? Definition
? Types
? Need
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? Inclusions? How to do that?
Quality Assurance
? It is the sum total of the organized arrangements with the objective
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of ensuring that products will be of the quality required for their
intended use.
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? It includes retrospective review and analysis of operationalperformance data to determine that the overall process is in a state
of control and to detect shift or trends that require attention.
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Quality Control
? Testing routinely performed tests/activities on materials and
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equipments to check their proper function? The monitoring system that checks the effectiveness of existing
process/steps by testing the quality of final products
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Quality System Essentials (QSEs)1. Organization and leadership
2. Facilities work environment and safety
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3. Human resources
4. Customer focus
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5. Suppliers and material management6. Equipment management
7. Process management
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8. Documents and records
9. Information management
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10. Management of non conforming events11. Monitoring and assessment
12. Process improvement
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Types
? Internal Quality control
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? External Quality ControlInternal Control
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? The internal quality control can be maintained bygoing through a complete checklist of items or test
daily to make sure that all systems are being
monitored and in control.
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? Immediate decisions can be taken to accept or reject
results / products.
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External Quality Control? External quality control is a way to compare the
performance of a laboratory with reference to other
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laboratories? External Quality Assurance also know as `proficiency
testing' or External Quality control
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Quality in Blood Transfusion ServicesIn blood transfusion service, the primary goal of quality
is 'transfusion of safe unit of blood.'
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The quality system deals with all aspects to ensure thatthe product or 'safe unit of blood' is as safe as possible.
Objectives of Quality in Blood Bank
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? 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.
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? To determine problems in the whole transfusion chainand solve it to achieve the goal .
Quality Management System in Blood Bank
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In a blood transfusion center, it means that a management system shouldexist 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
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Blood Bank
? Donor selection and Blood collection
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? Serology Laboratory? Transfusion transmitted Infection
? Component preparation
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? Cross-match & Antibody screening
? Storage , issue and transportation
Need for Quality
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A failure in the quality of blood collected or screening of donated
blood unit can be very serious and may result in fatal
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consequences.1. Failure to identify the patient correctly
2. Wrong sample labeling
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3. Mix-up of results amongst different patients
4. Failure to detect presence of an abnormality in the patient's sample
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5. Issue of unscreened blood due to clerical or technical errorsQuality Control for Reagents
The primary objective of a reagent quality control is to ensure that
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reagent is functioning as expected.Quality Control for Reagents
Reagent requirements
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? All reagents should be clearly labeled with batchnumber, expiry date and storage temp;
? Instructions for use should be in-form of SOP's
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with training.
? All reagents and kit should be used according to
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the manufacturer's instructions.? FIFO shall be maintained
Quality Control for Reagents
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? Use of positive & negative controls should be done with each
batch to show that reagents are potent and specific.
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? 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
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? Supply, storage and transportation of kits and reagents should
be strictly standardized & manufacturer's instructions should be
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fol owed with ensured continuous power supply and periodictemperature monitoring.
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Log of Reagents? Reagent records should include:
? The name of each reagent with
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? Lot number
? Batch number
? Expiry date
? Name of manufacturer
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? Date of receipt and put in use? Grade and strength of reactions at time of receipt (Kit
verification).
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Frequency of Quality Control of Reagent
Reagents
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Frequency of testing along withControls
Anti human serum
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Each day of use
Blood grouping serum
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Each day of useAntibody screening and reverse
Each day of use
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grouping cells
Enzymes
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Each runNormal saline (LISS and BPS)
Each day of use
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Bovine albumin
Each day of use
Quality Control of Reagent Red Blood Cells
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Parameters
Quality
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Frequency ofRequirement
Control
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Appearance
No haemolysis or
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Each dayturbidity in
supernatant by visual
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inspections
Reactivity and specificity Positive reactions with Each day
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known sera against redblood cells antigens
Quality Control of ABO Reagent
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(Anti-A, Anti-B and Anti-AB)
Parameters Quality Requirement
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Frequency of ControlAppearance No turbidity, precipitate, particles or gel
Each day
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formation by visual inspection
Specificity Positive reaction with red cel s having
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Daily and of each newcorresponding antigen(s); and no reaction with
lot/batch
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negative control
Avidity
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Macroscopic agglutination with 50% red cel sDaily and of each new
suspension in homologous serum/normal saline lot/batch
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using the slide test;
10 seconds for anti-A, anti-B and anti-AB with A1
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and/or B cel s at R.T; 20 seconds with A2 and A2Bcel s.
Reactivity No immune haemolysis, rouleaux formation or
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Each new lot/batch.
Prozone
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PotencyUndiluted serum should give +++reactions in
Each new lot/batch.
