Quality Improvement and Quality Control in Blood Transfusion Services

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Blood transfusion service is a vital part of the national health
service and there is no substitute for human blood and its
components. Increasing advancement in the field of transfusion
technology has necessitated enforcing strict control over the
quality of blood and its products.
Definition of Quality
“Quality is degree of excellence” or superiority of kind.
According to WHO definition, quality is “the consistent and
reliable performance of services or products in conformity with
specified standards”. In the patient’s view, the quality of service
is “free of defects and results free of faults”.
Quality Assurance (QA)
The term QA is for all measures from recruitment of donor to
transfusion of blood and blood products. This includes pre-
analytical, analytical and post-analytical processes. The
objective of QA is to achieve precision and accuracy. With QA
the efficiency and effectiveness of blood bank is enhanced.
Quality Control (QC)
QC is integral part of QA. QC is:
1. Management of testing process
2. Assessment of accuracy and reproducibility of the test
3. Equipment and instrument monitoring
4. Reagent testing
5. Quality of blood and blood products
22
Quality Improvement and
Quality Control in Blood
Transfusion Services
193

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Essentials of Blood Banking and Transfusion Medicine
The blood bank professionals come across quality of
standards set by variety of agencies that tend to have different
objectives.
The Joint Commission for Accreditation of Healthcare
Organization (JCAHO) focuses on service aspects, examination
of components of transfusion services involved in ordering,
processing and transfusion of blood.
The US Food and Drug Administration (FDA) in America,
recommends testing for 7 infectious diseases including Trypano-
soma cruzi and West Nile virus.
In order to improve the standards of blood and its compo-
nents, the central government through Drugs Controller
General of India has formulated a comprehensive legislation
to ensure better quality control system on collection, storage,
testing and distribution of blood and its components. Central
government amended from time to time the existing require-
ments of blood banks in the Drugs and Cosmetics Act, 1940
and rules thereunder to meet the latest standards.
National Blood Policy32
Government of India published the national blood policy in
the year 2002, later again revised in 2007. The objectives of the
policy is to provide safe, adequate quantity of blood, blood
components and products. The main aim of the policy is to
procure non-remunerated regular blood donors by the blood
banks. The policy also addresses various issues with regard to
technical personnel, research, development and to eliminate
profiteering by the blood banks by selling blood. The policy
also envisages that fresh licences to stand alone blood banks in
private sector shall not be granted and renewal of such blood
banks shall be subjected to thorough scrutiny.
Note: Refer to topic on “blood bank organization and its
management”.
National Accreditation Board for Hospitals
and Healthcare (NABH)
NABH offers accreditation services to hospitals and blood
banks. Accreditation of blood banks/blood centers and blood

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Quality Improvement and Quality Control
195
transfusion services by NABH strives to improve quality and
safety of collecting, processing, testing, transfusion and distri-
bution of blood and blood products. It assesses the quality and
operational systems in place within the facility.
National AIDS Control Organization (NACO)34
In order to improve the standards of blood banks and the blood
transfusion services in our country, National AIDS Control
Organization through Technical Resource Group on Blood
Safety, NACO, Ministry of Health and Family Welfare
Government of India, New Delhi in 2007 has formulated
comprehensive standards to ensure better quality control
system on collection, storage, testing and distribution of blood
and its components.
The objectives of NACO are the following:
• To bring about zero transmission of AIDS
• Blood safety program encouraged
• Only licensed blood banks allowed to operate in India
• Voluntary blood donation encouraged
• Zonal blood testing centers to be established which test the
samples of blood for blood banks and report HIV results on
the same day.
Blood as a Drug
The problems of transfusion associated acquired immuno-
deficiency syndrome resulted in a notification in 1989 under
the Drugs and Cosmetics Act which made the test for HIV
mandatory. The Drugs and Cosmetics Rules were again
amended (Rules 68A, Part XB and Part XIIB of Schedule F) in
the year 1992-93 and the DCGI was vested with the power of
central licence approving authority (CLAA) to approve the
license of notified drugs, viz blood and blood products, IV
fluids, vaccines and sera.
Human blood is covered under the definition of “Drugs”
under Section 2(b) of Drugs and Cosmetics Act. Hence, it is
imperative that the blood banks need to be regulated under
the Drugs and Cosmetics Act and Rules thereunder and the

