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Clinical Practice Guidelines

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Chapter 1

Introduction

1
Section 1.1
Background Discussion on Rational Clinical
Use of Blood and Blood Products

1.1.1 Current Transfusion Practices

A sample government and private blood bank facility


were surveyed to determine the current situation in blood
bank practices. Both facilities have their own policies and
guidelines regarding blood bank operations. The policies
and guidelines reviewed are for activities such as voluntary
blood donation programs, blood screening, collection,
storage, distribution and utilization.

Need for Blood Transfusion

In a private tertiary care hospital blood bank facility


that only caters to its own needs, the average requirement
is about 60 units of blood products per day and only 50
percent of these are served by the blood bank facility. To
serve the deficit, the facility encourages relatives or friends
to serve as blood donor replacement/s or source out their
needs from the Philippine Red Cross. A government tertiary
care hospital blood bank facility that also caters to other
hospitals' blood products needs requires about 100 units
of blood products per day and claim to serve 100%. In
both hospitals, approximately half of the volume is
allocated or served in the emergency room.

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Both the private and government tertiary care blood
bank facilities mandatorily screen their donors and blood
products for Hepatitis B, Hepatitis C, HIV 1/2, Malaria
and Syphilis. The private facility also screens for hepatitis
A.

Distribution Procedures

In the private tertiary care hospital, the blood bank


personnel is usually the one transporting the blood product
while in the government tertiary care hospital, the relative
of the patient claims the blood product from the blood
bank facility.

In the past, the DOH provides "blood express" to


transport blood to the different government and private
blood banks. The government blood bank facility is
"informally" designated as the distribution facility for other
government hospitals.

Blood Donation Program

Both private and government tertiary care hospitals


have blood donation programs. The blood donation program
in the private tertiary care hospital is partially funded by
the hospital but its activities are conducted within the
hospital. Sometimes, mobile blood donation activities are
held among employees of their partner companies or
students from colleges and universities. The blood donation
program of the government hospital however is in need of
additional funding but the facility is still able to conduct
out-of-hospital blood donation activities through its mobile
blood bank facility. They also maintain good personal
relationship with their voluntary blood donors by sending
greeting cards and simple tokens like towels.

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Unmet Need

While the need for additional facilities in not felt in


tertiary care hospitals, upgrading of facilities is needed in
other government and private hospitals that source their
blood products need in tertiary care hospitals. Tertiary
hospitals felt that their blood donation program is just
enough to serve their own needs. Formalizing the network
through memorandum of agreements not only in the
government sector but also in the private sector is needed.

Another felt need especially in government facility was


the use of standard monitoring forms and strategies to
prevent and detect blood transfusion reaction. These
strategies however are presently being used in private
tertiary care facilities. Currently, the DOH through its
National Voluntary Blood Service Program (NVBSP) has
recommended the use of standard form for monitoring and
reporting of the status of transfusion and adverse events.

1.1.2 Review of Existing Policy

DOH Administrative Order

The "National Blood Service Act of 1994" with its


Administrative Order 9 s1995 on rules and regulations for
implementation was formulated to ensure safe and efficient
blood banking and transfusion practices in the Philippines.
Regulation of blood services was placed under the Bureau
of Research and Laboratories. In 2005, the Philippine
National Blood Service was created amending some of
implementing rules in AO 9 s1995. Thus, Administrative
Order 2008-0008 was formulated to provide rules and
regulations governing blood service facilities.

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The objective of the most recent AO was to ensure
available licensed blood service facilities with adequate
staff, equipment and resources to perform all the required
functions safely, efficiently and effectively. The AO defined
general and specific guidelines for blood service facilities,
issues about ownership and service capability. It also
defined who will be responsible for implementing and
monitoring the standards and technical requirements. The
license to operate for hospital-based blood service facilities
will be given through the One-Stop-Shop Licensure for
Hospitals by the DOH. The non-hospital-based blood
service facilities will be required to get a separate license from
the DOH-Center for Health Development. However, the AO
implementation is currently limited and its impact on blood
supply once fully implemented needs further study.

PHIC Policies

A Philippine Health Insurance Corporation circular (no.


18, s-2009) was issued to update the case type classification
of some illness and procedure. This included conditions
that require blood transfusion from case type A to case
type B. This will mean that these conditions will now have
a higher limit for reimbursement. The circular however did
not indicate the conditions for appropriate blood transfusion
and non-payment for inappropriate blood transfusion.

1.1.3 Background and Rationale of the Clinical


Practice Guidelines and Strategies for
Implementation

These clinical practice guidelines address all issues that


could affect the quality, safety, availability and accessibility
of blood and blood products. It adopted a set of principles

5
that define a good policy process and a structured approach
to policy formulation. The clinical practice
recommendations were based on up-to-date scientific,
medical and epidemiological evidence, with due
consideration of economic, ethical and social factors. They
were made in the interest of public health and to promote
optimal use of available resources. Authority, responsibility
and accountability for the implementation of policy
decisions, including structural and functional relationships
were also defined.

The establishment and endorsement of a good practice


and policy recommendation were based on the following
principles:

• Evidence-based: maximization of health outcomes


when decision-making is based on robust evidence

• Efficiency and cost-effectiveness: prioritization of


resource allocation in the context of overall public
health and the prudent use of human, technical and
financial resources

• Participation and partnership: involvement of relevant


stakeholders in the policy process, under the umbrella
of the National Council for Blood Services (NCBS), to
ensure the legitimacy and effectiveness of policy;
stakeholders include the Department of Health,
national blood transfusion service, regulatory agency,
experts in blood transfusion, clinicians, blood donor
organizations, non-government organizations, patient
associations and the media

• Transparency: clear and open policy process to help


ensure the legitimacy and effectiveness of blood
program policy

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Section 1.2
Principles of Rational Clinical Use of Blood
and Blood Products

1.2.1 Risks of Blood Transfusion

Transfusion Transmissible Diseases

Blood transfusion can transmit infectious agents,


including HIV, hepatitis B, hepatitis C, syphilis, malaria and
Chagas disease to the recipient. Blood products can also
be contaminated with bacteria and very dangerous if it is
manufactured or stored incorrectly. The overall cellular
blood product contamination prevalence is 32.4 per 100,000
units. This translates into an approximate rate of 1
bacterially contaminated cellular blood product unit per
3,000 cellular blood product units. Platelets are at higher
risk of becoming contaminated as shown in the table below
(WHO, 2002). In most instances, the incidence of
transfusion-transmitted HIV has decreased to less than 1
case per 2 million screened and tested units in the US
compared to 1 per 1,000 in 1980. Similar improvements
have been observed for HBV and HCV. (Hillyer, et al. 2003)

Table 1. Prevalence of Bacterial Contamination in Different Blood


Products.

Product Prevalence of Bacterial Contamination

RBC 2.6 per 100,000

RDP platelet 33.9 per 100,000

SDP platelet 51.0 per 100,000

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Blood Transfusion Reaction

Red cell transfusion can cause serious hemolytic


transfusion reaction. Transfusion reactions can be classified
into simple categories i.e. acute and delayed transfusion
reactions. (WHO, 1997)

Acute transfusion-related reactions are:

• Mild reactions - mild allergic or urticarial reactions


• Moderately severe reactions - moderate to severe
urticarial reactions, febrile non-hemolytic reactions,
possible bacterial contamination
• Life-threatening reactions - acute intravascular
hemolysis, bacterial contamination and septic shock,
fluid overload, anaphylactic reactions, transfusion-
associated lung injury

Delayed transfusion reaction essentially falls into two


categories:

• Transfusion-transmitted infections
• Other delayed complications of transfusion which
occur days, months or even years after the transfusion
has been completed i.e. delayed hemolytic reactions,
post transfusion purpura, graft vs host disease and iron
overload in repeated transfusions. (WHO, 1997)

Hemovigilance: Hazards of Transfusion Process (SHOT - UK data)

The Serious Hazards of Transfusion (SHOT) is a


surveillance activity in United Kingdom and is on its second

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decade of reporting. It is one of the longest established
hemovigilance systems in the world. In its 2007 annual
report, a total of 561 cases of adverse incidents were
reported and these represent an increase of 5% from the
2006 total of 531. The incidence of incorrect blood
component transfusion averaged more than 300 per year.
The data on incorrect blood component transfused (IBCT)
reports 2003-2007 showed an increase from 9.5 per 100,000
to 11.4 per 100,000 while the cumulative transfusion-
transmitted infection (TTI) total was 43 in 2007. (SHOT,
2007)

Table 2. Cumulative Mortality/Morbidity Data, 1996-2007 (SHOT , 2007)

Serious Hazards of Transfusion No. of Cases

Death in which transfusion reaction was causal or contributory 115

Major morbidity probably or definitely attributed to


transfusion reaction 376

Minor or no morbidity as a result of transfusion reaction 3821

Outcome unknown 15

Total number of cases 4327

1.2.2 Definition of Appropriate Transfusion

Appropriate blood transfusion is defined as "the


transfusion of safe blood or blood products to treat a
condition leading to significant morbidity or mortality that
cannot be prevented or managed effectively by other
means". (WHO, 2002) A safe blood or blood product is a
properly screened, typed and cross-matched blood product
coming from a voluntary non-remunerated blood donor.
In addition, for transfusion to be safe and appropriate, the

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quality and safety of blood and blood products must be
assured from the selection of blood donors, processing and
storage until the administration of the blood product to
the patient. (WHO, 2002) Blood components are transfused
only when there is evidence for potential benefit, when no
valid alternatives, safe and quality products are available,
and risks and benefits are carefully assessed before the
decision to transfuse is made. (Grazzini, 2008)

Thus, as recommended by the WHO, appropriate


transfusion of blood or blood products requires the presence
of the following: (WHO, 2002)
• National standards and specifications for blood products
and a system of good manufacturing practice to ensure
these standards are maintained at all times.
• The development and correct use of standard operating
procedures.
• The training of all blood transfusion service staff and
clinicians to develop and maintain their knowledge and
skills.
• Monitoring and evaluation (audit) to ensure that correct
procedures are being used by all staff at all times.
• An effective system of independent inspection and
accreditation of the facilities that collect, process and
distribute blood products.

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Section 1.3
Objectives and Intended Users of the
Clinical Practice Guidelines

Objectives of the guideline recommendations:

• Develop and implement national policies for promoting


rational use of blood and blood products

• Promote rational use of blood and blood products by


clinical practitioners

Intended users of the guidelines:

• Medical and paramedical professionals

• Hospital transfusion committee

• PHIC for quality assurance and accreditation of


professionals and institutions

• DOH for licensing purpose

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Section 1.4
How the Guidelines Were Developed

The development of these clinical practice guidelines


was divided into several phases:

• Formation of the technical working group


• Development of decision points for practice
recommendation
• Formulation of initial draft
• Series of meetings on the draft
• Consensus development
• Dissemination

The role of the AIDS Society of the Philippines (ASP)


was to provide administrative support and management
financial assistance from the Global Fund to the project.
The Technical Working Group was mainly responsible for
the recommendations. The ASP did not in any way
influence the guideline recommendations or how the
recommen-dations and consensus was attained.

A Technical Working Group representing the different


stakeholders formulated the initial draft of the clinical
practice guidelines. The group with the assistance of the
scientific committee was also responsible for searching and
appraising the medical literature used as the basis for the
recommendations. The scientific committee was mainly
composed of resource persons from the Family Medicine

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Research Group (FMRG), a group of consultants in family
medicine who were trained in the application of evidence-
based medicine concepts in family practice.

An electronic search using MEDLINE, OVID, and


Internet resources was conducted to search for clinical
studies limited to humans, any language and all journal
publications from 1966 up to 2009. The citations generated
by the searches were examined for relevance to the issues
in question on the basis of article titles and/or clinical
abstracts available. The full texts of studies that are assessed
to be relevant to the guideline development were retrieved.
References of retrieved full texts were also reviewed for
articles relevant to the issues at hand, and their own full
texts retrieved. Existing clinical practice guidelines on blood
transfusion were also reviewed and became the basis of
most recommendations.

