Blood Transfusion

Study guide
Blood transfusion

Staff Groups Statutory & Mandatory Frequency Group O individuals therefore have, in their
Requirement plasma, antibodies to both group A and group B
Midwife Safe transfusion practice 2 yearly while group AB individuals do not have either of
Anti-D clinical 2 yearly these antibodies.
Doctor Safe transfusion practice 2 years The ABO is the most important blood group system.
All other clinical staff Safe transfusion practice 2 yearly The reason for the clinical importance is that if red
including HCA
cells carrying A or B antigens are transfused to
Phlebotomist Sample labelling section 2 yearly
only (pages 4 and 5)
someone who has antibodies to these then a severe
immune reaction can occur which may be fatal.
The transfusion of only a few mls of the wrong
Transfusion training is a core element of statutory (incompatible) ABO group can trigger a massive
and mandatory Transfusion training for all staff immune response leading to shock and DIC
involved in the transfusion process. Please see the (disseminated intravascular coagulation). Individuals
table above for staff specific requirements. may die from circulatory collapse, severe bleeding
or renal failure, often within minutes or hours.
Blood group serology
The patient should receive blood of their own
ABO ABO Group whenever possible. However, in a life
ABO groups are named after the antigens present threatening situation, Group O blood can be safely
on the red cell surface (see the diagram below). given to all groups of patients as there are no A or
In the ABO groups, individuals produce antibodies B antigens to react with the recipient’s antibodies.
(immunoglobulins) against the antigens that are not
Rh System
present on their own red cells.
The Rh system is the second most important blood
group system, since the RhD antigen is highly
immunogenic. Red cells which carry the RhD
antigen are RhD positive.
RhD essential facts:

85% of the population are RhD positive and
15% RhD negative

RhD positive patients can receive any RhD type
blood

RhD negative patients where possible should
receive RhD negative blood

RhD-negative patients can make anti-D if they
are exposed to RhD positive cells through
transfusion or pregnancy.

1
Consent Benefits of Blood Transfusion
General Principles of Consent Like other medical treatments blood transfusion is
not completely free of risk.
It is a general legal and ethical principle that valid
consent should be obtained from a patient (parent / Discussion of the risks with the patient should
guardian) before treatment is given. include the following:
For the consent process to be valid however, the 
Infectious
patient must be competent (have capacity) and 
Non-infectious risks
have received sufficient information to make an
informed decision 
Acute complications

Delayed complications
The Legal and Practical Aspects of Capacity
Every adult patient is presumed competent until Consent Procedure
proven otherwise. A patient is not incompetent Valid consent should be obtained and documented
because they make an unwise decision, a patient in the notes. This entails the provision of
has the right to make irrational, eccentric decisions information on risks, benefits and alternatives
or refuse treatment. available before asking the patient to give
It is imperative that you check local policies and consent. This does not have to include a signature
national guidance for your own area of practice from the patient
and seek further advice if you are unsure. Ideally the decision to transfuse should be made
with the patient or parent/carer in advance of any
Benefits of Blood Transfusion
planned transfusion
As part of the informed consent process you need
In the emergency setting, the information will need
to be able to explain the benefits and risks of
to be given retrospectively
transfusion to your patient.
Blood transfusions are essential for saving the lives Patient Information
and improving the health of millions of people in Patient information leaflets should be
the UK, a blood transfusion can: provided to the patients well in advance of a

Save the life of a patient who loses a large transfusion episode.
volume of blood

Enable patients to have surgery that involves
loss of a large volume of blood

Enable patients to receive treatment for
leukaemia or cancer

Maintain or improve the health of patients with
some chronic conditions

Improve quality of life by alleviating
symptomatic anaemia

2
 BLOOD TRANSFUSION

Requesting The clinical team needs to inform the laboratory if

a patient requires special blood components via a
Request Forms
special requirements request form
Complete the transfusion request form with the
following data set: Detailed information and the special requirements
request form can be found on the Blood

First Name Transfusion Intranet page.

Last Name Blood Transfusion Special Requirements

Date of Birth Form (http://bartshealthintranet/About-Us/
Clinical-Support-Services/Pathology/Documents/

Hospital number/ Unique identifier Notification-of-Special-Requirements-for-Blood-

Gender Transfusion.pdf)

Make sure you include: Prescriptions

reason for the request It is the responsibility of the practitioner (Doctor/

Nurse Prescriber) to accurately write the
the pre-transfusion test instruction for administration of the appropriate
number and type of component required component / product.
This must include:
any special requirements
The component / product to be administered
the date and time required
Volume
Every request form should include the name
of requesting doctor and the signature of the Duration
person taking the sample. Special Requirements

Special Requirements Date

Depending on a patients diagnosis and clinical Time
situation patients may require special blood Signature of prescriber
components
Transfusions for paediatrics should be prescribed
These include: Irradiated, CMV neg and HEV neg in mls. Please see table below:

Paediatric Transfusions
Components
Red cells
Platelets – Apheresis Platelets
Children <16 years old weighing
less than 15kg
Volume & Rate Time Additional information
5mL/Kg/h Within 4 hours Unless there is a major bleeding
10 – 20mL/Kg Apheresis platelets should be used for all children <16 years
old to reduce donor exposure.
Platelets should be ABO-compatible to reduce the risk of
haemolysis caused by donor plasma.

RhD negative girls should receive RhD positive platelets have

to be given, anti-D immunoglobulin should be administered
(a dose of 250 IU intramuscularly or subcutaneously should
cover up to five apheresis platelets donations given within a
6-week period.

Children above 15kg (may 10 – 20 mL/Kg at a

receive a single apheresis) rate of 10-20mL/Kg/h
FFP 12-15mL/Kg at a rate FFP should be administered prophylactically in non-bleeding
of 10-20mL/Kg/h patients or to ‘correct’ minor abnormalities of PT or APTT
before invasive procedures. When indicated, FFP should be
administrated with careful monitoring for acule transfusion
reaction or circulatory overlead. FFP should not be used to
reverse warfarin anticoagulation unless Prothrombin Complex
Concentration (PCC) is unavailable.