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196
Essentials of Blood Banking and Transfusion Medicine
licence is granted for operating a blood bank by the State and
Central Licensing Approving Authorities after inspection. Since
blood and blood products are drugs, license is required for
blood transfusion under Section 18 (c) of the said Act.
Continuous Quality Improvement (CQI)
This is based on view, that despite the almost care, processes
and systems may not be perfectly correct. Procedures to identify
these deviations have to be incorporated, such as:
1. Validation
2. QC
3. QA audit
4. Errors
5. Accidents
6. Complaints
7. Transfusion reactions.
These deviations are to be documented, investigated to find
the root cause and corrective actions have to be taken.
The main components of quality in blood transfusion services
involve the following components:
1. Organizational management
2. Infrastructure space instruments
3. Reagents and materials
4. Resources: Personnel, training and development
5. SOPs
6. Donors
7. Phlebotomy
8. Blood and blood products quality requirements
9. Safety in laboratory
10. Quality assurance
11. Internal and external quality control
12. Internal audit
13. Documentation
Organizational Management
For effective quality system, commitment and support from
management is required at all levels including financial assistance.

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Quality Improvement and Quality Control
197
Space and Instruments or Equipment
Space and instruments or equipment should be as per require-
ment by the guidelines.
For space, for blood and components please refer to chapter
on “blood bank organization and its management”.
Equipment
The equipment should have the record of the following:
1. Installation and verification documents
2. Calibration and maintenance schedule
3. Daily QC
4. Temperature and humidity monitoring
5. Breakdown follow-up
Calibration is a procedure done to know the performance
and efficiency of the equipment by comparing/testing against
a standardized equipment, so as to ensure the quality and safety
of the product produced/stored.
Each instrument should have record of:
1. Frequency for performance checking
2. Record of every major repair
3. Traceability records
The standard equipment used for calibration should have
traceability certificate by National Institute of Standards and
Technology (NIST), issued from time to time.
The instrument should also undergo:
1. Safety checks
Safety of electrical equipment includes the intrinsic safety of
the equipment and safety of its operations.
Majority of problems involving medical equipment are
caused by improper use of the equipment and failure to install
it correctly or not maintaining it satisfactorily.
All essential equipment in blood banks should have full
backup of emergency electric supply.
2. Corrective measures
If any equipment is not functioning properly, the results of
tests/products produced/stored are affected. So, corrective

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198
Essentials of Blood Banking and Transfusion Medicine
TABLE 22.1: Calibration frequency for instruments in blood banks
Equipment
Performance
Frequency for Minimum
performance
frequency of
checking
calibration
Temperature
Compare against cali-
Daily
Once in
recorder (display)
brated thermometer
6 months
Deep storage
Daily
Refrigerated
Observe speed, tempera- Each day of
Once a year
centrifuge
ture and time
use
Haematocrit
Observe speed, tempera- —
centrifuge
ture and time
General lab
Observe speed, tempera-
centrifuge
ture and time
Haemoglobino-
Standardized against
Each day of
Once a year
meter standard
cyanmethemoglobin
use
Blood bank
Standardized against
Each day of
refrigerator
known calibrated weight use
Blood bag
Container of known
Each day of
weighing machine calibrated weight
use
Refractometer
Each day of
use
Water bath
Observe temperature
Each day of
use
Autoclave
Observe temperature
Each day of
and pressure
use
Serological
Control for correct
Each day of
rotators
results
use
Laboratory
—
Before
thermometer
initial use
and every
6 months
Digital
—
Before
thermometer
initial use
and every
6 months
Blood agitator
Observe weight of first
Every
Once a year
blood filled container
15 days
for correct results
Platelet agitator
Each day
Once in
of use
6 months
Automated blood Known controls
Daily
cell counter
Pipettes
Volume
Once in a
Once a year
month
Incubator
Temperature
Once a year
Stop watch
Time