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saline tube test using a 3% red cel s suspensions
at R.T., titre should be 256 for anti-A, anti-B, and
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anti-AB with A1 and/or B cel s, 64 with A2 and A2Bcel s.
Quality Acceptable of Rh Anti-sera (Anti-D)
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ParameterQuality requirement
Frequency of control
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Appearance
No turbidity, precipitation,
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Each dayparticles or gel formation by
visual inspection
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Specificity
Positive reaction with R1r
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Each day and each newcells / Known D Positive cells lot/batch. And no reaction
with rr cells.
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Avidity
Visible agglutination with
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Each day and each new40% red cells suspension in lot/batch
homologous serum using the
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slide test.
Reactivity
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No immune haemolysis,Each new lot/batch
rouleaux formation or
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prozone phenomenon.
Potency
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Undiluted serum gives +++Each new lot/batch
reactions in designated test
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for each serum and a titre 32-
64 for anti-D.
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Acceptable Titre and Avidity of ABO ReagentsAnti-sera
Type of the reagent Type of red cells (2 Titre
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Avidity Time
Intensity
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-3% cellssuspension)
Anti-A
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Polyclonal
A1
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1:25610-12 sec
+++
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Monoclonal
A2
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1:12815-18 sec
++ To +++
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A2B
1:64
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15-18 sec++
O
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-
-
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-B
-
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-
-
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A11:256
3.4 sec
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+++
A2
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1:1285-6 sec
++ To +++
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A2B
1:64
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5-6 sec++++
O
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-
-
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-B
-
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-
-
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Anti-BPolyclonal
B
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1:256
10-12 sec
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+++Monoclonal
A1B
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1:128
12-15 sec
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++O
-
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-
-
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A1-
-
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-
B
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1:2563-4 sec
++++
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A1B
1:128
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5-6 sec+++
O
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-
-
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-A1
-
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-
-
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Anti-ABPolyclonal
A1
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1:256
10-12 sec
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+++Monoclonal
B
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1:256
10-12 sec
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+++A2
1:64
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15-18 sec
++ To +++
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O-
-
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-
A1
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1:2563-4 sec
++++
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B
1:256
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3-4 sec++++
A2
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1:128
5-6 sec
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+++O
-
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-
-
Acceptable Quality of Anti-globulin (Gel / Beads) Reagent
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Parameter
Quality requirement
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Frequency of controlAppearance
No precipitate, particles or Each day
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gel formation by visual in
inspection.
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Reactivity and SpecificityNo prozone phenomenon
Each lot
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No haemolysis or
Each day
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agglutination of
unsensitized red cells
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Agglutination of red cells
Each day and each new
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sensitised with anti-D serum lot/batch.containing not more than
0.2 mg/ml antibody activity
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Transfusion Transmitted Infection testing Done in Blood
Bank
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?HBs Ag?HIV 1 & 2
?HCV
?Syphilis
?Malaria Parasite
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Frequency of Transfusion Transmitted diseaseReagents
Frequency of testing along with
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controls
Hepatitis B Antigen
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Each runHIV 1 & 2 Antibody
Each run
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Hepatitis C Virus
Each run
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Syphilis serology reagentsEach run
Malaria Test
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Each run
Assuring quality of examination procedure
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? The daily QC values shall be documented on LeveyJennings curve and CV % from monthly QC data must be
calculated.
Flow chart should be made to manage "Out of control situation"
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? If a reagent produces results outside the limits set by the manufacturer
or Blood Bank, the deficiency should be reported to the Quality
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Manager.? Search for recent events that could have caused changes
? Examine environmental condition
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? Follow manufactures troubleshooting guide
? Refer to manufacturer of equipment, reagents or QC/Calibrator vendor.
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Quality Control in Blood/ Blood ComponentsFrequency of Testing
1% of component shall be tested for Quality Control out of
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which 75% shall match the acceptable ranges as per
National guidelines set by Govt. of India(DGHS).
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QC of blood/blood component preparation
1. Whole blood:
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? Frequency of control: 1% of all units with minimum of 4 unitsper month
? Storage :- 2?C to 6 ?C, for CPDA-1 the storage time is 35
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days, CPD & CD2D ? 22days.
Parameter
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Quantity RequirementFrequency of Control
Volume
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350/450 ml + 10%
1% of all units
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Anticoagulants49/63 ml
All units
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PCV (Hct)
30 to 40%
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4 units per monthHBsAg
Negative by ELISA
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All units
Anti-HCV
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Negative by ELISAAll units
Anti-HIV ?