3
Sampling Patient Identification
Sampling Procedure In the unconscious patient (or in paediatric practice)
it is imperative to verify the patient identification
Step 1
details with a second member of staff
Ask the patient to tell you their full name and
date of birth. Check this information against the All unnamed patients (e.g. those in A&E) must be
patient’s identification band for accuracy. identified with a unique identification number and
gender at every step in the transfusion process
Step 2
Check the following ID details on the patient’s If you are taking a sample for pre-transfusion
identification band: testing from a patient in the outpatient setting
where there may not be an identification band ask
First name
the patient to state:
Last name
Surname

Date of Birth
First name
Hospital number/ Unique identifier
Date of birth
Gender
The first line of address as an additional check
Compare these against patient identifiers e.g.

Check the unique patient identification
the blood request form /patient case notes to
number (ID)
ensure that they are accurate.
Cord blood samples must be clearly identified as
Step 3 cord samples.
Take the blood sample and immediately after,
hand write the tube at the patients bedside When dealing with neonates who have not yet
been named, it is important to state the:
L abel the sample tube with details from the
patient’s ID band Baby’s sex
Date & Time sample obtained Surname (e.g. Baby of Sharma)
 heck that the details on the sample tube and
C Date of birth
request form match before transporting to the
Hospital Transfusion Laboratory Hospital Number

All transfusion samples must be handwritten If the baby is from a multiple birth, it should be
Sample tubes must not be pre-labelled. clearly identified as Twin 1 or Twin 2, etc. and this
Addressograph labels must not be used. should be applied consistently to each request.
Only bleed 1 patient at a time.

4
 BLOOD TRANSFUSION

Misidentification of the patient is one of the Pre-Transfusion Testing

most common errors
On receipt of the pre-transfusion sample the Hospital
at the time of the blood sample for cross-
 Transfusion Laboratory database is checked to see if
match there are any previous results on the patient.

at the point of collection from the fridge
at the time of administration
Two Sample Rule
Two samples required (if patient is not known to
the Blood Transfusion Laboratory)
Identifying the ABO and RhD Group is very quick
(20-25 minutes).
The Antibody screen on the patient’s plasma detects
the patients who will have an atypical (unexpected)
red cell antibody due to a previous transfusion or
pregnancy (99% of patients will have a negative
antibody screen).

Needed for patient blood group confirmation If the antibody screen is negative then components
will be selected simply on the basis of being the
What is accepted: correct ABO and RhD group.

Two samples taken 30 minutes apart (by the If the patients antibody screen is positive it may
same person) take longer to supply units –always liaise with the
laboratory to avoid any unexpected delays.

Two samples taken at the same time (by two
different people with individual positive patient
identification) MUST DO’s For Phlebotomist only:
Complete phlebotomy quiz

Samples need to be sent in separate bags, with
Following successful completion your records
separate forms
will be updated automatically
The Blood Transfusion Laboratory do not need 2
samples every time
Collection
Blood Component Storage

Red Blood Cells essential facts:


Red blood cells have a
shelf life of 35 days and
must be stored at 4°C
Discuss with Blood Transfusion Laboratory if in doubt. (±2°C) in an authorised
blood fridge
Sample Validity
Current recommendations
Samples Valid for 7 days: advise that transfusion

Patients with no history of transfusion or of each unit of red cells
pregnancy within the preceding 3 months should be completed
within 4 hours
Samples Valid for 3 days:
Unused red cells that have

Patients who have been transfused or pregnant been out of refrigeration and have not been
within the preceding 3 months transfused for any reason within four hours,
must be returned to the Hospital Transfusion

or if the patient’s transfusion or obstetric history Laboratory with clear documentation confirming
is unknown the length of time out of refrigeration.

5
Platelets essential facts: Collection Procedure


Platelets are stored Before organising the collection of blood
at +20°C – +24°C components, the person requesting the
on an agitation rack. component must ensure there is patent IV access
and undertake step 1:

Never store in
the fridge, this Step 1 – Ensure that the details on the Blood
causes the platelets Collection Form/Slip or Drugs Chart match the
to aggregate information on the patient’s identification band.
irreversibly


Platelets have a
shelf life of 7 days.
If unused they must
be returned to the
lab, as the unit can be reissued


The transfusion of platelets should commence
as soon as possible following delivery to the
clinical area.


The infusion must be completed within 4 hours
of collection from controlled storage. The person collecting the component from the lab
Fresh Frozen Plasma (FFP) and or satellite fridge must undertake steps 2-4:
Cryoprecipitate Essential Facts: Step 2
Fresh Frozen Plasma
 
Locate and remove the blood component from
the fridge
and Cryoprecipitate
are stored at – 30°C 
Confirm that you have the correct blood
for up to 2 years. component by matching the details on the unit
removed from the fridge with the minimum
Once a request
 patient identification data set on the Blood
is received the Collection Form/printed patient Slip/Drug chart
component is
thawed at 37°C Minimum patient identification:

Forename
The transfusion

of FFP should 
Surname
commence as soon as possible following
delivery to the clinical area. 
DOB

The infusion must be completed within 4

hours of collection from controlled storage.

MRN/Hospital number
Step 3 – Document the removal of the unit on
the blood fridge register /
electronic release system.
You must document the
removal date / time as well
as providing your signature.

6

Step 4

Ensure prompt delivery of
the blood component to the
clinical area.