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Quality Improvement and Quality Control
199
measures are to be taken without fail. The person in charge
should identify the problem and suitable corrective steps have
to be taken. The manufacturer may be contacted for regular
and speedy repair.
Blood bank refrigerator
• Should be kept in clean and well-lit place.
• Should have continuous and stable power supply.
• Do not keep anything other than blood in the refrigerator.
• Record the temperature daily.
• Should have alarm system with periodic checkup.
• Calibration should be once in 12 months.
Standard thermometer
• Is used to compare laboratory thermometer daily.
• Should be calibrated once a year.
• Should have traceability certificate.
• Calibrated thermometers are necessary for checking the
temperature to assess the functioning of refrigerators, water
baths, incubators, etc.
BP apparatus: To be calibrated.
Reagents and materials
• Before choosing suppliers for reagents, evaluate the
authenticity.
• Acceptance and rejection criteria of reagents should be
viewed.
• Inventory should be maintained.
• Lot to lot verification should be done.
• Daily quality control should be run.
• They should be of good quality with minimum shelf life of
one year.
• Reagents should be checked daily for their specificity and
avidity, using known positive and negative controls.
• Reagents to be checked for appearance, turbidity and dis-
coloration. Those reagents suggesting contamination should
be discarded. Manufacturer’s insert should specify titer,
avidity and all other relevant information.

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200
Essentials of Blood Banking and Transfusion Medicine
• At any given time, there should be two different batches of
each reagent available—either from two different manufac-
turers or two different batches from the same manufacturer.
These should be used for positive samples.
• All reagents should be checked for expiry date, and
properly/clearly labeled. Instructions for use should be in
the form of SOPs.
• Use positive and negative controls.
• Reagents should be kept at 4–6°C and never be frozen or
follow manufacturer’s instructions.
• Storage, supply and transportation of kits and reagents
should be as per manufacturer’s instructions.
TABLE 22.2: Frequency of testing reagents and solutions in blood bank
Reagents and solutions
Frequency of testing with controls
Anti-human globulin sera
Blood grouping sera
Each day of use
Lectins
Red cells for serum grouping
Reagents used for TTDs
(Hepatitis B, C, HIV1 and 2, syphilis,
Each run
malaria)
Normal saline (LISS and PBS)
Each day of use
Bovine albumin
Quality Control of Reagents
Anti-human globulin (AHG) reagent
• One vial from every new batch should be checked for its
specificity and reactivity using (incomplete anti-Rh) IgG
coated cells.
• Each test should include positive and negative controls.
• Non-sensitized A, B and O cells should be checked to rule
out non-specific reactions.
• All negative AHG tests should be confirmed by addition of
IgG coated cells in the test. IgG coated cells should give
positive agglutination.

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Quality Improvement and Quality Control
201
Quality control of bovine albumin
• The reagent should be free of the non-specific agglutination
and should not react with saline suspension of A, B and
O cells.
• Reagent should give positive reaction with Rh(D) positive
cells coated with incomplete anti-Rh(D) antibodies.
Quality control of red cells (control red cells) used for testing
• Cells should be prepared daily and should be free of
haemolysis. There should be a pool of 3 individual cells for
each group.
• Each batch of reagent cells (A, B and O) for serum grouping
prepared should be tested to confirm specificity.
Red cell panel
• These are either commercially available or prepared in
house. The red cells should be stored frozen, or at 4°C.
• Red cells stored for more than 48 hours at 4°C, should be
checked for reactivity.
TABLE 22.3: Quality control of red cells
Parameter
Quality requirement
Frequency
Appearance
No haemolysis or turbidity in supernatant Daily
by visual inspection
Reactivity and Positive reaction with known sera against
specificity
red blood cell antigens
Quality control of ABO anti-seras and anti-D anti-seras
• Avidity: Denotes the speed of reaction for visual agglutina-
tion and overall binding strength of anti-sera (antibodies).
• Specificity: Denotes clear-cut reaction with RBCs bear-
ing the corresponding and no reaction with negative
controls.
• Potency (Titer): It denotes strength of the reagent. It is the
highest dilution of the anti-sera of which the macroscopic
agglutination is seen.
• Titration method: Doubling dilution (1:2, 1:4, 1:8, 1:16, 1:32,
1:64, 1:128, 1:256, 1:512, 1:1024).

