QUALITY ASSURANCE IN THE
BLOOD BANK
DR. WAN ASWANI WAN YUSOF
M. PATH YEAR 1
INTRODUCTION
 Quality management is an integrated systems of
quality assurance covering all matters which
individually or collectively influence the
components in order to guarantee their quality.
 Good Manufacturing Practice (GMP), quality
control and audit programmed, all are closely
linked together with the management of errors
and accidents.
 Internal quality control and proficiency testing
are aspects of quality system concerns with
examination of material component and the
proficiency of the staff
The quality requirements involve: Quality control and proficiency testing
 Internal and external audits
 Personnel and organization
 Premises, equipment and materials
 Documentation
 Blood processing
 Complaints and component recall
 Investigation of errors and accidents
Quality control- activities including steps of
verification and testing which are used to assure
the materials and processes meet their intended
specifications.
Proficiency testing – an aspect of Quality
Assurance which monitors the ability to perform
laboratory procedures within established limits of
accuracy through the analysis of unknown
specimens distributed by an external source
The line between QC and PT in some cases is ill
defined. The performance of QC procedures on
component and reagent will be in itself a measure
of the proficiency of the staff preparing these
components.
Internal audits- to ensure that all procedure and
associated quality control are performed according
to the principles of GMP, and should be carried out
according to an established programme by
responsible person.
External audits should also be performed by a
designated approved authority.
Personnel and organization- adequate number of
qualified and trained personnel.Presence of
organization chart showing the hierarchical
structure of the blood transfusion service.
Cont….
Premises- must be located , designed, constructed and
adapted to suit the operation to be carried out.It
should include separate areas for :a) Donor selection
b) Blood collection
c) Blood processing
d) Storage
e) Laboratory facilities
f) Auxiliary facilities
.
Cont…
Equipment- manufactured equipment should be
designed and maintained to suit its intended
purpose and should not present any hazard to
donors, components or operators. Periodic
maintenance and calibration should be carried
and documented according to established
procedures.
Documentation- adequate documentation prevent
errors which may result from communication.It
include:-all manufactures steps, data affecting the
quality of the component to be checked, from the
donor to the recipient of the blood component
and vice-versa
Cont…
Blood processing:a) Donor selection
b) Blood collection
c) Component preparation
d) Storage , issue and transportation
e) Contract testing
Complaints and component recall- investigate as
soon as possible the complaint and information that
may suggest the defective blood components
Investigation of errors and accidents- organization
involve with the blood bank should document and
investigate the errors and accidents in order to
identify system problems correction.”Near- miss”
events as well as actual events with benign
outcomes should be addressed as part of the quality
system review related to errors and
accidents.Document the corrective actions.
QA IN COLLECTION OF BLOOD
 The quality, safety and efficacy of the product
transfused is the result of many steps:-
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Donor selection
Blood collection
Component preparation
Storage , issue and transportation
Contract testing
Donor selection
 Principle of self-sufficiency from voluntary and
non- remunerated donations have been
recommended and promote by the Council of the
Europe Recommendations No.R(95)14
 Main purpose is to determine whether the person
in good health, in order to protect the donor
against damage to his/her own health, and to
protect the recipient against transmission of
disease or drugs which could be detrimental to
the patient.
 Information collection & evaluation
– Consent form
– Donor is registered for permanent record
– Donor must be checked for possible self harm or
potential harm to recipient( list of questionnaires).
 Preparation for collection
– Equipment must be cleaned, calibrated & checked for
performance eg:
– a)blood container should be inspected for any defect in
anticoagulant solution, moisture or discoloration of the
surface of the bag or leakage,
– b) blood bag refrigerator , centrifuge- need to be
checked
– c) instruments must be washed with disinfectant- to
minimize the contamination
Blood collection & processing
Aseptic technique
Seal closed method
Immediate storage at 1-6ºC
Components preparation has to be done
within 6 hours after collection
Labels/records : ABO and Rh grouping
Screening, expiratory date and volume of
the blood
QC of blood component
preparation
Whole blood:
Frequency of control: 1% of all units with
minimum of 4 units per month
Storage :- 2ºC to 6 ºC, for CPDA-1 the
storage time is 35 days, CPD & CD2D –
22days.