All components must
be transported in an
appropriate container/bags,
provided by the laboratory

Any delay in delivering the
blood component to the
clinical area may result in
wastage of the unit.
Emergency Units/Flying Squad
In emergency situations it may sometimes be
necessary to provide emergency group O blood
(emergency blood) which is not specifically
labelled for the patient.
This blood will be made available from either
the lab or selected blood fridges (see transfusion
policy for nearest available units).
Storage and transport are the same as for any
other unit of red cells.
The lab must be notified immediately if this blood
is removed from a blood fridge to ensure rapid
replacement of emergency units so that future
demands are not compromised.
Traceability documentation must be fully completed
and returned to the lab as per local policy.
Blood Availability (Emergency)
It may be necessary to supply blood before the
patient’s blood group is known. In these situations
Group O emergency blood is supplied.
Group O emergency blood (‘flying squad /
Emergency’) – immediate – 5 minutes
Group Compatible blood (i.e. same group as
patient) – 20 – 25 minutes
Fully crossmatched blood – 30 – 45 minutes (maybe
hours if antibody found).
BLOOD TRANSFUSION
Administration
Venous Access Devices
The recommended diameter is 18 – 20 gauge (23
gauge has been used successfully for paediatric
practice). Central lines are generally suitable for
transfusing blood components. When using a
multi-lumen catheter the lumen specified for
blood components should be used. Remember
when using a central line for rapid transfusion the
blood should be warmed through a commercial
blood warmer – no other device should be used
for warming blood.
Administration Sets
Must have integral mesh filter to remove
microaggregates. It is unnecessary to prime the
administration set with saline unless checking
patency of line.
Do not prime the administration set with Dextrose
or Ringer Lactate as this can cause haemolysis or
lead to clotting of the transfused components, do
not administer medication through a lumen used
for transfusion of blood. For ongoing transfusion
the administration set should be changed at least
every 12 hours.
Do not administer platelets through an
administration set that has previously been used
for red cells or other components as this may
cause aggregation of the cells.
7
Infusion Devices Administration Procedure

If using an infusion device or blood warmer follow Step 1: Check the compatibility label with the
the manufacturer’s instructions. Blood warmers blood bag label
are required when giving large volume rapid
transfusion or for exchange transfusion in infants.
DONOR
COMPONENT
Pressure devices should be used with a maximum NUMBER
pressure of 300 mmHg.

Blood group
RhD Group

Pre-administration Procedure

Step 1:Check the prescription form to ensure

If there is ANY discrepancy – DO NOT transfuse
that the component has been prescribed and if
If you are interrupted – STOP, and start the
the patient has any special requirements and any
checking procedure again
concomitant drugs prescribed

Step 2: Check that the patient has given consent Step 2: Ask the patient to tell you their:
to transfusion (if relevant to the clinical situation)

Full Name
Step 3: Check that venous access has been
established and all equipment is ready before Date of Birth
requesting blood component to be collected
Check this information
Step 4: Undertake baseline observations against the patient’s ID
wristband – patients
Step 5: Undertake visual inspection have had wristbands
transposed!

NO WRISTBAND = NO TRANSFUSION
Leaks discolouration Be extra vigilant when checking the identity of the
clumping unconscious / compromised patient

Expiry date

If there is ANY discrepancy – DO NOT transfuse

8
 BLOOD TRANSFUSION

Step 3: Blood should be commenced as soon as

possible and within 30mins of removal from the
Check the patient’s: temperature controlled storage or stopped within
4 hours of the unit being removed from the
First name
temperature controlled storage .This reduces the
Surname risk of septicaemia.

Date of birth

Hospital number

On the blood bag label and check all the details

with the patients wristband.

TWO person check

The wristband must be exactly the same as the

details on the blood bag label.

Observations Documentation Procedure

The majority of transfusion reactions will occur in the The BCSH guidelines on the Administration of
first 15 minutes after the transfusion has commenced Blood Components recommend that a record of the
transfusion should be kept in the patient’s medical
Observation should be taken and recorded : case notes.


Pre-Transfusion (up to 1hr before) Once you have identified the correct patient,
undertaken all required checks and started the

15 minutes after starting transfusion transfusion, sign the transfusion documentation.

Post – Transfusion (up to 1hr after) Record the donor component number on the
transfusion documentation
Patients should be monitored up to 24hrs post
transfusion or if discharged within this time should Fully complete traceability documentation and
be counselled about the possibility of a delayed return to the laboratory as soon as possible
adverse reaction

9
Management of Transfused Patient
Monitoring Procedure
You should advise your patient of the possible
adverse effects of transfusion and tell them to
inform someone if they experience any signs of
a reaction.
Transfusion of each blood component must
be completed within 4 hours of removal from
controlled storage
Patients should be monitored up to 24hrs post
transfusion or if discharged within this time should
be counselled about the possibility of a delayed
adverse reaction
10
Signs & Symptoms
In ALL cases where a patient develops new
symptoms or signs during a transfusion: STOP the
transfusion but leave the line connected and seek
URGENT medical review.

ASSESS the patients ‘ABCDE’

REPEAT & MONITOR the patients observations

CHECK Patient identification against that on the
blood component/product

CHECK the component for discolouration,
unusual clumps/particulate matter
A mild reaction may be the early stages of a
severe reaction – DON’T IGNORE IT
http://bartshealthintranet/About-Us/Clinical-
Support-Services/Pathology/Haematology/
Blood-Transfusion/Documents/Management-of-
Transfusion-Reactions.pdf

