood filtered through a
transfusion set using a 3 way-connector. If more 50 mL are to be administered, the syringe
will be filled several times through the transfusion set which is kept connected to the 3-way
connector.

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4.5. Monitor the patient

The patient’s condition and vital signs must be closely monitored throughout transfusion, and
afterwards, in order to respond immediately in the event of adverse reactions.
During the first 15 minutes:
Stay with the patient in order to detect warning signs: fever, chills, flushed feeling, urticaria,
pruritus, breathing difficulties, anxiety, and pain or haemodynamic instability.
Re-assess the patient’s condition and vital signs (RR, heart rate, BP) and oxygen saturation:
– 5 minutes after the start of transfusion,
– Every 15 minutes during the first hour,
– Every 30 minutes until the end of the transfusion; every 15 minutes in severely malnourished
children,
– When the transfusion is completed, and up to 4 to 6 hours thereafter.
The patient or the care giver should be instructed to alert the nurse of any discomfort, malaise
or unusual sensations. In an unconscious patient, the first manifestation of a transfusion
reaction may be hypotension or haematuria or diffuse bleeding.
Stop the transfusion and alert the physician in the event of warning signs, or if the patient’s
general condition changes (e.g. altered consciousness, agitation), or if vital signs deteriorate.
All information must be recorded on the monitoring form. Keep the monitoring form in the
patient file (Appendix 8).
Table 3.4 - Vital signs (normal values and alert thresholds) a

Respiratory rate Heart rate Systolic blood

(breaths/min) (beats/min) pressure (mmHg)
Age
Normal rangea Normal range Normal range

< 1 month 30-60 120-160 > 60

2-11 months 30-40 80-120 70-90

1-5 years 25-30 80-120 80-100

> 5-12 years 20-25 60-120 90-110

> 12 years 12-18 60-100 100-120

Adult 12-20 60-100 110-130

Urine output
If an urinary catheter has been inserted, urine output should be measured hourly. It should be:
30-60 mL/hour in adults
1 mL/kg/hour in children
0, 5-1 mL/kg/hour in neonates
1-3 mL/kg/hour in premature neonate
If there is no indication to insert an urinary catheter, check that the patient is voiding normally
throughout the transfusion and for up to 6 hours afterwards. In the event of doubt, notify the
physician.

a Respiratory rate in malnourished children may be 5 breaths/minute lower than in healthy children.

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In the event of macroscopic haematuria, notify the physician. It can be related to the transfusion
but may also be unrelated to the transfusion (e.g. acute haemolysis, malaria).

4.6. Once the transfusion is completed

– Reassess the patient’s condition and vital signs.
– Continue an infusion at a very slow rate to keep the vein open.
– Inform the physician that the transfusion has been completed and report the time on the
monitoring form. The physician must check the patient’s general condition.
– Administer malaria and syphilis treatment if indicated (Chapter 2, Section 6).
– The patient will be checked again up to 6 hours after the completion of the transfusion.

Checking post-transfusion Hb is not essential if clinical signs and symptoms of decompensated

anaemia have been alleviated by transfusion.

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5. Management of transfusion-related complications5

5.1. Immediate complications (< 24 h)

5.1.1. Possible causes of signs/symptoms ab

Signs and symptoms Most common causes Less common causes

Fever • A pre-existing infection • Acute haemolytic reaction

(with or without chills) • Non-haemolytic febrile • Septic transfusion reaction
transfusion reaction (NHFTR) • Transfusion-related acute
lung injury (TRALI)a

Urticaria, pruritus • Allergic reaction

Hypotension or shock • Patient’s underlying • Acute haemolytic reaction

condition (e.g. haemorrhage) • Septic transfusion reaction
• Anaphylactic reaction • TRALI

Dyspnoea • Pre-existing dyspnoea • Anaphylactic reaction

• Transfusion-associated • TRALI
circulatory overload (TACO)b

Pain • Patient’s underlying • Acute haemolytic reaction

condition (e.g. trauma) (pain at venepuncture site,
along the IV line; chest, back
or flank pain)
• Anaphylactic reaction
(abdominal cramping)
• TACO (chest pain)

Urinary signs • Patient’s underlying

(oliguria, dark urine, condition (e.g. haemolytic
haematuria) anaemia)
• Acute haemolytic reaction

Anxiety • Acute haemolytic reaction

Agitation

a TRALI : transfusion-related acute lung injury

b TACO : transfusion-associated circulatory overload

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5.1.2. Initial management

During the early stages of a reaction, it may be difficult to determine the cause. In all events:
– Stop the transfusion but keep the IV line open with 0.9% sodium chloride.
– Notify the physician immediately.
– Re-check that the right blood is being transfused to the right patient, i.e. check the blood
unit label and the patient’s identity. If there is a discrepancy:
• Check that other blood units administered at the same time on the same (or different)
ward have been given to the right patient(s)c. If necessary, stop transfusions temporarily
until all have been checked.
• Notify immediately the blood transfusion department.
– Assess vital signs. If clearly needed, insert a urinary catheter.
– Look for bleeding at the venepuncture site.
– Draw a blood sample into an EDTA tube and a urine sample for further analyses (Chapter 3,
Section 5.3).
– Do not remove the blood unit until a probable or possible diagnosis is made. If the blood
unit is removed, do not discard it; return it to the transfusion department for analysis.

5.1.3. Specific management

All transfusion reactions must be noted on a specific form filled on two copies, one for the
transfusion department and one kept in the patient’s file (Appendix 9).

Allergic reactions
Within a few minutes and up to 3 hours after the start of transfusion:
A. Minor allergic reaction
Signs and symptoms
– Urticaria (usually associated with pruritus), with no other symptoms
Management
– Temporarily stop the transfusion.
– Administer an antihistamine, e.g. chlorphenamine PO:
Child 1 to < 2 years: 1 mg 2 times daily
Child 2 to < 6 years: 1 mg 4 to 6 times daily (max. 6 mg daily)
Child 6 to < 12 years: 2 mg 4 to 6 times daily (max. 12 mg daily)
Child ≥ 12 years and adult: 4 mg 4 to 6 times daily (max. 24 mg daily; max.12 mg daily in
elderly patients)
– The transfusion can be restarted if the patient is stable and no other symptoms are present
after 30 minutes. This decision should be made by the physician.
B. Anaphylactic reaction
Signs and symptoms
– Breathing difficulties (dyspnoea, wheeze, fatigue, confusion, cyanosis) and/or airway
obstruction (hoarse voice, pharyngeal/laryngeal oedema, stridor, bronchospasm) with,
depending on the severity of the reaction, hypotension or circulatory collapse, tachycardia
or bradycardia, altered consciousness.
– Nausea and abdominal cramping may be present.
– Skin and mucosal changes (erythema and/or urticaria and/or angioedema) are present in
over 80% of anaphylactic reactions.

c Check patient’s identity, blood request/delivery form, concordance between the patient’s blood group and the
blood unit group, and bedside verification of ABO compatibility card.

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Management
– Definitively stop the transfusion, remove the blood unit and send it back to the blood
transfusion department.
– High flow oxygen administration.
– Administer epinephrine (adrenaline) IM, into the antero-lateral thigh, in the event of
hypotension, pharyngolaryngeal oedema, or breathing difficulties:
Use undiluted solution (1:1000 = 1 mg/mL) and a 1 mL syringe graduated in 0.01 mL:
Children under 6 years: 0.15 mL
Children from 6 to 12 years: 0.3 mL
Children over 12 years and adults: 0.5 mL
In children, if 1 mL syringe is not available, use a diluted solution, i.e. add 1 mg epinephrine
to 9 mL of 0.9% sodium chloride to obtain a 0.1 mg/mL solution (1:10 000):
Children under 6 years: 1.5 mL
Children from 6 to 12 years: 3 mL
– At the same time, administer rapidly Ringer lactate or 0.9% sodium chloride: 1 litre in adults
(maximum rate); 20 mL/kg in children, to be repeated if necessary.
– If there is no clinical improvement, repeat IM epinephrine every 5 to 15 minutes.
If shock persists after 3 IM injections, administration of IV epinephrine at a constant rate by
a syringe pump is necessary:
Use a diluted solution, i.e. add 1 mg epinephrine (1:1000) to 9 mL of 0.9% sodium chloride
to obtain a 0.1 mg/mL solution (1:10 000):
Children: 0.1 to 1 microgram/kg/minute
Adults: 0.05 to 0.5 microgram/kg/minute
If syringe pump is not available, see box page 70.
– In patients with bronchospasm, epinephrine is usually effective. If the spasm persists give
10 puffs of inhaled salbutamol.
Note: corticosteroids are not indicated in the initial treatment of anaphylaxis. They may
be administered once the patient is stabilised to prevent recurrence in the short term
(prednisolone PO: 0.5 to 1 mg/kg once daily for 1 to 2 days).
Once the patient has been stabilised, reassess if it is immediately necessary to continue the
transfusion. If required, order a new unit of blood which must imperatively be from a different
donor.

Non haemolytic febrile transfusion reaction (NHFTR)

NHFTR is a common reaction in patients previously transfused and in women who have been
pregnant.
Signs and symptoms
Within 4 hours after the start of transfusion:
– Chills followed by fever ≥ 38 °C or a change of ≥ 1 °C from the pre-transfusion value.
Notes:
– Always check pre-transfusion temperature as fever can be due to a pre-existing infection.
– Fever may also be the initial symptom of a more severe reaction such as haemolytic reaction,
sepsis or TRALI.

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Management
– Temporarily stop the transfusion.
– Administer paracetamol (oral, rectal or IV).
– Carefully restart the transfusion if no other symptoms are present (and after other causes of
fever have been eliminated).
This decision should be made by the physician. If fever continues rising or if the patient
develops other symptoms, stop transfusion and look for another diagnosis.

Acute haemolytic transfusion reaction due to incompatibility

Signs and symptoms
Within minutes of starting the transfusion, or possibly later during or after the transfusion:
– Anxiety, agitation, pain at venepuncture site and along the IV line, «feeling of impending
doom»/chest pain or flank pain.
– Fever, chills, tachycardia, hypotension, haemoglobinuria (dark urine) and uncontrolled
bleeding due to DIC.
– Oliguria is common and is followed by acute renal failure.
– In an unconscious or anaesthetized patient, hypotension and uncontrolled diffuse bleeding
may be the only signs of acute haemolytic reaction.
Management
– Stop the transfusion and remove the blood unit. Send it back to the blood transfusion
department.
– Maintain the BP and renal flow (0.5-1 mL/kg/hour) in order to prevent acute renal failure
using crystalloids at 20-30 mL/kg bolus.
– Reassess the patient and adjust according to clinical evolution.
– It may be necessary to induce diuresis, using furosemide IV at a dose of 0.5 to 1 mg/kg/
injection.
– If the patient improves but still requires blood, restart a transfusion with a new blood unit
from another donor. There is no increased risk of a second haemolytic reaction provided
that ABO compatible blood is transfused.
– If the patient does not improve (i.e. hypotension and oliguria still present), start an
epinephrine infusion.
If there are signs of DIC, administer FFP if available or fresh whole blood.

Septic transfusion reaction

Signs and symptoms
– Within 4 hours of the start of the transfusion:
High fever (≥ 39 °C) or change of ≥2 °C from pre-transfusion value or hypothermia (< 36 °C),
chills, tachycardia, drop or rise of 30 mmHg in systolic BP, nausea, vomiting.
– In severe sepsis or septic shock: profound hypotension, pallor, mottled skin, cold extremities,
sweating, thirst, cyanosis, dyspnea, tachypnea in varying degrees, anxiety, confusion, altered
consciousness, oligo-anuria.
Management
– Stop the transfusion and remove the blood unit. Send it back to the blood transfusion
department.
– Perform blood cultures if available, taking blood samples from the patient and the blood unit.
– Give vascular fluid replacement with Ringer Lactate or 0.9% sodium chloride or plasma
substitute.

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– Use of vasoconstrictors:
dopamine IV at a constant rate by syringe pump (see box):
10 to 20 micrograms/kg/minute
or, if not available
epinephrine IV at a constant rate by syringe pump:
Use a diluted solution, i.e. add 1 mg epinephrine (1:1000) to 9 mL of 0.9% sodium chloride to
obtain a 0.1 mg/mL solution (1:10 000). Start with 0.1 microgram/kg/minute. Increase the
dose progressively until a clinical improvement is seen.
If syringe pump is not available, see box.
– Give large spectrum antibiotics: ampicillin + gentamicin or ceftriaxone + ciprofloxacin.
ampicillin IV
Children over 1 month: 50 mg/kg every 6 to 8 hours
Adults: 1 to 2 g every 6 to 8 hours
gentamicin IM or slow IV (3 minutes)
Children ≥ 1 month and adults: 6 mg/kg once daily
ceftriaxone slow IVd (3 minutes)
Children: 100 mg/kg once daily
Adults: 2 g once daily
ciprofloxacin PO (by nasogastric tube)
Children: 15 mg/kg 2 times daily
Adults: 500 mg 2 times daily
Once the patient is stabilized with regards to the septic shock, reassess if it is immediately
necessary to continue the transfusion. If considered necessary, order a new blood unit which
must be from a different blood donor.
Note: in the event of septic transfusion reaction during or after transfusion of a paediatric unit
prepared from a pentabag system, all the remaining paediatric units prepared from the same
donation of 450 mL must be discarded.

Administration of dopamine or epinephrine at a constant rate requires the following

conditions:
– Dose medical supervision in a hospital setting;
– Use of a dedicated vein (no other infusion/injection in this vein), avoid the antecubital
fossa if possible;
– Use of an electric syringe (or infusion pump);
– Progressive increase and adaptation of doses according to clinical response;
– Intensive monitoring of drug administration, particularly during syringe changes.
Example:
dopamine: 10 micrograms/kg/minute in a patient weighing 60 kg
Hourly dose: 10 (micrograms) x 60 (kg) x 60 (min) = 36 000 micrograms/hour = 36 mg/hour
In a 50 mL syringe, dilute one 200 mg-ampoule of dopamine with 0.9% sodium chloride to
obtain 50 mL of solution containing 4 mg of dopamine per mL.
For a dose of 36 mg/hour, administer the solution (4 mg/mL) at 9 mL/hour.

d The solvent of ceftriaxone for IM injection contains lidocaine. Ceftriaxone reconstituted using this solvent must
never be administered by IV route. For IV administration, water for injection must always be used.

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If there is no electric syringe, dilution in an infusion bag may be considered. However, it is

important to consider the risks related to this type of administration (accidental bolus or
insufficient dose). The infusion must be constantly monitored to prevent any, even small,
change from the prescribed rate of administration.
Example for epinéphrine:
– In adults:
Dilute 10 ampoules of 1 mg epinephrine (10 000 micrograms) in 1 litre of 5% glucose
or 0.9% sodium chloride to obtain a solution containing 10 micrograms of epinephrine
per mL.
Knowing that 1 mL = 20 drops, in an adult weighting 50 kg:
• 0.1 microgram/kg/minute = 5 micrograms/minute = 10 drops/minute
• 1 microgram/kg/minute = 50 micrograms/minute = 100 drops/minute, etc.
– In children:
Dilute 1 ampoule of 1 mg epinephrine (1000 micrograms) in 100 mL of 5% glucose or
0.9% sodium chloride to obtain a solution containing 10 micrograms of epinephrine
per mL.
For administration, use a paediatric infusion set; knowing that 1 mL = 60 drops, in a child
weighting 10 kg:
• 0.1 microgram/kg/minute = 1 microgram/minute = 6 drops/minute
• 0.2 microgram/kg/minute = 2 micrograms/minute = 12 drops/minute, etc.

Note: account for all infused volumes when recording ins and outs.

Transfusion-associated circulatory overload (TACO)

Signs and symptoms
During or within 6 hours after transfusion:
– Respiratory distress (dyspnoea, tachypnoea) and cough
– Hypertension or normal BP, tachycardia, distended neck veins and peripheral oedema (e.g.
puffy eyes, swollen hands)
Management
– Stop temporarily the transfusion.
– Sit the patient in an upright position.
– Administer oxygen.
– Administer furosemide by slow IV:
Children: 0.5 to 1 mg/kg/injection
Adults: 20 to 40 mg/injection
Closely monitor the patient and repeat after 2 hours if necessary.
– Once the patient is stabilized, continue the transfusion if necessary.

Transfusion-related acute lung injury (TRALI)

Signs and symptoms
Within 6 hours after the start of the transfusion:
– Rapid onset of dyspnoea leading to acute respiratory distress with hypoxemia
– Cough, hypotension or normal BP
– Fever and chills are reported, but may be absent

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Management
Stop the transfusion, remove the blood unit and send it to the transfusion department.
Treatment is that for respiratory distress syndrome from any cause: oxygen; mechanical
ventilation often required. Symptoms may resolve in 24-48 hours.
Once the patient is stabilized regarding respiratory distress, reassess if it is necessary to
continue the transfusion. If considered necessary, order a new blood unit from a different
donor.
Notes:
It can be difficult to distinguish between anaphylactic reactions, TACO and TRALI.
In anaphylactic reactions, respiratory difficulties are usually associated with muco-cutaneous
signs and symptoms (cutaneous eruptions, pruritus, angioedema).
The risk of TACO is increased in children (especially malnourished children), the elderly and
patients with pre-existing cardiopulmonary disease.
All other possible causes of respiratory distress must be ruled out before deducing diagnosis
of TRALI.
Table 3.5 - Differences between TACO and TRALI

TACO TRALI

Temperature Unchanged Fever may be present

BP Hypertension or normal BP Hypotension or normal BP

Heart rate Tachycardia Normal or tachycardia

Neck veins Distension may be present Unchanged

Chest X-ray Normal heart size or enlarged Normal heart size

heart No vascular congestion signs
Vascular congestion signs: Diffuse opacity; perihilar nodules
Perihilar haze, Kerley’s lines; and infiltration of the lower lung
pleural effusion fields

Response to Yes No effect

diuretics Deterioration in hypotensive
patients

5.2. Delayed complications (> 24 h)

– Extravascular haemolysis: jaundice and anaemia, often preceded by a febrile reaction. This
reaction is usually mild and self-limited. The treatment is symptomatic.
– Graft-versus-host disease: rare but can be fatal; treatment is supportive; there is no specific
treatment.
– Iron overload in multi-transfused patients: use chelating agents.

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5.3. Investigating an immediate transfusion reaction

– According to the clinical presentation of the transfusion reaction:
• Repeat the blood group (ABO Rh D) on patient’s blood and on the blood unit.
• Repeat the crossmatch.
• Check for plasmatic haemoglobinaemia (pink plasma indicating free Hb in the patient’s
plasma).
• Check for haemoglobinuria with a urine dipstick.
• Perform a chest X-ray.
• Perform blood cultures on the patient and on the transfused blood unit.
Note: plasmatic haemoglobinaemia and haemoglobinuria are suggestive of acute haemolytic
reactions.
– Complete a transfusion reaction form (Appendix 9).
– Report all transfusion reactions to the Blood Transfusion Committee.