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Negative by ELISA
All units
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SyphilisNegative by Screening test
All units
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Sterility
By culture
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Periodically (1% of all units)Calculation for Total Volume of Whole Blood taken in
450 ml of Bag
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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
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(with Anticoagulant)
Volume (ml) =
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1.05* Weight of the empty Bag (with Anticoagulant) of 450 ml = 100 gms
2. Red cell concentrates
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? Perform the same assay as for Whole blood? Storage : 2o-6? C, for 35 days if prepared from WB
collected in CPDA-1
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The Quality Control of red cell concentrate (Prepared from 450 ml Blood)
Parameter
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Quantity RequirementFrequency of Control
Volume
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280 + 40 ml
1% of all units
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PCV (Hct)70%+ 5%
Periodically (1% of all units)
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The Quality Control of red cell in preservative sol. (ADSOL/SAGM)
Parameter
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Quantity RequirementFrequency of Control
Volume
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350 + 20 ml
1% of all units
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PCV (Hct)55-65%
Periodically (1% of all units)
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3. Platelet concentrates
? Prepared within 6 hours of blood collection
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? Must evaluate at least 1% of platelets monthly for plateletcount, pH and plasma volume
? Platelets should be selected from each centrifuge in use
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? Storage : 20o-24?C
Parameter Quality
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RequirementsFrequency of control
Volume
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50-70 ml
All units
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Platelets count> 5.5 x 1010
4 units per month/ 1% of all
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units (whichever is more)
pH
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>6.04 units per month/ 1% of all
units (whichever is more)
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RBC contamination
0.5 ml
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4 units per month/ 1% of allunits (whichever is more)
WBC contamination
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5.5x107 ?5x108
4 units per month/ 1% of all
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units (whichever is more)4. Quality of Platelet concentrate by Apheresis
Parameter
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Quality requirementVolume
>200 ml
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Platelets count
> 3.0 ? 7.0 x 1011
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pH> 6.0 (at the end of permissible
storage period)
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Residual leucocytes
< 5.0 x 106
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Red cellsTraces to 0.5 ml
5. Fresh Frozen Plasma
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? frozen within 6 hours of blood collection using ?80oC
deep freezers or blast freezers
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? Stored at ?30oC? Date of expiry one year
Parameter
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Quality control
Frequency of control
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Volume200?220 Plasma
4 units per month/ 1% of all
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units (whichever is more)
Stable coagulation factors
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200 units of each factor4 units per month
Factor VIII
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0.7 units/ml
4 units per month
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Fibrinogen200?400 mg
4 units per month
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6. Cryoprecipitate
Parameter
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Quality control
Frequency of control
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Volume10?20 ml
1% of all units
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Factor VIII
80?120 units
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1% of all unitsFibrinogen
150?250 mg
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1% of all units
Labeling
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? Unique identification number? ABO and Rh type
? Date of collection and expiry
? TTI screening sticker
? Volume of component
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Storage
Refrigerators
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? External ambient temperature
? Range: 2 to 6?C
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? Continuous monitor temperaturechart to record `fluctuations' -
? THERMOGRAPHS: Changed
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weekly & preserve records
? Bacterial cultures
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? Audible and visual alarm signal? Digital temperature display
Deep freezers
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? Temperature recording : Range: -35?C to -40?C
? Cooling down time: A full load of plasma packs at +25?C takes
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a max. of 5 hrs for all the packs to reach below -5?C and 30 hrsto below -20?C
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Platelet agitator? All PCs to be stored only in agitators:
continuous gentle flat bedded ?
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5 days
? Interruption compromises the
viability
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? Temperature monitoring
? "Swirling" to be checked before issue
? Regular Quality Control of RDPs and
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AP-PCsExternal Quality Assurance (EQA)
? Proficiency Testing Programme is designed to evaluate
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the overall performance and accuracy engaged in blood
banking testing.
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? Determine the performance of Individual Blood banksfor specific tests or measurement and to monitor Blood
Banks continual performance and improvement.
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? To provide additional confidence to Blood Bank /
Laboratory clients.
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? It i s a blind testingExternal Quality Assurance
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? The internal QC should be complemented by regular external qualityassurance e.g. participation in a proficiency testing programme
? Proficiency programme test, coded "normal" and "problem" blood
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samples are distributed from national or regional reference laboratory
to the participants usually 2x to 4x a year.
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Parameters / test covered under EQA1. HBsAg
2. Anti- HIV 1&2
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3. Anti- HCV
4. Syphilis (VDRL)
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5. Malarial Parasite6. NAT ( HBV/ HCV/ HIV-1, HIV-2, HIV-O & HIV-M)
7. Hemoglobin
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8. Blood Group
9. Cross-match
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10. Antibody Screening & Identification11. Factor VIII
12. Fibrinogen
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13. Sterility Testing
14. APTT
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