Clinical Practice Guidelines
Clinical Practice Guidelines
Clinical Practice Guidelines
Introduction
1
Section 1.1
Background Discussion on Rational Clinical
Use of Blood and Blood Products
2
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
3
Unmet Need
4
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
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.
6
Section 1.2
Principles of Rational Clinical Use of Blood
and Blood Products
7
Blood Transfusion Reaction
• 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)
8
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)
Outcome unknown 15
9
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)
10
Section 1.3
Objectives and Intended Users of the
Clinical Practice Guidelines
11
Section 1.4
How the Guidelines Were Developed
12
Research Group (FMRG), a group of consultants in family
medicine who were trained in the application of evidence-
based medicine concepts in family practice.
13
Table 3. Grading of Recommendations.
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
14
Chapter 2
15
2.1 Recommendations on Donor Recruitment
and Care
16
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.
17
2.2 Recommendations on the Process of Blood
Collection
18
2.3 Recommendations on Blood Processing and
Storage
Blood Storage
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
19
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)
Storage 6 days
Transport 24 hours
After issue, before transfusion 30 minutes
Open system and/or pooled 4 hours
20
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)
21
2.4 Recommendations on Transport and
Distribution of Blood Products
22
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)
23
Receiving Facility
24
2.5 Recommendations for Pre-transfusion Testing
25
26
Chapter 3
27
3.1 Fresh Whole Blood (FWB)
28
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)
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.
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.
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)
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)
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%
35
Handling and Storage of PRBC at Transfusion Area
36
Monitoring the Patient
Response to Transfusion
37
3.3 Washed Red Cell
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.
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)
39
1997)
Response to Transfusion
40
3.4 Leukocyte-reduced Red Cell
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)
42
3.5 Irradiated Blood Components (Red Cells,
Platelets, Whole Blood, Granulocytes)
Preparation
43
• recipients of HLA-compatible single donor platelets and
granulocyte transfusions
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
45
3.6 Random Donor Platelet (RDP)
Preparation
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
Post-transfusion Response
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
Indications
50
Volume
51
• every 30 minutes during transfusion
• on completion of the transfusion
• four hours after completing the transfusion
Post-transfusion Response
52
3.8 Fresh Frozen Plasma (FFP)
Preparation
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)
54
Volume
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
56
3.9 Cryoprecipitate
Preparation
Indications
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
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)
59
3.10 Cryosupernate
Preparation
Indications
Volume
60
Handling and Storage at Transfusion Area
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
64
4.2 Recommendations on Pre-transfusion
Procedures
65
4.3 Recommendations on Laboratory
Pretransfusion Testing
66
Sample Storage
67
4.4 Pre-transfusion Procedures in Emergency
Situation
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
70
4.6 Preparation of Supplies for Blood Component
Administration
Transfusion Set
71
Intravenous Fluids
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
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)
74
4.7 Procedure of Patient Identification
75
4.8 Recommendations on Pre-medication
76
4.9 Recommendations to Minimizing
Transfusion Risks
77
4.10 General Recommendations for Monitoring
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):
79
• unique donation numbers of all products transfused
• any adverse effects.
80
• EDTA, clotted and other samples, as necessar y,
collected immediately post-reaction and from the
opposite arm to the infusion site
81
82
Chapter 5
83
5.1 Blood Sparing Strategies
Crystalloid/Colloids
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)
85
coagulation among patients with established renal failure.
Dosage should not exceed 20 mL/kg body weight in 24
hours.
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)
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)
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):
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:
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.
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.
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.
96
British Committee for Standards in Haematology Blood Transfusion
Task Force. (1990). Guidelines for implementation of a maximum
surgical blood order schedule. Clinical Laboratory Haematology,
321-7.
CSL. (2009). Retrieved May 23, 2009, from 2009 CSL Limited:
www.csl.com.au
97
Group, National Blood Users. (1999). A Guideline for Transfusion of
Red Blood Cells in Surgical Patients.
98
UK Blood Transfusion and Tissue Transplantation Services. (n.d.).
Retrieved May 23, 2009, from Transfusion Guidelines.org.uk:
www.tranfusion guidelines.org.uk
Wiesen A, Hospenthal DR, Byrd JC, Keven GL, Howard RS, amd
Diehl LF. (1994). Equilibration of hemoglobin concentration after
transfusion in medical inpatients not actively bleeding. Ann Int Med
278-80.
99