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6. Particular case of fresh frozen plasma6

6.1 Sources and characteristics of fresh frozen plasma

Fresh frozen plasma (FFP) is prepared by an authorized blood transfusion facility equipped
with a laboratory centrifuge for blood units. It contains all plasma proteins and in particular
fibrinogen and thermo-labile coagulation factors V and VIII.
FFP is prepared from centrifuged whole blood or from plasmapheresis that has been fast
frozen below - 18°C within a maximum of 6 hours after collection.
FFP is usually available in units of 200 to 300 mL.

6.2 Storage
FFP units are immediately stored in a freezer at below – 18 °C and can be stored up to 3 months.
If the storage temperature is below – 25 °C, FFP units can be kept for up to one year.

6.3 Transport
FFP is dispatched to health facilities in negative cold chain containers (iceboxes filled with the
most frozen ice packs): the temperature of the cold chain must be constantly monitored to
check it remains below zero throughout transport.

6.4 Indications
Indications for the use of FFP are mainly therapeutic and sometimes preventive:
– Massive haemorrhage associated with coagulopathy related to fluid resuscitation and/or
transfusion of stored blood products which lack thermo-labile coagulation factors.
– Bleeding related to multiple coagulation factor deficiency associated with reduced synthesis
of clotting factors in liver disease or increased consumption of clotting factors in DIC.
– Severe bleeding associated with antivitamin K drugs overdose.
– Bleeding associated with a coagulation factor deficiency when specific concentrated
products are not available.
– Rare conditions such as thrombocytopenic thrombotic purpura and some specific plasma
proteins deficiencies.
The transfusion of FFP carries similar risks of TTI, allergic reactions and hypocalcaemia due
to citrate overload, as the transfusion of packed red blood cells or whole blood.
In no event is FFP to be used for fluid resuscitation or as a nutritional product.

6.5 Prescription
Compatibility
Prescribe FFP units that are ABO compatible, preferably identical. As FFP units have a long
storage life, it should always be possible to provide ABO identical FFP units.
However, ABO compatibility rules for the transfusion of plasma are the opposite of those for
the transfusion of red blood cells.

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Table 3.6 - Compatibility rules for FFP transfusion

ABO group of ABO group of the FFP unit

the recipient 1st choice 2nd choice 3rd choice 4th choice
O O B A AB
A A AB
B B AB
AB AB

As FFP does not contain red blood cells, there is no need for cross matching.

Volume to be prescribed
The initial therapeutic dose is 15 mL/kg (10 to 20 mL/kg).
In the absence of coagulation tests, additional doses are administered if bleeding persists.
When bleeding stops, this indicates the FFP dose is sufficient.
When coagulation tests are available, haemostasis is considered efficient if the TT or ACT is
less than 1.5 times the reference value. Nevertheless a return to efficient haemostasis may be
transitory and must therefore be monitored. It may be related to underlying conditions (fever
in particular).

Duration
In adults, the recommended transfusion rate is one unit in 30 minutes maximum.
In children up to 20 kg, the prescribed dose is 15 mL/kg transfused in one hour.

6.6 Preparation
FFP is thawed between 30 and 37°C in a water bath under continuous agitation. As soon as it
has thawed, FFP must be transfused immediately, or stored, while waiting to be transfused, at
4 °C for a maximum of 6 hours.
FFP must always be transfused using a transfusion set with a 170-200 microns filter.

6.7 Monitoring of FFP transfusion

Allergic reactions are common. It is essential to look out for severe anaphylactic reactions and
to have basic resuscitation drugs and material ready to be used.

Reminder:
FFP must NOT be used for:
– Volume replacement,
– To increase the albumin level,
– To reverse a coagulopathy that can be reversed by administration of vitamin K,
– To normalize coagulation tests in the absence of bleeding.

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References Chapter 3

1. WHO, Management of severe malaria, A practical handbook, third edition 2012.

http://apps.who.int/iris/bitstream/10665/79317/1/9789241548526_eng.pdf

2. WHO, The Clinical Use of Blood, WHO Blood transfusion safety, Geneva.
http://www.who.int/bloodsafety/clinical_use/en/Handbook_EN.pdf

3. Neonatology, Management, Procedures, On-call Problems, Diseases and Drugs, Tricia Lacy
Gomella , M. Douglas Cunningham , Fabien Eyal, 7th Edition, 2013.

4. The CRASH-e collaborators, The importance of early treatment with tranexamic acid in
bleeding trauma patients: an exploratory analysis of the CRASH-2 randomized controlled
trial, The Lancet Vol 377, March 26 2011, 1096:1101.

5. Handbook of transfusion medicine, Dr Derek Norfolk, United Kingdom Blood Services,

5th edition, 2013.
https://www.transfusionguidelines.org/transfusion-handbook

6. Fresh Frozen Plasma.

https://transfusion.com.au/blood products/components/plasma

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Set up and management of transfusion
activities

1. Setting up blood transfusion activities....................................................................... 79

2. Storage, transport and stock management of blood units.........................................82

3. Staff responsibilities................................................................................................... 87

4. Hospital Transfusion Committee ............................................................................... 89

5. Quality assurance in blood transfusion...................................................................... 90

6. Layout of premises..................................................................................................... 92

7. Waste management................................................................................................... 94

References...................................................................................................................... 96
 Chapter 4: Set up and management of transfusion activities

1. Setting up blood transfusion activities

1.1 Initial assessment

1.1.1 Assess blood needs
Health facilities that carry out few transfusions usually perform direct transfusions and do
not have stored blood. In facilities that regularly carry out transfusions, setting up a blood
transfusion department with stored blood, commonly called a “blood bank”, ensures a
constantly available supply of blood.
It is essential to estimate the number of blood units needed per week, or month, according to
current or expected activity. Demand for blood is high in malaria endemic areas, nutritional
centres and hospitals with obstetric and surgical activities, as well as in the event of an influx
of wounded.

1.1.2 Assess external sources of blood

External sources include the national blood transfusion service (NBTS) or other hospitals.
The capacity of an external source to supply safe blood must be assessed by a health professional
with the required competences. Below is a list of questions/criteria to be considered:
– Does the blood source belong to the national blood transfusion service, a governmental
organization, a non-governmental organization, a private organization?
– How are donors recruited, selected and retained?
– Are blood donations identified with bar codes?
– Are tests results disclosed to donors and, if so, how?a
– Are equipment, consumable items and reagents procured from validated sources?
– Are reagents stored under suitable conditions (temperature, humidity)?
– What test methods are used for blood grouping, red cell antibody screening and transfusion
transmissible infections (TTI) screening?
– Are procedures manual or automated? Are results double-checked?
– How are the test results recorded? Manually or using information technology?
– What quality control procedures are there?
– Who is responsible for the supervision of the blood collection department and the
laboratory?
– What is the reactivity rate for each TTI in blood donation? What is the local prevalence rate
for each TTI in the adult population?
– How are unsafe/untested blood units stored, separated from qualified blood units and
ultimately destroyed?
– Is cold chain performance satisfactory and monitored? During storage? Transport?
– Who (what institution) does the blood source report activity data and performance indicators
to?
– How many blood units can the supplying facility provide in a given time frame?
If the evaluator cannot determine alone whether the source is reliable or not, they should ask
a specialized professional to carry out the assessment.

a Blood transfusion departments that report HIV results directly to the donor may attract high-risk donors
looking for individual diagnosis.

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Blood supply:
– Can be combined supply from an external source and donor blood collection within the
health facility.
– Can be exclusively from either the NBTS or donor blood collection within the health facility.

1.1.3 Determine the feasibility of setting up a blood transfusion service

– Assess the availability of qualified medical staff (physicians, nurses, laboratory technicians)
and their competencies in transfusion.
– Assess technical environment (power supply, available space, cold chain equipment and
waste management).
– Determine needs in terms of staff recruitment and training, as well as equipment.
Evaluate advantages/disadvantages and cost effectiveness of setting up a blood transfusion
department, based on this assessment. Alternatively, it may be appropriate to set up an
effective patient referral system.1

1.2 Setting up a blood transfusion activity2

1.2.1 Obtain authorization from the health authorities and/or the NBTS
Obtain:
– The most recent national blood transfusion policy,
– National, or regional, blood donation promotion documents and donor retention tools.
Obtain authorization to:
– Store blood,
– Collect blood from donors,
– Organize mobile blood collections in specific areas.

1.2.2 Meet local leaders (political, religious or other)

Inform them that donors need to be recruited and try to obtain their collaboration in order to:
– Understand the community’s level of acceptance/knowledge concerning blood donation.
– Identify which groups in the community are most susceptible to giving blood.
– Translate blood donation information and promotion tools into the local language.
In sub-Saharan Africa, secondary school pupils (16-18 years old) are a sizeable source of
voluntary blood donations. Parental authorization for minors to give their blood must be
obtained. Communication with school principals and science teachers is crucial in encouraging
voluntary blood donation.

1.2.3 Order equipment according to needs

The transfusion module (Appendix 33) contains all the basic medical and laboratory equipment
required to collect and provide 50 safe transfusions.
For cold chain equipment, see Chapter 4, Section 2.

1.2.4 Organize premises and waste management

See Chapter 4, Section 6 and Chapter 4, Section 7.

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1.2.5 Train staff and ensure job descriptions are available for each position
Train staff in donor recruitment and selection, screening procedures, blood components
indications and administration procedures, cold chain maintenance, consumable stock
management, waste management.
For the list of tasks and responsibilities, see Chapter 4, Section 3. Each staff member must fully
understand their role and responsibilities.

1.2.6 Ensure procedures are written, adapted to the context and applicable

1.2.7 Set up a data collection system

Data analysis helps evaluate if the transfusion activity matches needs in terms of quality and
quantity. Data are usually collected on a monthly basis. A data collection tool, to be adapted to
the context, is described in Appendix 32. In particular, monitor the reactivity rate of each TTI in
blood donors, the rate of discarded qualified blood units and the average stock of blood units.

1.2.8 Set up the health facility’s blood transfusion committee

This committee is responsible for the implementation of good transfusion practices.
It includes the hospital director, at least one physician prescribing transfusions, the head nurse,
the blood transfusion department supervisor, the pharmacist, the designated logistician or
biomedical engineer and the designated health promoter. See Chapter 4, Section 4.

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2. Storage, transport and stock management of blood

units

The safe storage and transport of blood units is an integral component of blood safety.3

2.1 Cold chain

2.1. Equipment required in a blood transfusion department
Refrigerators for storage of blood units
– Blood units should be stored in a special refrigerator with the following characteristics:
• Electric-powered.
• Super-insulated, with sufficient holdover timea to keep the temperature below 8 °C for at
least 12 hours in the event of power failure.
• Cooling system, to maintain uniform temperature at all levels of the refrigerator.
• External thermometer display, for continuous monitoring of the temperature inside the
refrigerator.
• Visual and audio alarm system, that signals when the temperature rises above 6 °C or falls
below 2 °C.
These refrigerators should be used exclusively for the storage of blood. The number/size
of refrigerators to be ordered depends of the estimated number of units to be stored. Due
to its robustness and long holdover time the Electrolux MB 3000 G is one of the models
recommended for storing blood units: chest format (horizontal door), holds 100 x 450 mL
bags, walls lined with ice packs filled with water result in very efficient thermal inertia.
Gas-powered and petrol-powered refrigerators should not be used for blood storage: they
do not perform as well as electric powered refrigerators and require constant attention and
maintenance to ensure correct and stable temperatures.
Domestic refrigerators are not designed for blood storage. They have no external
thermometer display, poor insulation and poor temperature regulation (e.g. risk
of blood freezing in the event of contact with the walls of the refrigerator, rapid rise in
temperature in the event of power failure).
– Reagents and diagnostic tests should be stored in a separate refrigerator (e.g. Vestfrost
MK204® or Sibir V170®).

Cold boxes and vaccine carriers

– Cold boxes (e.g. Electrolux RCW®) are essential:
• To transport blood from an external source or mobile collection sites;
• To temporarily store blood, in the event of refrigerator dysfunction or during refrigerator
defrosting.
– Vaccine carriers e.g. Gio’Style® are necessary to deliver blood from the blood transfusion
department to wards if the delivery time exceeds 10 minutes.

a Holdover time is the period of time a refrigerator is able to maintain its internal temperature below 8 °C at a
given external temperature (usually 43 °C) during a power failure. Check the manufacturer’s specifications.

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Freezer and ice packs

A freezer (e.g. Vestfrost MF 114 (ou 214)®) is necessary to produce ice packs and, if applicable,
store FFP.

Temperature-monitoring devices
Every refrigerator must contain 3 types of temperature monitoring devices:
– A min-max thermometer records the minimum and maximum temperatures (temperature
range –50 °C to +50 °C) reached since the last reset.
– A "Fridge Tag 2” temperature data logger fitted with an external probe placed in a glycol vial.
The device displays the temperature inside the refrigerator without opening the door and
records all temperatures over the last 30 days. The glycol mimics blood temperature and is
insensitive to air temperature variations when opening the fridge door (see Appendix 36.1).
– A freezing indicator device: such as Freeze-tag®. This device indicates when the temperature
inside the refrigerator/cold box has dropped to 0 °C (± 0.3 °C) for over one hour (Appendix 36.2).

Remote alarm system

When the blood refrigerator is in a place where staff is not present 24/7, a simple robust
remote alarm system can be connected to the dry relay contacts of the blood refrigerator. The
alarm alerts healthcare staff on duty within a range of 50 metres in the event of any abnormal
temperature fluctuations. Alerted staff informs the person in charge of blood storage.

2.1.2 Electric power supply

Electricity can be supplied by a local provider, by a generator or by solar panels, provided the
power is sufficient, the voltage is stable, and the supply is uninterrupted. If there is a risk of
power cuts/breakdowns lasting over an hour, backup power (i.e. batteries) must be set up and
ready. The blood transfusion department supervisor together with the logistics officer, are
responsible for the correct functioning of the electric power supply and training staff how to
use the back-up system.

2.1.3 Cold chain maintenance

The logistics officer ensures the maintenance of cold chain equipment: checking and maintaining
refrigerator gaskets, monthly checking of alarm systems and thermostats, changing alarm
systems batteries and cleaning condensers every 6 months.
The blood bank supervisor ensures that the refrigerators are clean and regularly de-iced.

2.2 Blood storage conditions

2.2.1 Blood storage temperature
Long term storage temperature to keep red cells functional and inhibit bacterial growth is
between 2 °C and 8 °C. The refrigerator thermostat is set at 4 °C +/- 2 °C. An upper limit of 8 °C
is correct.
If blood is not intended to be transfused within 4 hours, leave it to cool down at a temperature
between 18-24 °C (in a temperate cool box or in an air-conditioned place or under a ventilator
by using a wet linen) for 2 to 4 hours. This allows the donor’s white blood cells to exercise their
bactericidal effect. In addition, this avoids placing warm blood in the blood refrigerator. Then
blood must be stored in cold chain with a thermostat set at 4 °C +/- 2 °C.

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Notes:
– If TTI tests have not been completed make sure the blood bags are clearly labelled as non-
qualified for transfusion and stored completely separate from qualified blood units.
– During mobile collection sessions, blood donations are placed in a cool-box maintained
between 2 °C and 8 °C until they can be stored in the refrigerator.
– Once stored in the refrigerator, blood units are not removed until they are to be transfused,
except for performing tests on the distal tube and preparation of paediatric units.
– Blood must never be frozen, as freezing causes red cell haemolysis.

Storage in blood refrigerator

Avoid repeated opening and closing of refrigerators. To ensure the correct circulation of cold
air, avoid overfilling refrigerators.
If there are only a few blood units in a refrigerator, fill bottles or icepacks with non-frozen
water to increase the thermal inertia of the refrigerator.

Storage in cold box

Ensure that blood units are not in direct contact with ice packs. Frozen ice packs are pre-
conditioned. Use pieces of cardboard or bubble wrap to prevent the blood units from touching
the icepacks.
Discard any blood unit that has been:
– Out of the cold chain for more than 30 minutes. Re-cooling blood that has reached room
temperature may stop bacterial growth but it does not prevent the release of endotoxins.
– Stored in cold chain at a temperature > 8 °C.
– Exposed to freezing temperatures (freezing indicator device displays ALARM).

2.2.2 Temperature monitoring

A staff member from the transfusion service or the laboratory must be specifically appointed
and trained to monitor the temperature of all cold chain appliances. A second person should
be identified to replace this person in the event of absence.
The logistics officer responsible for maintenance of the cold chain must be informed
immediately in the event of a cooling system dysfunction.
Depending on the cause/duration of the break in the cold chain and the refrigerator holdover
time, the transfusion department supervisor will decide whether to transfer blood to another
refrigerator or, failing that, to cool boxes.
Refrigerator temperatures must be checked and recorded on the monitoring sheet (Appendix 35)
twice daily, 7 DAYS PER WEEK.
Min-max thermometers must be reset after each reading.
Temperatures must be monitored in the same way if blood is temporarily stored in cold boxes
during refrigerator breakdown or de-icing periods.
Note: temperature devices inside cool boxes must be checked at delivery point.

2.3 Transport of blood units

From the transfusion department to the wards
Blood units to be used within 2 hours must be transported in a vaccine carrier if it takes more
than 10 minutes to take them from the blood refrigerator to the ward. If the transfusion is
delayed, blood units must be returned to the refrigerator in the blood transfusion department
and kept reserved for the recipient.

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From mobile collection to the blood transfusion department

Blood donations, once pre-cooled at between 18 - 24 °C, are placed and transported in a cool
box at between 2 °C and 8 °C until they can be stored in the refrigerator.

2.4 Blood shelf life

Blood shelf life depends on the preservative solution used (e.g. CPDA-1, SAGM)b. Check the
manufacturer‘s recommendations. Usually:
– CPDA-1: whole blood and PRBC can be stored for 35 days.
– SAGM: PRBC can be stored for 42 days. This type of blood bag is only used in transfusion
centres equipped with blood bag centrifuges.

2.5 Blood stock management

Tested blood units are stored in a refrigerator:
– By blood group (A, B, AB, O and Rh D positive and negative) and expiry date; e.g. all A Rh D
positive units are placed together in a basket with the unit expiring first at the front of the
basket.
– In an upright position, outlet port pointing down if concentrated red cells are to be transfused
(Appendix 12).
Note: if non-tested blood units need to be stored, place them apart in the refrigerator in a
specific basket clearly labelled ‘not-qualified for transfusion’.

2.6 Stock follow-up

A blood stock/delivery register is used to record entries and deliveries of blood units
(Appendix 29). The register must be used to choose the most appropriate blood unit according
to the patient’s blood group and specific needs as well as the expiry date.
A whiteboard is used to keep a daily updated record of blood available in stock. The board
must be visible at all times by the clinical staff and needs to be updated every day.
A physical inventory must be carried out once a week to check unit by unit that the units in
storage (physical stock) match the units noted in the stock register. This is an opportunity to
note either units that are in the physical stock but not recorded in the register, or units that
have been issued but not recorded as taken out of stock in the register. Possible errors can
be detected and corrected by checking the transfused patients register or the blood order/
delivery forms.
The minimum stock level should be determined according to transfusion activity and the
distribution of blood groups in the population. Group O blood should always be available in
stock. To be noted, 50 % of the population is group O nearly everywhere in sub-Sahara Africa.
A minimum security stock to cover 10 days of consumption is recommended. Ordering of
blood units and/or organizing mobile blood collection sessions must be scheduled to maintain
a sufficient stock of blood.
Small health facilities often have insufficient stocks and as a consequence:
– The lack of blood leads to families being pressured into blood donation which is strongly
discouraged.
– If the family or relatives cannot find a donor(s), the family may resort to paying for donors;
this must be avoided at all costs.

b CPDA-1 = Citrate Phosphate Dextrose Adenine; SAGM = Saline-Adenine-Glucose-Mannitol; CPD = Citrate

Phosphate Dextrose

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Chapter 4: Set up and management of transfusion activities

When there are a large number of blood units to be discarded, identify the underlying causes
(e.g. stock management problems, frequent breaks in the cold chain, screening after donation
in an area with a high prevalence of TTI, reduction in blood requirements) and find solutions
to address these issues.