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202
Essentials of Blood Banking and Transfusion Medicine
TABLE 22.4: Quality control of ABO reagents (anti-A, anti-B and anti-
AB reagents)
Parameter
Quality requirement
Frequency
Appearance
No turbidity, precipitate, particles or
Daily and with
gel formation by visual inspection
new lot/batch
Specificity
Positive reaction with known sera
against red blood cell antigens and
no reaction with negative controls
Avidity
Macroscopic agglutination with 50%
red cell suspension in homologous
serum/normal saline using slide test;
10 secs anti-A, anti-B and anti-AB with
A1 and B cells at room temperature,
20 secs with A2 and A2B cells
Reactivity
No immune haemolysis, rouleaux
formation or prozone
Potency
Undiluted serum should give +++
Daily and with
reactions in saline with 3% red cells
new lot/batch
suspension at room temperature,
titre of 1:256 for anti-A, anti-B and
anti-AB with A1 and B cells and 1:64
for A2 and A2B cells
TABLE 22.5: Acceptable titers and avidity and intensity of ABO blood
group reagents
Anti-sera
Type of reagent
Type of cells
Titer
Avidity
Intensity
Anti-A
Polyclonal
A1
1:256
10–12 secs
+++
A2
1:128
15–16 secs
++/+++
A2B
1:64
 15–18secs
++
Monoclonal
A1
1:256
3–4 secs
+++
A2
1:128
5–6 secs
++/+++
A2B
1:64
5–6 secs
++++
Anti-B
Polyclonal
B
1:256
10–12 secs
+++
A2B
1:128
12–15 secs
++
Monoclonal
B
1:256
3–4 secs
++++
A2B
1:128
5–6 secs
+++
Anti-AB
Polyclonal
A1
1:256
10–12 secs
+++
B
1:256
10–12 secs
+++
A2
1:64
15–16 secs
++/+++
Monoclonal
A1
1:256
3–4 secs
++++
B
1:256
3–4 secs
++++
A2
1:64
5–6 secs
+++

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Quality Improvement and Quality Control
203
In problematic ABO/Rh(D) typing
• Check with anti-A, anti-B and anti-Rh(D) reagents of two
different companies/batches.
• Rh-positive and Rh-negative controls to be tested.
• Always use washed RBCs.
• Do forward/reverse grouping.
• Any doubt, repeat with fresh sample.
TABLE 22.6: Quality control of Rh antisera reagents (anti-D)
Parameter
Quality requirement
Frequency
Appearance
No turbidity, precipitate, particles or
Daily and with
gel formation by visual inspection
new lot/batch
Specificity
Positive reaction with known Rh posi-
Daily and with
tive red blood cell antigens (RR) and
new lot/batch
no reaction with negative controls (rr)
Avidity
Macroscopic agglutination with 40%
Daily and with
red cell suspension in homologous
new lot/batch
serum/normal saline using slide test
Intensity
No immune haemolysis, rouleaux
With new lot/
formation or prozone
batch
Potency
Undiluted serum should gives +++
With new lot/
reactions in titre of 1:32 or 1:64
batch
TABLE 22.7: Acceptable titres and avidity and intensity of Rh antisera
reagents (anti-D)
Type of
Type of
Titre
Titre after
Avidity
Intensity
reagent
red cells
immediate
30–45 min
spin
incubation
IgM
1:64 to 1:128 1:128 to 1:256 5–10 secs +++
monoclonal
Blend IgM
1:32 to 1:64
and IgG
monoclonal
Blend IgM
Pooled O
1:128 to 1:256 10–20
+++
monoclonal O cells/
and IgG
R1R1
Same as
polyclonal
cells
above
Polyclonal
1:32 to 1:64
60 secs
+++
Anti-D
in alb, enz or
AHG test

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Essentials of Blood Banking and Transfusion Medicine
• Check for auto-agglutination.
• Coombs’ test, PS study to be done. Detailed clinical history
has to be taken.
• Du testing undertaken.
Enzyme Reagents
Enzymes like papain, ficin, trypsin or bromelin should be used
for incomplete antibodies.
The reagents should give specific results with positive and
negative controls. Working reagent has to be prepared according
to standard method.
Enzymes aliquoted and stored in frozen state. Only required
quantity for the day has to be thawed. Unused enzyme at the
end of the day has to be discarded.
Personnel, Training and Development
The number of personnel working in blood bank should be as
per guidelines. Qualification of personnel should be as mentioned
in the guidelines for:
• Blood bank medical officer, nurse
• Technical supervisor and
• Technician
The personnel should be competent enough and should have
undergone training in:
1. Specific to their work
2. Quality control procedures
3. SOPs
4. Competency evaluation
5. Personnel health
6. Safety measures
Standard Operating Procedures (SOPs)39
SOP is a document which contains detailed written procedures
and instructions describing the stepwise procedure of perform-
ing the tests and procedures in the laboratory.
SOP ensures uniformity, consistency and control over the
processes carried out.
The procedure described should be performed by all the staff
in the same way without any deviation. This is to ensure high
quality of standards.