A systematic assessment of the validity of the retrieved


full-text articles was done using the appropriate guide
questions. Evidences from articles that have been checked
for validity were categorized into different levels of validity,
the recommendations were graded based on the grading
system shown in Table 3.

The initial draft was then presented to the all the


members of the technical working group and other
stakeholders in a two-day workshop. Discussion was done
on each of the recommendation. Disagreements were
settled by discussion followed by voting if unresolved. After
the workshop, the initial draft was revised. The revised
version was then sent to the all the members of TWG and
stakeholders via e-mail for Delphi consensus development.

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Table 3. Grading of Recommendations.

Grade A Grade B Grade C


(All TWG (Significant (Slight majority
agreed to majority of of TWG agreed
recommend) TWG agreed to to recommend)
recommend)

Level 1
(Evidence from
randomized
controlled trials) A1 B1 C1

Level 2
(Evidence from
observational or
cross-sectional
studies) A2 B2 C2

Level 3
(Evidence from
experts' opinion) A3 B3 C3

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Chapter 2

Recommendations for the


Blood Banking System

15
2.1 Recommendations on Donor Recruitment
and Care

Voluntary non-remunerated blood donors are the safest


source of blood and the preferred source for blood
transfusion. Blood and blood products coming from paid
donors are not acceptable. (Grade A; Level 2) (WHO, 2002)
A sustainable voluntary blood donation program is therefore
necessary. The requirements of a voluntary blood donation
and screening program include adequately trained staff,
availability of equipment, reagents and testing kits (WHO,
1998).

Pre-donation Education and Counseling

Prospective donors should be asked to read educational


materials about the risks of blood donation. The donors'
concerns and issues must be addressed adequately by
properly trained personnel and this must be indicated in
writing by the donor. (Grade A; Level 3) (www.aabb.org,
2006) Thus, leaflets for donor awareness and education
should be available at screening area. (WHO, 1998) Before
the clinical screening process, donors should indicate in
writing that they have read and understood the risks of blood
donation, that they were given accurate information and the
opportunity to ask questions. (www.aabb.org, 2006)

Clinical Screening Recommendations

All donors must undergo a clinical screening process that


should include questions about transfusion-transmissible
diseases (WHO, 1998) and physical examination that
includes checking of blood pressure, pulse and temperature.
(www.aabb.org, 2006) (Grade A; Level 3)

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Laboratory Screening Recommendations
The test for the following diseases should be mandatory
screening program: human immunodeficiency virus (HIV),
hepatitis B, hepatitis C, syphilis and malaria. (WHO, 2002)
(National Blood Services Act 1994) All donor information
and examination results are confidential and must not be
released or made available to unauthorized persons. (Grade
A; Level 2). To discourage test-seeking behavior of persons
who are interested only in knowing their HIV status, and as
added measure to reduce the risk of window-period
donations, no official results are released to the donor.
Instead, a formal referral for post-test counseling is done.

Donor Counseling Recommendations


A policy or program for donor counseling should be
available in blood service facility and should be properly
implemented. (Grade A; Level 2) (WHO, 1998).

• Staff should be trained to prevent serious medical


and psychological implications. Donors who are at
high risk or tested positive should be referred to
existing government or non-government counseling
centers.

• In areas, where counseling facilities are not


developed (especially for HIV counseling), facilities
should refer them to designated health care and
support services. (WHO, 1998)

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2.2 Recommendations on the Process of Blood
Collection

The following should be done before phlebotomy;


registration, verify clinical and laboratory screening saying
the donor is fit to donate blood. The steps of the whole
blood donation process should be: (Grade A; Level 2)
(www.aabb.org, 2006)

• have donor lie down or sit in a reclining chair

• the ante-cubital area is cleansed using appropriate skin


disinfectant (70% alcohol and povidone iodine or
chlorhexidine solution)

• a new, sterile needle that is connected to plastic tubing


and a blood bag is inserted into the ante-cubital vein

• the donor is asked to squeeze repeatedly his or her hand


to help blood flow from the vein into the blood bag

• the blood collected is sent immediately to the laboratory


for Rh and ABO testing and component preparation

• the donor should be escorted to a donor care area for a


brief rest period

• the option for self-deferral or Confidential Unit


Exclusion (CUE) should be clearly explained to the
donor.

Individuals may be disqualified from donating blood


(deferred donors) at any point during the testing and
collection process. Self-deferral may also be allowed at any
point in the donation process when a donor voluntarily
chooses not to complete the process. (www.aabb.org, 2006)

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2.3 Recommendations on Blood Processing and
Storage

Blood Storage

Blood should be stored only in temperature controlled


blood refrigerators and NOT in ward or domestic
refrigerators. The different blood products must be stored in
temperatures as shown in the table and discussed below.
(Grade A; Level 2) (Australian and New Zealand Society
of Blood Transfusion Inc. Royal College of Nursing
Australia, 2004)

Table 4. Storage Temperature for the Different Blood Products.

Blood and Blood Products Storage Temperature

Whole blood and red cells +2°C to +6°C


Fresh frozen plasma -20°C or lower
Platelets +20°C to +24°C with
continuous agitation
Cryoprecipitate below -30°C

Whole blood and red cells must always be stored at a


temperature between +2°C and +6°C. The following table
summarizes the essential storage conditions for whole blood
and packed red cells (red cell concentrates). (WHO, 2005)

Table 5. Storage Temperature for Red Cells.

Condition Temperature Range Storage Time

Transport of pre-processed
blood +20°C to +24°C Less than 6 hours
Storage of pre-processed or
processed blood +2°C to +6°C Approximately 35 days
Transport of processed
blood +2°C to +10°C Less than 24 hours

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Fresh frozen plasma (FFP) is plasma that has been
separated from a unit of whole blood within 6 to 8 hours
of collection, and has been rapidly frozen and maintained
at all times at a temperature of -20°C or lower. (WHO,
2005)

Cryoprecipitate is the cold insoluble portion of plasma


remaining after FFP has been thawed between +1°C and
+6°C and is useful for correcting certain coagulation defects.
The optimal storage temperature is below -30°C. Table 2
shows the permitted storage times and temperatures for both
FFP and cryoprecipitate. (WHO, 2005)
Table 6. Storage Time According to Temperature for Fresh Frozen
Plasma and Cryoprecipitate.

Product Storage Temperature Maximum


Storage Time

FFP -65°C or below 7 years


FFP or Cryoprecipitate -40°C to -64°C 24 months
FFP or Cryoprecipitate -30°C to -39°C 12 months
FFP or Cryoprecipitate -25°C to -29°C 6 months
FFP or Cryoprecipitate -20°C to -24°C 3 months

Platelet concentrates should be stored at a temperature


of between +20°C and +24°C with continuous agitation.
Storage conditions and expiry dates should also be strictly
adhered to in order to prevent septic shock for the recipient.
(WHO, 2005)

Table 7. Length of Time Permitted for the Storage and Transport of


Platelet Concentrates Within the Temperature Range +20°C to +24°C.

Process Maximum Storage Time

Storage 6 days
Transport 24 hours
After issue, before transfusion 30 minutes
Open system and/or pooled 4 hours

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Plasma derivatives such as albumin or immunoglobulin
are concentrated, sterile specific proteins, obtained from large
pools of donor plasma through a complex pharmaceutical
process called plasma fractionation. It is essential to store
all plasma derivatives according to the manufacturer's
instructions. Table 4 gives a general guide for the storage
of these products. (WHO, 2005)

Table 8. Storage of Plasma Derivatives.

Products Storage Shelf Life Other

Albumin < + 25°C 3 years Do not freeze.


Plasma Protein
Fractions (liquid) +2°C to +8°C 5 years
Immune Serum +2°C to +8°C 3 years Do not freeze
(Lipid) globulin.
Use promptly.
Freeze Dried +2°C to +8°C 2 years Do not freeze.
Factor VIII <+25°C Up to 2 Use promptly
years after
reconstitution
Freeze Dried +2°C to +8°C year Do not freeze.
Factor IX Room 1 month Use promptly
Temperature after
reconstitution

Always follow the expiry date recommended by the manufacturer.

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2.4 Recommendations on Transport and
Distribution of Blood Products

Blood Cold Chain Policy

All blood service facility must have a blood cold chain


standard operating procedure that should specify a series of
interconnected activities involving equipment, vehicle,
personnel and processes that are critical for the safe storage
and transportation of blood from collection to transfusion.
(WHO, 2005) The cold chain standard operating procedure
shall cover the following items: 1) the staff responsible for
the procedure, 2) the education, training and competency
of these staff, 3) documentation/checking procedures, and
4) validated methods for transporting required blood
components. (ANZSBT, 2004)

The blood cold chain equipment for whole blood


includes freezers, blood bank refrigerators, platelet agitators
and transport boxes. Other important equipment also
includes standby generators and temperature monitors that
warn personnel as the refrigerator approaches unacceptable
temperatures. The policy must also include preventive
maintenance and rational use of equipment. (WHO, 2005)

The policy must also contain rules in transporting blood


or blood products. These include:
• Transport in boxes designated for these purposes and
should be validated as satisfactory for transporting blood
(ANZSBT, 2004)
• Label the container THIS WAY UP with an arrow
• Ice should be placed above the blood because cool air
moves downwards. (WHO, 2005)

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The recommended transport conditions must be
maintained when blood is moved from one location to
another, including: - from a mobile or satellite collection
site to the laboratory - from the blood bank to a different
facility (to a hospital or clinic or another blood bank) - from
the blood bank to hospital wards or operating rooms.
(WHO, 2005) Thus, each blood transport box must have
frozen ice packs as coolants in order to ensure an acceptable
cold life. (WHO, 2002)

The transport method in the policy must specify transport


conditions for the different individual blood products as
recommended below: (WHO, 2005)

• Red cell components - Ice should not be allowed to come


into direct contact with the blood as the red cells nearest
to the ice may freeze and hemolyse. Appropriate
materials and packing arrangements are therefore
necessary.
• Plasma - There should be at least as much wet ice in the
cold box as there is plasma. If possible, they should have
been placed in cardboard boxes before freezing to protect
the bags from developing small cracks.
• Platelets - Containers for transporting platelets should
be equilibrated at a temperature of +20°C to +24°C
before use. If outdoor temperatures are extremely high,
special chemical, coolant pouches are available that may
be shipped with platelets and will maintain temperatures
of approximately +20°C to +24°C for up to 12 hours.
• FFP and cryoprecipitate - They are thawed at between
+30°C and +37°C in the blood bank before issue and
transported to the ward at ambient temperature. They
must be used immediately and should never be refrozen.

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Receiving Facility

Acceptance of blood by the receiving facility is


CONDITIONAL upon the discretion of the blood service
facility staff and based on evidence of suitable storage and
handling while in transit from the issuing facility. (Grade
A; Level 2) Any products where there is any doubt regarding
the conditions of storage during transport must not be used
for transfusion. Any such items must be held in secure
quarantine until a decision regarding its fate is made.
(ANZSBT, 2007)

To facilitate the decision of the receiving facility, the


following may be done when transporting blood products
(ANZSBT, 2004):

• blood products for transport must have documentation


slip containing the patients identification details, blood
compatibility report and the specific blood component
labels
• the time and temperature when blood was removed from
the refrigerator and placed into a box
• the time unused blood should be returned to the blood
bank
• a member of appropriately trained staff should check
that the correct blood is delivered and sign the blood
collection slip

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2.5 Recommendations for Pre-transfusion Testing

Ever y hospital should have standard operating


procedures to ensure that blood and blood products to be
transfused are compatible with the patient's red cells and
the antibodies in the patient's plasma. (WHO, 2002) Such
SOPs must be prominently displayed in the blood bank area.
Donated blood unit should be routinely tested for ABO and
Rh (D) grouping. Pre-transfusion antibody screening of
patients and crossmatching with donors' blood using
sensitive techniques should be done on all whole blood and
red cell transfusions. (Grade A; Level 3) (WHO, 1998)

25
26
Chapter 3

Recommendations for Clinicians

27
3.1 Fresh Whole Blood (FWB)

What is Fresh Whole Blood?