2.7 Blood units received from external sources

Check the delivery form
The delivery form should indicate the time the blood units were taken out of the refrigerator
as well as each blood unit’s details: unit number, type of blood component (whole blood,
PRBC), group, volume, date of collection and expiry date.
Check if the delivery form matches the initial order and the units supplied.

Check transport conditions

Check time elapsed in transport, and the temperature devices inside the cold box:
– The temperature should be between 2 °C and 8 °C.
– The freezing indicator device should not display ALARM.
– The blood units should not be in direct contact with the ice packs.
If there is no thermometer in the cold box, place one between 2 blood units. If the temperature
is > 8 °C, discard or return the blood units and notify the supplier and the person in charge of
transportation in order to obtain replacement blood units.

Check each blood unit

– Check that the information on the label is readable and complete (blood group, date of
collection and expiry date, type of component, volume, TTI test results).
– Check that the tubing length is adequate (at least 50 cm), that the knots in the tubing are
correctly tightened and that there is no leakage.
– Check the appearance of red cells and plasma: red cells should be dark red, plasma should
be bright yellow and no clots should be seen. On visual observation, the proportion of red
cells in a unit of whole blood, if fully sedimented, should be at least 1/3 of the blood bag
contentc.
Discard the unit (or return to the NBTS) if clots are visible, if red cells are purple, brown or
black, if plasma is pink or pale yellow or if the proportion of red cells seems too low.
– Check that the blood bags are correctly filled and if in doubt, weigh the blood units. For
example, filled bags of whole blood gross weight is approximately:
• 150 mL bag: between 188 g and 219 g
• 250 mL bag: between 301 g and 354 g
• 450 mL bag: between 528 g and 622 g
Check the weight of the empty bags with the health facility that has provided the blood or
the manufacturer.
– Repeat the blood grouping and TTI screening on the distal segment of the tubing, unless the
external source of blood supply has been assessed by a competent medical professional and
is considered reliable.

c A blood unit cannot be opened to check the Hb level as the system must be kept closed.
Haematocrit can be visually estimated, by measuring the height of the sedimented red cells relative to the
height of the total blood volume. The proportion of sedimented red cells in a unit of whole blood should be at
least 33%.

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 Chapter 4: Set up and management of transfusion activities

3. Staff responsibilities

Position Tasks and responsibilities

Chief Medical • Obtain authorization from the Ministry of Health to set up blood
Officer transfusion activities in health facility.
(or Hospital • Assess the quality/capacity of external sources of blood, in
Director or collaboration with a laboratory/transfusion advisor, if necessary.
medical referent) • Organise training sessions with the head nurse, physicians and
laboratory technicians.
• Ensure that written, updated and context adapted procedures are
available and followed.
• Oversee the blood transfusion activity including analysis of quality
indicators.
Physicians/ • Assess the risks/benefits of transfusion for each patient.
Anaesthetists • Answer patient’s questions and concerns related to transfusion.
• Obtain written informed consent from the patient or their legal
guardian or witness.
• Prescribe the transfusion and note the reason for transfusion in the
patient file.
• Fill in and sign the blood request form.
• Manage transfusion adverse reactions.
• Examine the patient at the end of the transfusion and record
observations in the patient’s file.
• Fill in the transfusion reaction form in the event of an adverse
reaction.
• Supervise staff in charge of donor selection.
Ward nurses • Collect and label blood samples.
• Perform Hb level and blood grouping if there are no laboratory
technicians available.
• Check patient’s identity and concordance with the blood unit to be
transfused and the delivery form.
• Perform bedside ABO compatibility test prior to transfusion.
• Carry out the transfusion.
• Monitor the patient before, during and after transfusion and fill in
the monitoring sheet.
• Alert the physician in the event of adverse reactions and fill in the
transfusion reaction form.
• Supervise waste management on the ward.
Health promotors • In the health facility: participate in informing families about how
important it is to ‘replace’ the blood their relative has received.
• In the community: together with local leaders, identify suitable sites
to promote blood donation.
• Involve local radio stations in blood donation promotion messages.
• Participate in drafting blood donation documents and oral and visual
messages.
• Facilitate the creation of a local blood donors association.
• Participate in the organization of world blood donor day on June 14th.

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Chapter 4: Set up and management of transfusion activities

Position Tasks and responsibilities

Staff in charge of • Recruit donors and promote blood donation.
blood collection • Select donors (questionnaire, physical examination, Hb test); refer
donors to physician in the event of doubt (e.g. if on medication) or in
the event of abnormality on physical examination.
• Answer donors ‘questions/concerns.
• Ensure that the blood collection room is clean, welcoming and
comfortable.
• Perform blood collection.
• Take care of the donor during and after collection.
• Ensure adequate waste management in the collection room.
Laboratory • Measure Hb and perform donor and patient blood grouping, TTI
technicians screening tests and crossmatching.
• Issue compatible blood units.
• Fill in and sign delivery forms.
• Fill in registers.
• Manage the blood stock.
• Order, receive and check blood units from external sources.
• Ensure proper storage of blood units.
• Check that the cold chain is functioning correctly (including
temperature monitoring).
• Notify the logistics officer in the event of cold chain problems.
• Ensure correct waste management in the blood transfusion service.
Blood transfusion • Organize staff duty roster.
department • Organize the training of laboratory staff, ward nurses, blood collection
supervisor nurses.
• Ensure all documentation (registers, forms) is updated and all records
saved and archived.
• Participate in donor recruitment: raising family awareness, promotion
of voluntary blood donation, organization of mobile blood collection.
• Prepare the weekly or monthly consumable orders.
• Collect, analyse and transmit monthly data.
Pharmacist • Manage the stock of materials and tests/reagents in the pharmacy.
• If blood is stored in the pharmacy, monitor the cold chain.
These responsibilities can be shared with the laboratory technician,
depending on the human resources available and the division of tasks.
Logistics officer • Plan the layout of the laboratory/blood transfusion department with
the blood transfusion supervisor and head of the facility.
• Supervise the construction and organization of the premises.
• Set up and ensure maintenance of the cold chain, including backup
power.
• Set up a waste management system.
• Organize transport (vehicles for blood drives/blood units from
external sources).

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4. Hospital Transfusion Committee

Safe and effective transfusion practices require a multidisciplinary approach.

The hospital transfusion committee’s role is to ensure the implementation of transfusion
safety, good transfusion practices and quality assurance.4

Composition of the hospital transfusion committee

The hospital transfusion committee should be headed by the clinician of one of the wards with
most transfusion needs, or by the hospital director.
The hospital transfusion committee should include a member of each profession involved in
the transfusion chain:
– Prescriber of blood components,
– Head nurse,
– Supervisor of the blood transfusion department,
– Pharmacist,
– Logistics officer,
– Health promoter.
The role of the hospital transfusion committee is to:
– Elaborate policies and procedures (donor recruitment and selection, blood component
indications, patient information, identification of samples and blood components, storage
and transport conditions of blood components, blood administration , waste management
etc.), and give advices on their implementation.
– Ensure a non-interrupted supply of blood and a sufficient blood stock.
– Ensure the rational use of blood and regularly carry out reviews of patient ‘files.
– Set up a haemovigilance system: systematic data collection on adverse effects, discussions
with clinicians and transfusion service staff to establish if a major adverse event was
definitely, probably or unlikely related to transfusion and if appropriate corrective measures
were taken.
– Carry out critical analyses of data, including the number of blood units discarded.
– Approve HR and material/equipment needs, and provide technical support if needed.
– Facilitate staff training.
– Analyse causes of error or dysfunction and implement corrective measures.
– Transmit activity reports to the national blood transfusion service.
– Elaborate a contingency plan for mass casualties or an unusually high need of blood.
– Ensure the safety of staff and patient at all stages.
Meetings should initially be held monthly, then every 3 months when transfusion activities
are running satisfactorily. Ad hoc meetings may be held in the event of serious incidents or
exceptional events.

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5. Quality assurance in blood transfusion

The quality assurance system rests on four pillars:

5.1 Staff
Staff should be:
– Qualified,
– Trained in the application of standard procedures,
– Aware of their tasks and responsibilities,
– Supervised.

5.2 Procedures
Procedures are:
– Appropriate to the context and available equipment,
– Acknowledged, understood and implemented by staff,
– Updated at least once a year.

5.3 Premises and equipment

– Premises are functional and suitable for the activity.
– Equipment comes from a validated source, is checked and maintained regularly.
– Reagents/kits and blood bags come from a validated source and stored according to the
manufacturer’s recommendations.
– Laboratory equipment is calibrated on installation and at regular intervals.

5.4 Documentation
Documentation includes:
– Organizational details and description of the transfusion process (procedures, flow charts,
etc.).
– Staff safety policy (hepatitis B vaccination for all staff exposed to blood, procedure in the
event of accidental exposure to blood, etc.).
– Reference and training documents.
– Instruction leaflets for equipment, reagents, test kits.
– Standard operating procedures for every test carried out.
– Registers.
– Workbench logbook (tests performed, reagent quality control, etc.).
– Forms (order/delivery forms, pre-donation questionnaire, monitoring and transfusion
reaction forms, stock cards, etc.).
– Archived documents (forms and registers, results, quality controls, activity reports, etc.).
Regular critical analyses should be performed on the data collected from registers/documents
by the blood transfusion committee.

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5.5 Follow-up and methods for improving practices

The quality assurance process aims to improve practices with the active participation of all
staff involved.
Problems and errors must be discussed and analysed by the blood transfusion committee, in
order to understand how and why, and to quickly take corrective action that is communicated
to all health staff.

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6. Layout of premises

A transfusion department must include:

1. A waiting area for blood donors.
2. A consultation room for conducting the questionnaire and examining donors. This room
must be designed to provide the necessary confidentiality conditions for medical interview.
3. A well ventilated blood collection room.
4. A recovery area where the donor is monitored after blood collection for 15 minutes after
the donation; donors must always be in view of staff.
5. A laboratory room.
6. A storage room with cold chain equipment. The room should be air conditioned or at least
well ventilated. Allow enough space (50-60 cm) behind the refrigerator(s) for air circulation.

Notes:
– Areas 2 and 3 may be set up in the same room if there are only few donors at a time (less
than 5 donors per day).
– Areas 5 and 6 may also be in the same room.

See standard layout on the following page.

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Chapter 4: Set up and management of transfusion activities

7. Waste management

Blood units (and materials in contact with blood such as bags or tubes) are infectious waste,
even with negative TTI screening.
Adequate medical waste management must be set up from the start of transfusion activities,
regardless of whether the transfusion service is set up in an emergency or stable setting. If
there is a hygiene/infection control committee in the health facility, it must play a central role
in medical waste management.5
In order to minimize the risk of accidental exposure to blood, staff in charge of waste
management (laboratory technician, cleaners) should be adequately protected (i.e. gloves,
goggles, protective clothing) when handling and disposing of blood. It is recommended to
offer vaccination against hepatitis B and tetanus. If possible, waste from transfusion activities
should be treated on site to avoid contamination risks or re-use.
The disposal of large volumes of infected, expired or damaged blood units is complex. Every
effort should be made to minimize the volume of blood requiring disposal.
Blood units that cannot be used (infected, expired or exposed to a break in the cold chain) must
be discarded quickly. Blood units that cannot be discarded immediately should be removed
from the refrigerator and placed under lock and key in a container clearly labelled “blood for
destruction” (to avoid the intentional or mistaken use).

7.1 Waste disposal methods6

Incineration
Blood units and sample tubes must be incinerated without being emptied beforehand. This
technique requires a powerful incinerator, since blood, like any liquid, will extinguish a fire that
is not strong enough. The incinerator must be preheated. Blood units must be placed in the
incinerator one by one. Fuel should be added as required. It is important that the incineration
process is correctly carried out to avoid the production of toxic gases such as dioxins or furans.

Burying
Cement pit
Blood units and sample tubes are discarded into a cement pit, without being emptied
beforehand. The pit is filled with cement when it is full.
This method requires sufficient available space.
Organic pit
The blood of unused blood units may be emptied into an organic pit, then the bags can be
discarded as for empty blood bags (see below). The bags should be cut with scissors to avoid
blood splashing. Bags should not be pierced.

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 Chapter 4: Set up and management of transfusion activities

7.2 Waste material

Empty blood bags after transfusion
Empty blood bags after transfusion may be incinerated or buried in a cement pit.

Sample tubes
Blood from sample tubes can be poured down the drain of the laboratory sink and flushed down
with a 1% active chlorine solution. The empty tubes must then be disposed of as contaminated
medical waste. This method is only possible if the use of chlorine is authorised in the sewage
system. If chlorine use is not authorised, the sample tubes must be incinerated.
Note: this method should not be used for unused blood units.

Needles
Needles are never recapped and are discarded in sharps containers.

If large quantities of blood units need to be destroyed, ask the national blood transfusion
service for technical advice.

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Chapter 4: Set up and management of transfusion activities

References Chapter 4

1. WHO, Design Guidelines for Blood Centers, Western Pacific Region, 2010.
http://www.who.int/bloodsafety/publications/DesignGuideBloodCentres.pdf?ua=1

2. WHO, National Standard for Blood Transfusion Service, Edition 1-2013.

http://www.who.int/bloodsafety/transfusion_services/BhutanNationalStandardsBTServices.
pdf

3. National Blood Authority, Australia, managing blood and blood product inventory.
Guidelines for Australian Health Providers, 2014.
https://www.blood.gov.au/system/files/documents/managing-blood-and-blood-product-
inventory.pdf

4. Ira A.Shulman, Sunita Saxena, The Transfusion Services Committee-Responsibilities and

response to Adverse Transfusion Events, ASH Education Book, January 1, 2005, vol 1,
n°1 483-490.
http://asheducationbook.hematologylibrary.org/content/2005/1/483.full.pdf+html

5. Medical waste management, ICRC 2011.

https://www.icrc.org/eng/assets/files/publications/icrc-002-4032.pdf

6. Safe management of wastes from health care activities, 2nd Edition, WHO 2014.
https://www.healthcare-waste.org/fileadmin/user_upload/resources/Safe-Management-
of-Wastes-from-Health-Care-Activities-2.pdf

96
Appendices

1. Normal haemoglobin values and thresholds defining anaemia (WHO).....................99

2. Acute haemorrhage: assessment, classification and indication of transfusion........100
3. Intra-osseous transfusion......................................................................................... 102
4. Transfusion procedure.............................................................................................. 106
5. Informed consent for blood donation...................................................................... 107
6. Informed consent for a blood transfusion................................................................108
7. Transfusion volumes and rates - Neonates and children without hypovolemia
and/or shock............................................................................................................109
8. Transfusion monitoring form.................................................................................... 110
9. Transfusion reaction form........................................................................................ 111
10. Example of pre-donation questionnaire.................................................................112
11. Blood donation collection procedure..................................................................... 115
12. Preparation of PRBC by sedimentation from a single bag of whole blood.............120
13. Preparation of paediatric whole blood units from penta bag system....................121
14. Preparation of paediatric PRBC units from penta bag system................................124
15. Haemoglobin measurement using HemoCue 301®................................................128
16. ABO and Rh D grouping procedure (direct method on tile)...................................130
17. Blood group result form......................................................................................... 133
18.1. Bedside verification of ABO compatibility using Serafol® ABO............................134
18.2. Bedside verification of ABO compatibility using Eldoncard® 2551......................136
19. HIV 1/2 Determine® test........................................................................................ 138
20. HIV Uni-Gold® test.................................................................................................. 140
21. HIV 1/2 Stat-Pak® Chembio test............................................................................. 141
22. SD Bioline HBsAg WB® test..................................................................................... 142
23. SD Bioline HCV® test............................................................................................... 144
24. SD Bioline Syphillis 3.0® test................................................................................... 145
25.1. SD Bioline Malaria Ag P.f® test............................................................................. 146
25.2. SD Bioline malaria P.f/Pan® (Combo) test............................................................148
25.3. CareStart Malaria pLDH® (Pan) test..................................................................... 150
26. Crossmatch procedure (tile method)..................................................................... 152
27. Blood donations register........................................................................................ 153
28. Patients’ blood groups register............................................................................... 154
29. Blood stock/delivery register.................................................................................. 155
30. Transfused patients register................................................................................... 156
31. Blood request and delivery form............................................................................ 157
32. Example of monthly data collection........................................................................... 158
33. Transfusion module................................................................................................ 159
34. Blood bags.............................................................................................................. 162
35. Refrigerator temperature monitoring sheet...........................................................163
36.1. Fridge-tag®2 with external sensor in a glycol vial................................................164
36.2. Freezing indicator device (Freeze-tag®)...............................................................165
 Appendix 1

Appendix 1. Normal haemoglobin values and

thresholds defining anaemia (WHO)

Normal Anaemia
haemoglobin
values Haemoglobin Haematocrita
(g/dL) (g/dL) (%)

Neonates 13.5 to 18.5 < 13.5 < 34

Children 2 to < 6 months 9.5 to 13.5 < 9.5 < 28

Children 6 months to < 6 years 11 to 14 < 11 < 33

Children 6 to 12 years 11.5 to 15.5 < 11.5 < 34

Men 13 to 17 < 13 < 39

Women 12 to 15 < 12 < 36

Pregnant women
1str and 3rd trimester 11 to 14 < 11 < 33
2nd trimester 10.5 to 14 < 10.5 < 31

Adapted from the WHO, Clinical use of blood, 2005.

a The haematocrit (%) is approximately equal to 3 times the Hb concentration (g/dL) ONLY when red cells
are normal i.e. normochromic (normal mean corpuscular Hb concentration) and normocytic (normal mean
corpuscular volume), which is not usually the case in patients with anaemia.

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Appendix 2

Appendix 2. Acute haemorrhage: assessment,

classification and indication of transfusion

1. Normal blood volume

Neonates 85 to 90 mL/kg of body weight
Children 80 mL/kg of body weight
Adults 70 mL/kg of body weight

2. Hypovolaemia in adults
Hypovolaemic
Class I Class II Class III Class IV
class
Blood loss
< 750 750-1500 1500-2000 > 2000
(mL)

Blood loss
(% of blood < 15% 15%-30% 30%-40% > 40%
volume)

Heart rate >120 > 140

Normal 100-120
(beats/min) Weak Very weak

Systolic BP Normal Normal Low Very low

Capillary refill Normal Prolonged Very prolonged Absent

Coma/
Mental state Alert Anxious Confused
Unconscious

Respiratory rate > 45 or slow

Normal 20-30 30-40
(breaths/min) breathing

Urine output
> 30 20-30 5-20 <5
(mL/hour)

Crystalloids/
Crystalloids/
colloids
Replacement Crystalloids colloids
Crystalloids AND
fluids or colloids AND
blood likely to
blood required
be required

Adapted from the WHO and the American College of Surgeons.

