quality control in blood banking

2. Quality assurance in
blood banking

3. Quality is a process
• Quality is an ongoing
activity,

4. Quality control
• Checks puts in places
to ensure that
process, procedures
and products meets
the quality
requirements.
• (consistency)

5. How to start QC
• Start from today and make a plan for QC.

6. 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

7. RBB 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) (Supportive facilities)
.

8. QA IN COLLECTION OF BLOOD
• The quality, safety and efficacy of the product
transfused is the result of many steps:-
– Donor selection
– Blood collection
– Component preparation
– Storage , issue and transportation

9. • Donor Selection
• 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).
– Blood Collection:
• Aseptic technique
• Seal closed method

10. Blood processing
• After blood Collection immediate storage
at 1-6ºC
• Components preparation has to be done
within 6 hours after collection
• Labels/Records : ABO and Rh grouping
• Screening, expiry date and volume of the
blood

11. • Equipment requirements :-
• All the equipment in blood transfusion laboratory
should meet mandatory specifications.
• A written record of periodic function checks and
maintenance on each piece of equipment should be
mandatory.
• A preventive maintenance should be planned for
trouble free operation.
• Uninterrupted power supply should be maintained
for all the equipment with efficient back-up system.
• Annual maintenance contract with manufacturers
and suppliers should be obtained.

12. Equipments Method of control Frequency of
control
Control executed by
Laboratory
refrigerator,
freezers, water
bath
Thermometer, precision
thermometer
Daily Technologist
blood bag
refrigerators,
Freezer containing
transfusates
Graphic recorder plus
independent audible
and visual alarm for
appropriate high and
low temperature
parameter
Daily Technologist
Laboratory
refrigerator,
Freezer, water bath
Precision thermometer
# For Calibration #
Every 6 month Technologist
Equipments QC

13. Equipment Method of control Frequency of control Control executed
Cryofuge
Precision RPM meter plus
stopwatch to control speed,
acceleration and retardation
Twice / month Technologist
Cryofuge Temperature Daily Technologist
Table centrifuge RPM meter plus stopwatch
to control speed,
acceleration and retardation
Daily Technologist
Haemoglobin
spectrophotometer
Calibrate with standard Daily Technologist
Haemoglobin
spectrophotometer
Hb- QC Sample Monthly Technologist
Equipments QC

14. Equipment Method of control Frequency of control Control executed by
Cell counter Calibration; reference
samples,
Daily Technologist
pH meter Control solution
pH 4-7, 7-10
Each time of use
Technologist
Platelet agitator Frequency of agitation Monthly Technologist
Laminar flow hood Air pressure Daily Microbiologist
Laminar flow hood and
sterile area filter
Particle counter 3 times / Month Microbiologist
Equipments QC

15. Equipment Method of control Frequency of
control
Control executed by
Blood mixer Control weighing and mixing Twice /month BM Engineer
Blood bag tube
sealer
Pressure on bag and tube Every bag and
weld
Technologist
Blood transport
container
Temperature control device Every time on
use (on receipt)
Technologist
Equipments QC

16. -Control for equipment
–Control for reagents
–Control for techniques
Based upon internal QC and external QC.
Internal quality control are subdivided into
Color codes for Anti sera by the FDA:

17. Quality control for reagents
• Select the reagent with high specifications- reference
preparation has been established for ABO, Rh and anti-
human globulin (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

18. Grouping laboratory
Parameters to be
checked
Minimal
requirement for
testing
Control samples Frequency of
control
Control executed
by
ABO Typing Use of Anti A and
Anti B duplicate
reagent
One blood sample
each of the
following: O,A and
B
Each test series
or at least once a
day provided
the same
reagent are used
throughout
Grouping
laboratory

19. Parameters to be
checked
Minimal
requirement for
testing
Control
samples
Frequency of
control
Control
executed by
Rh- D typing
Using 2 anti D sera
from different
batches, and should
be different clones.
1 Rh – D Positive
1 Rh – D
Negative
Sample
Each test series
/ at least once a
day provided
the same
reagent are
used
throughout
Grouping lab.
Anti globulin
testing, tube method
Washing the cells 3
times before adding
anti globulin
Addition of
sensitized
blood cells to
negative test
Each negative
test
Grouping lab
Grouping laboratory

20. Blood Processing and Quality Control
No leakage or puncture.
• Whole blood
• Pack Red cell
• Platelets
• FFP
• Cryoprecipitate

21. QC of Blood Components
Products Storage Volume
W/B 2ºC to 6 ºC 500ml ±50 ml
P/C 2ºC to 6 ºC 280ml ± 50ml
Platelets 20ºC to 24ºC Volume > 40ml

22. QC of Blood Components
Blood Components Sterility
W/B No Growth
P/C No Growth
Platelets No Growth

23. FFP CP
Every 10 unit/week estimate the
volume
Volume: 220-250ml
Storage:
24 months at below –30ºC
12 months at –25 to –30ºC
3 months at –18 to –25ºC
Factor VIII : > 70 IU/unit
every 2 months
Every 10 unit/week estimate the
volume
Volume : 10-20 ml
Storage:
24 months at below –30ºC
12 months at –25 to –30ºC
3 months at –18 to –25ºC
Factor VIII : > 70 IU/unit
Fibrinogen : > 140 mg per
unit

24. FFP CP
Macroscopic : no
abnormal color or visible
clots
Residual cell:
Leukocyte: < 0.1 x 10⁹/l
Red cell: < 6.0 x 10 ⁹/l
Platelets : < 50 x 10 ⁹/l
Macroscopic : homogenous
Sterility: no growth

25. Transportation
W/B 1-10ºC
P/C 1-10ºC
Platelets 20 – 24 ºC
Frozen Components –18ºC or colder
Maintain cold chain during transportation

26. QC OF INFECTIOUS DISEASE TEST
• To reduce the blood borne infectious disease
• Does not use assay beyond its expiry date.
• Storage conditions for samples.
• Preparation of samples.
• Test kit manufacturer's controls for every assay
• Positive and negative control
• Positive and negative control as test sample.

27. –Following manufacturer instructions for
performing an assay
–Adequate training
–Using sensitive assays to screen samples
–IQAS (Internal Quality Assurance System)
–EQAS (External Quality Assurance System)