Fresh whole blood (FWB) is blood collected within 24


hours into a blood bag with appropriate anticoagulant. It
provides RBC, plasma and platelets. After 48 hours, it is
termed whole blood (WB) and contains the red cells and
plasma component of donor blood (Australian Red Cross
Blood Service, 2008). Platelet viability is decreased upon
storage in blood bank refrigerator. It has no functional
platelets and labile coagulation factors (V and VIII).

FWB or WB should be of the same ABO and Rh(D)


type as the patient whenever possible. When serologically
compatible units are not available, incompatible units may
be given after consultation between the physician and
laboratory. Group O red cells must be selected when the
patient's ABO group cannot be determined. Similarly Rh
(D) negative red cells should be used if a conclusive Rh(D)
group cannot be obtained (ANZSBT, 2007). Switching to
the patient's type may be done when type specific blood is
available. (Grade A; Level 3)

Indications for FWB Transfusion

The use of FWB and WB should be discouraged and


patients should be given the specific blood products as
indicated (WHO, 1998). However, the following may be
considered as indication for FWB or WB transfusion (Grade
A; Level 3):

• Evident massive blood loss and coagulopathy. Massive


blood loss is defined as the loss of significant 1 to 1.5

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times the whole blood volume within a 24 hour period.
Alternative definitions in acute situations is: 50% of
blood volume loss within 3 hours or a rate of loss of 150
ml/min. (British Committee on Standards in
Hematology, 2006)
• Trauma casualties who will be requiring massive
transfusion but only when specific blood products are
not available or when blood products are not enough to
resuscitate the patient
• Patients with hemorrhagic shock when optimal specific
blood product therapy is not available or when blood
products are not enough to resuscitate the patient
• Neonatal exchange transfusion. Use Group O or group-
compatible erythrocytes suspended in group compatible
or AB plasma. The whole blood should be less than 7
days old to ensure a greater than 90% post-transfusion
survival. Utilize leuko-reduced and irradiated cells since
exchange transfusion neonates are often than not sick
prematures and acutely-ill neonates who are considered
immunocompromised. (Nathan and Oski, 5th Ed)

Volume and Preparation of FWB

It is usually prepared up to 513 ml total volume but the


volume may vary in accordance with local policies. One bag
usually has 450 ml donor blood and 63 ml anticoagulant-
preservative solution.

Storage Temperature, Handling and Shelf-life of FWB

FWB must be stored only in blood refrigerators with


appropriate temperature monitor and not in wards or
domestic refrigerators. It must also be transported in boxes

29
(cardboard, styropore or plastic ) designated for this purpose
and which have been verified as satisfactory for transport
and time of storage. (Grade A; Level 3) (BCSH, 1999) If the
fresh whole blood is refrigerated within eight hours of
collection, it may be stored up to five days. (Joint Theater
Trauma System Clinical Practice Guidelines, Updated
November 2008) Only FWB stored for less than 24 hours at
20ºC - 24ºC can be considered a clinical source of viable
platelets or therapeutic levels of labile coagulation factors V
and VIII. After 24 hours, all room temperature stored FWB
units should be destroyed.

Only 1 unit of FWB or WB should be taken at a time for


each patient unless rapid transfusion of large amount of
blood is needed. Blood should be transfused as soon as
possible after delivery to the ward or operating room. If more
than 30 minutes has elapsed and a unit of blood is still not
transfused or cannot be transfused, the blood should be
returned to the blood bank. (BCSH, 1999) (Grade A; Level
3) They should be informed that it has been out of the
refrigerator for more than 30 minutes so that the blood bank
will dispose of it properly because of the risk of bacterial
growth.

Infusion Set and Rate of PRBC Transfusion

Blood should be transfused through a sterile giving set


designed for the procedure. The size of the cannula chosen
should depend on the size of the vein and the speed at which
the blood is to be transfused. A new transfusion set should
be used for every new unit to be transfused or if the
transfusion set has been used for 6 hours or more in order to
prevent bacterial growth. (Grade A; Level 3)

Electronic infusion pumps may be used for the


administration of RBC if they have been verified as safe

30
to use for this purpose and according the manufacturer's
instructions. In neonates, the use of infusion pump may be
helpful. Blood should only be warmed using a specifically
designed commercial device with a visible thermometer and
audible warning. A blood warmer is indicated at flow rates
of >50ml/kg/1hr in adults, >15ml/kg/hr in children and
for exchange transfusion in infants. (BCSH, 1999) It is
also indicated in transfusion for cold agglutinin disease.
Improvised infusion pumps and warmers are discouraged.

Never add medication to a unit of blood or administer


medication through a transfusion line during the transfusion.
(Grade A; Level 2)

Complete transfusion within 4 hours of commencement.


Upon completion of the transfusion, the empty bag should
be discarded according to the hospital policy for disposing
of clinical waste and the blood transfusion compatibility
report form should be filed in the patient’s medical records.
(BCSH, 1999) (Grade A; Level 3)

Monitoring the Patient

For each unit of blood transfused, monitor the patient


at the following stages (Grade A; Level 3) (WHO, 1997):

• before starting the transfusion


• as soon as the transfusion is started
• every 15 minutes after starting the transfusion for first
hour
• every 30 minutes during transfusion
• on completion of the transfuion
• four hours after completing the transfusion

31
In each of these stages, record the following information
on the patient’s chart: 1) patient’s general appearance,
2) temperature, 3) pulse rate, 4) blood pressure,
5) respiratory rate and 6) fluid balance of oral and IV fluid
intake and urine output (WHO, 1997) and 7) patient’s
subjective complaints. The following should also be
recorded in the patient’s medical chart: 1) time the
transfusion is started, 2) time the transfusion is completed,
3) volume and type of all products transfused, 4) unique
donation numbers of all products transfused and 5) any
adverse effects (WHO, 1997).

32
3.2 Packed Red Blood Cell (PRBC)

What is Packed Red Blood Cell?

Red cell concentrate [also called packed red blood cell


(PRBC), concentrated red cells or plasma-reduced blood] is
prepared by allowing the blood to separate under gravity
overnight in a refrigerator at a temperature of +2°C to +6°C
or by centrifuging the blood pack in a specially refrigerated
centrifuge. Red cell suspension is prepared by removing the
plasma into a second empty plastic pack, as described earlier.
An 'additive' diluent solution formulated for the best
preservation of the red cells is then transferred from a third
plastic pack into the original pack.

PRBC should be of the same ABO and Rh(D) type as


the patient whenever possible. When serologically compatible
units are not available, incompatible units may be given after
consultation between the physician and laboratory. Group
O red cells must be selected when the patient's ABO group
cannot be determined. Similarly, Rh (D) negative red cells
should be used if a conclusive Rh(D) group cannot be
obtained. (ANZSBT, 2007) Switching to the patient's type
may be done when type specific blood is available. (Grade
A; Level 3)

General Indications for PRBC Transfusion

The criteria for PRBC transfusion should be based on:


1) hemoglobin level, 2) the patient's clinical condition, and
3) risk for inadequate oxygenation. Transfusion is rarely
indicated when the hemoglobin concentration is greater than
10g/dl and is almost always indicated when it is less than
6g/dl. Between 6g/dl and 10g/dl, RBC transfusion should
be based on the patient's risks for complications or

33
inadequate oxygenation. The use of PRBC is likely to be
inappropriate when Hgb level is greater than 10 g/L. (Grade
A; Level 2) (ASA, 1996) (Finnish Medical Society) (Laudico,
et al. 2000) (NHMRC, 2001)

Adult Indications for PRBC Transfusion

PRBC may be given in patients with hemoglobin


concentration of <10 g/dl, and in such cases where there is
• disabling angina pectoris
• myocardial infarction
• congestive heart failure due to severe anemia
• end-stage renal disorder

(Grade A; Level 2) (Finnish Medical Society Duodecim)


(Mukhopadhyay, 2003):

PRBC transfusion is NOT indicated during


chemotherapy since it is not likely to achieve Hgb level
optimal for good quality of life or give anticancer therapy
the best prospects of success. (Vaupel, 2008) (Grade A;
Level 2)

Pediatric Indications for PRBC Transfusion

PRBC is indicated in neonates and premature infants


with (Nathan and Oski's, 5th Ed) (Grade A; Level 1):

• hemoglobin level of < 8 - 10 g/dl (hematocrit 0.25 - 0.30)


accompanied by tachypnea, tachycardia, recurrent
apnea, poor feeding and poor weight

34
• hemoglobin level of < 130 g/dl in acutely-ill neonates
with cardiorespiratory disease
• hemoglobin <80 g/L or hematocrit <25% in a stable
neonate with clinical manifestations of anemia, namely
tachycardia, tachypnea and poor feeding
• neonates and premature infants when there is shock
associated with blood loss or sepsis, and cumulative
loss of 10%

Above 4 months, the general indication for PRBC transfusion


as previously discussed applies.

Surgical Indications for PRBC Transfusion

Aggressive and early control of hemorrhage with volume


resuscitation using crystalloids and colloids should be
considered an integral part of resuscitation. PRBC is
preferred in patients with acute blood loss >2,000 ml or a
40% loss of blood volume. (Management of Bleeding
Following Major Trauma) In normovolemic patients with
acute anemia who have cardiac disease or are at risk of
cardiac disease may benefit from PRBC transfusion if their
Hgb concentration is less than 7g/dL. (Laudico, et al. 2000)
(Grade A; Level 2)

Volume and PRBC Preparation

PRBC is available in bags of 230ml-330ml from which


most of the plasma has been removed. A bag contains
hemoglobin approximately 20 g/100 ml (not less than 45g
per unit) and hematocrit at 55%-75%.

35
Handling and Storage of PRBC at Transfusion Area

Only 1 unit of PRBC should be taken at a time for


each patient unless rapid transfusion of large amount of
blood is needed. Blood should be transfused as soon as
possible after delivery to the ward or operating room. If
more than 30 minutes has elapsed and a unit of blood is
still not transfused or cannot be transfused, the blood should
be returned to the blood bank. (BCSH, 1999) (Grade A;
Level 3) They should be informed that it has been out of
the refrigerator for more than 30 minutes so that the blood
bank will dispose of it properly because of the risk of
bacterial growth.

Infusion Set and Rate of PRBC Transfusion

PRBC should be transfused through a sterile giving set


designed for the procedure. The size of the cannula chosen
should depend on the size of the vein and the speed at which
the blood is to be transfused. A new transfusion set should
be used for every new unit to be transfused or if the
transfusion set has been used for 6 hours or more in order to
prevent bacterial growth. A duration of 2-3 hours is given
for PRBC. PRBC should be transfused slowly 10-15 drops/
min for the first 10 minutes. (Grade A; Level 3) (BCSH, 1999)
(Finnish)

If blood warmer is needed, a specifically designed


commercial device with a visible thermometer and audible
warning should be used to warm blood in patients with cold
agglutinins or at flow rates > 50ml/kg/hr in adults and
> 15ml/kg/hr in children. Improvisations, such as
warming blood in hot water, should not be used (BCSH,
1999).