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 Appendix 2

Standard estimated blood loss in adults

Fractures Internal haemorrhages

Humerus 0.5 litre Ectopic pregnancy 0.5-2 litres
Tibia 1 litre Haemothorax 1-1.5 litre
Femur 1.5 litres Spleen 2-3 litres
Pelvis 2-4 litres Retro peritoneal 2-3 litres

3. Hypovolaemia in children
Hypovolaemic
Class I Class II Class III Class IV
class
Blood loss
(% of blood < 15% 15%-25% 25%-40% > 40%
volume)

Heart rate Increased

Increased > 150 > 150
(beats/min) or bradycardia

Systolic BP Normal Reduced Very reduced Undetectable

Capillary refill Normal Prolonged Very prolonged Absent

Mental state Alert Irritable Lethargic Coma

Respiratory rate > 45 or slow

Normal 20-30 30-40
(breaths/min) breathing

Urine output
<1 <1 <1 <1
(mL/kg/hour)

Crystalloids
Crystalloids
Replacement AND
Crystalloids Crystalloids AND
fluids blood likely to
blood required
be required
Source: Clinical use of blood, WHO, 2005.

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Appendix 3

Appendix 3. Intra-osseous transfusion

3.1 Overview
Indications
Intra-osseous (IO) needle installation must be performed by a physician trained in the technique
or by a trained nurse working under the supervision of a physician.
The IO route is only used if an IV catheter cannot be inserted in a life-threatening emergency
(i.e. after three failed attempts at inserting an IV line within 90 seconds); the only exception is
cardiopulmonary arrest when every second counts.
In experienced hands, IO access can be established within 1 minute. Although primarily used
in young children, it can also be used in older children and adults.

Contraindications
– Fractured or infected limb
– Limb with vascular problems or skin problems (burn or infection)
– IO needle insertion in the previous 24 hours in the same site (risk of extravasation due to
previous perforation)
– Osteosynthesis material or prosthesis in the bone used as an access site
– Recent surgical procedure near the insertion site

Risks
– Fracture of the bone during insertion (especially in neonates)
– Growth plate injury
– Dislodging of the IO needle
– Extra medullary (intramuscular, sub-cutaneous) infusion with risk of compartment syndrome
– Infection or osteomyelitis (the risk is minimal if aseptic procedures are followed; proceed
with caution in children with Kwashiorkor).

Precautions
– The procedure must be performed under strict aseptic conditions: handwashinga, disposable
material, disinfection of the insertion site.
– Limit attempts at placement to one attempt per site.
– Insert a peripheral IV cannula as soon as possible. The IO needle should not remain in place
for more than 24 hours.

Monitoring
– Colour of the limb
– Position and fixation of the needle, patency of the IO route, appearance of the insertion site
– Presence of subcutaneous oedema, increasing limb size (extravasation)
– Time elapsed since placement

3.2 Insertion sites

The best site is the flat antero-medial aspect of the proximal tibia as it lies just under the skin
and can easily be located.

a Wash with soap and water or disinfect with an alcohol-based handrub (ABHR).

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 Appendix 3

Possible insertion sites in adults: proximal tibia, distal tibia, proximal humerus.
In children > 2 years old: prefer the proximal and distal tibia.
In children ≤ 2 years old: prefer the proximal tibia.

Proximal Tibia (best site)

Insert the IO needle in the proximal tibia about 2 cm below the patella and on the flat surface
located distal and medial to the tibial tuberosity (not on the tibial ridge).

3.3 Method using a mechanical intra-osseous insertion device

The EZ-IO is a battery powered medical drill fitted with a trocar and IO needle used to pierce
the bone and insert the IO.

Equipment
– EZ-IO battery powered medical drill
– EZ-IO needle set, single-use, sterile
Three types of needle exist: they only differ in length and colour. The gauge stays the same.
• 15 mm needle, pink, for children from 3 to 39 kg
• 25 mm needle, blue, for children above 40 kg and adults
• 45 mm needle, yellow, for obese adults and for humeral site in adults
– EZ-infusion set extension, sterile, single-use
– Transfusion set
– Non-sterile disposable gloves
– Sterile compresses, 10% polyvidone iodine
– 5 or 10 mL syringe of Ringer lactate
– Adhesive, sterile, single-use dressing
– Infusion set + Ringer lactate bag
Note: do not use adult needle in children less than 40 kg (high risk of traumatic complications).

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Appendix 3

Insertion of the EZ-IO needle in proximal tibia

1. Prepare the patient, stabilize the leg (e.g. using a rolled towel under the knee), in slight
external rotation.
2. Determine the insertion site.
3. Wear disposable gloves (after hand washing or disinfection with ABHR).
4. Disinfect the insertion site with 10% polyvidone iodine.
5. Open IO kit and needle’s sterile packaging, place needle on the EZ-IO drill.
Concurrently, prepare and flush the EZ-Connect extension tubing using a syringe (preferably a
luer lock i.e. screw-top) filled with Ringer lactate.
6. Take the cap off the needle. Position the needle on the insertion site at 90° to the bone
(perpendicular).
7. Start the drill by pressing the trigger. Proceed gently, do not use force. Stop the drill as the
needle passes through the cortex (a "give" release of resistance is felt).
8. With one hand, securely hold the needle in place. With the other, take the drill off the
needle, unscrew the stylet and connect the flushed extension tubing.
9. Check for a flash (small amount of blood) in the catheter to confirm the proper placement
of the needle. If the flash is not seen proceed as in step 10 to check IO needle placement.
10. Confirm correct needle placement by injecting a rapid flush of 5 to 10 mL of Ringer lactate
with a syringe. The rapid flush is essential. No flush = no flow. Repeat flush if the flow
does not seem sufficient. If the IO needle is functional the flush should flow freely without
excessive pressure on the syringe.
11. Connect the EZ infusion set extension to the IO needle and then the transfusion set.
12. Secure the catheter (EZ sterile adhesive bandage or sterile gauze and adhesive tape).
Beware of sudden movements, as for a peripheral IV.
13. Start the transfusion. The transfusion can be started by gently pressing the blood unit.
14. Indicate the date and time of placement of the IO on the monitoring sheet. If available,
also attach the IO identification bracelet (supplied with the IO kit) with date and time of
placement of the IO needle.
15. Monitor the transfusion at least every 15 minutes during the first hour.
If the attempt at IO needle placement is unsuccessful, remove the needle and try on the other
leg with another needle.

IO needle removal
1. Stop transfusion.
2. Wear disposable gloves (after hand washing or disinfection with ABHR).
3. Remove fixation.
4. Remove the extension tubing.
5. Fit a luer lock syringe to the IO needle and pull the needle out with a twisting motion. In
the absence of a luer lock syringe, unscrew by hand.
6. Dispose of the needle in a sharps container.
7. Disinfect the site with 10% polyvidone iodine.
8. Apply pressure to the insertion site for a few minutes if necessary.
9. Cover the insertion site with a sterile dressing (sterile gauze).

3.4 Manual insertion method

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 Appendix 3

Equipment
– Disposable sterile IO needle, 16G or 18G according to age and weight
– EZ-infusion set extension, sterile, single-use
– Non-sterile disposable gloves
– Sterile compresses, 10% polyvidone iodine
– Syringe with 5 or 10 mL of Ringer lactate
– Adhesive, sterile, single-use dressing
– Infusion set + transfusion set+ Ringer lactate bag

Insertion of the IO needle

The procedure is the same as above (using a mechanical drill) in terms of preparation, skin
cleansing, patient positioning and verification of needle placement, flow and fixation but:
– Grasp the needle in the palm of the hand, index and middle fingers approximately 2 cm from
the tip;
– Insert the needle at 90° to the entry site using downward pressure and a twisting motion
until resistance decreases as the needle passes through the cortex of the bone.

IO needle removal
As above when using the mechanical device but gently rotate the needle and remove it slowly.

105
Appendix 4

Appendix 4. Transfusion procedure

1. If the blood unit has just been taken out of the refrigerator, leave at room temperature for
10 minutes before transfusion. Cold blood administered at very high rates (i.e. > 25-30 mL/min
for an adult or > 15 mL/min for a child) can cause cardiac arrest. It is therefore important to
have an infusion/blood warmer available in the resuscitation room. If there is no infusion/
blood warmer available, it is critical to keep the patient warm.
However, blood should never be warmed in hot water as this can lead to haemolysis.
Have basic resuscitation drugs and equipment within reach in case of adverse
reactions.
2. Prepare a monitoring form and place the supplies needed on a tray (blood giving set, non-
sterile gloves and compresses, antiseptic solution, tourniquet, IV catheter, adhesive tape,
possibly 3-way connector).
3. Measure and record on the monitoring form pre-transfusion vital signs: temperature, heart
rate, blood pressure, respiratory rate and oxygen saturation.
4. Wash hands, or disinfect them with an alcohol-based solution. Wear gloves.
Insert the IV catheter, check that it is correctly placed and secured.
Connect the blood giving set to the bag, with the flow regulator closed.
Squeeze the drip chamber to fill it.
Open the flow regulator, prime the tubing, then close the flow regulator.
Connect the giving set to the catheter, using an antiseptic-soaked compress.
Do not add any medication to the blood unit.
5. Set the transfusion rate according to the volume and the duration prescribed.
For all blood giving sets, the dripping chamber delivers 15 drops/mL of whole blood or
PRBC.
The pictogram printed on some packaging of blood giving sets means
20 drops/mL, which can be a source of confusion because the number refers
to 20 drops of water/mL and not of blood/mL.
Example of calculation of transfusion rate in drops/minute for 250 mL of PRBC over 3 hours:
Calculate the number of drops to be transfused 250 (mL) x 15 (drops) = 3750 drops
Calculate the transfusion duration in minutes 3 (hours) x 60 (minutes) = 180 minutes
Divide the number of drops by the number of
3750 ÷ 180 = 21 drops per minute
minutes
Transfusion rates in drops/minute in children can be found in Appendix 7.
6. Safely dispose of waste. Remove gloves. Wash hands, or disinfect them with an alcohol-
based solution.
7. Complete the monitoring form: transfusion start time, rate, anticipated end time, etc.
Note: if the blood flow slows down or stops, rotate/adjust the needle gently.
If this fails: clamp the blood giving set, remove it from the catheter (but do not disconnect it
from the bag); then insert a second blood giving set to the second outlet of the bag, prime it
then connect it to the catheter.

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 Appendix 5

Appendix 5. Informed consent for blood donation

Donor’s last name: _ _______________________ Donor’s first name: _________________

Date of birth: _ ____________________________

Address: ____________________________________________________________________

Telephone number : ________________________

I confirm that:
– My personal data and contact information mentioned above are correct.
– I have received and understood all the information concerning blood donation.
– I have received all necessary explanations regarding my health and that of the patient who
will receive my blood.
– I have answered the medical questionnaire to the best of my knowledge.
– I know that the information contained in the medical questionnaire is confidential.
– I know that my blood will be tested to detect infectious diseases that can be transmitted by
blood.
– I accept that the blood I will voluntary give will be used to treat patients that need it and
who are not necessarily part of my family.

I give my informed consent to give my blood.

Regarding the results of the blood tests:

I accept to be informed of the results of the biological tests.
I do not accept to receive the results of the biological tests.

Date: _____ /_____ /_____ (day/month/year)

Donor’s signature

or Legal guardian
(last name, first name and signature)

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Appendix 6

Appendix 6. Informed consent for a blood transfusion

I, the undersigned,

Last name: __________________________ First name: ____________________________

Date of Birth: ________________________

Certify that I have been informed by:

Dr (Last name and first name): _____________________________
Of the necessity of a blood transfusion.

I (the patient) confirm that:

– I understand the medical reasons for a blood transfusion.
– I understand the expected benefits of a blood transfusion.
– I understand that during or after the blood transfusion, I may suffer an unexpected reaction.
– I understand that in spite of the negative test results on the unit(s) of blood which will be
transfused to me there exists a small risk of being contaminated by an infectious disease.
– I have received all the necessary explanations.
– I understand that if I refuse the blood transfusion, my health situation may deteriorate
further, even possible leading to death.

I accept the blood transfusion.

I refuse the blood transfusion.

Date: _____ /_____ /_____ (day/month/year)

Donor’s signature

or Legal guardian
(last name, first name and signature)

108
 Appendix 7

Appendix 7. Transfusion volumes and rates - Neonates

and children without hypovolemia and/or shock
(including severely malnourished children)

Whole blood PRBC

Weight 20 mL/kg at 5 mL/kg/hour 15 mL/kg at 5 mL/kg/hour
(kg) Volume Rate Volume Rate
Duration Duration
(mL)* (drops/min) (mL)* (drops/min)
3 60 4 4 hours 45 4 3 hours
4 80 5 4 hours 60 5 3 hours
5 100 6 4 hours 75 6 3 hours
6 120 7 4 hours 90 7 3 hours
7 140 9 4 hours 105 9 3 hours
8 160 10 4 hours 120 10 3 hours
9 180 11 4 hours 135 11 3 hours
10 200 12 4 hours 150 12 3 hours
11 220 14 4 hours 165 14 3 hours
12 240 15 4 hours 180 15 3 hours
13 260 16 4 hours 195 16 3 hours
14 280 17 4 hours 210 17 3 hours
15 300 19 4 hours 225 19 3 hours
16 320 20 4 hours 240 20 3 hours
17 340 21 4 hours 255 21 3 hours
18 360 22 4 hours 270 22 3 hours
19 380 24 4 hours 285 24 3 hours
20 400 25 4 hours 300 25 3 hours
* 1 mL of blood = 15 drops

Blood units usually contain a volume greater than the prescribed volume. For example, for a child
weighing 6 kg, who must receive 120 mL of whole blood, the transfusion department will issue a
150 mL or 250 mL whole blood unit. For a patient over 20 kg, order a blood unit of 450 mL.
To ensure that the prescribed volume is administered, at the correct hourly rate, the duration of
administration and drops per minute shown in the above table must be respected.
For example, in order to administer 120 mL of whole blood in a child weighing 6 kg, the transfusion
must be set at 7 drops per minute over 4 hours. At the end of 4 hours, the transfusion must be stopped
(as 120 mL will have been given), and the remaining blood must be discarded.

109
Appendix 8

Appendix 8. Transfusion monitoring form

Date: ____ / ____ / ____ Ward:_ ________________________________

Patient
Name: ______________________________ Medical file No:_________________________
Age:________________________________ Sex:___________________________________
Blood group: _________________________ Weight:_______________________________

Transfusion Blood unit number:______________________

Prescribing physician: _________________ Whole blood PRBC
Nurse in charge: ______________________
Volume of blood to be administered:______ mL
Duration of transfusion: ________________ Rate (drops/min):_ ______________________
Transfusion start time:_ ________________ Anticipated end time:_ ___________________

Monitoring
Heart Urine General
Time T° BP RR SpO2
rate output condition
Before transfusion
5 min
15 min
30 min
45 min
1h
1 h 30
2h
2 h 30
3h
3 h 30
4h
4-6 h after the end
of the transfusion

Transfusion end time:_______________________ Volume administered:_____________

Signature of the nurse in charge:

110
 Appendix 9

Appendix 9. Transfusion reaction form

Patient name: __________________________________ Age: ________ Sex: ________

Ward: _____________ Bed No. _______ Medical file No. _________ Date: ___/___/___

Patient’s blood group:__________

Blood unit group: _____________ Blood unit number: ___________

Indication for transfusion: ______________________________________________________

Transfusion start time: ____________ Time the reaction occurred: ____________

Volume transfused: ____________ mL

Signs and symptoms:

Initial hypothesis:

Management and evolution:

Transfusion removed: No Yes Time: ______

Blood unit returned to the transfusion department: No Yes
Samples sent to the transfusion department: No Yes
Observations and additional examinations performed:

Type of transfusion reaction: Very likely Possible

Physician’s name and signature Nurse’s name and signature

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Appendix 10

Appendix 10. Example of pre-donation questionnaire

Pre-selection process
1) Questionnaire

Donor’s
Questions Comments
answers

How old are you? Exclude if < 15 or > 65 years.

How much do you weigh? Exclude if < 45 kg.

Are you feeling well today? If unwell, do not continue, and refer to
the doctor.

When was the last time you donated Min. 8 weeks between 2 donations
blood? (time needed to replenish iron stores).
Collect 150-250 mL max. if last
donation > 8 weeks but < 12 weeks.
Max. 4 times/year for men and
3 times/year for women.

For female donors

Are you pregnant? Exclude if pregnant.

Have you given birth or had a Exclude if yes.

miscarriage in the last 6 months?

Are you currently breastfeeding? Exclude if exclusively breastfeeding.

Is the child exclusively breastfed? If not exclusively breastfeeding: collect
only if the child is > 1 year.

2) Hb level measurement
+ blood group + malaria testing in endemic areas if direct donation

Questionnaire
Donor’s
Questions Comments
answers

What is your occupation? High-risk occupation: sex workers,

drivers, military personnel and any
person with itinerant activity or
separated from their family.
See contraindications, Chapter 2.

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 Appendix 10

Donor’s
Questions Comments
answers
Are you suffering from a chronic illness See contra-indications, Chapter 2.
(epilepsy, diabetes, cancer, heart,
kidney, blood disease)?

Are you taking any medical treatment? See contra-indications, Chapter 2.

In the past, have you suffered from See contra-indications, Chapter 2.

jaundice?

Have you had any dental procedure in If yes, exclude temporarily, see
the past 3 days? Chapter 2.

In the past 3 weeks: If yes, perform malaria test.

Have you had fever? See malaria screening, Chapter 2.
Have you had malaria?
Have you travelled to an area where
there is malaria?

In the past month: Exclude temporarily (2 weeks) after

Have you received any vaccine(s)? immunisation with live vaccines.

In the past 3 months: Exclude: risk of HIV infection, TB,

Have you suffered from night sweats, chronic illness.
weight loss, persistent fever, diarrhoea
or swollen glands?

In the past 4 months: See contra-indications, Chapter 2.

Have you engaged in unprotected Unprotected casual sex includes forced
casual sex? sexual intercourse (rape).
Have you had more than one partner?

In the past 4 months: See contra-indications, Chapter 2.

Have you been treated for STI (syphilis,
gonorrhoea, chlamydia, genital ulcer or
herpes)?

In the past 6 months: See contra-indications, Chapter 2.

Have you been hospitalised?
Have you had surgery or endoscopy?

In the past 6 months: Exclude for 6 months after transfusion.

Have you received a blood transfusion?

In the past 6 months: If yes, exclude.

Have you shared used needles or
syringes?
Have you had scarification, tattoos or
piercing (ears, body)?

Date: ___ / ___ / ___

Do you wish to give blood regularly? Yes No
Do you wish to receive your tests results? Yes No
Can we contact you in future? Yes No

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Appendix 10

Physical examination

Criteria Results Comments

Weight (if unknown) Exclude if < 45 kg.