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Quality Improvement and Quality Control
205
SOP should be available on the working table (laboratory
bench work manual).
SOPs are controlled documents and necessary changes can
be brought only with permission of the head of the laboratory
or laboratory quality manager.
Note: Also refer to Blood Bank Organization and its Manage-
ment.
Donor Recruitment
Quality blood comes from the quality donors.
Hence donor recruitment should be viewed seriously and
care for the following to be taken.
1. Policy to get and retain voluntary blood donor pool
2. Donor selection—questionnaire and pre-donation counseling
and consent
3. Interval between donations
4. Physical examination—general fitness
5. Donor notification of abnormal testing (TTI)
6. Post-donation counseling and referral
7. Donor reactions—manage properly
Donor criteria to be followed are:
Age: 18–65 years.
Blood pressure: 100–140 mm Hg of systolic pressure, 60–100 mm
Hg of diastolic pressure.
Pulse: 60–100/minute.
Weight with calibrated scale: >45/>55 kg haemoglobin >12.5 g/dL.
Blood group—slide or matrix get card method: Re-checked
again with another method.
Platelet count more than 1.5 lakhs/cumm.
For other criteria refer to the topic on ‘blood donation‘.
Phlebotomy
Hospital infection control team should be involved.
Aseptic precautions should be taken. Spirit and betadine
applied—leave for 30 seconds. Spirit and betadine should be
applied in a circular motion from inside out.
Care should be taken while handling the blood bag and needle.

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Essentials of Blood Banking and Transfusion Medicine
Blood should freely flow into the blood bag. The blood bag
should be below the level of donor arm. Raise the cuff pressure
to 60–70 mm Hg. Remove the clamp. Reduce the pressure to
40–50 mm Hg once the flow establishes. There should be
continuous squeezing of the fist. The technician should
continuously mix of the blood with anticoagulant in the blood
bag. The time taken for whole procedure is <10 minutes. The
exact volume of blood drawn is 350 mL ±10% for whole blood
and for component preparation it is 450 mL ±10% blood.
Note: Also refer to Donor Health Screening, Donor Suitability
Evaluation, Phlebotomy, Post-Donation Care and ADR.
Blood Bag Selection40
• Single/double/triple/quadriple with integral filters can be
used according to the need of component preparation.
• Use single bag when components are not separated, for
autologous transfusion or for therapeutic phlebotomy.
• Check the bag visually for leakage/anticoagulant turbidity
should be checked.
• Defective bags should be discarded.
• CPD/CPDA1/SAGM anticoagulant can be used.
• Anticoagulant: Blood ratio has to be 14 mL anticoagulant:
100 mL blood.
• Volume of blood collected is 350/450 ± 10%.
• Donor’s weight more than 55 kg, 450 mL can be collected.
• Donor’s weight 45–55 kg, 350 mL to be collected.
• Enter the following data on donor card and register:
– Type of bag
– Manufacturer’s name
– Batch No.
– Expiry date
Blood Bag Labeling41
• Numeric identification number to be written.
• Expiry date to be mentioned.
• Donor number on bag to be written.
• ABO group and Rh type to be mentioned.
• Volume of blood collected to be mentioned.
• TTI result to be mentioned.

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Quality Improvement and Quality Control
207
• Labeling of pilot tubes.
• Traceability of blood bag.
• Label should be clear and readable.
• Also colored label is put for different blood groups as given
below.
a. ‘A’ blood group: Yellow color
b. ‘B’ blood group: Pink color
c. ‘O’ blood group: Light blue color
d. ‘AB’ blood group: White color
Blood and Blood Products Quality Requirements
• All preparation procedures should be done in a sterile
environment.
TABLE 22.8: QC requirements of whole blood, red cells and platelets
QC Whole blood
Parameter
Quality requirement
Frequency of QC
Volume
350/450 ± 10%
1% of all units
PCV (Hct)
45–55%
1% of all units
Sterility
By culture
1% of all units
Infectious diseases
ELISA/as per guidelines All units
Red cell concentrate (prepared from 450 mL)
Volume
225–350 mL
1% of all units
Hct
65–75%
Periodically, 1%
of all units
Leucocyte poor red cells
Post-filtration/apheresis Leucocytes less than
4 units a month
procedure
5 × 106
Platelets (RDPs)
Volume
50–70 mL
All units
Platelets counts
3.5/4.5 × 1010
1% of all units/
4 units per month
pH
>6
whichever is more
Residual leucocytes
<5.5 × 107 – 5 × 108
Platelets (SDPs)
Volume
>200 mL
All units
Platelets counts
>3.5 × 1011
1% of all units/
4 units per month
pH
>6
whichever is more
Red cells
Traces to 0.5 mL
Residual leucocytes
<5 × 106