36
Monitoring the Patient

For each unit of blood transfused, monitor the patient


at the following stages (Grade A; Level 3) (WHO, 1997):

• before starting the transfusion


• as soon as the transfusion is started
• every 15 minutes after starting the transfusion for first
hour
• every 30 minutes during transfusion
• on completion of the transfuion
• four hours after completing the transfusion

In each of these stages, record the following information


on the patient’s chart: 1) patient’s general appearance,
2) temperature, 3) pulse rate, 4) blood pressure, 5) respiratory
rate, and 6) fluid balance of oral and IV fluid intake and
urine output (WHO, 1997) and 7) patient’s subjective
complaints. The following should also be record in the
patients medical chart: 1) time the transfusion is started,
2) time the transfusion is completed, 3) volume and type
of all products transfused, 4) unique donation numbers of
all products transfused and 5) any adverse effects. (WHO,
1997)

Response to Transfusion

Infusion of 1 unit of packed RBC increases the


hemoglobin of 1 gm/dl and hematocrit by 3%. In patients
who are not actively bleeding, repeat hemoglobin
determination may be done 15 minutes after transfusion.
(Wienen, 1994) (Grade B; Level 2)

37
3.3 Washed Red Cell

Washed Red Cell Preparation

The red cells are washed with 0.9% sterile isotonic saline
by a manual method to remove the majority of plasma
proteins, antibodies and electrolytes. The washed red cells
are then re-suspended in additive solution (Australian Red
Cross Blood Service, 2008). It is depleted of plasma,
platelets and leukocytes.

Indications for Washed Red Cell Transfusion

Washed red cell is used in patients with indication for


PRBC transfusion and the following conditions: (Australian
Red Cross Blood Service, 2008) (Grade A; Level 3):

• confirmed deficiency of immunoglobulin A


• recurrent severe allergic-type adverse events (fever,
generalized urticaria, dyspnea)
• Paroxysmal Nocturnal Hemoglubinuria (PNH)

It may reduce the incidence of severe recurrent febrile,


urticarial and possible anaphylactic transfusion reactions in
multi-transfused patients (Australian Red Cross Blood
Service, 2008).

Volume Preparation, Handling, Storage and Transfusion

The volume is usually >130 ml, with hemoglobin > 40g/


unit and hematocrit: 0.50-0.70. Washed RBC must be
transfused within 24 hours after washing. It must be
transfused through an intravenous line approved for
administration and incorporating a standard (170um to
200um) filter. The time outside required storage conditions

38
prior to commencing transfusion should not exceed 30
minutes. Transfusion of each unit should be completed
within four hours of commencing transfusion. (Australian
Red Cross Blood Service, 2008) (Grade A; Level 3) Washed
red cells can be good up to 28 days at 2ºC-6ºC if re-
suspended in additive solution. (Australian Red Cross Blood
Service, 2008)

Monitoring the Patient

For each unit of blood transfused, monitor the patient


at the following stages (Grade A; Level 3) (WHO, 1997):

• before starting the transfusion


• as soon as the transfusion is started
• every 15 minutes after starting the transfusion for first
hour
• every 30 minutes during transfusion
• on completion of the transfuion
• four hours after completing the transfusion

In each of these stages, record the following information


on the patient’s chart: 1) patient’s general appearance,
2) temperature, 3) pulse rate, 4) blood pressure, 5) respiratory
rate, 6) fluid balance of oral and IV fluid intake and urine
output (WHO, 1997) and 7) patient’s subjective complaints.
The following should also be recorded in the patient’s
medical chart: 1) time the transfusion is started,
2) time the transfusion is completed, 3) volume and type of
all products transfused, 4) unique donation numbers of all
products transfused, and 5) any adverse effects. (WHO,

39
1997)
Response to Transfusion

The response to infusion of 1 unit of washed RBC may


be lower than the response to PRBC. In patients who are
not actively bleeding, repeat hemoglobin determination may
be done 15 minutes after transfusion. (Wienen, 1994)
(Grade B; Level 2)

40
3.4 Leukocyte-reduced Red Cell

Preparation of Leukocyte-reduced Red Cells

Leukocyte-depleted (filtered) red cell is obtained by


removing most of the plasma using third generation filter
either at the blood service facility or patient bedside. The
red cells are filtered to remove most leukocytes. (Australian
Red Cross Blood Service, 2008)

Indications for Leukocyte-reduced Red Cells

In general, leukocyte-reduced red cell has similar


indication with PRBC but this is given to (Nathan and Oski,
5th Ed) (Grade A; Level 3):
• immunocompromised patients (all premature and
acutely-ill neonates, patients with congenital deficiency
syndromes, patients on chemotherapy, transplant
patients) to reduce the risk of CMV and TAGVD
• patients likely to be dependent on long-term red cell
support to prevent recurrent febrile non-hemolytic
transfusion reactions
• after hematopoietic cell transplantation in patients with
severe aplastic anemia to reduce but not totally prevent
graft rejection
• fetal/neonatal transfusion

Volume, Handling, Storage and Transfusion

The volume is >200 ml; hemoglobin >40g/unit;


hematocrit: 0.05-0.70. Shelf life, storage: 42 days at 2ºC-

41
6ºC with the appropriate additives. Transfuse through an
intravenous line approved for administration and
incorporating a standard BT filter for centrally prepared
leukocyte-reduced RBC. For bedside filtration, the third
generation filter serves as the BT set. Transfusion of each
unit should be completed within four hours of commencing
transfusion. (Australian Red Cross Blood Service, 2008)
(Grade A; Level 3)

Monitoring the Patient

For each unit of blood transfused, monitor the patient


at the following stages (Grade A; Level 3) (WHO, 1997):
• before starting the transfusion
• as soon as the transfusion is started
• every 15 minutes after starting the transfusion for first
hour
• every 30 minutes during transfusion
• on completion of the transfusion
• four hours after completing the transfusion

At each stage, record the following information on the


patient’s char t: 1) patient’s general appearance,
2) temperature, 3) pulse rate, 4) blood pressure,
5) respiratory rate, 6) fluid balance of oral and IV fluid
intake and urine output, (WHO, 1997) and 7) patient’s
subjective complaints. The following should also be
recorded: 1) time the transfusion is started, 2) time the
transfusion is completed, 3) volume and type of all products
transfused, 4) unique donation numbers of all products
transfused, and 5) any adverse effects. (WHO, 1997)

42
3.5 Irradiated Blood Components (Red Cells,
Platelets, Whole Blood, Granulocytes)

Preparation

Blood components that contain viable lymphocytes may


be irradiated to prevent the proliferation of T-lymphocytes,
which is the immediate cause of transfusion-associated graft-
versus-host-disease. The minimum dose achieved in the
irradiation field should be 25Gy, with no part receiving
greater than 50Gy. (Australian Red Cross Blood Service,
2008)

Indications for Irradiated Blood Components

Irradiated blood products are given to prevent


transfusion-associated graft-versus-host-disease (TA-GVHD)
and there is general indication for RBC transfusion.
(Australian Red Cross Blood Service, 2008) (Standards
Committee of AABB) (Grade A; Level 2) They are indicated
in:

• recipients of intrauterine transfusion


• neonates who have previously received intrauterine
transfusions
• patients with congenital immune deficiencies, Hodgkins
disease or receiving purine analogue drugs
• recipients of stem cell or bone marrow transplants
• patients with aplastic anemia receiving immuno-
suppressive therapy
• recipients of directed donations from family members

43
• recipients of HLA-compatible single donor platelets and
granulocyte transfusions

Storage Temperature and Shelf-life

Red cells may be irradiated at any time up to 14 days


after collection and thereafter stored for another 14 days
from irradiation. Platelets can be irradiated at any stage in
their five day storage and thereafter can be stored up to their
normal shelf life of five days after collection. Granulocytes
for all recipients should be irradiated as soon as possible
after production and thereafter transfused with minimal
delay. (Australian Red Cross Blood Service, 2008)

Infusion Rate of Irradiated Blood Products

Blood for intrauterine and exchange transfusion should


be used within 24 hours of irradiation. Blood for pediatric
transfusion should be used within 48 hours of irradiation.
(Australian Red Cross Blood Service, 2008) (Grade A; Level
2) Gamma irradiation of red cells increases the rate of efflux
of extracellular potassium. Hence, consider the clinical
significance of this in determining both the speed and volume
of the transfusion and the age of the blood. In general, it
should follow the rate recommended for the type of
irradiated blood product.

Monitoring the Patient

For each unit of blood transfused, monitor the patient


at the following stages (Grade A; Level 3) (WHO, 1997):

• before starting the transfusion

44
• as soon as the transfusion is started
• every 15 minutes after starting the transfusion for first
hour
• every 30 minutes during transfusion
• on completion of the transfuion
• four hours after completing the transfusion

In each of these stages, record the following information


on the patient’s chart: 1) patient’s general appearance,
2) temperature, 3) pulse rate, 4) blood pressure, 5) respiratory
rate, 6) fluid balance of oral and IV fluid intake and urine
output (WHO, 1997) and 7) patient’s subjective complaints.
The following should also be recorded in the patient’s
medical chart: 1) time the transfusion is started,
2) time the transfusion is completed, 3) volume and type
of all products transfused, 4) unique donation numbers of
all products transfused, and 5) any adverse effects. (WHO,
1997)

45
3.6 Random Donor Platelet (RDP)

Preparation

Platelets derived from whole blood within 8 hours of


blood donation are called random donor platelet (RDP). It
contains > 5.5 x 10 10 platelets (average content
approximately 8.0 x 10 10) per bag in approximately 50 ml
of plasma. Anticoagulant is the same as used for whole
blood collection.

RDP should be ABO and Rh(D) type compatible with


the recipient. However, ABO-incompatible RDP may be used
if ABO-compatible platelets are not available. Platelet
concentrates prepared from RhD positive donors should
not be given to a RhD negative potential child-bearing
female. (World Health Organization, 1997) When Rh(D)
positive platelets are transfused to an Rh(D) negative female
of child bearing potential, prevention of Rh(D)
immunization by use of Rh(D) immunoglobulin should be
considered. (Australian Red Cross Blood Service, 2008)
(Grade A; Level 3)

Indications for RDP

RDP is indicated for patients with the following


conditions (Grade A; Level 1):

• ongoing massive bleeding to maintain platelet count


>50 x 10 9 /L (BJH, 135), if with CNS trauma or
bleeding, maintain platelet count >100 x 109/L (ARC)
• patients with massive blood transfusion and with platelet
count <20 x 109/L

46
• episodes of hemorrhage or during times of active
treatment in chronic, stable, severe thrombocytopenia
such as aplastic anemia and myelodysplasia (JCO, 19)
• when mucosal bleeding persists in patients with
hemolytic disorders (Haemophilia, 2004)
• adult patients receiving therapy for acute leukemia at a
threshold of 10,000 u/L
• patients with solid tumors receiving aggressive therapy
as well as those patients with necrotic tumors to maintain
a threshold of 20,000 u/L (JCO, 19)
• patients with qualitative platelet dysfunction with
bleeding or will be undergoing surgical intervention

Volume and Preparation

Volume approximately 50 ml; platelet count > 200


x10 9/unit; pH (at expiry) 6.4-7.4. (Australian Red Cross
Blood Service, 2008)

Handling and Storage at Transfusion Area

Platelets must be agitated gently and continuously on a


platelet agitator during storage in a single layer. (Australian
Red Cross Blood Service, 2008) (Grade A; Level 3)

Transfusion Set, Rate and Dose

Transfuse platelets through an intravenous line approved


for blood administration and incorporating a clean standard
(170-200 um) filter. Transfusion of each unit may proceed
as fast as tolerated but should be completed within four hours
after commencing transfusion. The number of platelet units
to be administered depends on the clinical situation of each
patient. (Australian Red Cross Blood Service, 2008) In
neonates, it is given at 5ml-10ml per kilo and in children, it
47
is given at 1 unit per 10 kg. They can also be given as fast
as tolerated. (Grade A; Level 1)

Monitoring the Patient

For each unit of blood transfused, monitor the patient


at the following stages (Grade A; Level 3) (WHO, 1997):
• before starting the transfusion
• as soon as the transfusion is started
• every 15 minutes after starting the transfusion for first
hour
• on completion of the transfusion
• four hours after completing the transfusion

At each stage, record the following information on the


patient’s char t: 1) patient’s general appearance,
2) temperature, 3) pulse rate, 4) blood pressure,
5) respiratory rate, 6) fluid balance of oral and IV fluid
intake and urine output (WHO, 1997) and 7) patient’s
subjective complaints. The following should also be
recorded in the patient’s medical chart: 1) time the
transfusion is started, 2) time the transfusion is completed,
3) volume and type of all products transfused, 4) unique
donation numbers of all products transfused, and 5) any
adverse effects. (WHO, 1997)

Post-transfusion Response

To determine the effectiveness of platelet transfusion,


a platelet count should be obtained before transfusion, at 1

48
hour, and at 24 hours after transfusion. (Grade A; Level 2)
Generally, expect an adult platelet count increment of
approximately 7-10,000/mm 3 for each RDP given.
(American Red Cross, 2007) In neonates and infants, a dose
of 5-10 ml/kg of platelet (RDP or SDP) should result in a
50-100,000/mm 3 increment.