Exclude if axillary T° > 37.5 °C and test

Temperature
for malaria in endemic area.
Exclude if heart rate < 50/min
Heart rate or > 100/min or irregular.

Systolic BP Exclude if systolic BP < 100

or > 180 mmHg.

Signs suggesting an acute or chronic AND

infection including HIV infection Refer the donor to the physician if
or hepatitis: yellow conjunctiva any abnormality observed on physical
(jaundice), enlarged lymph nodes, skin examination.
rash, oral thrush, etc.

Donor excluded Permanently

Temporarily Until ___ / ___ / ___ (Day/Month/Year)

Donor selected

Maximum volume to collect _____________ mL

Snacka

a A snack may be given before donation if the donor is fasting.

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 Appendix 11

Appendix 11. Blood donation collection procedure

Collecting blood carries a risk of bacterial contamination and thus, a risk of secondary infection
in the patient transfused with the contaminated blood. The procedure must be carried out
with one single puncture, strict aseptic technique and respecting the principle of a sterile
closed system.

One bag = One needle = One puncture

Equipment
– Blood bag (Appendix 34)
– Dressing tray
– Non-sterile, single use gloves
– Protective glasses
– Non-sterile compresses
– Antiseptic solution (polyvidone iodée 10%) for skin desinfection
– Tourniquet
– Adhesive tape
– Scissors
– EDTA tube
– Electronic scale for blood bags, or blood collection monitor (refer to end of procedure for its
use)
– Support for the scale (e.g. stool, small table)
– Sheet to place under donor’s arm
– Sharps container
– Chlorhexidine or 0.5% chlorine solution (or another disinfectant) for material and surface
disinfection
– Fine tip permanent marker

Procedure
1. Explain the procedure to the donor.
2. Inspect the donor’s arms: the skin should be free of scars and lesions. The puncture site
must be clean. If necessary, ask the donor to wash his/her forearms with soap and water,
especially the antecubital fossa.
3. Place the donor in a semi-sitting or lying position.
4. Wash your hands or disinfect them with an alcohol-based solution.
5. Prepare the material and place the electronic scale or the blood collection monitor 20-30
cm lower than the donor's arm to use gravity during the blood collection. Place a sharps
container as close as possible of the donor’s arm.
6. Prepare the blood bag:
• Choose the bag size according to the volume of blood to be drawn, taking into account
the donor ’s age, weight, Hb level and the available blood stock and further needs. For
direct donation, collect only what the patient needs, e.g. a 150 mL bag if the volume of
blood prescribed is 100 mL.

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Appendix 11

A maximum of 8-10 mL/kg of blood can be drawn. The amount of collected blood should
be limited to:
- 500 mL in an adult > 50 kg
- 250 mL if the donor’s age is between 15 and 18 or if the donor’s weight is between
45 and 50 kg.
• Remove the blood bag from its packaging. Check the bag is in correct condition: no leaks,
anticoagulant clear and colourless.
• Label the bag with the donation number, collection date and expiry date. The donation
number is unique. All the components issued from this donation keep the same number.
It allows traceability between recipient and donation/donor.
• Close the clamp on the bag tubing (5 cm from the bag).
• Make one loose knot at the far end of the tubing, 10 cm from the needle (Figure 11.1).

Figure 11.1

7. With the empty blood bag on it, adjust the electronic scale to 0, so that the scale displays
only the weight of the blood collected (see below, at the end of the procedure, how to use
a blood collection monitor).
8. Prepare the venipuncture site:
• Put a clean sheet under the donor‘s arm, to protect the armrest/bed from blood spills.
• Put the tourniquet on and locate a good vein in the antecubital fossa.
• Wear gloves and protective glasses.
• Disinfect the puncture site and let it dry without wiping. Repeat the procedure.
• After the skin has been disinfected, the vein should not be palpated again. Make sure you
do not splutter on the disinfected site, or wear mask.
9. Perform the puncture, while slightly pulling the skin towards the hand with the needle
bevel upwards:
9.a. Bag without sampling arm (=without diversion pouch)
• Open the clamp only after the needle has penetrated into the skin.
• As soon as a few mL of blood are in the bag, start mixing the blood with the
anticoagulant by gently rocking the bag, off the scale.
• When blood flow is satisfactory, secure the needle and the tubing with adhesive
tape on the forearm.
9.b. Bag with sampling arm (= with diversion pouch)
• Close the 2 clamps (main line and diversion line) before the puncture. Fold the
“breaker” to open it (Figure 11.2).

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 Appendix 11

Figure 11.2

• Open the clamp only after the needle has penetrated into the skin.
• As soon as the diversion pouch is filled, close the clamp to the diversion pouch, and open
the main collection line clamp.
• As soon as a few mL of blood are in the main bag, mix the blood with the anticoagulant
by gently rocking the bag, off the scale.
• When blood flow is satisfactory, secure the needle and the tubing with adhesive tape.
• If tests are performed after blood donation, immediately fill the EDTA tube from the tube
holder attached to the diversion pouch and label the tube with the donation number.
10. Collect blood
• Blood collection usually takes 7 to 8 minutes and should not last more than 12 minutes.
• Repeat the manual mixing manoeuvre every minute until the bag is filled. Regularly
check the weight of the blood bag. Stop the collection when the correct weight (volume)
is reached (± 10%).
Final weight of a filled blood bag (Terumo bags) a

Minimum-maximum Weight of collected Expected final

Blood bag size volume to be blood in g weighta in g
(in mL) collected (minimum-maximum) (minimum-maximum)
alone (no bag, no including bag and
(in mL) anticoagulant) anticoagulant

150 135-165 157 (142-173) 203 (188-219)

250 225-275 262 (236-289) 327 (301-354)
450 405-495 472 (425-520) 575 (528-623)

11. Stop blood collection

• Release the tourniquet.
• Close the clamp prior to removing the needle; otherwise air will be introduced into the
bag and may contaminate the blood.
• Remove the needle.
• Ask the donor to press firmly on the puncture site with a compress, keeping the arm
straight.
• Immediately slide the protective device over the needle.
• Tighten the loose knot near the needle. The bag is now safely closed.

a Blood density: 1.05 g/mL

117
Appendix 11

12. If tests are performed after donation, collect sample (Figure 11.3), in case of bag without
sampling arm:
• Cut the bag tubing between the knot and the needle, close to the knot. When cutting the
tubing, beware of blood spills. Position a compress to absorb the blood when cutting the
tubing.
• Open the EDTA tube and empty the blood from the cut off piece of tubing.
• Close the EDTA tube and label it immediately with the donation number and date.

Figure 11.3

13. Discard immediately the needle in the sharps container.

14. Final steps of blood collection
• If a tube stripper is available, strip the giving line twice to get anticoagulated blood in the
giving line.
• Make 5 tight knots in the tubing at intervals of 10-15 cm, creating 4 segments to be used
for further testing: 2nd blood group, 2nd HIV test, crossmatch (Figure 11.4).
Or make segments with the tube sealer.

Figure 11.4

• Disinfect the armrest using a 0.5% chlorine (chlorhexidine) solution and dispose of waste.
• Disinfect the scissors using a 0.5% chlorine (chlorexidine) solution and rinse thoroughly
with running water to avoid cross-contamination with the following sample.
• Remove and discard the gloves; wash your hands or disinfect them with an alcohol-based
solution.
• Send the EDTA tube to the laboratory in order to perform the tests as soon as possible.

118
 Appendix 11

15. Donor care

• Tape a dry compress over the puncture site after checking that it has stopped bleeding.
• The donor should remain in a sitting position for 5 minutes before slowly getting up. The
donor should then be kept under observation and rest for 10 minutes. Encourage them
to drink (500 mL); advise them to avoid strenuous activity for a few hours.
16. Blood storage
• If the collected blood is not be transfused within 4 hours, let it cool down (in a temperate
cold box, an air conditioned room or by using a wet cloth) to a temperature between
18-24 °C for 2 to 4 hours. This allows the bactericidal activity of the white blood cells to
take place. Also, “pre-cooling” blood bags reduces the risk of raising the temperature
inside the blood refrigerator.
• Blood must then be stored in a refrigerator between 2-6 °C.
Note: if not all the required tests have been performed, make sure that untested blood bags
are stored separately from qualified blood units, in a clear manner for all staff.

Blood collection with a blood collection monitor

– Set up the volume of the selected bag.
– Place the satellite bags on the tray with the primary bag on top.
– Slide the giving line in the metal clamp.
– After the needle has penetrated into the skin, start the collection monitor: the clamp will
open automatically, and the tray will start rocking.
The monitor constantly measures the weight of collected blood and displays the corresponding
volume, measures the collection flow, signals in the event of slow blood flow, clamps and
triggers a visual and audible signal when the target volume is reached.

Possible incidents during or after blood donation

– Blood flows slowly or stops flow in:
• Check the blood bag is 30 cm lower than the puncture site.
• Ask the donor to close and open the fist (pump).
• Adjust the tourniquet.
• Move delicately the needle in order to place it in the lumen of the vein.
– Blood collection had to be stopped before the minimum required volume is reached:
• Blood cannot be used. Discard the bag. Each bag must be filled so that the ratio
anticoagulant/blood is adequate.
• If donor accepts, try a second puncture on the other side, using a new blood bag. Its size
will depend on the volume already drawn in order not to exceed the maximum authorised
volume per donation (e.g. if 150 mL have been collected, use a bag of 250 mL for the
second try, if the donor is able to give 450 mL).
– Fainting:
Up to 5% donors faint during or after blood collection.
Anxiety or getting up too abruptly are facilitating factors.
Donor feels weakness, malaise associated with profuse sweating, eye sight deterioration,
brief episode of unconsciousness and looks pale.
In case of loss of consciousness, stop definitively blood collection. Put the donor on his back
with raised legs. Once he has recovered, ensure he is correctly hydrated.
– In case of exposure to blood:
Follow standard procedure.

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Appendix 12

Appendix 12. Preparation of PRBC by sedimentation

from a single bag of whole blood

Packed red blood cell (PRBC) concentrates are preferred for:

– Patients with anaemia without hypovolaemia,
– Patients at risk of developing fluid overload,
– Patients transfused with non-ABO identical blood.
PRBC prepared by centrifugation are sometimes provided by national/regional transfusion
services but are unlikely to be available in many settings.
PRBC can be prepared by storing the blood bag of whole blood in the refrigerator, in an upright
position, placing the transfusion set outlet pointing down, for 24 to 48 hours. This allows the
red cells to sediment. The longer the sedimentation time the more distinct the separation
between red cells and plasma.
The sedimented blood unit must be carefully transported from the transfusion department to
the ward in order for the red cells not to be mixed back with the plasma. The sedimented red
cells must not be disturbed during transfusion as well.
Care must be taken to stop the transfusion when the plasma reaches the bottom of the blood
unit or when the volume prescribed has been administered.

Sedimented red cells

Whole Blood
occupy a volume of
450 mL bag 205 mL
250 mL bag 115 mL
150 mL bag 69 mL
100 mL paediatric bag 41 mL

Plasma and
anti-coagulant

Sedimented
red cells

Figure 12.1
Packed red blood cells prepared by sedimentation

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 Appendix 13

Appendix 13. Preparation of paediatric whole blood

units from penta bag system

Paediatric units can only be prepared once grouping and TTI screening have been performed
on the donor or on the donated blood.
The penta bag system is a closed system made up of one primary 450 mL bag, containing
anticoagulant-preservative solution, and four 100 mL satellite bags attached to the primary
bag, which do not contain anticoagulant. This system is used to transfer the blood collected
in the primary bag into 4 sub-units of less than 150 mL, while keeping the system closed and
sterile, for paediatric use.

Equipment
– Hook or stand to hang the primary bag
– Scissors
– Compresses
– Chlorhexidine solution
– Non-sterile, single use gloves
– Protective glasses
– Fine-tip permanent marker
– Electronic scale for blood bags
– Tube sealer if available

Procedure
1. Wear gloves and protective glasses.
2. Label the four satellite bags. Write on each bag:
• The blood donation number of the 450 mL bag, plus an index number for each unit from
1 to 4,
• The collection and expiry dates,
• The ABO Rh D group,
• The TTI testing results,
• The type of component: whole blood.
3. Fill the 4 satellite bags:
• Homogenize the blood thoroughly by gently tilting the 450 mL bag.
• Open the 4 clamps and position them as close as possible to the 450 mL bag.
• Hang the 450 mL bag high enough to let the 4 bags hang down.
• Firmly fold the “breaker” to open the circuit (Figure 13.1).
• The four satellite bags will fill up simultaneously and equally, until the primary bag is
empty. If not, check that the “breaker” is fully open. Once the 4 satellite bags have been
filled, each one contains 100 to 125 mL of blood depending on the volume contained in
the primary bag (between 405 and 495 mL + 63 mL of anticoagulant).
4. Refill the tubing back with blood to allow performing the crossmatch on the tubing:
• Press gently on bag N°1 to evacuate the air from the tubing and fill it with blood
(Figure 13.2).
• Close the clamp.
• Repeat for bag N° 2, N° 3 and N° 4.
• Once the 4 clamps are closed, unhook the primary bag.

121
Appendix 13

5. Close each bag and separate them:

• For each bag, tie a knot in the tubing below and near the clamp and tighten securely. Cut
the tubing between the knot and the clamp while protecting from spills with a compress.
• Tie two more knots in the tubing, or use the tube sealer.
6. Waste management:
• Disinfect the scissors with a chlorhexidine solution and rinse thoroughly under running
water.
• Safely dispose of the empty 450 mL bag.
7. Weigh each paediatric bag, subtract 20 g (weight of the plastic) and note the weight/volume
on each bag (Figure 13.3).
8. Enter the four paediatric units of whole blood in the blood stock register.
9. Store them in the blood refrigerator.

Figure 13.1 Figure 13.2

Fold the “breaker” Refill the tubings back with blood

Figure 13.3
4 paediatric whole blood units filled, closed, separated and labelled

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 Appendix 13

Notes:
– To obtain volumes inferior to 100-125 mL (e.g. 50 mL or 75 mL), satellites bags can also be
filled one by one by closing the 3 other clamps. In this case, place the empty satellite bag on
the scale and adjust the scale to 0, so that the scale displays only the weight of the blood.
Fill the bag until the desired weight (volume) is reached, i.e. 79 g for a unit of 75 mL and 52 g
for a unit of 50 mL. Indicate the volume of whole blood on the label.
– All the remaining units prepared from the same 450 mL donation must be discarded if:
• An abnormality is detected in one satellite unit.
• A septic transfusion reaction occurs during or after transfusion of one paediatric unit.
– Paediatric whole blood units may be stored in an upright position, placing the transfusion set
outlet pointing down, for a minimum of 24 hours, to obtain units of paediatric concentrated
red cells (Appendix 12).

123
Appendix 14

Appendix 14. Preparation of paediatric PRBC units

from penta bag system

Paediatric units can only be prepared once grouping and TTI screening have been performed
on the donor or on the donated blood.
The penta bag system is a closed system made of one primary 450 mL bag, containing
anticoagulant-preservative solution, and four 100 mL satellite bags attached to the primary
bag, which do not contain anticoagulant. This system is used to transfer in a sterile manner
the blood collected in the primary bag into 4 sub-units of less than 150 mL, while keeping the
system closed, for paediatric use.

Equipment
– Plasma extractor
– Scissors
– Electronic scale for blood bags
– Compresses
– Chlorhexidine solution
– Non-sterile, single use gloves
– Protective glasses
– Fine-tip permanent marker
– Tube sealer if available

Procedure
1. The penta bag of whole blood is placed in the refrigerator, in an upright and stable position,
placing the transfusion outlets pointing upwards, for 24 to 48 hours. This allows the red cells
to sediment. The longer the sedimentation time the more distinct the separation between
red cells and plasma.
2. 2..Take the penta bag system delicately out of the refrigerator and check that the red cells/
plasma separation is clear and that the height of the plasma corresponds to at least half
of the height of the bag’s content. Immediately hang it vertically on the wall or place it
delicately in the plasma extractor.
3. Wear gloves and protective glasses.
4. Label 3 of the 4 satellite bags. Write on each bag:
• The blood donation number of the 450 mL bag and an index number on each unit: (1) on
bag 1, (2) on bag 2, (3) on bag 3,
• The collection and expiry date,
• The ABO Rh D group,
• The TTI testing results,
• The type of component: PRBC.
5. Close the clamps of the 3 labelled satellite bags.
6. Firmly fold the “breaker” to open the circuit (see Appendix 13, Figure 13.1).
7. While releasing slowly the spring of the plasma extractor or applying a constant pressure
on the 450 mL bag with a flat object, transfer the plasma to the non-labelled satellite bag.
Leave 2 cm height of plasma above the red cells. Clamp (see Figure 14.2).

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 Appendix 14

8. Unhook the primary bag. Homogenize thoroughly the concentrated red cells by rocking the
primary bag (see Figure 14.3).
9. Transfer the concentrated red cells in each of the 3 labelled satellite bags by opening and
closing the respective clamp (see Figure 14.4). According to the desired paediatric unit
volume, the concentrate red cells can be separated into the 3 satellite bags, or into the
3 satellite bags and the primary bag which will then be labelled as PRBC with the index
number 4 (see Figure 14.5).
10. For each bag, tie a knot in the tubing just below the clamp and tighten securely. Cut the
tubing between the knot and the clamp while protecting from spills with a compress.
11. Tie two more knots in the tubing, or use the tube sealer.
12. Disinfect the scissors, and rinse thoroughly under running water.
13. Waste management: safely dispose of the remaining plastic material and the bag of plasma:
it is not fresh frozen plasma, but ordinary plasma which has no therapeutic use.
14. Weigh each PRBC paediatric unit, subtract 20 g for the plastic (and 40 g for the primary bag)
and note the weight/volume on each bag.
15. Enter the 3 or 4 PRBC paediatric units in the blood stock register.
16. Store them in the blood refrigerator.

Note:
– All the remaining units prepared from the same 450 mL donation must be discarded if:
• An abnormality is detected in one satellite unit.
• A septic transfusion reaction occurs during or after transfusion of one paediatric unit.

Figure 14.1
Sedimented whole blood bag ready for plasma transfer

125
Appendix 14

Figure 14.2
Transfer of plasma to the non-labelled satellite bag

Figure 14.3
Homogeneisation of concentrated red cells

126
 Appendix 14

Figure 14.4
Transfer of concentrated red cells to satellite bags

Figure 14.5
Four units of pediatric PRBC (3 units in satellite bags, 1 unit in primary bag)
separated, closed, and labelled

127
Appendix 15

Appendix 15. Haemoglobin measurement using

HemoCue 301®

HemoCue 301® is a hand-held analyser allowing quantitative determination of Hb from

capillary or venous blood samples.

HemoCue301® HemoCue 301® cuvette

Equipment
– HemoCue 301® analyser
– HemoCue 301® cuvettes
– Non-sterile, single use gloves
– Non-sterile compresses
Note: cuvettes 201 (in red top container) and 301 (in white top container) look similar, but are
not interchangeable. It is not possible to insert 201 cuvettes in the HemoCue 301®, and vice
versa.

