Download MBBS (Bachelor of Medicine, Bachelor of Surgery) 1st Year, 2nd Year, 3rd Year and Final year Transfusion Medicine and Blood Bank 9 Quality Control In Blood Bank PPT-Powerpoint Presentations and lecture notes
QUALITY CONTROL IN
BLOOD BANK
Content
? Definition
? Types
? Need
? Inclusions
? How to do that?
Quality Assurance
? It is the sum total of the organized arrangements with the objective
of ensuring that products will be of the quality required for their
intended use.
? It includes retrospective review and analysis of operational
performance data to determine that the overall process is in a state
of control and to detect shift or trends that require attention.
Quality Control
? Testing routinely performed tests/activities on materials and
equipments to check their proper function
? The monitoring system that checks the effectiveness of existing
process/steps by testing the quality of final products
Quality System Essentials (QSEs)
1. Organization and leadership
2. Facilities work environment and safety
3. Human resources
4. Customer focus
5. Suppliers and material management
6. Equipment management
7. Process management
8. Documents and records
9. Information management
10. Management of non conforming events
11. Monitoring and assessment
12. Process improvement
Types
? Internal Quality control
? External Quality Control
Internal Control
? The internal quality control can be maintained by
going through a complete checklist of items or test
daily to make sure that all systems are being
monitored and in control.
? Immediate decisions can be taken to accept or reject
results / products.
External Quality Control
? External quality control is a way to compare the
performance of a laboratory with reference to other
laboratories
? External Quality Assurance also know as `proficiency
testing' or External Quality control
Quality in Blood Transfusion Services
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 'safe unit of blood' is as safe as possible.
Objectives of Quality in Blood Bank
? 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 determine problems in the whole transfusion chain
and solve it to achieve the goal .
Quality Management System in Blood Bank
In a blood transfusion center, 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.
Steps involving Quality Control in
Blood Bank
? Donor selection and Blood collection
? Serology Laboratory
? Transfusion transmitted Infection
? Component preparation
? Cross-match & Antibody screening
? Storage , issue and transportation
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.
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 clerical or technical errors
Quality Control for Reagents
The primary objective of a reagent quality control is to ensure that
reagent is functioning as expected.
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 in-form of SOP's
with training.
? All reagents and kit should be used according to
the manufacturer's instructions.
? FIFO shall be maintained
Quality Control for Reagents
? Use of positive & negative controls should be done with each
batch to show that reagents are potent and specific.
? Al 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
? Supply, storage and transportation of kits and reagents should
be strictly standardized & manufacturer's instructions should be
fol owed with ensured continuous power supply and periodic
temperature monitoring.
Log of Reagents
? Reagent records should include:
? The name of each reagent with
? Lot number
? Batch number
? Expiry date
? Name of manufacturer
? Date of receipt and put in use
? Grade and strength of reactions at time of receipt (Kit
verification).
Frequency of Quality Control of Reagent
Reagents
Frequency of testing along with
Controls
Anti human serum
Each day of use
Blood grouping serum
Each day of use
Antibody screening and reverse
Each day of use
grouping cells
Enzymes
Each run
Normal saline (LISS and BPS)
Each day of use
Bovine albumin
Each day of use
Quality Control of Reagent Red Blood Cells
Parameters
Quality
Frequency of
Requirement
Control
Appearance
No haemolysis or
Each day
turbidity in
supernatant by visual
inspections
Reactivity and specificity Positive reactions with Each day
known sera against red
blood cells antigens
Quality Control of ABO Reagent
(Anti-A, Anti-B and Anti-AB)
Parameters Quality Requirement
Frequency of Control
Appearance No turbidity, precipitate, particles or gel
Each day
formation by visual inspection
Specificity Positive reaction with red cel s having
Daily and of each new
corresponding antigen(s); and no reaction with
lot/batch
negative control
Avidity
Macroscopic agglutination with 50% red cel s
Daily and of each new
suspension in homologous serum/normal saline lot/batch
using the slide test;
10 seconds for anti-A, anti-B and anti-AB with A1
and/or B cel s at R.T; 20 seconds with A2 and A2B
cel s.
Reactivity No immune haemolysis, rouleaux formation or
Each new lot/batch.
Prozone
Potency
Undiluted serum should give +++reactions in
Each new lot/batch.
saline tube test using a 3% red cel s suspensions
at R.T., titre should be 256 for anti-A, anti-B, and
anti-AB with A1 and/or B cel s, 64 with A2 and A2B
cel s.