49
3.7 Single Donor Platelet (SDP) or Platelet Pheresis

Preparation

Single donor platelet (SDP) is obtained using automated


instrumentation and should contain >3.0 x10 11 platelets
(average content approximately 3.5-4.0 x 1011) per bag is
about 250 ml of plasma. Anticoagulant is ACD. (American
Red Cross, 2007) SDPs should be ABO-identical with the
recipient when possible. (American Red Cross, 2007)
Platelets may also be "washed" to remove 95%-99% of
plasma for recipients who are sensitive to plasma proteins
or plasma components. Washed platelets are most commonly
used to administer maternal platelets to infants with neonatal
alloimmune thrombocytopenia. (NATP)

SDP should be ABO and Rh(D) type compatible with


the recipient. However, ABO-incompatible SDP may be used
if ABO-compatible platelets are not available. Platelet
concentrates prepared form Rh(D) positive donors should
not be given to a RhD negative potential child-bearing
female. (World Health Organization, 1997) When Rh(D)
positive platelets are transfused to an Rh(D) negative female
of child bearing potential, prevention of Rh(D)
immunization by use of Rh(D) immunoglobulin should be
considered. (Australian Red Cross Blood Service, 2008)
(Grade A; Level 3)

Indications

Indication for SDP is the same as random donor. But in


general, SDP should be recommended to older children and
adult patients as much as possible, especially those on
repeated platelet transfusions. (American Red Cross)
(Grade A; Level 3)

50
Volume

Single donor unit in a volume of 250ml-300ml of


plasma should contain: 1) at least 55 x 109 platelets, 2) 1.2
x 109 red cells and 3) <0.12 x 109 leucocytes. (World Health
Organization, 1997)

Handling and Storage at Transfusion Area

It can be stored at 20ºC -24ºC (with agitation) for up to


5 days in specialized platelet packs. Longer storage increases
the risk of bacterial proliferation and septicemia in the
recipient.

SDP should be infused as soon as possible generally


within 4 hours. It must not be refrigerated before infusion as
this reduces platelet function. (World Health Organization,
1997) (Grade A; Level 3)

Infusion Set, Rate

SDP units should be infused through a fresh standard


blood administration set. SDP should be infused over 2-3
hours to a maximum of 4 hours. (World Health
Organization, 1997) (Grade A; Level 3)

Monitoring the Patient

For each unit of blood transfused, monitor the patient


at the following stages (Grade A; Level 3) (WHO, 1997):

• before starting the transfusion


• as soon as the transfusion is started
• every 15 minutes after starting the transfusion for first
hour

51
• every 30 minutes during transfusion
• on completion of the transfusion
• four hours after completing the transfusion

At each of these stages, record the following information


on the patient’s chart: 1) patient’s general appearance,
2) temperature, 3) pulse rate, 4) blood pressure, 5) respiratory
rate, 6) fluid balance of oral and IV fluid intake and urine
output (WHO, 1997) and 7) patient’s subjective complaints.
The following should also be recorded in the patient’s
medical chart: 1) time the transfusion is started, 2) time
the transfusion is completed, 3) volume and type of all
products transfused, 4) unique donation numbers of all
products transfused and 5) any adverse effects. (WHO,
1997)

Post-transfusion Response

To determine the effectiveness of platelet transfusion, a


platelet count should be obtained before transfusion, at 1
hour, and at 24 hours after transfusion. (Grade A; Level 2)
Generally, expect an adult platelet count increment of
approximately 30-60,000/mm 3 for each SDP given.
(American Red Cross, 2007). To be specific, one unit of
platelet concentrate/10 kg body weight in a 60-70 kg adult,
4-6 single donor units containing at least 240 x 109 platelet
should raise the platelet count by 20-40 x 109/L. (World
Health Organization, 1997) In neonates and infants, a dose
of 5-10 ml/kg of platelet (RDP or SDP) should result in a
50-100,000/mm 3 increment.

52
3.8 Fresh Frozen Plasma (FFP)

Preparation

Plasma consists of the non-cellular portion of blood that


is separated and frozen after donation. It may be prepared
from whole blood or collected by apheresis. This is separated
from whole blood and frozen at -25°C or colder within 6-8
hours of donation in order to preserve its labile coagulation
factors (Factors V and VIII). (WHO, 2005)

FFP is frozen at -18ºC or colder within 6-8 hours of


collection and contains functional quantities of all
coagulation factors. Plasma frozen within 24 hours (FP24)
and thawed plasma may contain variably reduced levels of
Factors V and VIII. Despite the differences between FP24,
thawed plasma and FFP, they are generally used for the same
indications. (American Red Cross, 2007)

Plasma for transfusion must be ABO-compatible with


the recipient’s red cells. (Grade A; Level 1)

Indications for FFP Transfusion

FFP is indicated for (BSH, 126) (Grade A; Level 1):

• multiple coagulation factor deficiencies associated with


severe bleeding or disseminated intravascular coagulation
with bleeding
• single coagulation factor deficiencies when no virus-safe
fractionated product is available
• bleeding due to hemorrhagic disease of the newborn,
neonates with coagulopathy who are bleeding or about
to undergo an invasive procedure

53
• for neonatal exchange transfusion AB or type specific
FFP may be used to reconstitute maternal blood type
specific PRBC (AABB) (Grade A; Level 2)
• severe bleeding due to warfarin or patients taking
warfarin who will undergo emergency surgical procedure
(Grade A; Level 3)
• special situations like open heart surgery with more than
6 units PRBC transfused (Grade A; Level 3)
• trauma casualties with 30% or more blood loss and who
will be requiring massive transfusion (Grade A; Level 3)

Massive transfusion protocols involve the administration


of red cells and plasma initially, then adding platelet units
or cr yoprecipitate later. The pur pose is to prevent
coagulopathy rather than wait for coagulopathy to develop
before treating it. Transfusion with more than five units of
red cells together with crystalloid inevitably leads to
dilutional coagulopathy as shown in some modeling studies.
The benefits of administering blood products in the absence
of laboratory tests usually outweigh the risks of transfusion
in trauma patient in hemorrhagic shock and with ongoing
bleeding. (www.itaccs.com Section III Transfusion. Clinical
Practice)

FFP should NOT be used for the reversal of warfarin


anticoagulation in the absence of severe bleeding. (BSH, 126)
(Grade A; Level 3)

When used to correct isolated coagulation factor


deficiencies like hemophilia A, B or C for which no
concentrated preparation is available (eg factor V or XI) or
hemophilia, the type of which is not yet determined. The
dosing depends on the half-life of the specific factor, the
pre-transfusion level of the factor, the desired post
transfusion level and the duration of raised levels required.
(American Red Cross, 2007)

54
Volume

The volume of the unit is approximately 250ml but


variation may be expected. (American Red Cross, 2007) The
volume may vary from 180ml to 300ml.

Handling and Storage at Transfusion Area

Prior to transfusion, frozen plasma must be thawed in a


protective plastic overwrap and dipped in a water bath at
37ºC or plasma thawer. It should be infused immediately or
stored at 1ºC-6ºC for up to 6 hours. (American Red Cross,
2007) If Factor VIII replacement is not necessary, thawed
FFP may be stored at 4ºC in a blood storage refrigerator as
long as transfusion will be completed within 24 hours of
thawing. (BSH, 126) (Grade A; Level 3)

Transfusion Dose and Rate

Plasma should be administered in doses calculated to


achieve a minimum of 30% of plasma factor concentration
and is usually achieved with the administration of
10ml/kg-20ml/kg. (Grade A; Level 2) The dose of plasma is
determined by the patient size and clinical condition.
(American Red Cross, 2007)

Monitoring the Patient

For each unit of blood transfused, monitor the patient


at the following stages (Grade A; Level 3) (WHO, 1997):

• before starting the transfusion


• as soon as the transfusion is started

55
• every 15 minutes after starting the transfusion for first
hour
• every 30 minutes during transfusion
• on completion of the transfusion
• four hours after completing the transfusion

In each of these stages, record the following information


on the patient’s chart: 1) patient’s general appearance,
2) temperature, 3) pulse rate, 4) blood pressure, 5) respiratory
rate, 6) fluid balance of oral and IV fluid intake and urine
output (WHO, 1997) and 7) patient’s subjective complaints.
The following should also be recorded in the patient’s
medical chart: 1) time the transfusion is started,
2) time the transfusion is completed, 3) volume and type
of all products transfused, 4) unique donation numbers of
all products transfused, and 5) any adverse effects. (WHO,
1997)

Measuring Response to FFP Transfusion

If FFP was given because of bleeding, the clinical


response is the best indication of effectiveness of transfusion.
If FFP was given to correct abnormal coagulation
parameters, the degree of correction should be documented.
Monitoring may be through measuring coagulation activities
by traditional laboratory techniques. (British Committee for
Standards in Haematology, Blood Transfusion Task Force ,
2004) (Grade A; Level 1) A prothrombin time (PT) greater
than 1.5 times the mid-range of normal, an activated partial
thromboplastin time (APTT) greater than 1.5 times the top
of the normal range or a factor assay less than 25% can be
used as thresholds at which therapeutic or prophylactic
replacement may be indicated in an appropriate clinical
setting. (American Red Cross, 2007)

56
3.9 Cryoprecipitate

Preparation

Also referred to as cryoprecipitate pool, cryo, or pooled


cryo, it is prepared by thawing one unit of FFP between
1ºC-6ºC and recovering the cold insoluble precipitate. The
cryoprecipitate is refrozen within 1 hour. Cryoprecipitate
contains concentrated levels of fibrinogen, Factor VIII:C,
Factor VIII:vWF (von Willebrand factor), Factor XIII and
fibronectin. Each unit of cryoprecipitate should contain at
least 80 IU Factor VIII:C and 150mg fibrinogen in 5ml-20ml
of plasma. (American Red Cross, 2007) The cryoprecipitate
specifications require that 75% of the packs contain at least
140 mg of fibrinogen and 70 IU/ml of FV III. (BCSH, 2004)

Cryoprecipitate is considered to be acellular blood


component and that compatibility testing is unnecessary.
However, it is preferable to use cryoprecipitate that is ABO-
compatible with the recipient's red cells. RH type need not
be considered. (American Red Cross, 2007) (Grade A; Level
3)

Indications

Cryoprecipitate may be considered in patients with:

• fibrinogen deficiency where there is clinical bleeding, an


invasive procedure, trauma (NHMRC, 2001) (American
Society of Anesthesia, 1996) (Grade A; Level 2)

• DIC with bleeding (British, 2004) (Grade A; Level 3)

The use of cryoprecipate is NOT generally considered


appropriate in the treatment of hemophilia, von Willebrand's
disease or deficiences of factor XIII or fibronectin, unless

57
alternative therapies are unavailable. (NHMRC, 2001)
Cryoprecipitate can be used in von Willebrand disease when
other treatment modalities are not available or have failed.
(BSH, 126) (Grade A; Level 3)

Volume

Volume prepared ranges from 10ml - 15ml. (BSH, 126)


The cryoprecipitate specifications require that 75% of the
packs contain at least 140 mg of fibrinogen and 70 IU/ml
of FV III. (BCSH, 2004) The dose depends on the clinical
situation and its monitoring. (Grade A; Level 3)