Sample
– Capillary blood, for immediate testing.
– After capillary prick, wipe off the 2 first drops. Make sure the puncture site is dry.
Warning: to ensure good capillary flow, make sure the puncture site is warm by gently
massaging or applying a warm wet cloth; ensure the puncture site is lower than the heart;
choose a site with thin skin (e.g. ear lobe)

Procedure
– Switch on the analyser. It will automatically perform an auto-test with calibration.

128
 Appendix 15

• Introduce the pointed end of the cuvette into the centre of the
drop of blood holding it horizontally.
• Let the cuvette fill (10 microliters of blood) by capillary action
in one continuous process. It must be filled completely and
uniformly.

Wipe off excess blood on the outside of the cuvette with a

compress, without removing blood from inside the cuvette.

Ensure that no air bubbles are present in the cuvette.

• Pull the cuvette holder to the loading position.

• Insert the cuvette in the cuvette holder.
• Gently push the cuvette holder. It will close automatically.

– A filled cuvette must be analysed within 40 seconds of filling.

– Result is displayed within 30 seconds.
– Remove the cuvette and dispose of it in a sharps container.
– Push the cuvette holder back.
Note: if the test is performed on whole blood collected in an EDTA tube, mix the blood by
tilting the tube 10 times in order to homogenize the blood sample. Apply one drop of blood on
a clean glass slide or any waterproof surface then fill the cuvette.

Common causes of error

– Insufficient filling of the cuvette
– Presence of air bubbles
– Non-uniform filling of the cuvette due to presence of “rouleaux” or agglutination
– Blood taken from the perfused side
– Finger or heel not warmed, too much pressure applied to the puncture site
In these situations, repeat the test with another cuvette.

Cleaning of cuvette holder and optical unit

The cuvette holder should be cleaned at the end of each working day.
The optical unit should be cleaned at least once a month, or after 50 tests, or when the analyser
shows an error message.
Follow the manufacturer s instructions.

Storage
Hemocue 301® and disposable 301® cuvettes are designed to operate between 10 °C and 40 °C.
When stored between 10 °C and 40 °C, cuvettes can be used until the expiry date.
When stored between 40 °C and 50 °C, they must be used within 6 weeks.
After opening the cuvettes container, cuvettes should be used within 3 months.

129
Appendix 16

Appendix 16. ABO and Rh D grouping procedure

(direct method on tile)

Direct grouping determines the presence of antigens on the red cell membrane using
monoclonal antisera, which have agglutinating properties at room temperature.

Equipment and reagents

– Smooth white ceramic tile (approx. 15 x 30 cm), degreased and dry
– Applicators (wood or plastic mixing sticks, round bottomed tube, needle cap or similar item)
– Permanent marker
– Reagents vials:
• Antisera:
Anti-A Blue
Anti-B Yellow
Anti-AB Colourless
Anti-D Colourless

• Rh negative control colourless (the reagent must be from the same manufacturer as the
anti-Rh D antiserum).
The vial labels are prone to becoming unstuck due to condensation. It is advisable to secure
the labels by wrapping the vials with clear adhesive tape, as anti-AB, anti-Rh D and control
reagent are all colourless, and can easily be confused.
Keep the set of 5 grouping vials in use in a designated stand.

Sample
Blood grouping of a donor or a patient:
– Capillary blood, for immediate testing
– Whole blood in EDTA tube
Checking the blood group of a blood bag:
– Blood from the distal segment of the bag tubing

Procedure
1. Allow the reagents to reach room temperature.
2. Ensure the tile is dry.
3. With the marker, divide the tile into 6 columns:
• In the first column, note the sample identification:
- For donor or patient blood grouping: initials and date of birth or patient’s name or
donor’s name
- For blood group verification on a blood unit: blood unit number
• In the 5 remaining columns, note in the following order: anti-A, anti-B, anti-AB, anti-Rh D
and negative control.
4. Deposit 1 drop of each reagent in its respective labelled area of the tile.

130
 Appendix 16

5. Deposit 1 small drop of whole (approximatively 20 microliters), blood beside each reagent
drop.
6. Mix the 2 drops in circles of 3 cm diameter with an applicator. Wipe the applicator between
each test zone (or use a new one).
7. Rock the tile gently, in a three-directional movement, for 2 minutes, while observing the
reactions. They may develop at different rates and to different extents. Be careful that the
mixtures do not run into each other.
If no agglutination with anti Rh D is visible at 2 minutes, extend agitation and observation
to 3 more minutes: the reaction is slower and agglutinates are thinner than with anti-A and
anti-B antisera.

Results and interpretation

The interpretation of ABO Rh D grouping is possible only if the control reagent (Rh neg. control)
is clearly negative.
Agglutinates form progressively, and leave the background free of red cells. When the mixture
remains homogeneously coloured, no agglutination is present.
The presence of agglutination means that the antigen is present on the red cell surface.
If the reaction is not obvious, repeat the procedure using less blood (fewer red cells) and/or
more reagent.
Interpretation chart – Direct ABO Rh D blood grouping
Rh neg.
Anti-A Anti-B Anti-AB Anti-D Interpretation
control

+ – + + – A Rhesus positive

+ – + – – A Rhesus negative

– + + + – B Rhesus positive

– + + – – B Rhesus negative

+ + + + – AB Rhesus positive

+ + + – – AB Rhesus negative

– – – + – O Rhesus positive

– – – – – O Rhesus negative

+ ou – + ou – + ou – + ou – + No interpretation possible

+ : Presence of agglutination – : Absence of agglutination

Reporting and registering the result

– A, B, O letters must be written in capital letters.
– Rh D group must be written in letters i.e. pos. or neg.
– Record the ABO Rh D group:
• For a blood donor/donation, in the donations register and on the blood bag label using a
permanent marker.
• For a patient, in the patients’ blood group register, the blood group result form, the
medical file and the blood request/delivery form.

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Appendix 16

Common causes of error

– Sample clotted or haemolysed
– Cross-contamination of reagents (by swapping caps)
– Cross-contamination of the reaction zones during mixing on the tile
– Cord blood contaminated with Wharton’s jelly in neonates

Main causes of interpretation difficulties

Weak agglutination:
– Repeat the test using less blood (fewer red cells) and/or more antiserum.
– Agglutination may be incomplete if the patient was recently transfused with non- ABO or
Rhesus identical blood.
Positive reaction with the Rh negative control reagent:
– This can happen in the following circumstances:
• Rouleaux (piles of red cells) can be confused with agglutinates.
• Auto-agglutination of red cells is encountered in some pathologic conditions.
– If the reaction with the Rh negative control is not clearly negative, wash the red cells with
normal saline:
• Add normal saline to a few drops of whole blood in a new plastic tube, mix, centrifuge
(1000 ga, 2 minutes), and discard the supernatant.
• Perform a second washing and use the washed red cells to perform the grouping
procedure.
– If the reaction with washed red cells is still positive, the grouping procedure is not validated.
Thus:
• When grouping a donor: do not use the collected blood as the blood group cannot be
determined. This is however exceptional.
• When grouping a patient: consider the patient as an O Rh neg. recipient.
When cold agglutinin is suspected, perform the blood group on a warm tile (approx 37 °C) and
using warmed washed red blood cells and warm antisera.

a g : centrifugal force

132
 Appendix 17

Appendix 17. Blood group result form

Patient’s last name:_________________________ First name: _________________________

Date of birth: _ ____________________________ Place of birth: _ _____________________

Medical file number: _______________________

1st determination 2nd determination

Capillary blood Venous blood Capillary blood Venous blood

Drawn by: Drawn by:

Ward: Ward:

Date: ___ / ___ / ___ Time: Date: ___ / ___ / ___ Time:

Determination done by: Determination done by:

Result: Result:

Concordance Yes No

Laboratory technician’s signature

133
Appendix 18.1

Appendix 18.1. Bedside verification of ABO

compatibility using Serafol® ABO

The bedside verification of ABO compatibility aims at preventing ABO incompatibility accidents
resulting from mislabelling of tubes/blood unit or misidentification of patients. The ABO group
of both recipient and blood unit are checked.
The verification is performed:
– By the nurse or doctor who carries out the transfusion.
– At the patient’s bedside.
– Immediately before starting transfusion.
– Using the recipient’s capillary blood (taken from finger, heel, or ear lobe) and blood from the
tubing segment of the blood unit.

Equipment
– A card with 6 zones:
• 4 circles containing a drop of desiccated blood grouping reagent: 2 circles with anti-A
(blue) and 2 circles with anti-B (yellow) reagents
• 2 squares (BLOOD) to deposit blood: 1 for the recipient’s blood and 1 for the blood unit

134
 Appendix 18.1

– 4 plastic sticks for mixing

– 1 sheet of transparent adhesive
– 1 lancet
– One 5 mL vial of normal non-sterile saline solution

Procedure
1. Note on the upper part of the card (recipient section) the recipient’s identification (full
name, date of birth and medical file number).
2. Note on the lower part of the card (blood unit section) the blood unit number in the box
“Unit No.”, the date of the control and the operator's name.
3. Apply 1 drop of normal saline solution on each drop of desiccated reagent.
4. Apply 1 drop of the recipient’s capillary blood on the upper square. Ensure that there is
enough blood to allow an obvious interpretation of the reaction. If necessary, massage
and/or warm the puncture site.
5. Cut the extremity of the segment of the blood unit tubing and apply 1 drop of blood on the
lower square. Avoid applying clots.
6. With a stick, transfer the recipient’s blood to the upper anti-A circle; mix the blood and the
reagent.
7. With a new stick, transfer the recipient’s blood to the upper anti-B circle; mix.
8. Repeat the same procedure with the blood from the blood unit, on the lower anti- A and
anti-B circles, using a new stick for each circle.
9. Rock the card in a three-directional movement for 1 minute and read.
10. Note the interpretation (in the recipient section and in the blood unit section) and sign:
If the blood issued is ABO identical: check that reactions are identical.
If the blood issued is ABO compatible: check that reactions show that the blood is compatible
with the recipient.
Interpretation must be unequivocal. In the event of any doubt, the procedure must
be repeated unquestionably.
Any reaction that shows agglutination with the blood unit and no agglutination with the
patient’s blood categorically contra-indicates the transfusion.
In case of doubt, do not start the transfusion and call the physician in charge.

11. Once the card is dry, apply the adhesive. The card must be kept in the patient’s file.

Storage
Serafol® ABO should be stored below 25 °C.

Note: this verification does not replace a blood grouping test and is not a cross-match
procedure.

135
Appendix 18.2

Appendix 18.2. Bedside verification of ABO

compatibility using Eldoncard® 2551

The bedside verification of ABO compatibility aims at preventing ABO incompatibility accidents
resulting from mislabelling of tubes/blood unit or misidentification of patients. The ABO group
of both recipient and blood unit are checked.
The verification is performed:
– By the nurse or doctor who carries out the transfusion.
– At the patient’s bedside.
– Immediately before starting transfusion.
– Using the recipient’s capillary blood (taken from finger, heel or ear lobe) and blood from the
tubing segment of the blood unit.

Equipment
– A card with 4 circles covered with a drop of desiccated blood grouping reagent: 2 circles with
anti-A (green) and 2 circles with anti-B (pink) reagents

– 4 plastic sticks for mixing

– 1 piece of transparent adhesive
– 1 lancet
– 1 vial of 5 mL of non-sterile normal saline solution

Procedure
1. In the RECIPIENT zone (left side, yellow bar), note the recipient’s identification (full name,
date of birth and medical file number).

136
 Appendix 18.2

2. In the DONOR zone (right side), note the blood unit number (in the box “Name”).
3. Note date, time and operator's name.
4. Apply 1 drop of normal saline solution on each drop of desiccated reagent.
5. Apply 1 small drop of the recipient’s capillary blood on the RECIPIENT anti-A and anti-B
circles. It is essential to apply enough blood to ensure an unequivocal reading of the
reaction. If necessary, massage and/or warm the puncture site.
6. Cut the extremity of the segment of the blood unit tubing and apply 1 small drop of blood
on the DONOR anti-A and anti-B circles. Avoid applying clots.
7. In each circle, mix the blood and the reagent, using a new stick for each circle.
8. Rock the card in a three-directional movement for 1 minute and read.
9. Note the interpretation (in the RECIPIENT zone and in DONOR zone) and sign:
If the blood issued is ABO identical: check that reactions are identical.
If the blood issued is ABO compatible: check that reactions show that the blood is compatible
with the recipient.
Interpretation must be unequivocal. In the event of any doubt, the procedure must
be repeated.
Any reaction that shows agglutination with the blood unit and no agglutination with the
patient’s blood categorically contra-indicates the transfusion.
In case of doubt, do not start the transfusion and call the physician in charge.

10. Once the card is dry, apply the adhesive. The card must be kept in the patient’s file.

Storage
Eldoncard® 2551 should be stored below 37 °C.
Note: the cards are not individually packaged and may stick to each other in humid conditions.

Note: this verification does not replace a blood grouping test and is not a cross-match
procedure.

137
Appendix 19

Appendix 19. HIV 1/2 Determine® test

HIV 1/2 Determine® test is a lateral flow rapid test for the detection of HIV 1 and 2 antibodies.

Description
– Membrane covered with HIV 1 and HIV 2 recombinant antigens and synthetic peptides.
– Strips individually sealed, attached in cards of 10 (10 cards), packed in an aluminium pouch.
The pouch has a grip closing system and contains a desiccant.

← Sample identification
zone

← Control bar C
← Test bar T

← Sample pad

Sealed and unsealed strips

Warning: the chase buffer to be used when testing whole blood is not included in the kit and
must be ordered separately.

Sample
– Plasma or whole blood (EDTA tube) or serum (plain tube)
– Capillary blood

Procedure
1. Break off the strip(s), at the right hand side of the card, by folding several times along the
perforated line. Put the remaining strips back into the pouch with the desiccant and seal
securely.
2. Mark the sample number on the strip between the 2 plain green-grey bands at the top,
using a fine tip permanent marker.
3. Carefully tear off the protective foil cover.

138
 Appendix 19

4. If using whole blood:

• Apply 50 microliters to the sample pad.
• One minute later, apply 1 drop of chase buffer to the sample pad.
If using serum/plasma:
• Apply 50 microliters to the sample pad. DO NOT add chase buffer.

Interpretation
– Read the result no sooner than 15 minutes and no later than 60 minutes.
– The test is validated only if the internal control bar is visible. Otherwise, the test is invalid.

Interpretation of HIV 1/2 Determine test®

Storage
The kit should be stored between 2 °C and 30 °C and must not be frozen. Check the expiry date.

139
Appendix 20

Appendix 20. HIV Uni-Gold® test

HIV Uni-Gold® test is a lateral flow rapid test for the detection of HIV 1 and 2 antibodies.

Description
– Membrane covered with recombinant immunodominant antigens of HIV 1 (gp 41 and gp
120) and HIV 2 (gp 36).

Contents of the kit

– 20 devices, individually packed in an aluminium pouch
– 20 plastic capillary pipettes
– 1 vial of wash reagent in a dropper bottle (2 mL)

Sample
– Plasma or whole blood (EDTA tube) or serum (plain tube)
– Capillary blood

Procedure
1. Open the pouch immediately before use.
2. Mark the device with the sample identification using a thin permanent marker.
3. Apply 2 drops (approx. 60 microliters) of whole blood, serum or plasma to the circle marked
SAMPLE.
4. Apply 2 drops (approx. 60 microliters) of wash reagent to the circle marked SAMPLE.

Interpretation
– Read between 10 and 12 minutes after the application of the wash reagent.
– The test is validated only if the internal control line is visible. Otherwise, the test is invalid.

Negative: Positive:
A pink line is 2 pink lines are visible, one in
visible in the the control region C and one in
control region C. the test region T.

C = internal control line

Invalid:
T = test line
There is no
visible line in the
control region C.
Repeat the test
with a new
device.

Interpretation of the HIV Uni-Gold®

Storage
The kit must be stored between 2 °C and 27 °C and must not be frozen. Check the expiry date.

140
 Appendix 21

Appendix 21. HIV 1/2 Stat-Pak® Chembio test

HIV 1/2 Stat-Pak® test is a lateral flow rapid test for the detection of anti-HIV-1 and anti-HIV 2
antibodies.

Description
The membrane is coated with HIV 1 and 2 antigens on the test band (T), and immunoglobulins
G on the internal control band (C).

Contents of the kit

– 20 devices, packed individually in an aluminium pouch with a desiccant bag
– 20 disposable plastic loops for sampling 5 microliters
– 1 dropper bottle of running buffer

Sample
– Plasma or whole blood (EDTA, or heparin, citrate) or serum (plain tube)
– Capillary blood

Procedure
1. Open the pouch immediately before performing the test. If the test has been stored in the
refrigerator, leave the device and running buffer to reach ambient temperature.
2. Mark the device with the sample identification number.
3. Fill the loop with the sample.
4. Apply the sample to the circle noted S while holding the loop vertically to transfer the
5 micrograms to the membrane.
5. Apply 3 drops of running buffer to the circle S while holding the vial vertically.

Interpretation
– Read the test between 5 and 20 minutes after adding the buffer.
– The test is validated only if the internal control band is visible. If not, the test is invalid.

Positive Negative Invalid Invalid

Storage
The kit must be stored at a temperature between 2 °C and 30 °C and must not be frozen. Check
the expiry date.

141
Appendix 22

Appendix 22. SD Bioline HBsAg WB® test

SD Bioline HBsAg WB® test is a lateral flow rapid test for the qualitative detection of hepatitis
B surface antigen.

Description
– Membrane covered with mouse monoclonal anti-HBs Ag virus antibodies.
– The SD Bioline HBs Ag WB kit (ref. code: 01FK10W) contains:
• 30 test cartridges with desiccant in individual pouch
• Package insert
Materials required but not provided:
• Automatic pipette, adjustable volume 10-100 microliters
• Tips, yellow for automatic pipette, 10-100 microliters

Sample
– Plasma or whole blood (EDTA, heparin or citrate tube) or serum (plain tube)
Note: the test is not pre-qualified for use on capillary blood.

Procedure
1 Serum/plasma should be centrifuged for approximately 5 minutes at 1,000-1,300 g (approx.
3,000 rpm with Hettich EBA 200).
2. Allow all components of the test to reach room temperature (15- 40 °C) prior to testing.
3. Check the pouch for damages and holes and discard if damaged. Open the foil pouch
and look at the test device and the desiccant. The humidity indicator should be yellow. If
dessicant is not present or its colour is green, discard the test.
4. Label the device with patient identifier.
5. Transfer 100 microliters of serum, plasma or whole blood specimen using a precision
pipette.
6. Dispense 100 microliters of serum, plasma or whole blood specimen into the specimen
well.
7. Interpret the test result after 20 minutes and maximum 30 minutes after adding the sample.

Reporting and interpretation of results

Non-reactive
The presence of only the control line (C) within the
result window indicates a non-reactive result.

Reactive
The presence of the test line (T) and the control line
(C), regardless of which line appears first, indicates
a reactive result.
Caution: the presence of any test line, no matter
how faint, is considered a reactive result.

