In a welcome move, the Pharmacy Council of India has recently re-structured the syllabus of the
Bachelor of Pharmacy course. In the effort to make the content more relevant to the practice of
pharmacy in its current form, we now find new, important subjects introduced, and Pharmaceutical
Quality Assurance is one of them.
A Critique of the Proposed National Education Policy Reform
BB_Quality_Control_Lecture.ppt
1. Quality control and documentation
Ahmad Shihada Silmi,Msc, FIBMS
Lecturer of Haematology & Immunology
Faculty of Science, IUG
BY
2. Quality Management
All activities of the overall management
function that:
Determine quality policy objectives
Implement them by means such as quality
planning, quality control, quality assurance,
and quality improvement within the system.
3. Quality assurance
This describes all the steps taken both in and
outside the laboratory to achieve reliable results,
starting with the preparation of the patient and
collection of the specimen and ending with the
correct interpretation of the results.
4. Quality assurance
WHO summarized quality assurance as:
" the right result at
right time on
the right specimen from,
the right patient with,
result interpretation based on ,
with correct reference data and at
the right price" .
6. QUALITY CONTROL
Is process for assessing the accuracy and
precision of a test as the following:
Accuracy : agreement between the best
estimate of quantity and its true value.
Precision : it is the agreement between
replicate measurements .
7. Objectives of quality
Main objectives
To help lab staff to establish, manage and
monitor a testing process to assure the
analytical quality of the test results .
To determine problems and solved it .
To develop uniform standard of lab.
8. Objectives of quality
To increase lab staff confidence .
To increase client confidence.
Available good database for decisions maker.
Help health planer to improve the programs.
Reduce cost.
9. 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
10. Internal Quality Control ( IQC )
IQC refers to the set of procedures
undertaken by the laboratory staff for the
Continuous and immediate
monitoring of the laboratory work in order to
decide whether the results are reliable
enough to be released
11. What is IQC?
The regular testing of quality control [QC]
material along with the patient samples
Comparison of the QC results to specific
statistical limits [ranges]
Rejection of patient results if QC is outside of
limits
But does this apply to qualitative tests?
If not, Why not?
12. Why do we need
Internal Quality Control?
Ensure that test results are reliable
Ensure that test results are reproducible
Control quality of daily routine work
13. External Quality Control ( EQC )
Is the objective evaluation by an outside
agency of the performance by a number of
laboratories on material which is supplied
specially for the purpose.
Is usually organized on a national or regional
basis
14. Why do we need
External Quality Assessment?
To detect hidden problem
To receive help and support
To compare our performance with others and
improve quality
15. Quality
= Excellence
= Conformance to specifications
= Fitness for use
= Value for the price.
“Totality of characteristics of an entity
that bear on its ability to satisfy stated
and implied needs
[ ISO 8402,2.1:1994]”
18. Quality in blood bank
A simple definition of quality is 'fitness for a
purpose'. In blood transfusion service, the
primary goal of quality is 'transfusion of safe
unit of blood.'
The quality system deals with all aspects to
ensure that the product or the tested and
'safe unit of blood' is as safe as possible.
19. Objectives of quality in blood bank
Is to ensure availability of a sufficient supply
of blood, blood components of high quality
with maximum efficacy and minimum risk to
both donors and patients.
To ensure maximum efficacy and safety of
blood
To determine problems in the whole
transfusion chain and solved it .
20. Need for Quality
A failure in the quality of blood collected or screening of
donated blood unit can be very serious and may result in fatal
consequences.
A failure in the quality system can lead to numerous situations
which may be potentially dangerous to the patient, i.e.
1- failure to identify the patient correctly
2- wrong sample labeling
3-mix-up of results amongst different patients
4-failure to detect presence of an abnormality in the patient's
sample.
5- issue of unscreened blood due to faulty laboratory procedures
21. Quality Assurance in blood bank
In a blood transfusion centre, it means that a
management system should exist to look into
provision of a safe unit of blood and, if any
errors are identified, these should be
corrected
22. QC in Blood Bank Technology
Donor services and Blood collection
Blood grouping
Crossmatch & antibody screening
Transfusion
Component preparation
Storage , issue and transportation
23. QC in Blood Bank
Positive and negative controls on all tests
Reverse grouping
Good documentation, SOPs etc
Equipment monitoring, calibration,
maintenance
24. Donor selection
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.
25. 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).
