1. Quality
And
Blood Bank
By
Dr. Hoda Faramawy

4. Quality Cycle Juran
triology
Quality
planning
Quality
control
Quality
improvement
(Juran institute):
• Freedom of deficiencies
• Product features both services and goods that attract and satisfy patient,
meet customer expectations and distinguishing one practitioner or
organization from the other.

5. Blood Bank System
outcome
process
Structure

6. Quality is endless and ongoing
process
– The quality requirements involve:-
– Premises, equipment and materials
– Personnel and organization
– Policies and procedures
– Documentation
– Blood processing
– Quality control and proficiency testing
– Internal and external audits
– Complaints and component recall (tracing)
– Investigation of errors and accidents

7. – why do we need P&P
– Standardization
– Evidence based practice
– Orientation and education of staff
– Auditing
– Clarity of responsibilities
– Trust
– Just culture
Quality is endless and ongoing
process

8. Blood Bank Policies &
Procedures
– Patient identification
– Communication
– Donation
– Processing
– Pre TRX tests
– Storage
– Blood TRX request
– Compatibility tests
– Issuing
– Blood administration
– Massive blood TRX
– Shift to non-specific group
– TRX reactions & incident reporting
– Blood conservation
– Max. surgical blood ordering
schedule
– Safety policy
– Infection control policies
– Audit and review policy
– Training and education

9. Blood Bank must be located , designed, constructed
and adapted to suit the operation to be carried out.
It should include separate areas for:-
– Donor selection
– Blood collection
– Blood processing
– Storage
– Laboratory facilities
– (Supportive facilities)

10. Donor selection
As discussed with Prof. Dr. Mona Hilmy Alrayes

11. Equipment requirements
– 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. Quality control
– Based upon internal QC and external QC.
– Internal quality control are subdivided into
– Control for equipment
– Control for reagents
– Control for techniques

13. Equipments QC
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

14. Equipments QC
Equipment Method of control Frequency of control Control executed
Cooling centrifuge Precision RPM
meter plus
stopwatch to control
speed, acceleration
and retardation
Twice / month Technologist
Cooling centrifuge Temperature Daily Technologist
Table centrifuge
RPM meter plus
stopwatch
to control speed,
acceleration and
retardation
Daily Technologist

15. Equipments QC
Equipment Method of control Frequency of
control
Control executed by
Blood mixer Control weighing
and mixing
Twice /month BM Engineer
Haemoglobin
spectrophotometer
Calibrate with
standard
Daily Technologist
Haemoglobin
spectrophotometer
Hb- QC Sample Monthly Technologist

16. Equipments QC
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

17. Quality control for reagents
– Select the reagent with high specifications: reference preparation has
been established for ABO, Rh and antihuman globulin (AHG)
– e.g. Anti-A International minimum potency reference preparation from National
Institute of Biological Standards and Controls (NIBSC), UK – 03/188 (NATIONAL
INSTITUTE OF BIOLOGICALS (Ministry Health & Family Welfare)
Government of India
– Use according to manufacturer's instruction
– The new reagent has to be assessed
– The appearance checked each day
– The reactivity and specificity has to be 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
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.

19. Grouping laboratory
Parameters
to be checked
Minimal
requirement
for testing
Control
samples
Frequency of
control
Control
executed by
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

20. 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

21. QC of Blood Components
Products Storage Volume
Whole Blood 2ºC to 6 ºC 500ml ±50 ml
Packed Red Cells 2ºC to 6 ºC 280ml ± 50ml
Platelets conc. 20ºC to 24ºC Volume > 40ml
Vol (ml) = weight of bag + blood (g) - weight of empty bag (g)
1.05

22. QC of Blood Components
– PACKED RED BLOOD CELLS (PRBC):
– PRBC is the residue of cells that remains in the blood bag after plasma is
expressed out.
– TO CHECK:
– 1. Volume 280 ml (10% when processed from 450 m1 bag.
– 2. Free of contamination (Bacterial or particular)
– 3. Hematocrit 60-70%
– 4. Specific gravity 1.09
– 5. Storage temperature 1-6 °C (avoid freezing causes hemolysis bacterial
contamination
– 6. Frequency of check- weekly
– 7. Indication of HIV, HbsAg, HCV status, blood group type and Rh on label
– 8. Mention expiry date.