142
 Appendix 22

Invalid
If the control line(C) is not visible, the result is
considered invalid. Instructions may not have been
followed correctly or the test may have deteriorated.
It is recommended that the specimen is retested
using a new test device.

Quality control
– The test device has letter ‘T’ and ‘C’ representing ‘test line’ and ‘control line’ on the surface
of the case. Both lines are not visible before applying the specimen.
– The internal control line is a procedural control and should always appear if the test procedure
is performed properly. The presence of the control line shows that the active ingredients on
the strip are functional and that the migration was complete. It is not an assurance that the
specimen has been properly applied.

Causes of error
– Insufficient volume of sample applied to the test device.
– Reading test results at 10-15 minutes may result in a weak band and reddish background.
Reading at 20-30 minutes results in clear background and accurate result.
– Storage outside 1-40 °C, especially for prolonged times.

Limitations and notes

– The test device is sensitive to both heat and humidity. Check the humidity indicator on the
desiccant for color change (Ok if yellow, discard if green). Perform the test immediately after
removing the test device from the foil pouch.
– Although this test has been demonstrated to be able to detect common genotypes of
hepatitis B, it is limited in its ability to detect virus mutants.
– Due to inherent design of qualitative IVD tests, a faint or absent test line (false non-reactive)
may occur in specimens containing high concentrations of HBs Ag (prozone effect).
– Do not use the test kit beyond its expiration date. The expiration date of the test is printed
on the outer package.
– Do not use the kit if the pouch is damaged or the seal is broken.
– A non-reactive result does not preclude the possibility of infection with HBV.

Storage
The test kit should be stored at 1-40 °C. Check the expiry date.

Shelf-life upon manufacture

24 months

143
Appendix 23

Appendix 23. SD Bioline HCV® test

SD Bioline HCV® test is a lateral flow rapid test for the detection of anti-HCV antibodies.

Description
– Membrane covered with recombinant (core, NS3, NS4, NS5) HCV antigens
– Devices packed individually in an aluminium pouch with desiccant
– One dropper bottle of buffer

Sample
– Plasma or whole blood (EDTA tube) or serum (plain tube)

Procedure
1. Open the pouch immediately before use. Look at the test device and the desiccant. The
humidity indicator should be yellow. If desiccant is not present or its color is green, discard
the test.
2. Mark the sample identification on the device using a thin permanent marker.
3. Apply 10 microliters of plasma with an automatic pipette to the sample well S.
4. Apply 4 drops of buffer to the sample well S.

Interpretation
Read the test after 10 but before 20 minutes.
The test is validated only if the internal control band is visible. Otherwise, the test is invalid.
Non-reactive
The presence of only the control line (C) within the
result window indicates a non-reactive result.

Reactive
The presence of the test line (T) and the control line
(C) within the result window, regardless of which line
appears first, indicates a reactive result.
Caution : the presence of any test line, no matter how
faint, is considered a reactive result.

Invalid
If the control line(C) is not visible within the result
window after performing the test, the result is
considered invalid. Instructions may not have been
followed correctly or the test may have deteriorated. It
is recommended that the specimen is retested using a
new test device.

Storage
The kit should be stored between 2 °C and 30 °C and must not be frozen. Check the expiry date.

144
 Appendix 24

Appendix 24. SD Bioline Syphillis 3.0® test

SD Bioline Syphillis 3.0® test is a lateral flow rapid test for the detection of anti-Treponema
pallidum antibodies.

Description
– Membrane covered with recombinant T. pallidum antigens
– 30 devices packed individually in an aluminium pouch
– Plastic capillary tubes (20 microliters for testing on whole blood) in a plastic bag
– One dropper bottle of buffer

Sample
– Plasma or whole blood (EDTA tube) or serum (plain tube)
– Capillary blood

Procedure
1. Open the pouch immediately before use.
2. Mark the sample identification on the device using a thin permanent marker.
3. If using serum or plasma: apply 10 microliters to the sample pad S.
If using whole blood: apply 20 microliters to the sample pad S.
4. Apply 3 to 4 drops of buffer to the sample pad S.

Interpretation
The test is validated only if the internal control line is visible. Otherwise, the test is invalid.
Read the test:
– After 5 to 20 minutes, if serum or plasma is used.
– After 10 to 20 minutes, if whole blood is used.
Positive
Invalid

S = Sample pad
T = Test line
Negative C = Internal control line

Interpretation of SD Bioline® Syphilis test

Storage
The kit should be stored between 2 °C and 30 °C and must not be frozen. Check the expiry date.

145
Appendix 25.1

Appendix 25.1. SD Bioline Malaria Ag P.f® test

SD Bioline Malaria Ag P.f® test is a lateral flow rapid test for the detection of Plasmodium
falciparum histidine-rich protein 2.

Description
– Membrane coated with specific anti-P. falciparum HRP-2 antibodies
– 25 devices packed individually in an aluminium pouch, with a desiccant
– 25 inverted cups to collect 5 microliters of blood
– 25 lancets
– Assay buffer in dropper bottle

Internal control zone P. f (HRP2) test zone

Round sample well S Square buffer well

Malaria Ag P.f SD Bioline® device

Sample
– Venous whole blood (EDTA tube)
– Capillary blood

Procedure
1. Open the pouch immediately before testing.
2. Check the colour of the desiccant: it should be bright yellow/orange. If it is green, discard
the device.
3. Mark the sample identification on the device using a thin permanent marker.
4. Collect 5 microliters of capillary blood with the inverted cup by touching the drop of blood.
If using a venous sample, dip the inverted cup into the EDTA tube (previously mixed by
gentle swirling) making sure there is no air bubble trapped in the cup, or use an automatic
pipette adjusted to 5 microliters.
5. Immediately apply the blood to the membrane of the round sample well S. When using the
inverted cup, touch it to the sample pad, in a vertical position.

146
 Appendix 25.1

6. Apply 4 drops of assay buffer into the square well by holding the dropper bottle vertically.

Interpretation
Results should be read no sooner than 15 minutes and no later than 30 minutes.
The test is validated only if the red control line C appears.
Note: test and control lines are well-delineated red lines and must not be confused with the
pink background.
1. Only the line C appears: negative test.

2. The lines C and P.f appear: positive test.

3. There is no line C: invalid test. Repeat the test.

Storage
The tests should be stored between 1 °C and 40 °C and must not be frozen. Check the expiry
date.

147
Appendix 25.2

Appendix 25.2. SD Bioline malaria P.f/Pan® (Combo)

test

SD Bioline malaria P.f/Pan® (Combo) test is a lateral flow rapid test for the combined
detection of Plasmodium falciparum histidine-rich protein 2 (HRP2) and Plasmodium lactate
dehydrogenase of all plasmodium species i.e. P. falciparum, P. vivax, P. ovale and P. malariae
(Pan pLDH).

Description
– Membrane coated with specific anti-P. falciparum and anti-Pan pLDH antibodies
– 25 devices packed individually in an aluminium pouch, with a desiccant
– 25 inverted cups
– 25 lancets
– Assay buffer in dropper bottle
Pan pLDH line
internal control line HRP 2 P.f line

round sample well S square buffer well

Malaria Combo SD Bioline® device

Sample
– Venous whole blood (EDTA tube)
– Capillary blood

Procedure
1. Open the pouch immediately before testing.
2. Check the colour of the desiccant: it should be bright yellow/orange. If it is green, discard
the device.
3. Mark the sample identification on the device using a thin permanent marker.
4. Collect 5 microliters of capillary blood with the inverted cup. If using a venous sample, dip
the inverted cup into the EDTA tube (previously mixed by gentle swirling) making sure there
is no air bubble trapped in the cup or use the automatic pipette.
5. Immediately apply the blood to the round sample well S. When using the inverted cup,
touch it to the sample pad, in a vertical position.

148
 Appendix 25.2

6. Apply 4 drops of assay buffer into the square well by holding the dropper bottle vertically..

Interpretation
The test is validated only if the red control line C appears.
Results should be read no sooner than 15 minutes and no later than 30 minutes.
Note: test and control lines are well-delineated red lines and must not be confused with the
pink background.
1. Only the line C appears: negative test for all species.

2. The line C appears and one or 2 lines appear in front of the arrows Pan and/or P.f: positive
test.

3. There is no line C: invalid test. Repeat the test.

Storage
The tests should be stored between 1 °C and 40 °C and must not be frozen. Check the expiry
date.
Note: This simplified interpretation is applicable ONLY for blood donors/donations screening.

149
Appendix 25.3

Appendix 25.3. CareStart Malaria pLDH® (Pan) test

CareStart Malaria pLDH® (Pan) test is a lateral flow rapid test for the detection of Plasmodium
lactate dehydrogenase common to of all plasmodium species i.e. P. falciparum, P. vivax, P.
ovale and P. malariae (Pan pLDH).

Description
– Membrane coated with specific anti-Pan pLDH antibodies
– 60 devices packed individually in an aluminium pouch, with a desiccant
– 60 inverted cups
– 60 lancets
– 60 Alcohol swabs
– Assay buffer in dropper bottle
control line C test line T assay buffer well A

sample well S

Sample
– Venous whole blood (EDTA tube)
– Capillary blood

Procedure
1. Open the pouch immediately before testing.
2. Mark the sample identification on the device using a thin permanent marker.
3. Collect 5 microliters of capillary blood with the inverted cup. If using a venous sample, dip
the inverted cup into the EDTA tube (previously mixed by gentle swirling) making sure there
is no air bubble trapped in the cup or use an automatic pipette set at 5 microliters.
4. Immediately apply the blood to the square sample well S, using the inverted cup, by touching
the sample pad in a vertical position.

5. Apply 2 drops of assay buffer into the round well “A” by holding the dropper bottle vertically.

150
 Appendix 25.3

Interpretation
The test is validated only if the red control line C appears.
Results should be read no sooner than 20 minutes and no later than 30 minutes.
Note: test and control lines are well-delineated red lines and must not be confused with the
pink background.
Reading and Reporting Results
Line T: line Test
Line C: internal control

C C C

T T T

Negative Positive Invalid

Interpretation of the test
– Negative result
The presence of one single colour line ("C" Control line) within the result window indicates
a negative result.
– Positive result
Both lines, line T (Test) and line C (Control) are visible.
– Invalid result
If the control line does not appear in the result window, the test is invalid. The directions
may not have been followed correctly or the test may have been deteriorated. The specimen
must be retested.
Limitations and remarks
– If the background is red, too much blood was applied: a weak line may be masked.
– Good sensitivity to detect P. falciparum and P. vivax, a bit lower for P. ovale and P. malariae.
– The test does not differentiate between species.

Storage
The tests should be stored between 4 °C and 30 °C and must not be frozen. Check the expiry
date.

151
Appendix 26

Appendix 26. Crossmatch procedure (tile method)

The objective of crossmatching blood units is to verify the compatibility between the red cells
of the blood to be transfused and the plasma of the recipient.
Crossmatch is performed in the laboratory just before releasing the blood unit (or within 3
days before planned surgery, when the need for transfusion can be anticipated).
When this test is performed on tile at room temperature, it can detect naturally occurring
regular (anti-A and anti-B) and some irregular (anti-Lewis a, anti-P) agglutinating antibodies.

Equipment
– White, smooth tile
– Plastic tube
– Automatic pipette (10-100 microlitres)
– Pipette tip
– Applicator
– Manual or electric centrifuge (to obtain the recipient’s plasma rapidly)

Samples
– Recipient’s plasma from EDTA tube (drawn < 3 days) AND
– Red cells from the blood unit

Procedure
1. Mark the blood unit number and the recipient’s identification number on the tile.
2. Mark the blood unit number on the plastic tube.
3. Cut the distal segment of the blood unit tubing.
4. Empty the contents of the segment into the plastic tube: the segment contains coagulated
blood. Place a tip on the pipette and extract 20 microliters of free red cells.
5. Deposit 20 microliters of red cells on the tile.
6. Deposit 100 microliters of recipient’s plasma on the tile, next to the red cells.
7. Mix in a circle of 3 cm diameter with an applicator.
8. Rock the tile gently, in a three-directional movement, for 2 minutes, while observing the
reaction.

Interpretation
– If there is no agglutination: the crossmatch is negative. The blood can be transfused to the
patient.
– If there is agglutination: the crossmatch is positive. This indicates that the blood unit is
incompatible with the recipient’s blood, i.e. the recipient has antibodies directed against the
red cells from the blood unit: this could provoke a haemolytic reaction. The blood cannot be
transfused to the patient.

152
 Appendix 27. Blood donations register
Hepatitis Blood
Blood HIV # 2 Donor/
Donation HIV group
Date group Syphilis Malaria on bag Donation Signature
number #1 on bag
#1 B C tubing qualified
tubing
Appendix 27

153
154
Appendix 28. Patients’ blood groups register
First blood group Second blood group
Appendix 28

Date of
LAST NAME Medical Place Place Final Lab tech’s
birth Date/ Drawn Group Date/ Drawn Group
first name file N° blood Result blood Result result signature
/age Time by done by Time by done by
taken taken
 Appendix 29. Blood stock/delivery register
Depending on the level of transfusion activity, plan one register per blood group or a register divided into 4 sections (A,B,AB, O) with thumb nails. It will be easier to find the blood
unit corresponding to the patient’s blood group.

Blood unit Patient

Reason Lab
Collec- Medi- Cross- Delive-
Unit ABO Com- Expiry Last name, ABO Hb for tech Time
tion Volume Date Age Sex Ward cal match red to
N° Rh D ponent date first name Rh D (g/dL) transfu- sign
date File N°
sion
Appendix 29

155
156
Appendix 30. Transfused patients register
Appendix 30

Patient Blood unit

Reason Compo-
Fist name ABO for nent Unit ABO Compo- Expiry Cross- Date/ Lab. tech.
Age Sex Hb Ward Doctor Volume
LAST NAME Rh D transfu- Volume N° Rh D nent date match Time signature
sion requested
 Appendix 31

Appendix 31. Blood request and delivery form

Blood request form

Patient’s Last name: First name: Sex: M/F

Age or date of birth: Place of birth: Weight:
File number: Ward: Bed n°:

Patient blood group: Hb: g/dL

Reason for transfusion: Malaria test result:
Previous transfusions: No Yes Date: ___ / ___ / _____
Unit number(s):

PRESCRIPTION Urgent*:
Planned transfusion: date of surgery ___ / ___ / _____
Volume requested: mL Type of component:
Volume to be transfused: mL Date: ___ / ___ / _____ Time:
Prescribing doctor: Nurse:
Signature: Signature:

* Urgent if delivery < 1 hour

Blood delivery form

N° of blood unit, type of Blood unit
Expiry date Comments
component, volume group
1.

2.

3.

4.

5.

Prepared by: Signature:

Date: ___ / ___ / _____ Time:

Received by: Ward: Time:

157
Appendix 32

Appendix 32. Example of monthly data collection

No. of blood units %
National/regional blood centre
Source of blood Other external sources
Blood collected within health facility (internal source)
Total 100
No. of donations %
Direct
Type of blood Replacement
donations Voluntary
Walking blood bank
Total 100
No. of donors %
Eligible donors
Donor selection
Excluded donors by medical questionnaire and exam.
Total 100
No. donations
Blood dona- %
collected
tions collected
On single bags
within health
On penta bags
facility
Total 100
No. donations %
No. positive
tested positive
HIV No.1
HIV No.2
TTI screening
Hepatitis B
Hepatitis C
Syphilis
Malaria
No. of BU
%
transfused
Paediatrics
Medicine
OB/Gyn
Operation theater
Blood use
Surgery ward
Emergency room
Nutrition
Other wards
Units delivered outside the hospital
Total 100
No. of ABO incompatibility accidents
Accidents
No. of other major transfusion reactions
related to BT
No. of minor transfusion reactions
Mortality No. of deaths due to BT adverse effects
related to BT No. of deaths due to lack of blood
Quality of No. of files reviewed during the hospital transfusion
transfusion committee meeting
procedure No. of files with bedside verification card
(patient files No. of files with pertinent transfusion indications
reviewed) No. of files with correct transfusion monitoring form
No. of Blood Units expired
No. of BU discarded due to cold chain failure
Blood stock
Mean stock end of the week (over 4 or 5 weeks)
management
No. days of stock (mean stock / monthly consumption
x 30)

158
 Appendix 33

Appendix 33. Transfusion module

LABORATORy MODULES | MODULES LABORATOIRE

MODULE, TRANSFUSION, 50 MODULE TRANSFUSION, 50

MODULE, TRANSFUSION, 50 Thermosensitive: *CF
KMEDMTRA01-
MODULE TRANSFUSION, 50 Justification Code: PM

SPECIFICATIONS SPÉCIFICATIONS
This module contains all the necessary equipment for Ce module contient tout le matériel nécessaire pour
sampling, testing and giving blood (transfuse). prélever, tester et donner du sang (transfuser).
The quantities are calculated for 50 transfusions. The Les quantités sont calculées pour 50 transfusions. Le
module contains 150, 450 ml and penta (450ml + 4x100ml) module contient des poches à sang de 150, 450 ml et penta
blood bags. (450ml + 4x100ml).
(Cf Blood transfusion, MSF, 2010) (Cf Transfusion, MSF, 2010)

INSTRUCTIONS FOR USE CONSEILS D'UTILISATION

The transfusion module is divided in sub-modules. One of Le module transfusion est divisé en sous-modules. Un des
the sub-modules contains the equipment: haemoglobino- sous-modules contient l’équipement: hémoglobinomètre,
meter, centrifuge and scale. centrifugeuse et balance.
If you order several transfusion modules, you can ask to Si vous commandez plusieurs modules transfusion, vous
receive the equipment part only once! pouvez demander de ne recevoir la partie équipement
qu’une seule fois!
The screening tests should not be performed on whole Les tests de dépistage ne doivent pas être effectués sur
blood, except the malaria test: HRP-2/pan pLDH (SD sang total, à l'exception du test malaria: HRP-2/pan pLDH
Bioline). (SD Bioline).
CAUTION: heat sensitive item ! ATTENTION: produit sensible à la chaleur!
KMEDMTRA01B MUST be transported by COLD CHAIN with KMEDMTRA01B DOIT être transporté en CHAINE DE FROID
3 temperature monitors. avec 3 indicateurs de température.
KMEDMTRA01B: control with 3M card and Freeze-tag KMEDMTRA01B: contrôle avec carte 3M et Freeze-tag
*CF *CF
Windows A, B, C, D white => OK Fenêtres A, B, C, D blanches => OK
Windows A, B blue => OK Fenêtres A, B bleues => OK
Windows C, D blue => PROBLEM! Fenêtres C, D bleues => PROBLEME!
Freeze tag displays => PROBLEM! Freeze tag affiche “ALARM” => PROBLEME!
"ALARM"
(Cf Introduction: Thermosensitive products) (Cf Introduction: Les produits thermosensibles)

■ Storage ■ Conservation
• Keep refrigerated between 2º - 8º C. • Au réfrigérateur entre 2º - 8º C.
• Do not freeze! • Ne pas congeler!