26. Donor selection
Old age 17-60 year
Hb more than 13.5g% and 12.5g% for female
HCT more than 38%for male and 36% for
female
27. Preparation for collection
The donation room must be wide with light
enough
Equipment must be cleaned, calibrated &
checked for performance e.g:
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
28. 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
29. 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.
30. QC of blood component preparation
• Volume : 450ml ± 10 % of body volume
excluding anticoagulant
• HCT : 40±5%
• pH > 6.5
• K < 27mmol/L
• Sterility : no growth
31. 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
QC:
• Volume : 280ml± 50ml, frequency of control 1% of all units
• HCT : 65% -75%
• pH > 6.5
• K < 78 mmol/L
• Hb : minimum 45g/unit
• Sterility : no growth
32. 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
34. Platelet concentrates:
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.
35. Platelet concentrates: QC
• Volume > 40ml
• pH : 6.8-7.4
• Plt count : at least 5.5 x 1010 /bag
• WBC contamination: < 2 x 103/bag
• RBC contamination: < 2 x 109/bag
• Macroscopic appearance : no visible
platelets aggregates
• Sterility : no growth
36. Fresh Frozen Plasma
Storage:
• 24 months at below –70ºC
• 12 months at –25 to –30ºC
• 3 months at –18 to –25ºC
Thawed at Tº between 30-37ºC and
transfused within 24H after thawing
37. Fresh Frozen Plasma
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
38. Fresh Frozen Plasma
Volume: 220-250ml
Factor VIII : > 0.7IU/ml- every 2 months
No leakage after pressure in plasma extractor,
before freezing and after thawing
39. Cryoprecipitate
Assayed on at least 4 bags/ month –for factor VIII
Storage:
24 months at below –70ºC
12 months at –25 to –30ºC
3 months at –18 to –25ºC
Must be thawed at 37ºC and used within 6H
40. Cryoprecipitate
Volume : 10-20 ml
Factor VIII : > 70 IU/unit
Fibrinogen : > 140 mg per unit
Macroscopic : homogenous
Sterility: no growth
41. QC of Blood storage and
Transportation
Storage :- 2ºC to 6 ºC, for CPDA-1 the
storage time is 35 days, CPD & CD2D –
22days.
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.
42. QC of Blood storage and
Transportation
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
43. Transportation
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
44. QC IN BLOOD GROUP SEROLOGY
Principle:
The four main blood group A,B,O and AB are
determined by forward grouping " cell typing"
to detect presence or absence of A and B
Antigens on red blood cells with Anti A and
Anti B " Antisera"
Rh positive or Rh negative red blood cells
are classified by presence or absence of D
Antigen which can be detected by Anti D.
45. QC IN BLOOD GROUP SEROLOGY
Blood sample for ABO grouping
1. Type of specimen is whole blood ,
collected in EDTA tube , 2ml of volume .
We reject the clotting sample , Inadequate
identification of specimen. Samples should
be stored at 4°C and preferably be tested
within 48 hours.
46. QC IN BLOOD GROUP SEROLOGY
5. Cells from the test sample should be
washed in 0.9% normal saline and a 2-5%
cell suspension should be prepared
47. QC IN BLOOD GROUP SEROLOGY
1. ABO grouping tests should be done at room temperature
2. Antisera used in the ABO grouping must be used as per the
manufacturer’s instructions.
3. Before use all the reagents must be checked grossly to rule out
any turbidity or contamination.
4. Tubes, slides, tiles, microplates or gel cards should be labelled
properly.
48. QC IN BLOOD GROUP SEROLOGY
6. The glassware used should be dry and clean.
7. Results should be recorded immediately after
observation.
8. Concave mirror (agglutination viewer) or microscope
may be used to examine reactions that appear
negative by the naked eye.
49. 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
50. 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
51. 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.
52. QC of ID-Card Compatibility Test
Procedure:
Prepare red cell suspension of sensitized and
non-sensitized cells as follows:
Allow diluents to reach room temperature before
use
Dispense 1.0 ml of ID-Diluent's 2 into a clean
tube.
Add 10µI of packed cells, mix gently .
Prepare the ID-Card by labeling positive and
negative on one side and the user and date on
the other side.
53. QC of ID-Card Compatibility Test
Pipette 50µI of red cell suspensions to the
appropriate micro tubes.
Incubate the ID-Card for 10 minutes 37º C in
the ID-Incubator.