Handling and Storage at Transfusion Area

Frozen cryoprecipitate is thawed in a protective plastic


overwrap in a waterbath at 30ºC-37ºC up to 15 minutes.
Thawed cryoprecipitate should be kept at room temperature
and transfused as soon as possible after thawing or within 6
hours if it is a closed single unit or has been pooled prior to
freezing. (Grade A; Level 3)

Dosing, Transfusion Set and Transfusion Rate

Cryoprecipitate must be given using transfusion set


designed for the procedure. The frequency of dosing depends
on the half life and recovery of the coagulation factor that
is being replaced. A typical dose for the treatment of
hypofibrinogenemia is one cryoprecipitate unit per 7kg-10kg
of body weight. It is given as a fast drip. (American Red
Cross, 2007) (Grade A; Level 2)

The number of cryoprecipitate units can be estimated


by using the following calculations:

58
• Weight (kg) x 70 ml/kg = blood volume (ml)
• Blood volume (ml) x (1.0-hematocrit) = plasma volume
(ml)
• Fibrinogen required (mg) = (desired fribrinogen level,
mg/dl) - initial fibrinogen level (mg/dl) multiplied by
plasma volume in ml divided by 100.
• Bags of cryoprecipitate required = mg fibrinogen
required divided by 250 mg fibrinogen per bag of
cryoprecipitate. (American Red Cross, 2007)

Monitoring the Patient

For each unit of blood transfused, monitor the patient


at the following stages (Grade A; Level 3) (WHO, 1997):

• before starting the transfusion


• as soon as the transfusion is started
• every 15 minutes after starting the transfusion
• on completion of the transfusion
• four hours after completing the transfusion

In each of these stages, record the following information


on the patient’s chart: 1) patient’s general appearance,
2) temperature, 3) pulse rate, 4) blood pressure, 5) respiratory
rate, 6) fluid balance of oral and IV fluid intake and urine
output (WHO, 1997) and 7) patient’s subjective complaints.
The following should also be recorded in the patient’s
medical chart: 1) time the transfusion is started,
2) time the transfusion is completed, 3) volume and type
of all products transfused, 4) unique donation numbers of
all products transfused, and 5) any adverse effects. (WHO,
1997)

59
3.10 Cryosupernate

Preparation

Cryo-poor plasma or cryosupernate is the supernate


plasma removed during the preparation of cryoprecipitate.
(BCSH, 2004) It contains most clotting factors in similar
amounts to apheresis FFP but is deficient in factor VIII,
fibrinogen, vWF (the high molecular weight multimers are
more thoroughly removed than the smaller multimers), factor
XIII and fibronectin. (Australian Red Cross Blood Service,
2008)

Compatibility tests before transfusion are not necessary


but the unit should be ABO group compatible with the
recipient's red cells. (Grade A; Level 3)

Indications

Cryosupernate is indicated for (Grade A; Level 2):

• plasma exchange in TTP


• alternative to FFP for the treatment of coagulopathy
where there is no significant reduction in factor VIII,
fibrinogen, factor XIII or vWF
• rapid temporary warfarin reversal in patients requiring
emergency surgery
• warfarin overdose with life threatening bleeding in
addition to prothrombin complex concentrates

Volume

The volume of 1 unit is 200 ml ±10% and can be stored


for 12 months at -25ºC or colder. (Australian Red Cross
Blood Service, 2008)

60
Handling and Storage at Transfusion Area

Thawed plasma and cryosupernate should be transfused


immediately. Keep at 4ºC if there is any delay in
transfusion. After thawing, and when FV III replacement is
not required, it may be stored at 4ºC in an approved blood
storage refrigerator before administration to the patient so
long as the infusion is completed within 24 hours of thawing.
(BCSH, 2004) (BSH, 126) (Grade A; Level 2)

Transfusion, Infusion Set and Rate

Once thawed, it should be infused immediately or


allocated by a medical practitioner for a designated patient
under his or her care. Before transfusion, mix thoroughly by
inversion before and transfuse through an intravenous line
approved for blood administration and incorporating a
standard (170-200um) filter. Transfusion of each unit may
proceed as fast as tolerated but should be completed within
four hours of commencing transfusion. (Australian Red
Cross Blood Service, 2008) (Grade A; Level 3)

Monitoring the Patient

For each unit of blood transfused, monitor the patient


at the following stages (Grade A; Level 3) (WHO, 1997):

• before starting the transfusion


• as soon as the transfusion is started
• every 15 minutes after starting the transfusion
• on completion of the transfusion
• four hours after completing the transfusion

61
In each of these stages, record the following information
on the patient’s chart: 1) patient’s general appearance, 2)
temperature, 3) pulse rate, 4) blood pressure, 5) respiratory
rate, 6) fluid balance of oral and IV fluid intake and urine
output (WHO, 1997) and 7) patient’s subjective complaints.
The following should also be recorded in the patient’s
medical chart: 1) time the transfusion is started, 2) time
the transfusion is completed, 3) volume and type of all
products transfused, 4) unique donation numbers of all
products transfused and 5) any adverse effects. (WHO,
1997)

62
Chapter 4

General Guidelines
for Appropriate
Blood Administration

63
4.1 Recommendations on Informed Consent

The physician in charge of the patient should be


responsible for obtaining informed consent for RBC or
plasma administration and the patient's consent should be
obtained and recorded in the medical chart. (Grade A; Level
3) (Report of the Expert Working Group 1997) (ANZSBT,
2004) An informed consent for the administration of blood
or blood products signifies that the significant risks, benefits
and alternative to transfusion including patient’s right to
refuse the transfusion have to be discussed. (ANZSBT, 2004)
Even before admission to a hospital, patients should be
informed that transfusion of RBC, plasma or both is a
possible element of the planned medical or surgical
intervention and provided with information about its risks,
benefits and available alternatives.

64
4.2 Recommendations on Pre-transfusion
Procedures

A formal request for pre-transfusion testing (cross-


matching) or issuance of blood products must be made
and may either be handwritten or in an electronic form using
the prescribed format of NVBSP. (Grade A; Level 3) The
request form must clearly and legibly identify the patient
and the following information must be provided: family
name, given name in full, unique hospital record number
and/or date of birth, gender and signature and contact
details of the sample collector. Requests for the release or
issuance of blood and/or blood products must be made in
person by a nurse, nurse aide and other health care provider
presenting at the laboratory or other acceptable means as
stated in hospital policies. (ANZSBT, 2007)

The laboratory must have record system in place to trace


every blood or blood products from the requesting unit to its
final recipient. (Grade A; Level 3) Blood samples for pre-
transfusion testing must be in adequate amount. The sample
tube(s) used for collection must be legibly labelled with the
following: 1) patient’s family name, first name in full and
hospital record number or date of birth, 2) date and time of
collection, and 3) signature or initials of the collector. The
patient's identity must be positively confirmed at the time
of sample collection by: 1) direct questioning and 2) checking
(where available) the patient's hospital identification
wristband. Patients who cannot be identified must not be
extracted with blood. If the patient is unconscious or cannot
be identified, the hospital must have a written policy for
temporarily identifying them. (ANZSBT, 2007)

65
4.3 Recommendations on Laboratory
Pretransfusion Testing

An ABO and Rh(D) group must be determined for


samples submitted for pre-transfusion testing. The ABO
group must be determined by testing recipient’s red cells with
anti-A and anti-B (anti-A, -B, if desired) reagent. A reverse
group (of the recipient's serum/plasma tested against A1
and B red cells) must be performed. The Rh(D) group must
be determined by direct agglutination using an anti-D
reagent. (Grade A; Level 2) (ANZSBT, 2007)

Pre-transfusion testing must include an antibody screen


capable of detecting potentially clinically significant red cell
antibodies: indirect anti-globulin test [IAT] performed at
37ºC (2) anti-A and -B and -A, B must always be regarded as
clinically significant. The antibody screen must be capable
of detecting anti-D at a concentration of 0.1 IU/ml or lower.
(ANZSBT, 2007)

The laboratory must have procedures in place to exclude


incompatibility between the recipient and donor using
suitable cross-matching techniques such as immediate-spin,
IAT or computer cross-matching. The cross-matching
procedures must be able to detect ABO incompatibility. A
cross-match is initially valid for the lifetime of the sample
blood. Once transfusion has commenced, the cross-match
will cease to be valid either at the original expiry date/time
of the sample or 72 hours from starting transfusion of the
unit of red cells, whichever eventuates first. Once a
transfusion episode has commenced, subsequent sample
from the patient will have an expiry of 72 hours until a gap
of three months between transfusions has occurred.

66
Sample Storage

Samples from patients to whom blood has been


transfused should be retained for at least 3-7 days post-
transfusion for the purpose of investigation of reported
transfusion reactions. (Grade A; Level 3)

Recommendations for Sample Storage

EDTA Whole Blood Separated Plasma/Serum

18ºC-25ºC Up to 48 hours Up to 48 hours

4ºC Up to 7 days Up to 7 days

-20ºC N/A Up to 1 month

67
4.4 Pre-transfusion Procedures in Emergency
Situation

In cases of emergency need for a transfusion, pre-


transfusion samples should be obtained as soon as possible.
Samples must be labeled in accordance with routine pre-
transfusion practice and standard pre-transfusion testing
performed. If the antibody screen is positive or a subsequent
cross-match incompatible, the treating medical officer and
the laboratory director must be informed. If blood is required
urgently and there is incompatibility with available blood,
inform the physician that there may be a delay in the release
of compatible blood. (Grade A; Level 3)

Where blood products are required before pre-transfusion


testing can be performed or until an identified compatible
blood has been obtained: 1) red cell product to be given
should be group O and 2) plasma product to be given should
be group AB. (Grade A; Level 2) (ANZSBT, 2007)

If ABO non-identical red cell product was transfused, a


return to red cells of the same group as the patient should
be done as soon as possible. It is recommended that absence
of anti-A or anti-B be confirmed prior to reverting to the
patients confirmed blood group. (Grade A; Level 2)
(ANZSBT, 2007)

Red cells must NOT be given based on prior knowledge


of blood group. (Grade A; Level 2) (ANZSBT, 2007)

Red cells issued prior to pre-transfusion testing being


completed must be clearly labeled; e.g. 'uncrossmatched
blood' or ' emergency issue - compatibility testing not
completed'. A waiver may be obtained by the blood service
facility personnel before issuing blood prior to completion
of pre-transfusion testing. (Grade A; Level 2)

68
In a massive transfusion event, where the patient has
received red cells of their own ABO group, further red cells
can be issued without a serologic cross match. ABO
incompatibility must still be excluded through appropriate
serological confirmation of the blood groups of both
patient and selected red cell units.