AMP, PART COMPLEMENT if electricity, compulsory

Included in: KMEDKHAX3OP
PMA, PARTIE COMPLEMENT si électricité, obligatoire
WARD, PART medical equipment ward 20-40 beds compulsory
KMEDKHWE1CO
HOSPITALISATION, PARTIE équip.médical 20-40 lits obligatoire

MSF Code Composed of | Composé de Tot Qty

MODULE, TRANSFUSION, 50, part 1

KMEDMTRA01A 1
MODULE TRANSFUSION, 50, partie 1
MODULE, TRANSFUSION, 50, part 2, cold chain
KMEDMTRA01B 1
MODULE TRANSFUSION, 50, partie 2, chaine de froid
MODULE, TRANSFUSION, 50, part 3, equipment
KMEDMTRA01E 1
MODULE TRANSFUSION, 50, partie 3, équipement

End of list

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Appendix 33 KMED_2 I LABORATORY MODULES | MODULES LABORATOIRE

MSF Code Detailed list of articles | Liste détaillée des articles Qty

MODULE, TRANSFUSION, 50, part 1

KMEDMTRA01A 1
MODULE TRANSFUSION, 50, partie 1
MARKER, permanent, black, fine point
ELABMARK1B- 2
MARQUEUR, permanent, noir, pointe fine
(aut.pip.) TIP YELLOW, 2-200µl, rack (Eppdf)
ELABPIATyR- 288
(pip.aut.) EMBOUT JAUNE, 2-200µl, rack (Eppdf)
(tube Ø 13/15 mm, 5 ml) RACK
ELABTUBE12R 1
(tube Ø 13/15 mm, 5 ml) PORTOIR
(HemoCue Hb 201+/301) CLEANER, 5pcs, HE139123
ELAEHAEC001 2
(HemoCue Hb 201+/301) NETTOYANT, 5pcs, HE139123
(HemoCue Hb 301) MICROCUVETTE, s.u.
ELAEHAET305 200
(HemoCue Hb 301) MICROCUVETTE, u.u.
TOURNIQUET, elastic, 100 x 1.8 cm
EMEQTOUR1-- 1
GARROT élastique, 100 x 1,8 cm
MONITOR CARD cold chain (3M) English
PCOLMONI1CE 5
CARTE DE CONTROLE chaîne de froid (3M) anglais
MONITOR CARD refrigeration (Stop!Watch)
PCOLMONICSC 1
CARTE DE CONTROLE réfrigération (Stop!Watch)
FREEZING INDICATOR (Freeze-tag) electronic
PCOLMONIFFE 5
INDICATEUR DE CONGELATION (Freeze-tag) électronique
BLOOD BAG + sampling arm, single, CPDA1, 150 ml, s.u.
SINSBABS1-- 20
POCHE A SANG+ poche échantillon, unique, CPDA1, 150 ml, u.u.
BLOOD BAG + sampling arm, single, CPDA1, 450 ml, s.u.
SINSBABS4-- 20
POCHE A SANG+ poche échantillon, unique, CPDA1, 450 ml, u.u.
BLOOD BAG + sampl. arm, Penta, CPDA1, 450 ml + 4x100ml, s.u.
SINSBABS4B4 10
POCHE A SANG + échant., Penta, CPDA1, 450 ml + 4 x 100 ml
CONTAINER, sharps, 1 to 2 l, plastic
SINSCONT2P- 4
CONTAINER, récupération aiguilles 1 à 2 l, plastique
SET, BLOOD TRANSFUSION, with 200 µ filter, sterile, s.u.
SINSSEBG1-- 70
TRANSFUSEUR, avec filtre 200 µ, stérile, u.u.
GLOVE, EXAMINATION, latex, s.u. non sterile, medium
SMSUGLOE1M- 100
GANT D'EXAMEN, latex, u.u. non stérile, moyen
BEDSIDE CONTROL CARD, ABO compatibility (Serafol)
SSDTBLOC1-- 100
CARTE CONTROLE AU LIT DU PATIENT compatibilité ABO (Serafol)
(bedside control card Serafol) ADHESIVE FOIL
SSDTBLOC101 100
(carte contrôle au lit du patient Serafol) FEUILLE ADHESIVE
(bedside control card Serafol) MIXING STICK, plastic
SSDTBLOC102 100
(carte contrôle au lit du patient Serafol) BATONNETS plast.
HEPATITIS B TEST HBsAg (SD Bioline), ser/pl/wb,1test 01FK10W
SSDTHBTE30T 120
TEST HEPATITE B AgHBs (SD Bioline), sér/pl/st, 1test 01FK10W
HEPATITIS C TEST (SD Bioline), ser/pl/wb, 1 test 02FK16
SSDTHCTE25T2 100
TEST HEPATITE C (SD Bioline), sér/pl/st, 1 test 02FK16
HIV 1 + 2 TEST (Determine), ser/pl/wb, 1 test 7D2343
SSDTHIVD10T 100
TEST VIH 1 + 2 (Determine), sér/pl/st, 1 test 7D2343
HIV 1 + 2 TEST (STAT-PAK), ser/pl/wb, 1 test, 60-9500-0
SSDTHIVS20T 100
TEST VIH 1 + 2 (STAT-PAK), sér/pl/st, 1 test, 60-9500-0
MALARIA HRP-2/pan pLDH TEST (SD Bioline), wb,1 test 05FK60
SSDTMALP25T 125
TEST MALARIA HRP-2/pan pLDH (SD Bioline), st,1 test 05FK60
SYPHILIS TEST (SD Bioline 3.0), ser/pl/wb, 1 test 06FK10
SSDTSyPT30T 120
TEST SYPHILIS (SD Bioline 3.0), sér/pl/st, 1 test 06FK10
(blds.syst.) TUBE, VACUUM, plastic, K2EDTA, 4ml, purple
STSSBSVT5E- 150
(s.prél.sang.) TUBE SOUS VIDE, plastique, K2EDTA, 4ml, mauve
(blds. syst.) HOLDER for VACUUM TUBE with needle ejector
STSSBSVVH1- 10
(s.prél.sang.) CORPS PORTE TUBE avec éjecteur d'aiguille
(blds.syst.) NEEDLE, sterile, 21G (Vacutainer)
STSSBSVVN21 100
(s.prél.sang) AIGUILLE, stérile, 21G (Vacutainer)
SAFETY LANCET, medium flow, needle 21G x 1.8mm, green, s.u.
STSSLANCSAM2 100
LANCETTE DE SECURITE débit moyen, aig.21Gx1,8mm, vert, u.u.
MODULE, TRANSFUSION, 50, part 2, cold chain
KMEDMTRA01B 1
MODULE TRANSFUSION, 50, partie 2, chaine de froid
(HemoCue Hb 301) CONTROL SOLUTION, kit 3 x 2 bottles
ELAEHAET301 1
(HemoCue Hb 301) SOLUTION DE CONTROLE, kit 3 x 2 flacons

Médecins Sans Frontières Internal Document 2

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 Appendix 33
KMED_2 I LABORATORY MODULES | MODULES LABORATOIRE

MSF Code Detailed list of articles | Liste détaillée des articles Qty

BLOOD GROUPING TEST, anti A (Lorne), 10 ml, dropper bot.

SSDTBLOG1A- 2
TEST GROUPE SANGUIN, anti A (Lorne), 10 ml, fl. compte-gtt
BLOOD GROUPING TEST, anti AB (Lorne), 10 ml, dropper bot.
SSDTBLOG1AB 2
TEST GROUPE SANGUIN, anti AB (Lorne), 10 ml, fl. compte-gtt
BLOOD GROUPING TEST, anti B (Lorne), 10 ml, dropper bot.
SSDTBLOG1B- 2
TEST GROUPE SANGUIN, anti B (Lorne), 10 ml, fl. compte-gtt
RH NEGATIVE CONTROL (Lorne),monoclonal antibodies, 10ml, bot
SSDTBLOG1C- 2
RH CONTROLE NEGATIF (Lorne),anticorps monoclonaux, 10ml, fl.
BLOOD GROUPING TEST, RHESUS anti D (Lorne), 10 ml, drop.bot.
SSDTBLOG1D- 2
TEST GROUPE SANGUIN, RHESUS anti D (Lorne), 10 ml, fl.
(test HIV 1+2 Stat-Pak) CONTROLS 3 x 0.25 ml, 60-9549-0
SSDTHIVS201 1
(test VIH 1+2 Stat-Pak) CONTROLES 3 x 0,25 ml, 60-9549-0
MODULE, TRANSFUSION, 50, part 3, equipment
KMEDMTRA01E 1
MODULE TRANSFUSION, 50, partie 3, équipement
SCALE, mechanical, adult 0-150 kg, grad. 500 g
EANTSCAL3A- 1
BALANCE mécanique, adulte 0-150 kg, grad. 500 g
PIPETTE, AUTOMATIC, adjustable vol. 10-100 µl (Eppendorf)
ELABPIAA0100 1
PIPETTE AUTOMATIQUE, vol. réglable 10-100 µl (Eppendorf)
TILE, blood grouping, white and smooth
ELABTILE1-- 10
CARREAU DE CERAMIQUE, groupage sanguin, blanc et lisse
PLATE, blood grouping, smooth, with 5 cavities
ELABTILE5-- 2
PLAQUE, groupage sanguin, lisse, avec 5 cavités
TIMER, electronic
ELABTIME1E- 1
MINUTEUR électronique
CENTRIFUGE, hand-operated for 4 tubes 15 ml
ELAECENE1M- 1
CENTRIFUGEUSE, manuelle pour 4 tubes 15 ml
HAEMOGLOBIN PHOTOMETER (HemoCue Hb 301) tropicalized
ELAEHAEE3-- 1
PHOTOMETRE HEMOGLOBINE (HemoCue Hb 301), tropicalisé
SCALE, electronic for blood bank (Kern), 0 - 2200 g, 1 g
ELAESCAE5-- 1
BALANCE électronique banque de sang (Kern), 0 - 2200 g, 1 g
PRESSURE CUFF, for pouch 500/1000 ml
EMEQCUFF5-- 1
MANCHETTE A PRESSION, pour poche 500/1000 ml
GLASSES, PROTECTIVE, plastic
EMEQGLAS1P- 2
LUNETTES DE PROTECTION, plastique
SPHYGMOMANOMETER, one-hand manometer, velcro, adult
EMEQSPHy1A- 1
SPHYGMOMANOMETRE, manopoire, velcro, adulte
STETHOSCOPE, single head, adult diaphragme
EMEQSTET1-- 1
STETHOSCOPE, simple, diaphragme adulte
Blood transfusion + CD-Rom
L002TRFM01E-P 1
Blood transfusion + CD-Rom
Transfusion + CD-Rom
L002TRFM01F-P 1
Transfusion + CD-Rom

End of list

MSF Code Related Articles | Articles apparentés Type Relation

TUBE STRIPPER, for blood bag tubing, manual

ELABFOBB1-- is Related to
PINCE A REFOULER, pour tubulure poche à sang, manuelle
PLASMA SEPARATION STAND, manual
ELABPLSS1-- is Related to
PRESSE A PLASMA, manuelle
BLOOD BANK REFRIGERATOR (MB3000G), 230V, 100 bags 450ml
ELAEBBRE3-- is Related to
REFRIGERATEUR BANQUE DE SANG (MB3000G), 230V,100poches 450ml
BLOOD BANK REFRIGERATOR (GBR50AC), 230V, 42bags 450ml
ELAEBBRE8-- is Related to
REFRIGERATEUR BANQUE DE SANG (GBR50AC), 230V,42poches 450ml
BLOOD COLLECTION MONITOR, 230V (Hemotek2)
ELAEBDRE2-- is Related to
AGITATEUR DON DE SANG, 230V (Hemotek2)
CENTRIFUGE, electrical (Hettich EBA 200), 8 tubes, 230V
ELAECENE9-- is Related to
CENTRIFUGEUSE électrique (Hettich EBA 200), 8 tubes, 230V
BLOOD BAG TUBE SEALER (Delcon HemoWeld T), 115-230V
ELAESEAE1-- is Related to
SOUDEUSE de TUBULURE POCHE SANG (Delcon HemoWeld T),115-230V
REUSABLE SHARPS CONTAINER (RSC), 1.2 litre
SINSCONT1R- is Related to
CONTAINER REUTILISABLE POUR OBJETS TRANCHANTS, 1,2 litre

End of list

3 Médecins Sans Frontières Internal Document

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Appendix 34

Appendix 34. Blood bags

Presentation
– 150 mL single bag containing 21 mL of CPDA1 (anticoagulant-preservative solution)
– 250 mL single bag containing 35 mL of CPDA1
– 450 mL single bag containing 63 mL of CPDA1
– 450 mL bag containing 63 mL of CPDA1, attached to a set of four 100 mL satellite bags that
do not contain CPDA1 ( called “penta-bag”)
Bags are packed in an aluminium foil pack. The number of bags per pack depends on the
type of bags. Each bag is individually packed in a protective pouch. Follow manufacturer’s
instructions for maximum shelf life after opening the aluminium pack.

Inspection
– Prior to collection, inspect the bag for any abnormality or damage.
– Discard the blood bag if:
• It is damaged (leak, air, etc.).
• It contains a white precipitate or the anticoagulant solution is cloudy.
• There is any brown deposit in the tubing.

Storage
– At room temperature, protected from light and freezing.
– Avoid prolonged exposure to temperature > 40 °C.

Instructions for use

– Remove blood bag from its protective pouch just before use.
– Do not remove anticoagulant from a blood bag.
• Do not let air in at the beginning nor at the end of blood collection.
• Do not fill partially a blood bag.

162
 Appendix 35. Refrigerator temperature monitoring sheet
Appendix 35

163
Appendix 36.1

Appendix 36.1. Fridge-tag®2 with external sensor in a

glycol vial

Fridge-tag® 2
with external sensor (PCOLMONITF2B)
in a glycol vial (PCOLMONIEF2)

Description
In a refrigerator for blood storage, the temperature data logger Fridge-tag®2, with an external
sensor placed in a glycol vial, displays the inside temperature of the refrigerator without
opening the door and records temperatures over the last 30 days. A visual alarm flashes when
the temperature falls outside the set range.
The sensor placed in a leak-proof vial of glycol records the temperature of a viscous liquid
similar to blood. The measured temperature is therefore insensitive to the short temperature
variations of the air when opening the fridge door.

Installation
1. Activation and setting of date, time and temperature in °C format. This is done by the local
logistician or biomed engineer.
2. Pre-set of the duration of lower and upper alarms limits to 15 minutes: the alarm will
activate only after 15 minutes outside the desired temperature range.
3. Pre-set of the temperature alarm trigger:
a. Lower alarm : + 2 °C
b. Upper alarm : + 6 °C
4. Connect the cable to the reader.
5. Fix the reader on the wall behind the refrigerator for a chest refrigerator, or on the side of
a vertical blood refrigerator, at eye level for easy reading.
The reader should be removable in order to be able to download the 30 last day temperatures
using the USB cable located at the top of the reader.

Use
Place the glycol vial with the sensor inside the blood refrigerator at upper basket level, either
between cooled blood bags, or hung between the upper baskets.

Remarks
– Ensure the glycol vial is not in contact with any freshly collected blood (which is not yet fully
refrigerated) or the refrigerator sides or is not close to the bottom of the refrigerator.
– The temperature displayed by the Fridge-tag®2 reader may be different from that
displayed at the front bottom right of the refrigerator by up to 1 °C. The built-in sensor
of the MB 3000 G is located lower and close to the wall of the refrigerator and displays a
“calculated” temperature, not the real temperature inside the refrigerator. Take into account
the temperature displayed by the Fridge-tag®2.

164
 Appendix 36.2

Appendix 36.2. Freezing indicator device (Freeze-tag®)

Freeze-tag® is a freezing indicator placed in every refrigerator or cold box containing blood
that shows if blood kept in the cold chain has been exposed to freezing temperatures.

Instructions for use

– Before reading, maintain the Freeze-tag® at a temperature above 0 °C for at least 2 minutes.
– Read the result:

The blood was never exposed to a temperature below 0 °C. = OK

The blood was exposed to a temperature below 0 °C for

= ALARM
longer than 1 hour.

If the display remains blank, maintain the Freeze-tag® at room temperature and wait at least
2 more minutes. If the display remains blank, check expiry date.
– Once the alarm has been activated, the device cannot be re-used.

Storage
Freeze-tag® must not be stored below 4 °C.

Safety measures
The Freeze-tag® contains a lithium battery: do not open or destroy the case of the
Freeze-tag®; do not incinerate.

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Glossary

Glossary

Alloantigen: an antigen present only in some individuals that prompts the generation of
specific antibodies when introduced in individuals who do not express this antigen.

Alloantibodies: specific antibodies generated after the introduction of an alloantigen.

Antibodies:
– Naturally occurring antibodies: are present in individuals with no previous exposure to
transfusion or pregnancy. They are IgM class antibodies that are able to activate complement
and therefore lyse red cells in the blood stream. In transfusion, naturally occurring antibodies
refer to anti-A and anti-B, as well as anti-Lewis and anti-P. They have agglutinating properties
in vitro at room temperature.
– Acquired (or immune) antibodies: are present in individuals after exposure to transfusion or
pregnancy. They are IgG class antibodies, usually unable to activate complement (previously
described as incomplete antibodies) and therefore rarely cause intravascular haemolysis. To
detect them, specific laboratory procedures are required, such as incubation at 37°C, use of
albumin, enzymes, antiglobulin and low ionic strength solution. Acquired antibodies include
anti-Rhesus, anti-Kell, anti-Duffy, anti-Kidd and antibodies of other blood groups systems
and immune anti-A and anti-B antibodies.
– Regular antibodies: antibodies that are consistently found in all individuals lacking the
corresponding antigen (e.g. naturally occurring anti-A and anti-B).
– Irregular antibodies: antibodies that are not consistently found in all individuals lacking the
corresponding antigen. They are either naturally occurring (such as anti-Lewis, anti-P) or
acquired after transfusion or pregnancy.

Antigen: a foreign substance that enters the body and prompts an immune response, including
the generation of specific antibodies.

Batch testing: a laboratory procedure in which one given test is carried out simultaneously on
several specimens.

Dangerous O donors: group O donors who carry acquired IgG class anti-A and anti-B antibodies
of high titer that can induce delayed haemolysis if their blood is transfused to non-O recipients.

Fresh whole blood: blood that has been drawn less than 4 hours prior to use and has not been
refrigerated. Platelets and labile clotting factor functions are fully preserved.

Haemolysins: red cell antibodies causing haemolysis. They usually refer to hyper-immune
anti-A and anti-B antibodies of dangerous O donors.

Packed red blood cells (PRBC): blood with a minimum of residual plasma. PRBC are prepared
by centrifugation (or, if not feasible, by sedimentation for at least 24 hours).

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 Glossary

Qualified blood unit: a blood donation

– With the correct blood/anticoagulant ratio,
– That has undergone all pre-transfusion tests (immuno-haematological tests and TTI markers),
– Appropriately sealed, with a minimum of 3 segments on the giving line,
– Is correctly labelled,
– And has been stored at the right temperature.
A qualified blood unit is suitable for transfusion. This definition applies also to the components
issued from such a donation.

Window period: the time period between infection and the development of detectable
markers of infection.

167
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Achevé d’imprimer en France par ISI Print, 93210 La Plaine Saint-Denis

Janvier 2019