Centrifuge the ID-Card for 10 minutes in the
ID-Centrifuge. warning don't use the open
ID-Card
54. QC of ID-Card Compatibility Test
Read and record the results in Q.C. register.
Assess results obtained.
Interpretation:
If sensitized cells give positive reaction and -
nonsensitized cells give negative reaction its
mean that the test is reliable
55. Quality Control of Equipments
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.
56. Quality Control of Equipments
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.
Guidelines for quality control of equipment in
blood transfusion service
59. Quality control for reagents
The primary objective of a reagent quality
control is to ensure that reagent is
functioning as expected.
60. Quality control for reagents
Reagent requirements
All reagents should be clearly labeled with
batch number, expiry date and storage temp;
instructions for use should be enclosed with
each reagent packing.
All reagents & kit should be used according
to the manufacturer’s instructions.
61. Quality control for reagents
Use of positive & negative controls should be done
with each batch to show that reagents are potent
and specific.
All reagents must be carefully stored at
recommended temp.
Reagents to be kept at 4-6oC should never be
frozen and are stored according to manufacturer’s
instructions only
All reagents must be of high quality and have a
shelf-life of at least one year.
62. Quality control for reagents
Supply, storage and transportation of kits and
reagents should be strictly standardized &
manufacturer’s instructions should be
followed with ensured continuous power
supply and periodic temperature monitoring.
63. Quality control for reagents
All the reconstituted reagents should be
stored and reused according to
manufacturer’s instructions.
If a reagent produces results outside the
limits set by the manufacturer, the deficiency
should be reported to the manufacturer.
64. Quality control for reagents
Reagent records should include:
– The name of each reagent with lot number, batch
number, expiry date and name of manufacturer
– Grade and strength of reactions.
65. 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)
67. Documentation
Blood transfusion service should develop
and maintain documents that demonstrate
the achievement of specified quality
standards.
68. Documentation
Documentation provides the ability to trace
prospectively and retrospectively all steps in
all procedures, dating from collection of the
blood to monitoring techniques, component
preparation, laboratory testing, issue and
transfusion of blood.
69. Documentation
An effective record system helps to
judge the performance of the blood
transfusion service
Traces any donated unit of blood from its
source to the final fate
Helps in legal or investigational purposes.
70. Documentation
Record and documents also help to identify possible
sources of error in any technique.
All records must include the date and signature of
the laboratory staff performing the test.
Records should be retained for at least 5 years and
kept confidential.
71. Con…
Various aspects which need proper
documentation are :
Donor records including details of donor
information, rare donor panels, and adverse
donor reactions.
72. Documentation
Record of results and interpretation of all
laboratory tests.
Patient’s record (for all patients and
specifically important in patients with
multiple transfusions, previous transfusion
reactions, presence of unexpected
antibodies or cross-match problems).
Record of component preparation.
73. Documentation
Inventory of blood, blood components, reagents and
consumables, etc.
Record of compatibility testing.
Record of discarded blood units.
Record of issue of blood.
Quality control record (which helps in taking
corrective actions to improve the performance of any
procedure or working of any equipment and
reagents).
74. Documentation
Computers are being widely employed in
maintaining the records. With the growing
demand for improving the efficiency,
accuracy and effectiveness it has become
imperative to introduce computers in the
blood transfusion service.
Computers can help the functions of a blood
transfusion service in:
75. Documentation
Donor identification / registration
Donor blood collection
Processing of blood
Maintenance of records of laboratory testing
Inventory management
Issue & labeling of blood
76. Sop Standard operating procedures
Standard operating procedures (Sop)
Definition: A set of instructions on laboratory
organization and laboratory procedures with
advice of laboratory staff
77. Standard operating procedures (Sop)
What should the laboratory manual contain?
Test name.
Principle of test.
Specimens required and if any special preparation is
needed
78. Standard operating procedures (Sop)
Reference material
• Equipment.
• Method (step by step, and its limitation).
• Reagents
• Standards.
* Controls.
79. Standard operating procedures (Sop)
.Sources of errors and how to minimize or eliminate
them.
. Calculations.
. Quality control measures.
80. Standard operating procedures (Sop)
Elements of organization of blood banks
Staff needed in a blood bank
Blood donation
Laboratory procedure followed in blood group serology
Screening procedure practised for transfusion transmittable
diseases.
Preparations of and storage conditions of blood components
Maintenance of cold chain and mechanical equipments and
other monitoring methods of their performance
Requirements and proper maintenance of records