Haemovigilance
Transfusion Adverse
Events & Reactions
Serious Hazards of Transfusion (SHOT) is a
anonymised reporting scheme, which aims
to collect data on the serious adverse events
and serious adverse reactions of transfusion
and to make recommendations to improve
transfusion safety.
Since the launch in 1996, SHOT has
demonstrated that the biggest risk is the patient
receiving an incorrect blood component (IBCT).
The general public and most staff assume that
the greatest risk is ‘Transfusion Transmitted
Infection’ but SHOT have shown that the risk
of Transfusion Transmitted Infection (TTI) is
extremely low
Immunological conditions, e.g., ATR, HTR, PTP,
TA-GVHD or TRALI are not readily preventable.
However, early recognition may reduce
associated morbidity.
BLOOD TRANSFUSION
Errors have been shown to occur in every part
of the transfusion process and in every clinical
area, wards, theatre, accident & emergency,
intensive care and outpatient clinics. SHOT
have reported that:
Multiple errors were implicated in around

half of cases reported to SHOT over a 14
year period
MUST DO’s

Successfully complete Safe Transfusion
Practice quiz
Following successful completion your records
will be updated automatically
11
Safe practice – Anti-D
Understanding material sensitisation
RhD factor and pregnancy
Blood types can be categorised as either RhD positive
or RhD negative. Individuals with red blood cells that
lack the RhD antigen are RhD negative.
In the UK around 1:6 of the population are RhD
negative although the incidence varies among
ethnic groups.
If a RhD negative woman is pregnant with a RhD
positive fetus she may have a potentially harmful
immune response resulting in the formation of anti-D
antibodies. During pregnancy the placenta normally
prevents maternal and fetal blood from mixing. Feto-
maternal haemorrhage (FMH) is the term used to
describe any bleed from the fetus into the maternal
circulation. Such an event increases the risk of
maternal sensitisation to fetal antigens. FMH is most
common in the third trimester and around the time
of birth. FMH is often associated with a potentially
sensitising event (PSE), such as vaginal bleeding, but
may also occur in the absence of any obvious PSE.
Genetic determinants of blood RhD
factor diagram
The RhD positive gene is
more common than the RhD
negative gene, and is more
dominant. If one of the two
genes is RhD positive and
the other RhD negative, your
blood type is RhG positive. It
takes a pair of RhD negative
genes to make your blood
type RhD negative.
The diagrams opposite demonstrate how a RhD
negative woman can have RhD positive baby. By
looking at the parents we can determine the possible
RhD type of child. Click through the examples to see
the different matches.
12
Example 1: RhD negative Mother and RhD
positive Father
If the father has one RhD positive and one
RhD negative gene, the fetus will inherit one of
them, either:
* A RhD positive gene, resulting in a RhD positive
fetal blood type, or * A RhD negative gene which,
when paired with the woman’s RhD negative gene,
results in a RhD negative fetal blood type.
Genetic determinants of
blood RhD factor diagram
The RhD positive gene is
more common that the RhD
negative gene, and is more
dominant. If one of the two
genes is RhD positive and the
other RhD negative, your blood
type Is RhD positive. It takes a pair of RhD negative
genes to make your blood type RhD negative.
Example 2: RhD negative Mother and RhD
positive Father
If the father has two RhD positive genes the fetus
will inherit a RhD positive gene.
* A RhD positive gene paired with the woman’s
RhD negative gene results in a RhD positive fetal
blood type.
Genetic determinants of
blood RhD factor diagram
The RhD positive gene is
more common that the RhD
negative gene, and is more
dominant. If one of the two
genes is RhD positive and
the other RhD negative, your
blood type Is RhD positive. It
takes a pair of RhD negative
genes to make your blood type RhD negative.
Example 3: RhD negative Mother and RhD
negative Father
If the father has two RhD negative genes the fetus
will inherit a RhD negative gene from him.
* A RhD negative gene paired with the woman’s
RhD negative gene results in a RhD negative fetal
blood type.