On expire date :- measure HCT, pH, total Hb ,
K+ and perform sterility assays
 QA:-
• Volume : 450ml ± 10 % of body volume
excluding anticoagulant
• HCT : 40±5%
• pH > 6.5
• K < 27mmol/L
• Hb minimum 45g/unit
• Sterility : no growth
Red cell concentrates
 Perform the same assay as for Whole blood on
the expiry date
 Storage : 2-6º C, for 35 days if prepared from
WB collected in CPDA-1
 QA:
• Volume : 280ml± 50ml, frequency of control 1% of all
•
•
•
•
•
units
HCT : 0.65-0.75
pH > 6.5
K < 78 mmol/L
Hb : minimum 45g/unit
Sterility : no growth
Platelet concentrates:
 Prepared within 6H of blood collection
 Must evaluate at least 4 platelet preparations
monthly for platelet count,pH and plasma volume
 Platelets should be selected from each centrifuge
in use
 The Tº at which pH is measured should be the
same as stored
 Label the volume, the actual volume by
measurement must be 10% of the stated volume
 Storage : 20-24ºC
 Tº should be recorded at least every 4H during
storage.
 QC
• Volume > 40ml
• pH : 6.8-7.4
• Plt count : at least 5.5 x 1010 /bag in at least 75% of
the units tested at the end of the storage.By apheresis :
minimum 3 x 1011/bag platelets in at least 75% units
tested
• WBC contamination: < 2 x 103/bag
• RBC contamination: < 2 x 109/bag
• Macroscopic appearance : no visible platelets
aggregates
• Sterility : no growth
Fresh Frozen Plasma
 Every 10 unit/week estimate the volume
 Storage:
• 24 months at below –30ºC
• 12 months at –25 to –30ºC
• 3 months at –18 to –25ºC
 Thawed at Tº between 30-37ºC and transfused
within 24H after thawing
 QC
 Volume: 220-250ml
 Factor VIIIc : > 0.7IU/ml- every 2 months
 No leakage after pressure in plasma extractor, before
freezing and after thawing
QC
 Macroscopic : no abnormal color or visible
clots
 Residual cell:
Red cell: < 6.0 x 109/l
Leukocyte: < 0.1 x 109/l
Platelets : < 50 x 109/l
Cryoprecipitate
 Assayed on at least 4 bags/ month –for factor
VIII
 Storage:
24 months at below –30ºC
12 months at –25 to –30ºC
3 months at –18 to –25ºC
 Must be thawed at 37ºC and used within 6H
 QC
Volume : 10-20 ml
Factor VIII : > 70 IU/unit
Fibrinogen : > 140 mg per unit
Macroscopic : homogenous
Sterility: no growth
Granulocytes
 Prepared by apheresis
 Storage: 20-24ºC for 24H
 QC
Volume : < 500ml
Granulocytes : > 10 x 109 per unit- present in
at least 75% of all units tested
Transportation
 A system must be use to ensure that all blood and blood
components shipped by or received into a blood bank or
blood transfusion service have been maintained within T
required.
 All liquid RBC components kept at T of 1-10ºC during
transport
 All component routinely stored at 20-24ºC should be
maintain T during shipment
 All frozen components should be transport in frozen state at
–18ºC or colder
 Periodic T check and documented to ensure the
transportation adequate to meet the criteria
QC IN BLOOD GROUP
SEROLOGY
 To ensure safety by providing a good and
uniform quality and minimizing errors.
 Staff training, assessment of staff capability,
equipment maintenance and calibration is
important.
 Errors : 2 major categories
– Errors of organization due to incorrect identification of
samples or mistaken in transcription or in filing of
results
– Technical errors due to poor quality of equipment,
reagent or performance of the test.
Cont..