23. QC of Blood Components
– PLATELET CONCENTRATES:
– To ensure adequate hemostasis as a low count is associated with bleeding.
– TO CHECK:
– 1. Volume -50-60ml
– 2. Free of contamination
– 3. PH-6 ( ensure viability)
– 4. Platelet count - 50 x 1010 unit (75% units checked should give this
count).
– 5. Swirling present till last day
– 6. Storage at 20-24°C in a platelet shaker
– 7. On the label check date of expiry and infectious disease status.

24. QC of Blood Components
– FRESH FROZEN PLASMA (FFP):
– Plasma separated from whole blood and frozen within 6 hrs of blood collections
called FFP. Freezing is important to maintain activity of clotting factors.
– To check:
– Volume I50-200ml
– Mention blood group, unit no. and disease screening test results on the bag.
– Stable coagulation factors - 200ml
– Factor VIII C should not be less than 0.7 IU/ml
– Fibrinogen 250 – 400mg/ml.
– Store at -20oC or low
– Store in such a manner that bags do not adhere.
– Protect attached tubing as it breaks easily.
– Check weekly

25. QC of Blood Components
– CRYO PRECIPITATE: -
– Snap freezing of FFP bags is needed to maintain yield of factor 8 in
cryoprecipitate.
– To check:
– Volume I5-20ml
– FVIII-( 80-120 U)
– VWF - 40 -70% of original
– Fibrinogen 150 -250 mg
– F12 - 20-30% of original
– F2,5,9- small amount
– Store at -20oC or lower
– Assay done on 4 bags /months OR I bag / week.

26. QC OF INFECTIOUS DISEASE
TEST
– Do 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 as test sample.
– 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)

27. Internal Quality Control for
Quantitative Tests
– Implementing QC program for Quantitative tests operates on the following
steps:
– Select quality controls.
– Collect at least 20 control values over a period of 20- 30 days for each level of
control.
– Perform statistical analysis.
– Develop Levey-Jennings chart.
– Monitor control values using the Levey-Jennings chart and/or Westgard rules.
Take immediate corrective action, if needed. Record actions taken.

30. Internal Quality Control for
Quantitative Tests
– Qualitative test (rapid card) for transfusion transmitted
disease with built in controls are adequate provided the
kit has been qualified with at least one positive and one
negative control from external sources (can be in-house
also).
– These shall be validated by two qualified personnel and
documented.
– Qualitative test in blood group serology is carried out
daily and documented

31. Maximum surgical blood
ordering schedule
– Each facility should develop guidelines for maximum surgical blood
ordering schedules (MSBOS) based on the needs of individual
patients, utilization practices and facility experience.
– MSBOS should be reviewed periodically and modified.

32. Work safety training programs should ensure that
all personnel:
– Have access to a copy of pertinent regulatory texts and an explanation of
the contents.
– Understand how hepatitis viruses and (HIV) are transmitted and how
often
– Know that they are offered vaccination against HBV.
– Recognize tasks that pose infectious risks, and distinguish them from
other duties.
– Know what protective clothing and equipment are appropriate for the
procedures they will perform and how to use them.
– Know and understand the limitations of personal protective equipment
and where they are kept.
– Become familiar with and understand all requirements for work practices
specified in standard operating procedures for the tasks they perform,
including the meaning of signs and labels.

33. Work safety training programs should ensure that
all personnel:
– Know how to remove, handle, decontaminate, and dispose of
contaminated material.
– Know the appropriate actions to take and the personnel to contact if
exposed to blood or other biologic, chemical, or radiologic hazards.
– Know the corrective actions to take in the event of spills or personal
exposure to fluids, tissues, and contaminated sharp objects; the
appropriate reporting procedures; and the medical monitoring
recommended when parenteral exposure may have occurred.
– Know fire safety procedures and evacuation plans.

34. OBJECTIVES OF INTERNAL
AUDITS
1-To verify the compliance with the requirements of the quality
management system.
2- check that the management system fulfils the requirements of
National Standard of blood transfusion.
3- These audits should also check whether or not the requirements
stated in the organization's quality manual and related documents are
applied at all levels of work.
4- The non-conformities found in internal audits give valuable
information for the improvement of the organization's management
system and should thus be used as input to management reviews.