Pathogenesis of Haemolytic Disease of the
Fetus and Newborn
Fetomaternal Haemorrhage
Fetal and maternal
circulations are entirely
separate. In certain
circumstances fetal
red cells can cross the
placenta and enter the
maternal circulation (FMH)
This is only significant if
the fetus is Rh D positive
and mother is RhD negative
During pregnancy the placenta normally
prevents maternal and fetal blood from
mixing. Feto-maternal haemorrhage
(FMH) is the term used to describe any bleed
from the fetus into the maternal circulation.
Such an event increases the risk of maternal
sensitisation to fetal antigens. FMH is most
common in the third trimester and around the
time of birth. FMH is often associated with
a potentially sensitising event (PSE), such as
vaginal bleeding, but may also occur in the
absence of any obvious PSE.
Anti-D Formation
The spleen is activated by
fetal RhD positive RBC to
produce anti D antibodies
The presence of foreign
RhD positive fetal RBC
in maternal circulation
stimulates the production
of anti-D antibodies
Anti-D not given
Anti-D antibiodies cross
the placenta and bind to
the fetal postice RCBs.
Without anti-D
immunoglobulin the
maternal anti-D antibodies
will become permanent
and irreversible (maternal
BLOOD TRANSFUSION
sensation). It is highly unlikely that this pregnancy
will be affected. However, in a future pregnancy,
if the baby is RhD positive, the maternal immune
response will be greater. The maternal anti-D
antibodies will cross to the fetal circulation and
destroy fetal RBCs. This leads to HDFN.
Anti-D given
Anti-D immunoglobulin
prophylaxis is administered
to prevent maternal
sensitisation with anti-D
antibodies.
The woman should not
become sensitised.
Maternal Sensitisation
A woman is considered sensitised if she develops
antibodies such as anti-D in her blood. Once
sensitisation occurs it is irreversible. If a woman
is sensitised (has immune anti-D antibodies in
her blood) anti-D immunoglobulin will have no
impact. It should therefore not be given to women
with immune anti-D in their blood even if they
experience a potentially sensitising event (PSE).
The antibody(ies), which are formed, as a result
of the sensitisation, do not affect the mother’s
health however, they could affect future
pregnancies where the baby is RhD positive.
Impact of Sensitisation on Pregnancy
During the pregnancy that results in a woman
becoming sensitised, anti-D antibody is rarely
produced at a high enough level to cause
Haemolytic Disease of the Fetus and Newborn
(HDFN). Abnormal breakup of red blood cells
in the fetus or newborn. This is usually due to
antibodies made by the mother directed against
the baby’s red cells.
A subsequent pregnancy may however, be
at risk of HDFN if the baby is RhD positive.
The anti-D antibody, which resulted from the
earlier sensitisation, can cross the placenta and
attack and destroy RhD positive fetal red cells
causing HDFN. The anti-D antibody resulting
from maternal sensitisation will only attack RhD
positive fetal red blood cells.
13
Anti-d prophylaxis
Introduction of Anti-D Prophylaxis
Approximately 83% of Caucasians have the RhD
antigen and are therefore referred to as RhD
positive. The remaining 17% do not have the RhD
antigen and are considered RhD negative.
In the 1960s it was recognised that administration
of anti-D immunoglobulin to RhD negative
women, soon after the birth of a RhD positive
baby, dramatically reduced the incidence of
maternal RhD sensitisation.
Widespread introduction of Routine antenatal
anti-D immunoglobulin prophylaxis (RAADP) saw
a dramatic fall in deaths attributed to RhD HDFN
across the developed world.
Adverse Events related to Anti-D Administration
Serious Hazards of Transfusion (SHOT) data shows
that over the last ten years there has been a steady
increase in reported incidents involving anti-D
immunoglobulin administration. SHOT have stated
that this could be a result of increased awareness of
the need to report adverse events associated with
the administration of this blood product.
Published evidence suggests that poor compliance
with guidelines for anti-D immunoglobulin
administration is a contributing factor to
maternal sensitisation in the UK. In particular
there is consistent failure to recognise potentially
sensitising events in pregnancy, and failure to
manage them appropriately when they do occur.
For RAADP to be effective it must be administered
in the third trimester of pregnancy.
Anti-D adverse events Reporting
The SHOT working group advise healthcare
professionals to report all errors relating to the
14
administration of anti-D immunoglobulin to ensure
accuracy of data capture.
Successive SHOT reports have highlighted the
following errors relating to anti-D immunoglobulin
administration: Cases in which administration of
anti-D immunoglobulin was delayed or omitted.
These cases meet the SHOT definition of major
morbidity as they expose women to the risk of
sensitisation. It is possible that failure to give anti-D
immunoglobulin is often not apparent to healthcare
professionals, and that this is a category where
there may be significant under reporting to SHOT.
Cases where anti-D immunoglobulin was
inappropriately administered, resulting in
unnecessary exposure to a human blood product.
SHOT Case Study
1) The laboratory issued anti-D immunoglobulin
for a named woman, Mrs E, who was due to
attend the antenatal clinic. A midwife in the clinic
clipped the ampoule to Ms B’s notes. Another
midwife subsequently administered the anti-D
immunoglobulin to Mrs B, instead of to Mrs E, the
woman for whom the anti-D immunoglobulin had
been issued.
This SHOT case study highlights:

The unnecessary exposure of Mrs B to a
blood product

Failure to complete basic ID checks before
administering the anti-D immunoglobulin

Potential omission of prophylactic anti-D
immunoglobulin, placing Mrs E at risk of RhD
sensitisation.
2) A RhD negative pregnant woman attended
hospital as an outpatient after experiencing
a potentially sensitising event. Anti-D
immunoglobulin was issued by the laboratory, but
was returned unused. It later became apparent that
clinical staff believed the anti-D immunoglobulin
was unnecessary because the woman was due
to receive routine antenatal anti-D prophylaxis
(RAADP) a week later. Unfortunately by the time
she returned to receive RAADP, more than 72 hours
had passed since the potentially sensitising event.

This SHOT case study highlights:

Failure of the staff treating this woman,
to understand the mode of action and
the administration policy for anti-D
immunoglobulin

Failure to provide care in line with policy,
placing the woman at risk of RhD sensitisation.
3) A RhD negative pregnant woman gave birth
during the night and was discharged home
the next morning. The discharge checklist was
incomplete and the community midwife who
took over the woman’s care did not realise that
anti-D immunoglobulin was required. The error
only came to light when the anti-D that had been
issued for the woman was found in the ward
fridge 2 weeks later. By this time it was too late to
administer anti-D immunoglobulin.
This SHOT case study highlights:

Failure of communication between hospital
and community staff

Omission of postnatal anti-D immunoglobulin
prophylaxis, placing the woman at risk of
RhD sensitisation.
Management of pregnancies at
increased risks
How Maternal Sensitisation Occurs
Certain events during pregnancy are known to
increase the risk of FMH and subsequent maternal
sensitisation. These are known as Potentially
Sensitising Events (PSEs).
Gestation is an important factor in determining
how a PSE is managed. If anti-D immunoglobulin
is required, it should be given within 72 hours of a
PSE occurring.
The decision to give anti-D immunoglobulin
in response to a PSE should not affect or be
affected by routine ante or post natal anti-D
immunoglobulin prophylaxis.
BLOOD TRANSFUSION
PSEs include:
any vaginal bleeding
blunt abdominal trauma