69
4.5 Recommendations for Pick-up and Delivery
Procedures

Before releasing the blood product, the hospital blood


bank staff should check the expiry date and inspect blood
and blood components before the release of the blood
requested with particular attention to (BCSH, 1999) (Grade
A; Level 3):

• checking for leaks at the ports and the seams


• evidence of hemolysis in the plasma or at the interface
between red cells and plasma
• evidence of unusual discoloration or turbidity and the
presence of large clots

When blood is issued from the blood bank, the time of


issue must always be recorded. To avoid wastage, only one
unit of red cells should be taken from the blood bank
refrigerator at a time, unless rapid transfusion of large
quantities of blood is required. (WHO, 2005) (Grade A; Level
3)

Blood must be transported in containers designated for


this purpose and which have been verified as satisfactory
for transport and time of storage. (BCSH, 1999) (Grade
A; Level 3)

70
4.6 Preparation of Supplies for Blood Component
Administration

Transfusion Set

Blood or components must be administered safely


through a peripheral or central venous access device.
Peripheral intravenous access should be sufficient to maintain
an adequate rate for the transfusion without causing a risk
of hemolysis. The size of cannula chosen depends on the
size and integrity of the vein. Blood components particularly
red cells and whole blood should be mixed thoroughly by
gentle inversion before use and then transfused through an
intravenous line approved for blood administration
incorporating a standard 170-200 micron filter. A peripheral
vein cannula 18-20G size is recommended for adults while
22-24G or larger is recommended for pediatric patients.
(Grade A; Level 2) Smaller gauge devices can be used but
restrict the flow rate of the transfusion and result in a much
longer time to infuse a component. When blood is being
administered by syringe to small infants or neonates, the
blood should be drawn into the syringe via a 170-200 micron
filter. (ANZSBT, 2004)

A new transfusion set should be used for every new unit


of blood product. In an emergency or operating room
procedure where several units may be administered in a short
time, the transfusion set should be changed every 6 hours.
A transfusion set used for red cells should NOT be re-used
for platelet transfusion since red cell debris trapped in the
filter would trap the platelets. (ANZSBT, 2004) (Grade
A; Level 3)

71
Intravenous Fluids

The standard set to be used in a blood transfusion


should be primed with normal saline (0.9 NSS) or the blood
component. Dextrose containing solutions should not be
used for priming the blood transfusion set. The only fluids
that can be given concurrently through the same IV device
as a red cell transfusion are: 1) normal saline, 2) 4%
albumin, 3) plasma protein fractions, or 4) ABO-compatible
plasma. Electrolyte and colloid solutions containing
calcium or 5% dextrose should NOT be given with blood
components. (ANZSBT, 2004) (Grade A; Level 2) Blood
transfusion sets should not be 'piggy-backed' into other lines.
Similarly, medication should not be added to any blood
component prior to its transfusion.

General Blood Transfusion Rates

Unless otherwise indicated by the patient's clinical


condition, the rate should be no greater than 5ml/minute
for the first 15 minutes. All blood components should be
infused within 4 hours unless otherwise specified. (ANZSBT,
2004) (Grade A; Level 3)

Blood Warming Indications and Devices

Red cells should only be warmed using a specifically


designed commercial device with a visible thermometer and
audible warning. Blood warming devices should undergo at
least a 12 monthly maintenance and validation program.
(Grade A; Level 3) A blood warmer is indicated when:

• at flow rates of > 50 mL/kg/hour in adults


• at flow rates of 15 mL/kg/hour in children
• for exchange transfusion in infants

72
• when transfusing patients with clinically significant cold
agglutinins
• neontal transfusion
• trauma situations in which core-rewarming measures
are indicated
• rewarming phase of patient during cardio-pulmonary
bypass surgery

Operating temperature of the commercial blood warmer


shall be recorded on the patient's infusion record when used
to warm red cells or blood components. Blood and blood
components shall not be warmed above 41ºC. (ANZSBT,
2004)

Use of Pressure Devices

External pressure devices approved for transfusion should


only be used in an emergency situation and with a large gauge
venous access needle. An external device should:

• exert pressure evenly over the entire bag


• have a gauge to measure the pressure
• never exceed 300mmHg of pressure
• be monitored at all times when in use
• used with a 170-200micron filter for RBC product
transfusion
Improvised mechanical devices are NOT recommended.
(ANZSBT, 2004) (Grade A; Level 2)

Electronic volumetric pumps at specified flow rates are


indicated in the following situations: 1) transfusion of
patients via a central venous catheter (including PICC and
implanted ports) where 'free flow' cannot be guaranteed,
2) transfusion to small pediatric patients where very slow

73
rates are required, and 3) only those pumps shown by their
manufacturers to be "safe" for blood components. Both
pump setting and volume delivered should be monitored
hourly to ensure that expected volume is delivered. The
attending physician must be informed of any adverse
outcome as a result of using a pump. (ANZSBT, 2004)

Syringe drivers are devices in which a standard syringe


is placed on a housing that depresses the plunger at a given
rate. The device is useful for transfusion to neonates and/or
for continuous infusion of coagulation factors such as factor
VIII or factor IX. Syringes used for transfusing blood
components should:

• incorporate an in-line filter 170-200 micron


• be single used only and discarded appropriately
• have leur-lock connections
• have a label attached showing date and time of
preparation and expiry date and time
• have identical donor/patient information as the original
pack from which the component was drawn. (ANZSBT,
2004)

74
4.7 Procedure of Patient Identification

Bedside check is a vital step in preventing transfusion


error and staff must be vigilant in checking the patient’s
identification details match those on the blood transfusion
prescription or report form and the compatibility label
attached to the blood pack. At least two staff members, at
least one must be a doctor or a registered nurse, should be
responsible for carrying out the identity check of the patient
and the unit of blood at the patient’s bedside. (BCSH, 1999)
(Grade A; Level 3) A blood transfusion compatibility report
form and/or the blood transfusion prescription sheet must
be signed by the member of the staff carrying out the
identity check and the date and time of the commencement
of the transfusion of each unit of blood or blood component
indicated on both.

75
4.8 Recommendations on Pre-medication

The use of acetaminophen or diphenhydramine as pre-


medications in patients scheduled for blood administration
is NOT routinely recommended. However, antihistamines
may benefit patients with a history of allergic transfusion
reactions. In such patients, using leuko-reduced or washed
red cell products is advised when indicated. (Grade A; Level
2) Risks associated with the use of acetaminophen may
include hepatotoxicity which is a product of
acetaminophen's primar y metabolites, N-acetyl-p-
quinoneeimmine. Risks associated with the use of
diphenhydramine are related to its anticholinergic and
antihistaminic effects and may include drowsiness,
decreased alertness, impaired cognitive performance,
paradoxical restlessness and nervousness and cardiotoxicity
and arrhythmias (Geiger, 2007).

76
4.9 Recommendations to Minimizing
Transfusion Risks

Transfusion risk may be minimized by the following


strategies (Grade A; Level 3):

• Careful inspection of the safety of blood product


packaging
• Close monitoring of patient undergoing transfusion
• Use of appropriately stored blood product

Transfusion risks may be minimized by inspecting packs


of blood or blood product before transfusion. When there
is flocculation, discoloration, apparent leaks when put under
pressure and other unexpected appearance prior to
transfusion, the pack should be rejected. (BSH, 2004) Close
observation and monitoring of the patient is the best way to
minimize transfusion reactions. Thus, transfusion should be
given in clinical areas where patients can be readily observed
by members of the clinical staff. The start and finish times
of the infusion of each unit should be clearly indicated on
observation charts. (BCSH, 1999) Use of blood products less
than 3 days old should be avoided as there is an increased
risk of transmission of viral infections from fresh blood
which may get inactivated on storage. Reducing the
exposure of patient to different donors will also decrease
the risk of transfusion-transmitted diseases. (WHO, 1998)

77
4.10 General Recommendations for Monitoring

A policy for the care and monitoring of patients


receiving administration of blood and blood components
should be in place and shall clearly define the following:

• the staff responsible for the care and monitoring of


transfused patients
• the information to be given to the patient about possible
adverse effects of transfusion and the importance of
reporting immediately any adverse effects including
shivering, rashes, flushing, shortness of breath, pain in
extremities or in the loins
• the parameters for visual observation of the patients
• a clear plan of action to be followed in case of an
emergency or transfusion reaction (ANZSBT, 2004)
(Grade A; Level 3)

Vital signs (temperature, pulse and blood pressure) should


be measured and recorded at baseline (before the start of
each unit of blood or blood components) and the end of
each transfusion. Vital signs related to transfusion should
be recorded in a sheet separate from routine observation and
clearly dated. Temperature and pulse should be measured
15 minutes after the start of each unit of blood or blood
component for the first hour, then every 30 minutes until
consumed. Transfusion reactions should be considered when
there is deterioration in patient's condition especially during
the first 15-20 minutes following administration of a blood
or blood component unit. Further observations during the
transfusion of each unit of blood or blood component are
at the discretion of each clinical area and need only be
taken should the patient become unwell or show signs of a
transfusion reaction. (BCSH, 1999)

78
Specific strategies for monitoring are recommended in
the previous discussion for each blood compnent. In general,
for each unit of blood transfused, monitor the patient at the
following stages (WHO, 1997) (Grade A; Level 3):

• before starting the transfusion


• as soon as the transfusion is started
• 15 minutes after starting the transfusion then every 15
minutes until consumed for fast-drip transfusions or every
30 minutes until consumed for non-fast drip transfusions
• on completion of the transfuion and four hours after
completing the transfusion.

At each of these stages, record the following information


on the patient’s chart (WHO, 1997) (Grade A; Level 3):

• patient’s general apperance


• temperature
• pulse
• blood pressure
• respiratory rate
• fluid balance of oral and IV fluid intake and urine output

The following should be recorded in the patient’s medical


chart (WHO, 1997) (Grade A; Level 3):

• time the transfusion is started


• time the transfusion is completed
• volume and type of all products transfused

79
• unique donation numbers of all products transfused
• any adverse effects.

In cases of suspected severe reaction to blood transfusion,


the transfusion episode should be stopped and urgent medical
advice sought. The blood administration set should be
changed and venous access maintained using normal saline
running slowly to keep the vein open (BCSH, 1999) (Grade
A; Level 3)

Management of Transfusion Reactions

The blood bank facility must have written procedures


for the identification, management, investigation and
reporting of suspected transfusion reactions and other
transfusion-related adverse events. (Grade A; Level 2)
Suspected serious transfusion reactions should be
investigated prior to further transfusion. Patient
identification and compatibility labels must be rechecked at
bedside. This includes checking the identity of the patient
on the request forms, pre- and post-transfusion samples,
compatibility labels and the pre-transfusion testing records.
A visual inspection of the unit and segments for signs of
clot, hemolysis or discoloration must also be done. The
following should be immediately sent to the laboratory
accompanied by a request form given full clinical signs and
symptoms of the reaction:

• the remains of the product being transfused at the time


of reaction, IV administration set and empty bags from
previously transfused products

80
• EDTA, clotted and other samples, as necessar y,
collected immediately post-reaction and from the
opposite arm to the infusion site

The following laboratory testing should be performed:

• Visual examination of the patient's post-transfusion


serum/plasma for hemoglobinemia/hemolysis
• ABO/Rh(D) typing, antibody screen and DAT on
patient's pre and post transfusion samples. [A negative
DAT post-tranfusion does not exclude a severe hemolytic
transfusion reaction]
• Checking the ABO/Rh(D) type of the unit being
transfused at the time of the reaction and any previously
transfused units where available [for platelets and plasma
products, a reverse group only is required]
• Checking the ABO/Rh(D) type of the unit being
transfused at the time of the reaction and any previously
transfused units where available [for platelets and plasma
products a reverse group]
• IAT crossmatch of all red cells units given against the
patient's pre and post-transfusion samples. (ANZSBT,
2007)

81
82
Chapter 5

Alternative to Blood Transfusion

83
5.1 Blood Sparing Strategies

Pharmacological Agents for Patients with Bleeding Diathesis

Antifibrinolytic agents such as tranexamic acid and


aprotinin are NOT recommended to decrease blood loss in
trauma but may reduce the need for RBC transfusion during
and after surgery (WHO, 1998). Desmopressin or topical
hemostatics such as fibrin glue or thrombin gels may be
considered when excessive bleeding occurs (ASA, 2006).
(Grade A; Level 2)

Crystalloid/Colloids

Rapid administration of crystalloid solutions through


large bore (up to 14 gauge) peripheral cannulae often controls
hypovolemia . The use of albumin and non-albumin colloids
versus crystalloids for volume replacement is still a subject
of debate since studies showed that they are clinically
equivalent. (BCSH, 2006) (Grade A; Level 1)

Intravenous replacement fluids are the first-line treatment


for hypovolemia which can be life-saving and provide some
time to control bleeding. Normal saline or balanced salt
solutions have a similar concentration of sodium to plasma
and are effective as replacement fluids. Dextrose (glucose)
solutions do not contain sodium and are poor replacement
fluids. Crystalloid replacement fluids should be infused in a
volume at least three times the volume lost in order to correct
hypovolemia. (World Health Organization. Blood
Transfusion Safety.) All colloid solutions (albumin, dextrans,
gelatins and hydroxyethyl starch solutions) are replacement
fluids but are not shown to be superior to crystalloids in
resuscitations. Colloid solutions should be infused in a
volume equal to the blood volume deficit. Plasma should

84
never be used as a replacement fluid. Plasma-derived colloids
are all prepared from donated blood or plasma and should
NOT be used simply as replacement fluids. (Grade A; Level 2)

Normal saline (sodium chloride 0.9%) and/or balanced


salt solutions (Ringer's lactate/Hartmann's solution) can be
used for replacement of blood volume and other extracellular
fluid losses. Precautions in situations where local edema
may aggravate pathology (eg. head injury) and may
precipitate volume overload and heart failure. Do not use
in patients with established renal failure. Dosage is at least
3 times the blood volume lost.