 General approach in QC- to compare ABO- and
Rh-typing results with previous data.This will
disclose errors of both categories.
 Based upon internal QC and external QC.
 Internal quality control are subdivided into:
– Control for equipment
– Control for reagents
– Control for techniques
QC FOR EQUIPMENT
Quality control for reagents
 Select the reagent with high specifications- reference
preparation has been established for ABO, Rh and antihuman globulin (AHG) by FDA
 Color codes by the FDA:
• Blue for anti-A
• Yellow for anti-B
• Green for AHG
 Use according to manufacturer's instruction
 The new reagent has to be assessed & confirmed
satisfactory
 The appearance each reagent has to be checked each day
 The reactivity and specificity has to checked each new lot
Quality control of technique
Provided the quality of equipment and
reagents fulfill the requirement, false result
are due to technique itself, either
inadequate method or operational
errors(inaccurate performance or incorrect
interpretation)
External Quality Assurance
 The internal QC should be complemented by
regular external quality assurance eg :
participation in a proficiency testing programme
 Proficiency programme test, coded “normal” and
“problem” blood samples are distributed from
national or regional reference laboratory to the
participants usually 2x to 4x a year.
 The exercise limited to compatibility testingABO-grouping, Rh-typing and phenotyping and
alloantibody detection
QC OF INFECTIOUS DISEASE
TEST
 To reduce the blood borne infectious disease
 The specific approach to quality of the screening
must rely on the following categories:– Internal QC covering the reagents and techniques.
Batch pre acceptance testing(BPAT) of new batches of
kits could be performed as an additional QA measure
– External quality checks, in confirmation of +ve
findings should be carried out
– Occasional internal exercise, using a panel of sera
which have been built up by comparison with
standards available
Cont…
– External proficiency exercise, involving the testing of
panel of sera circulated to lab by an approved reference
institution
– Implementation of new technique should involve
assessment on specificity and sensitivity
– Collection of representative data may be useful to
monitor performance test.
QC IN TRANSFUSION PRACTICE
 Safety measure :– Transfusion transmitted diseases
– Donor compatibility
• Comparing the identity information received from pt with
data on the lab certificate of compatibility testing
• Checking the certificate of the pt’s blood group against the
blood group denoted on the blood unit label
• Checking the expiry date
• Recording the identity of the pt
– Sterility
Cont…
 Clinical surveillance
– Careful observation of the pt during early stage of
transfusion is mandatory to observe any transfusion
reaction
– Transfused blood components on recommended time
to avoid compromising clinical effectiveness and
safety.
 Warming of blood
– Warming device used must be controlled and
monitored to ensure the correct Tº achieved
Cont..
 Addition of medical products or infusion
solutions to components
– No medical products added to prevent the risk of
damage to blood components
 Handling of frozen units
– Handle with great care, no leak and transfused as
soon as possible after thawing.
 The risk of air embolism
– It is possible under circumstances if the operator isn’t
careful and skillful.
Cont…
 Transfusion complication
– Include adverse reactions and failure of expected
therapeutic response
– Investigate:
• Check all identification of recipient and blood product
• Check that the ABO and Rh blood group of the blood unit
label is compatible with the patient’s blood group certificate
• A blood sample taken before the transfusion and after the
transfusion, the blood unit with the transfusion set maintained
in site sent for investigation. Recommended to do a direct
smear, bacterial culture of the blood unit, serological Ix for
blood group incompatibility and inspection for any damage.
Cont…
 Hospital transfusion committees
– Should include representatives of the blood
transfusion center and the main clinical units with a
significant transfusion activity
– Include:physicians,nurses and administrative
personnel
– Main goals are :• To define blood transfusion policies adapted to the local
clinical activities
• To conduct regular evaluation of blood transfusion practices
• To analyze any undesirable events due to blood transfusion
• To take any corrective measures if necessary
Reference:
Guide to the preparation, use and quality
assurance of blood components, 7th edition,
Council of Europe Publishing
Technical Manual American Association of
Blood Banks, 11th edition