invasive antenatal testing (amniocentesis, CVS)
external cephalic version
miscarriage or termination of pregnancy
ectopic pregnancy
intrauterine death, stillbirth
Birth of a RhD positive baby.
The management of a PSE varies
according to gestation:
Prior to 12 weeks gestation anti-D immunoglobulin
is occasionally indicated following PSE. Between 12
and 20 weeks gestation a minimum dose of anti-D
immunoglobulin is recommended.
At 20 weeks gestation and onwards, a minimum
dose of anti-D is also required, however more
anti-D immunoglobulin may be required depending
upon the size of FMH
Management of Potentially Sensitising Events
Before 12 weeks gestation, anti-D immunoglobulin
should be considered if PV bleeding is heavy or
persistent and/or associated with severe pain,
particularly when approaching 12 weeks gestation.
Anti-D immunoglobulin is always indicated
following surgical intervention to remove products
of conception (miscarriage and termination of
pregnancy). Anti-D immunoglobulin should always
be given in cases of termination of pregnancy,
whether by surgical or medical methods. In some
cases anti-D immunoglobulin is also offered if
early pregnancy loss, due to miscarriage or ectopic
pregnancy, is managed medically.
At 20 weeks gestation and onwards, a minimum
dose of anti-D is also required, however more
anti-D immunoglobulin may be required depending
upon the size of FMH.
15
A standard dose of anti-D immunoglobulin at Barts
Health is 1500 IU and will be effective against a
FMH of up to 4ml. Beyond 20 weeks gestation it is
possible to have a FMH greater than this.
Maternal testing
Maternal testing Kleihauer and/or flow cytometry
should be undertaken to determine the size of
the FMH and the dose of anti-D immunoglobulin
required to treat it.
Management of Pregnancies at Increased Risk Due
to Maternal Sensitisation
Some RhD negative women will be known to
be sensitised before their first visit to the ante-
natal clinic, or will be discovered to be sensitised
during pregnancy. Although sensitisation is of little
consequence to the woman’s health, the baby is at
risk of developing HDFN.
Sensitisied women require specialised care during
pregnancy to monitor the health of their baby.
They should be referred to a consultant obstetrician
and have a haematologist or transfusion specialist
involved in planning their care.
Sensitisation is irreversible, there is no treatment
for it. Anti-D immunoglobulin SHOULD NOT be
given to sensitised women. In the event that it is
inadvertently administered the only consequence
is the unnecessary exposure of the woman to a
blood product.
Sensitisation is only likely to cause problems for a
woman should she become pregnant with a RhD
positive baby or require a blood transfusion. It may
be difficult to crossmatch blood and transfusion
reactions could occur if RhD positive blood is given
inadvertently e.g. during an emergency.
Specialised care
This will usually mean regular monitoring of the
anti-D antibody level in maternal plasma. Usually
the higher the antibody level, the greater the risk
of harm to the baby. There is no effective treatment
that can change the levels of antibody produced,
and levels are likely to rise during pregnancy if the
fetus is RhD positive.
16
Management of Pregnancies at Increased Risk Due
to Maternal Sensitisation
Specialist investigations such as serial ultrasound
including Middle Cerebral Artery Doppler scanning
can be used to monitor the health of the developing
baby and referral to a fetal medicine unit may be
appropriate. Serial maternal antibody quantification
in a laboratory can help to predict the risk to the
baby from RhD HDFN.
Babies of women known to have anti-D antibodies
should be delivered in a hospital with neonatal
care facilities. It should be recognised that a future
pregnancy with a RhD positive baby is likely to be at
even greater risk of RhD HDFN.
Middle Cerebral Artery – Measurement of Doppler
flow through the middle cerebral artery can help to
identify babies with anaemia. Babies with anaemia
have increased blood flow and should be referred to
a fetal medicine unit.
A fetal medicine unit – In the most serious cases
intrauterine blood sampling may be indicated to
determine the fetal haemoglobin level. If a fetus
is found to be very anaemic, intrauterine blood
transfusion may be required.
Neonatal care – Babies born to sensitised women are
at risk of HDFN. They should be assessed at birth by
a paediatrician and may require treatment tailored to
the degree of HDFN.
Future pregnancies – Women should be counselled
about the likely risk of HDFN in future pregnancies.
This should include follow up appointments with
an obstetrician and/ or haematologist/transfusion
specialist, and liaison with their general practitioner.
Anti-D routine use
Booking visit
A woman’s blood type should be identified early
in her pregnancy to allow for optimal care to be
provided to her and her baby.
A maternal blood sample should be taken early in
the pregnancy, ideally at the first antenatal clinic visit
and before 16 weeks of gestation. This is to establish
ABO and RhD type of the woman and to screen for
the presence of red cell antibodies.

If known, parity and any transfusion history should
be included on the request form to assist the
effective interpretation of results and communication
between the laboratory and care providers.
ABO and RhD type – ABO typing is done to identify
and record the maternal ABO and RhD type.
Women who are RhD negative should be informed
about the risks of PSE (Potentially Sensitising Event)
and offered RAADP (Routine Antenatal Anti-D
Immunoglobulin Prophylaxis).
Routine antibody screening identifies anti-D and
any other clinically significant red cell antibodies,
for example anti-Kell, that may cause haemolytic
disease of the fetus and newborn.
Red cell antibodies – Routine antibody screening
identifies anti-D and any other clinically significant
red cell antibodies, for example anti-Kell, that may
cause haemolytic disease of the fetus and newborn
Request forms should include some or all of the
following information:

Correct identity of the woman including first
name, surname and date of birth
Unique hospital number, NHS or CHI number
Pregnancy gestation
Previous transfusion history
Obstetric history including miscarriages