Gelatins (haemaccel, Gelofusine) can be used for


replacement of blood volume. Precaution in its use since it
may precipitate heart failure, caution in renal insufficiency
and do not mix haemaccel with citrated blood because of
its high calcium concentration. It is contraindicated among
patients with established renal failure.

Dextran 60 and Dextran 70 can be used for replacement


of blood volume and prophylaxis of postoperative venous
thrombosis. Precautions for its use include occurrence of
coagulation defect, inhibition of platelet aggregation and
some preparations may interfere with compatibility testing
of blood. Do not use in patients with pre-existing disorders
of hemostasis and coagulation. Dextran 60 should not exceed
50ml/kg body weight in 24 hours while Dextran 70 should
not exceed 25 ml/kg body weight in 24 hours. Dextran 40
and Dextran 110 are not recommended as replacement fluids.

Hydroxyethyl starch (Hetastarch or HES) can be used


for replacement of blood volume. Precautions include
occurrence of coagulation defects and may precipitate
volume overload and heart failure. This should not be used
in patients with pre-existing disorders of hemostasis and

85
coagulation among patients with established renal failure.
Dosage should not exceed 20 mL/kg body weight in 24
hours.

Surgical Strategies to Minimize Need for Blood Transfusion

An anesthesiologist or a surgeon prescribing a transfusion


of any blood products should be familiar with the
indications for and the benefits and risks from the use of
these fractions. Documentations that support the
transfusion of any of the blood components should be
found in the patient's surgical records. (Guidelines for Red
Blood Cells and Plasma Transfusion for Adults and Children
1997) Correct anemia and replace depleted iron stores before
planned surgery. Use intravenous fluid replacement with
crystalloids or colloids in cases of acute blood loss.

Good anesthesia and surgical management are


recommended (WHO, 1997) (Grade A; Level 2) including:

• using the best anesthetic and surgical techniques to


minimize blood loss during surgery
• stopping anti-coagulants and anti-platelet drugs before
planned surgery
• minimizing the blood taken for laboratory use
• salvaging and reinfusing surgical blood losses
• using alternative approaches such as desmopressin,
aprotinin or erythropoetin

Pre-Operative Blood Transfusion

All patients undergoing elective surgery should be


assessed pre-operatively to identify and treat anemia

86
medically. (Group, National Blood Users 1999) There is
no single value of hemoglobin level that justifies or requires
transfusion. The patients' clinical situation should also be
a factor in the decision. (Guidelines for Red Blood Cells
and Plasma Transfusion for Adults and Children 1997)
Surgical patients with asymptomatic anemia usually do not
need transfusion before surger y. (A Guideline For
Transfusion of Red Blood Cells in Surgical Patients 1999)
RBC transfusion should be given to alleviate symptoms,
signs or morbidity due to inadequate tissue oxygen delivery.
In the setting of acute blood loss, RBC transfusion should
not be used to expand vascular volume when the oxygen
carrying capacity is adequate. (Grade A; Level 3)

Pre-operative identification of high risk patients should


be performed and all available pre-operative and peri-
operative measures of blood conservation should be
undertaken. (The Society of Thoracic Surgeons Blood
Conservation Guidelines Task Force 2007) For an elective
surgery, discontinuing anticoagulation therapy if clinically
feasible should be done. The schedule of elective surgery
must be done with sufficient time for the effect of anti-
coagulants to dissipate. (ASA, 2006) Hemoglobin levels
>7.0 g/dl in patients older than 65 years and patients with
chronic cardiovascular or respiratory diseases justifies
transfusion (The Society of Thoracic Surgeons Blood
Conservation Guidelines Task Force 2007) Predonation of
autologous blood should be considered a therapeutic option
for adolescents and adults undergoing elective surgery in
which the likelihood of transfusion is substantial (e.g. 10 %
or more) (Report of the Expert Working Group 1997) A
visual assessment of the surgical field should be jointly
conducted by the anesthesiologist and surgeon to determine
excessive blood losses and should also include checking
suction, surgical sponges, and surgical drains. (ASA, 2006)
A blood transfusion is indicated for hemoglobin levels

87
<6g/dl. In the event of thrombocytopenia in patients who
will undergo an invasive procedure or surgery, platelet
transfusion should be done to achieve platelet count of
>50,000/uL immediately before surgery. (Perioperative
platelet transfusion. Recommendations of the French Health
Products Safety Agency 2003) (Grade A; Level 2)

Maximum Surgical Blood Order Schedule (MSBOS)

MSBOS is a table of elective surgical procedures which


lists the number of units of blood routinely crossmatched
for each procedure pre-operatively. This schedule is based
on a retrospective analysis of actual blood usage associated
with the individual surgical procedure and it aims to correlate
the amount of blood crossmatched to the amount of blood
transfused to monitor the efficiency of the scheme. (British
Committee for Standards in Haematology Blood Transfusion
Task Force, 1990) It is a tool for transfusion services, surgical
services and anesthesia to predict blood utilization based
on historical experience within an institution. The MSBOS
is meant as a guide and should not replace the use of clinical
judgment related to individual patient needs.

It is recommended that hospital operating rooms


maintain an MSBOS. The data in the MSBOS include the
following (Ontario Regional Blood Coordinating Network)
(Grade A; Level 3):

• list of commonly performed elective surgical procedures


• number of red cell units ordered by procedure
• number of red cells units transfused by procedure;
Additional optional data can include ordering physician
and the pre-operative hematocrit

88
Data can be gathered prospectively or retrospectively
and a comparison between the number of units ordered
and the number of units transfused by procedure can be
made either over a specific time frame or for a pre-
determined number of procedures performed. The
introduction of a MSBOS in an institution will have the
following advantages (British Committee for Standards in
Haematology Blood Transfusion Task Force, 1990):

• reduction in crossmatching work load of the blood


transfusion laboratory
• reduction in the level of stress
• more efficient use of blood stocks and a reduction in
wastage due to out-dating

The implementation of the MSBOS is directly related to


the degree of cooperation and commitment by the surgeons,
anesthetists and transfusion service medical directors.
Flexibility of the ordering process should be observed to
allow for individual clinical judgment related to exceptional
cases. (Ontario Regional Blood Coordinating Network)

89
90
Chapter 6

Recommended Strategies
for Implementation

91
Section 6.1
Identification and Assessment of
Strategies for Implementation
The strategy options listed below are analyzed according
to the following elements:

• Impact on health outcomes and public health: assessing


improvements in the quality, safety and availability of
blood and blood products
• Access and fairness: assessing the effects on access to
safe blood and blood products and the impact on
individuals and groups (e.g. region, gender, ethnic,
socioeconomic)
• Cost and value for money: assessing cost-effectiveness
and correlation with impact
• Operational capacity: assessing the operational capacity
of the institutions involved and their compatibility with
the requirements of the new policy

Strategy Option 1 – DOH conducts phased implementation of the


DOH AO 8 s 2008, starting in areas with the following criteria:
1) mutual willingness of DOH-CHD and LGUs to share in the
provision of resources implement the policy, and 2) previous history
of a successful voluntary blood donation activity.

• Impact on health outcomes and public health – A phased


implementation will cushion the effect of potential
shor tage of blood component supply. A phased
implementation of DOH AO policies accompanied by a
good voluntary blood donation program will ensure
adequate blood component supply.

92
• Access and fairness – A phased implementation will
allow other hospitals and health facilities to improve their
capability to meet the new standards set by the DOH
AO 8 s 2008. This will also prevent a possible acute
shortage of blood supply in areas where the resources
and facilities are minimal.
• Cost and value for money – The readiness of PHIC to
provide enhanced reimbursement for appropriate blood
transfusion will allow facilities to cushion the impact of
their investment for newly acquired facilities on their
financial status.
• Operational capacity – The phased implementation is
also in line with the current operational capacity of DOH
where shortage of personnel and resources limit large
scale and simultaneous program implementation.

Strategy Option 2 – PhilHealth uses the following criteria for


ensuring the delivery of quality services of its health care providers:
1) rational use of blood or blood products as stated in this clinical
practice guideline, 2) evidence that the blood or blood products came
from authorized blood service facilities, and 3) evidence that the
patient or the relative has given consent for blood transfusion.

• Operational capacity – PhilHealth medical evaluators


and surveyors in accreditation are trained in terms of
implementing specific quality standards. Additional
training for them on this clinical practice guideline will
improve their technical capacity.
• Impact on health outcomes and public health –
PhilHealth reimbursement for blood transfusion to be
considered appropriate may be determined by matching
the type of blood component given and the disease
diagnosis of the patient. Paying for appropriate blood

93
component transfusion and ensuring that the unit came
only from a reliable source will improve public health
outcomes i.e. appropriate clinical response to patient and
decrease in transmission of blood-borne infections.
• Access and fairness - In case of inappropriate blood
transfusion, PhilHealth may consider non-payment of
professional fees of the attending physician as well as
non-reimbursement of benefit. The consent for blood
transfusion is photocopied and attached to PhilHealth
claim form 2 to ensure that the patient or the relative is
fully aware of the consequences of transfusion.
• Cost and value for money – Appropriate use of funds
will be promoted with the policy.
• Evidence of compliance to policy – The following are
evidences of compliance: 1) attached claim form 2 with
complete diagnosis and appropriate blood component
given, 2) attached serial number of blood component
transfused and 3) attached photocopy of consent for
blood transfusion.

Strategy Option 3 – The Philippine Red Cross and the Department


of Health develop a national blood donation program that has
the following elements: 1) involvement of both the public and
private sector, 2) done on a quarterly basis, and 3) efficient use of
resources.

• Impact on health outcomes and public health – Voluntary


blood donation has been shown to be safer than the paid
blood sources. This will lead to lower rate of transfusion-
related infections. Regular frequency of blood donation
program will also ensure adequate supply and improve
the health outcomes of disease requiring blood
component transfusion.

94
• Access and fairness – A regular supply of blood products
from a regularly conducted blood donation program will
ensure access such blood products.
• Cost and value for money – Partnership with both the
private and public sector will optimize utilization of
available resources. Public money is limited and there
are private organizations with enough resources who can
contribute to the blood donation program.
• Operational capacity – The Philippine National Red
Cross has a significant number of volunteers and
members across the country and is capable of regularly
conducting a voluntary blood donation program.

Strategy Option 4 – Blood bank facilities and the medical


professions that utilize blood components form an organizational
alliance that will have the following responsibilities: 1) self-
regulation, 2) updating, dissemination and implementation of the
clinical practice guidelines, 3) maintaining a registry and
monitoring of blood component utilization and associated reactions
and 4) advocacy for the voluntary blood donation program.

• Impact on health outcomes and public health – Self-


regulation will ensure cooperation among the suppliers
and users of blood products. This will ensure better
compliance to the clinical practice guideline
recommendations and therefore better outcomes for
blood transfusion interventions.
• Access and fairness – With self-regulation, the fear of
regulators encroaching into the autonomy of clinical
practice will be avoided.
• Cost and value for money – Self-regulation will also avoid
the high cost of external regulation and monitoring.
• Operational capacity – The operational capacity of such
alliance however needs to be enhanced.
95
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