Quality Acceptable of Rh Anti-sera (Anti-D)
Parameter
Quality requirement
Frequency of control
Appearance
No turbidity, precipitation,
Each day
particles or gel formation by
visual inspection
Specificity
Positive reaction with R1r
Each day and each new
cells / Known D Positive cells lot/batch. And no reaction
with rr cells.
Avidity
Visible agglutination with
Each day and each new
40% red cells suspension in lot/batch
homologous serum using the
slide test.
Reactivity
No immune haemolysis,
Each new lot/batch
rouleaux formation or
prozone phenomenon.
Potency
Undiluted serum gives +++
Each new lot/batch
reactions in designated test
for each serum and a titre 32-
64 for anti-D.
Acceptable Titre and Avidity of ABO Reagents
Anti-sera
Type of the reagent Type of red cells (2 Titre
Avidity Time
Intensity
-3% cells
suspension)
Anti-A
Polyclonal
A1
1:256
10-12 sec
+++
Monoclonal
A2
1:128
15-18 sec
++ To +++
A2B
1:64
15-18 sec
++
O
-
-
-
B
-
-
-
A1
1:256
3.4 sec
+++
A2
1:128
5-6 sec
++ To +++
A2B
1:64
5-6 sec
++++
O
-
-
-
B
-
-
-
Anti-B
Polyclonal
B
1:256
10-12 sec
+++
Monoclonal
A1B
1:128
12-15 sec
++
O
-
-
-
A1
-
-
-
B
1:256
3-4 sec
++++
A1B
1:128
5-6 sec
+++
O
-
-
-
A1
-
-
-
Anti-AB
Polyclonal
A1
1:256
10-12 sec
+++
Monoclonal
B
1:256
10-12 sec
+++
A2
1:64
15-18 sec
++ To +++
O
-
-
-
A1
1:256
3-4 sec
++++
B
1:256
3-4 sec
++++
A2
1:128
5-6 sec
+++
O
-
-
-
Acceptable Quality of Anti-globulin (Gel / Beads) Reagent
Parameter
Quality requirement
Frequency of control
Appearance
No precipitate, particles or Each day
gel formation by visual in
inspection.
Reactivity and Specificity
No prozone phenomenon
Each lot
No haemolysis or
Each day
agglutination of
unsensitized red cells
Agglutination of red cells
Each day and each new
sensitised with anti-D serum lot/batch.
containing not more than
0.2 mg/ml antibody activity
Transfusion Transmitted Infection testing Done in Blood
Bank
?HBs Ag
?HIV 1 & 2
?HCV
?Syphilis
?Malaria Parasite
Frequency of Transfusion Transmitted disease
Reagents
Frequency of testing along with
controls
Hepatitis B Antigen
Each run
HIV 1 & 2 Antibody
Each run
Hepatitis C Virus
Each run
Syphilis serology reagents
Each run
Malaria Test
Each run
Assuring quality of examination procedure
? The daily QC values shall be documented on Levey
Jennings curve and CV % from monthly QC data must be
calculated.
Flow chart should be made to manage "Out of control situation"
? If a reagent produces results outside the limits set by the manufacturer
or Blood Bank, the deficiency should be reported to the Quality
Manager.
? Search for recent events that could have caused changes
? Examine environmental condition
? Follow manufactures troubleshooting guide
? Refer to manufacturer of equipment, reagents or QC/Calibrator vendor.
Quality Control in Blood/ Blood Components
Frequency of Testing
1% of component shall be tested for Quality Control out of
which 75% shall match the acceptable ranges as per
National guidelines set by Govt. of India(DGHS).
QC of blood/blood component preparation
1. Whole blood:
? Frequency of control: 1% of all units with minimum of 4 units
per month
? Storage :- 2?C to 6 ?C, for CPDA-1 the storage time is 35
days, CPD & CD2D ? 22days.
Parameter
Quantity Requirement
Frequency of Control
Volume
350/450 ml + 10%
1% of all units
Anticoagulants
49/63 ml
All units
PCV (Hct)
30 to 40%
4 units per month
HBsAg
Negative by ELISA
All units
Anti-HCV
Negative by ELISA
All units
Anti-HIV ?