Previous anti-D immunoglobulin administration
in this pregnancy (date, time and dose)
Previous pregnancies affected by HDFN
Routine Antenatal Care
At the 28 week antenatal clinic visit a maternal
blood test must be taken to recheck the ABO
and RhD type, and to screen for the presence of
any clinically significant antibodies. The woman
should then be offered Routine Antenatal Anti-D
Prophylaxis (RAADP).
RAADP is given as either a single dose at 28
weeks or as two doses given at 28 and 34 weeks.
Check the local policy for the agreed dose given
in your area. The standard RAADP dose at Barts
Health is 1500IU at 28 weeks.
BLOOD TRANSFUSION
The blood test must be taken before the woman
is given RAADP. If anti-D immunoglobulin has
previously been given for a potentially sensitising
event, antibody screening should still be undertaken.
However, the date of administration of anti-D
immunoglobulin must be highlighted on the
request form.
Blood test – Blood tests cannot always detect
the difference between immune anti-D made by
a sensitised woman and anti-D immunoglobulin
administered as part of prophylaxis. Giving RAADP
after the blood sample has been taken minimises
the risk of misinterpreting laboratory results.
It is not necessary to wait for the results of the 28
week blood test, as it is unusual for a woman not
to require anti-D immunoglobulin. It is accepted
practice to give RAADP to all non-sensitised RhD
negative women at this visit.
Routine Antenatal Anti-D Immunoglobulin
Prophylaxis (RAADP)
Routine antenatal anti-D immunoglobulin
prophylaxis (RAADP) should be offered to all non-
sensitised RhD negative women at 28
weeks gestation.
RAADP aims to prevent silent sensitisation and must
be given regardless of any anti-D immunoglobulin
required/administered following a potentially
sensitising event.
Silent sensitisation occurs when a pregnant woman
develops red cell antibodies without experiencing
any obvious potentially sensitising event (PSE).
It mainly occurs in the third trimester. RAADP
maintains a prophylactic level of anti-D in the
maternal circulation throughout the third trimester,
with the aim of preventing silent sensitisation.
A leaflet explaining the benefits, procedure and
risks should be given to the woman.
Please refer to the Trust’s Anti-D administration
checklist (http://bartshealthintranet/About-Us/
Clinical-Support-Services/Pathology/Haematology/
Blood-Transfusion/Documents/Anti-D-
Adminstration-Checklist.pdf)
Women who do not receive RAADP at 28 weeks
e.g. as a result of a missed appointment, may still
benefit from treatment at a later stage of gestation.
17
The individual circumstances should be discussed
with medical staff.
Decline RAADP
If the woman decline RAADP, this should be
recorded in her case notes.
Some women may choose not to accept RAADP.
Situations where treatment may be declined are:

Women who choose to be sterilised following
delivery

Where the woman is sure that the father is
known to be RhD negative

Where the woman is sure she will not have
another child.
However, it may be difficult for the woman to
be certain about these factors, and the decision
to decline should only be made after careful
consideration and counselling.
Postnatal Care
At birth a cord blood sample is taken from the baby
to check for the ABO and RhD type.
If the baby is RhD negative: No further investigation
or treatment is required for this birth.
If the baby is RhD positive: Give anti-D
immunoglobulin as soon as possible, and within 72
hours, following the birth.
A maternal blood sample should be taken no
sooner than 30-45 minutes after the placenta
has separated.
The maternal sample is needed to determine the
presence and size of any fetomaternal haemorrhage
(FMH) using flow cytometry or equivalent test.
Waiting 30-45 minutes after placental separation
allows time for any fetal cells to become apparent
in maternal blood.
If the baby is RhD positive and an FMH of more
than 4 mLs has occurred, a larger dose of anti-D
immunoglobulin will be required. Any additional
anti-D immunoglobulin dose will be calculated by
the laboratory carrying out the confirmatory tests.
Anti-D immunoglobulin is NEVER administered to a
baby. It is administered to the woman.
18
Anti-D Informed Decision Making
Health care professionals have a responsibility
to support RhD negative women to make a
fully informed decision about the use of anti-D
immunoglobulin in pregnancy (NICE guidance).
Women should be given access to accurate
information that allows them to understand the
risks, benefits, and alternatives to, accepting or
declining anti-D immunoglobulin. This information
should be tailored to each woman’s particular
circumstances and communicated in a timely and
readily understandable manner.
Administration of anti-D immunoglobulin and
RAADP in particular, will benefit a small number
of women and may carry some risks. Both health
care professionals and the woman herself should
be aware that the decision to accept or reject
anti-D is hers.
Potential Benefits of Anti-D Immunoglobulin
In the UK, a RhD negative pregnant woman who
does not receive RAADP has an approximately 1%
chance of becoming sensitised to the RhD antigen
during a pregnancy. With RAADP the risk of
sensitisation is predicted to fall to around 0.35%.
The risk of sensitisation following a PSE depends on
several factors including gestation and is impossible
to quantify.
Before prophylactic anti-D immunoglobulin was
introduced, the rate of maternal sensitisation
was about 16%. The impact of sensitisation on a
future pregnancy can vary greatly and depends on
several factors.
In most sensitised pregnancies the baby will not
develop clinically significant HDFN. However HDFN
can be very serious, and in around 10-12% of
sensitised pregnancies the fetus will require one or
more intra-uterine blood transfusions. At present
RhD HDFN causes about 37 fetal and neonatal
deaths each year in the UK, and around the same
number of babies are born with developmental
problems caused by HDFN.
Anti-D immunoglobulin is a human blood product
and therefore is not without risk.

However, anti-D immunoglobulin contains no
whole blood cells, just antibodies present in the
plasma. This, coupled with the production process
(which is designed to eliminate known viruses)
means that in over 30 years, and millions of
administered doses, there has been no reported
case of transmission of a blood borne virus by
an intramuscular anti-D immunoglobulin product
(NICE 2002).
All human plasma used in the manufacture of
anti-D immunoglobulin is screened for viruses
known to be transmitted by blood and in addition
anti-D immunoglobulin is only manufactured from
plasma donated in countries outside the UK. This is
to minimise any potential risk of variant Creutzfeldt-
Jakob Disease (vCJD). The risk of viral transmission
by anti-D immunoglobulin is considered to be
exceptionally low.
In the late 1970s cases of Hepatitis C transmission
by intravenous anti-D immunoglobulin were
reported in Europe prior to the introduction of
Hepatitis C screening of blood donors
Known side effects of anti-D immunoglobulin occur
infrequently and include: localised pain
at the injection site, fever and/or malaise and
allergic reaction.
Special Circumstances
There are some RhD negative women who do
not need or will not benefit from receiving anti-D
immunoglobulin. However, for these women the
decision to decline anti-D immunoglobulin may
be difficult.
Examples of such circumstances are:

Women who are certain that the father of this
baby is also RhD negative. Paternal RhD blood
group testing is not usually offered routinely,
but if requested, must be determined by formal
laboratory tests. Hearsay information is not
acceptable.