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Essentials of Blood Banking and Transfusion Medicine
• Blood bags should have closed system.
• The personnel should be trained.
• All the equipment used for the procedure should be calibrated
and well maintained.
• SOPs should be followed.
• Records and registers should be maintained.
• Preparation of the blood components should be within
<6 hours.
Fresh frozen plasma: Frozen within 6 hours of collection,
using –80 deep freezers or blast freezes, stored at –18°C and
date of expiry is one year.
TABLE 22.9: QC requirements of fresh frozen plasma
Parameter
Quality requirement
Frequency of QC
Volume
200–220 mL plasma
1% of all units/4 units per
month, whichever is more
Factor VIII
0.7 units/mL
Same as above
Fibrinogen
200–400 mg
Same as above
TABLE 22.10: QC requirements of cryoprecipitate
Parameter
Quality requirement
Frequency of QC
Volume
10–20 mL
1% of all units/4 units per
month, whichever is more
Factor VIII
80–120 units/mL
Same as above
Fibrinogen
150–250 mg
Same as above
QC of TTI screening
• Controls to be included in each run.
• If minimum number of recommended controls not included
in a run, test is invalid in spite of having normal acceptable
range of control values.
• Kits to be used before the expiry date.
• For incubation time and temperature, follow manufacturer’s
instructions.
Safety in Laboratory41
Persons working in the blood bank may be exposed for
infectious agents arising from blood and blood products

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Quality Improvement and Quality Control
209
especially the blood borne infectious diseases. Also they can
be at risk by the chemicals. The environment in the blood bank
is also at risk of being contaminated with hazardous material
used and waste generated in the laboratory. Hence, safety of
both staff and environment is essential and the following
measures need to be taken.
1. Documentation of laboratory safety policies and procedures.
2. All laboratory personnel should be aware of these policies.
3. All laboratory personnel should follow safe hygienic
practices and wear glove and protective clothing during
working hours.
4. List of hazardous material should be listed and properly
disposed.
5. Biohazard symbol should be used on all containers having
hazardous material.
6. There should be proper preservation and security of speci-
mens.
7. Laboratory personnel should be thoroughly trained to
manage spillage of infectious material.
8. Adequate fire extinguishers should be available and staff to
be trained for managing fire.
9. Accidental events should be brought to the notice of desig-
nated authorities with description of events and analysed
periodically to prevent and control such events.
Internal and External Quality Control
There are two types of laboratory quality control programmes:
• Internal quality control
• External quality control
Internal quality control: The technical staff in the own labora-
tory checks the performance by themselves and evaluate the
reliability of the techniques.
Immediate decision can be taken to accept or reject the test
results/products on daily basis.
This is required for daily monitoring of precision and accuracy.
• Accuracy: This is closeness of the measured value to true
value.

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210
Essentials of Blood Banking and Transfusion Medicine
• Precision: This reproducibility of test results, may or may
not be close to the true value.
External quality control: The same may be evaluated by the
external agency. It gives comparison of the performance with
many blood banks.
It also gives long-term accuracy and performance of the
analytical method.
Thus the external QC:
1. Establishes inter blood bank comparability
2. Ensures credibility of blood bank
3. Ensures high standards of practice
4. Encourages to use standard reagents and methodology
5. Encourages to improve
6. Helps to identify common errors
Internal Audit42
The quality assurance programmes must be monitored and one
of the most effective ways of assessing this is through a regular
internal audit of all activities. Internal audits also provide
opportunities to identify areas that need improvement.
Documentation
Documentation is to ensure traceability of all blood transfusion
service activities. These include:
1. Development of quality manual describing policies, stan-
dards and procedures.
2. Documentation of all activities including SOPs, forms, labels,
etc.
3. Maintenance of records.
4. Documentation regarding issue, use, etc.