Negative by ELISA
All units
Syphilis
Negative by Screening test
All units
Sterility
By culture
Periodically (1% of all units)
Calculation for Total Volume of Whole Blood taken in
450 ml of Bag
Volume of Whole Blood: 450 ml ? 10% OR 472 gms. ? 10%
Calculate the volume from the formula given below:
Weight of the Bag with Blood (gms) Weight of the empty Bag
(with Anticoagulant)
Volume (ml) =
1.05
* Weight of the empty Bag (with Anticoagulant) of 450 ml = 100 gms
2. Red cell concentrates
? Perform the same assay as for Whole blood
? Storage : 2o-6? C, for 35 days if prepared from WB
collected in CPDA-1
The Quality Control of red cell concentrate (Prepared from 450 ml Blood)
Parameter
Quantity Requirement
Frequency of Control
Volume
280 + 40 ml
1% of all units
PCV (Hct)
70%+ 5%
Periodically (1% of all units)
The Quality Control of red cell in preservative sol. (ADSOL/SAGM)
Parameter
Quantity Requirement
Frequency of Control
Volume
350 + 20 ml
1% of all units
PCV (Hct)
55-65%
Periodically (1% of all units)
3. Platelet concentrates
? Prepared within 6 hours of blood collection
? Must evaluate at least 1% of platelets monthly for platelet
count, pH and plasma volume
? Platelets should be selected from each centrifuge in use
? Storage : 20o-24?C
Parameter Quality
Requirements
Frequency of control
Volume
50-70 ml
All units
Platelets count
> 5.5 x 1010
4 units per month/ 1% of all
units (whichever is more)
pH
>6.0
4 units per month/ 1% of all
units (whichever is more)
RBC contamination
0.5 ml
4 units per month/ 1% of all
units (whichever is more)
WBC contamination
5.5x107 ?5x108
4 units per month/ 1% of all
units (whichever is more)
4. Quality of Platelet concentrate by Apheresis
Parameter
Quality requirement
Volume
>200 ml
Platelets count
> 3.0 ? 7.0 x 1011
pH
> 6.0 (at the end of permissible
storage period)
Residual leucocytes
< 5.0 x 106
Red cells
Traces to 0.5 ml
5. Fresh Frozen Plasma
? frozen within 6 hours of blood collection using ?80oC
deep freezers or blast freezers
? Stored at ?30oC
? Date of expiry one year
Parameter
Quality control
Frequency of control
Volume
200?220 Plasma
4 units per month/ 1% of all
units (whichever is more)
Stable coagulation factors
200 units of each factor
4 units per month
Factor VIII
0.7 units/ml
4 units per month
Fibrinogen
200?400 mg
4 units per month
6. Cryoprecipitate
Parameter
Quality control
Frequency of control
Volume
10?20 ml
1% of all units
Factor VIII
80?120 units
1% of all units
Fibrinogen
150?250 mg
1% of all units
Labeling
? Unique identification number
? ABO and Rh type
? Date of collection and expiry
? TTI screening sticker
? Volume of component
Storage
Refrigerators
? External ambient temperature
? Range: 2 to 6?C
? Continuous monitor temperature
chart to record `fluctuations' -
? THERMOGRAPHS: Changed
weekly & preserve records
? Bacterial cultures
? Audible and visual alarm signal
? Digital temperature display
Deep freezers
? Temperature recording : Range: -35?C to -40?C
? Cooling down time: A full load of plasma packs at +25?C takes
a max. of 5 hrs for all the packs to reach below -5?C and 30 hrs
to below -20?C
Platelet agitator
? All PCs to be stored only in agitators:
continuous gentle flat bedded ?
5 days
? Interruption compromises the
viability
? Temperature monitoring
? "Swirling" to be checked before issue
? Regular Quality Control of RDPs and
AP-PCs
External Quality Assurance (EQA)
? Proficiency Testing Programme is designed to evaluate
the overall performance and accuracy engaged in blood
banking testing.
? Determine the performance of Individual Blood banks
for specific tests or measurement and to monitor Blood
Banks continual performance and improvement.
? To provide additional confidence to Blood Bank /
Laboratory clients.
? It i s a blind testing
External Quality Assurance
? The internal QC should be complemented by regular external quality
assurance e.g. 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.
Parameters / test covered under EQA
1. HBsAg
2. Anti- HIV 1&2
3. Anti- HCV
4. Syphilis (VDRL)
5. Malarial Parasite
6. NAT ( HBV/ HCV/ HIV-1, HIV-2, HIV-O & HIV-M)
7. Hemoglobin
8. Blood Group
9. Cross-match
10. Antibody Screening & Identification
11. Factor VIII
12. Fibrinogen
13. Sterility Testing
14. APTT
THANK YOU
This post was last modified on 08 April 2022