If the father is RhD negative all the babies born
to this couple will be RhD negative and the
woman cannot become sensitised to the RhD
antigen. Sensitive counselling may be required
to establish that the woman is certain of the
identity of this baby’s father prior to paternal
RhD blood group testing.
BLOOD TRANSFUSION
 
Women who are certain that this will be their
final pregnancy

Sensitisation is only likely to impact on future
pregnancies. Women who seem certain that this
will be their last pregnancy should be counselled
on the risk should an unplanned pregnancy
ensue. For those who will be sterilised at birth
or soon afterwards anti-D immunoglobulin is of
no benefit.
Information Sources
Information leaflets are an important resource for
facilitating informed decision making. Information
provided should use readily understandable
language and include:
The reason anti-D immunoglobulin is offered:
 
The potential benefits of anti-D immunoglobulin
 
The potential risks of anti-D immunoglobulin
injections
 
The fact that women have the option to decline
anti-D immunoglobulin
 
A list of PSEs and action to be taken in relation
to them
 
Sources of further information about anti-D
immunoglobulin
 
A statement offering the opportunity to discuss
anti-D immunoglobulin prophylaxis further
The level of information about anti-D
immunoglobulin that individual women require will
vary. All women should be offered an opportunity
to discuss anti-D prophylaxis face to face with their
care provider(s).
Health care professionals should ensure that all
women understand the information they have been
given. Some women will require more detailed
information. Provision of this information is the
responsibility of the health care professional.
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Anti-D immunoglobulin
Anti-D immunoglobulin is manufactured using
pooled plasma from human donors. In 1998 the
UK Committee on Safety of Medicines advised
that UK plasma should no longer be used to make
pooled plasma derived products including anti-D
immunoglobulin. Anti-D immunoglobulin is now
sourced from accredited blood donors within and
outside the EU.
There are a number of licensed products available
e.g Rhophylac and D-Gam. Anti-D immunoglobulin
should be stored according to manufacturers’
instructions under appropriate cold chain conditions
between +2 and +8°C in a refrigerator, and
brought to room temperature before use. If it is
stored incorrectly anti-D immunoglobulin may be
ineffective in preventing sensitisation.
If the contents of the vial of anti-D immunoglobulin
contains any deposits it must not be used.
20
Ordering of Anti-D
Anti-D immunoglobulin is usually given as a
standard dose, which depends upon gestation
and specific clinical circumstances. Standard doses
may vary and staff should check their local policy
for the standard doses of anti-D immunoglobulin
administered in their area. RAADP is always given
as a standard dose.
A standard dose of anti-D immunoglobulin is also
recommended following a PSE, and after birth of
a RhD positive baby, the standard dose for anti-D
immunoglobulin is 1500iu at Barts Health. Further
anti-D immunoglobulin may be required, depending
on FMH test result.
Anti-D immunoglobulin can be supplied by
the local hospital transfusion laboratory, or by
pharmacy. Staff should familiarise themselves
with local procedures for ordering(Remember
that accurate patient identification is vital at every
stage of this process) returning (In the event
that anti-D immunoglobulin has been issued
for a woman who declines treatment, the vial(s)
must be retuned to the transfusion laboratory/
pharmacy for safe disposal).

Administration of Anti-D
Before administering anti-D immunoglobulin it is
imperative to ensure that the woman has been
confirmed as RhD negative during this pregnancy.
Anti-D immunoglobulin is made from human
plasma and is subject to the same ID checks and
stringent documentation that are applied to the
administration of other blood products.
The recommended site of injection is the deltoid
(upper arm) muscle, and to be effective it should be
given as an intramuscular injection. Please follow
manufacturer’s instructions for administration.
An injection in the deltoid muscle is less likely to
be inadvertently given sub-cutaneously as there
is less fat in this area. Particular care should be
taken when administering the injection in the
gluteal area and to women who have higher Body
Mass Index, in order to ensure that the injection
is intramuscular and not sub-cutaneous. Muscle is
more vascular than subcutaneous fat and therefore
anti-D immunoglobulin is absorbed much more
effectively. Giving a subcutaneous injection could
mean less anti-D reaches the blood stream and
is subsequently present in an insufficient dose to
prevent maternal sensitisation.
Late administration, omission or administration of
anti-D immunoglobulin to the wrong patient must
all be reported via the SHOT reporting system.
Documentation
The administration of anti-D immunoglobulin must
be correctly documented in the woman’s maternity
record. A record should also be held centrally,
for example in the local hospital blood bank or
pharmacy computer. The record must include
the following:

First name and last name of the woman

Date of birth

Unique ID/hospital number and whether
consent was given

The name of the product, dose, batch number,
route, site,

Time and date of administration
BLOOD TRANSFUSION

The name and signature of the member of staff
who administered the anti-D immunoglobulin
Accurate documentation is also important to
enable clinicians to plan future treatment in the
event of recurring PSEs. It also allows laboratory
staff to accurately interpret test results to help
determine whether any anti-D present is passive
or active.
It is recognised that methods of documentation
may vary depending on local arrangements.
Whatever these arrangements are, it is essential
that records of anti-D administration are kept.
The EU guide on good manufacturing practice
recommends that records are kept to enable
traceability of all blood products (including anti-D)
from donors to recipients and vice versa (European
Commission 2000).
Adverse Reactions
As with any blood product occasional undesirable
effects may occur. All adverse reactions must be
recorded and the patient’s GP informed. Pain,
redness and discomfort at the injection site are the
most common complaints. Less often women may
experience fever, malaise, headache, cutaneous
reactions and chills.
If anti-D immunoglobulin is given in a community
setting, it is recommended that, where practicable,
the woman should be observed for 20 minutes
after administration.
Serious suspected reactions must be reported via
the Yellow Card reporting scheme. Serious reactions
to anti-D immunoglobulin are extremely rare. They
may include hypotension, tachycardia and allergic
or anaphylactic reactions.
MUST DO’s

Successfully complete Anti-D quiz
Following successful completion your records
will be updated automatically
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