Professional Documents
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IQC
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DEFINITION OF QUALITY
WHAT IS QUALITY ?
IT IS NOT VISIBLE
IT CANNOT BE MEASURED
IT HAS NO UNIT OF MEASUREMENT
IT CAN ONLY BE COMPARED AGAINST A
STANDARD
IT CANNOT BE ACHIEVED IN ONE STEP
IT CAN ONLY BE ACHIEVED OVER A PERIOD
AND IN STEPS
THEN HOW DO WE ASSES QUALITY IN
MEDICAL LAB?
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Quality Control
Is not
Quality Assurance
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Quality Improvement
Quality Assurance
Quality Control
Quality Plan
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Trained operators
Environment monitoring
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QUALITY CONTROL IN
PRE-ANALYTICAL PHASE
Preanalytical phase - included all processes from the
time a laboratory request is made by a physician until
the sample is ready for testing.
Why is it important ?
Errors occurring at this stage often become apparent
only later in the analytical and post-analytical phases.
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QUALITY CONTROL IN
PRE-ANALYTICAL PHASE
1. Test Request generation – Patient identification errors &
misidentification, wrong test request, wrong labelling.
2. Patient preparation as appropriate must be done -time of
day, food intake & its time, type of food, drug intake
2. Collection of specimen in right container – type of
additive, preservative, anti coagulant, sterile container,
3. Appropriate blood-Additive or AC ratio
4. Proper mixing– No. of times mixing to be done – 5
inversions
5. Transport at appropriate temperature & time interval
6. Proper processing of specimen – centrifugation speed &
time
7. Appropriate storage conditions till analysis
QUALITY CONTROL IN
POST-ANALYTICAL PHASE
1. Correlation of results with previous results & with
clinical condition of patient if available
2. Transmission of correct results & patient details on
to final test report
3. Minimizing transcription errors – decimals &
calculated values
4. Timely Notification of CRITICAL results & URGENT
to the referring clinician
5. Maintaining & Monitoring TAT – Turn Around Time
for tests
6. Minimizing amendment & revision of test reports
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COMPONENETS OF QUALITY
CONTROL IN ANALYTICAL PHASE
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TERMINOLOGIES IN QC
(FROM TEITZ TEXTBOOK OF CLINICAL CHEMISTRY &
MOLECULAR DIAGNOSTICS 6TH EDITION)
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Characteristic “bell-shaped”
curve
68.2 % values – 1SD
95.4% values – 2SD
99.8% values – 3SD
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STANDARD DEVIATION
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STANDARD DEVIATION
When a QC measurement falls within 2 SD range, there is 95.5%
confidence that the measurement is correct
In other words
Mean 200.6
SD 8.21
Range limits in our example
+ 1 SD- 200.6 + 8.21= 208.81
-1 SD- 200.6 - 8.21= 192.39
1 SD limits are 192.39 to 200.81
+ 2 SD-200.6 + (2x 8.21) = 217.02
+ 2 SD-200.6 + (2x 8.21) = 217.02 - 2 SD-200.6 - (2x 8.21) = 184.15
- 2 SD-200.6 – (2x 8.21) = 184.18
2 SD limits are 184.18 to 217.02
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COEFFICIENT OF VARIATION
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Which is better?
Based on just SD, one might conclude that the
Level 1 is more precise than the level 2
Cholesterol
LEVEL l LEVEL 2
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SOURCES OF
INTERNAL QUALITY CONTROL MATERIALS
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THIRD 4 MONTHS
FIRST 4 MONTHS SECOND 4 MONTHS
Inst.
Manufacturer LOT 2
LOT 1 LOT 3
Reagent
Inst.
Manufacturer LOT 1 LOT 2 LOT 3
Control
Inst. LOT 2
Calibrator LOT 1 LOT 3
Third Party
Control (SAME) LOT 1
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Also Equipment need to be validated for the entire range and likely patient
values
If unable to assay all three levels daily or with each shift, use a
combination
Should resemble the patient sample or test specimen (matrix & interfering
substances apt. conc.) – ‘commutability’
After vial has been opened and material prepared, it should remain stable
for the period of use –
Material should be low vial-to-vial variability.
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ESTABLISHING
RANGE FOR IQC MATERIALS
Use product insert ranges only as a guideline
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ESTABLSIHING
RANGE FOR IQC MATERIALS
ESTABLSIHING LAB
RANGE FOR IQC MATERIALS
Provisional Mean – Collect minimum 20 data points from separate
analytical runs on different days (10 to 20 days)
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Make sure the calculated target value is not far away from
the manufacturer's target.
Lab mean has some uncertainty & may need to be redefined if
measurement conditions fluctuate (e.g new Reagent lot / Calibrator
lots, equipment maintenance, new calibration etc)
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234
213
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Mean – 274.77
Range 266.58-280.23
Glucose (Jan 2011) with Lab defined Mean & Ranges
(SD – 2.73; CV- 0.99%) SD – 2.73
CV 0.99 %
280.23
277.5
274.77
272.04
269.31
266.58
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
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Date
Date
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65.44
61.02
56.6
52.18
47.76
43.34
Date
73.14
69.05
64.96
60.87
56.78
52.69
Date
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LEVEY-JENNINGS CHART –
PLOT TIME ON X-AXIS & THE CONTROL VALUES ON Y-AXIS
C o n tro l Valu es (e.g . m g /d L )
115
110
105
100
95
90
85
80
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
LEVEY-JENNINGS CHART
STEP 1. CALCULATE THE MEAN AND STANDARD DEVIATION
STEP 2. PLOT THE MEAN AND +/- 1,2 AND 3 SD CONTROL LIMITS ON Y-AXIS
115 113
+ 3 SD
110 108
+ 2 SD
105 + 1 SD
103
100 MEAN
95 93 - 1 SD
90 88
- 2 SD
85 - 3 SD
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
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LEVEY-JENNINGS CHART –
STEP 3 : PLOT CONTROL VALUES FOR EACH RUN
STEP 4 : LOOK FOR QC RULE VIOLATION
C o n tro l Valu es (e.g . m g /d L )
115
110
105
100
95
90
85
80
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24
• The Westgard rules are more useful when two level controls are
used in single run.
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R4s: Rejection’
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RESOLVING QC PROBLEMS
• Take action in a sequential manner to identify a problem – not
in a random manner
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CUSUM CHARTS -
Set a mean
Set ‘Threshold’ to ‘initiate’ Cusum calculations
Consistent interpretation
More objective
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CUSUM CHARTS -
CUSUM CHARTS -
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Helps to differentiate
between SE & RE
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3
Point A –Both Levels 2
Normal & -Abnormal are
1
> +3SD
Systematic Error
-1
Point C –Both Levels
-2
Normal & Abnormal are
> - 2SD
Systematic Error
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Sample Calibrations
-carryover - too frequent
-interference -variable age
Reagent
QC material -variable reagent mixing
-varying tests
- variable preparation -splashing
- variable age
Instrument
-variable cuvettes
-intermittent failure
- Sudden Voltage problems
- Air bubbles & Short sampling
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1. Empirically on experience
2. Based on a % difference
3. Calculating & establishing RCV using Cva & BVi & BVg
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THANK YOU !
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If a problem is identified
2. Recalibration done
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quality control.
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If Reagents, Calibrators & QC materials are from the same source QC results may fail to
identify a shift in calibration
In such cases it is recommended to use third party QC materials that are independent of the
kit & calibrator lot and
Avoid changing lots of QC material at the same time as changing lots of reagent or
calibrators.
Measuring patient samples always provides a reliable approach to verify the consistency of
results after changes in lots of reagents or calibrators changes in other measurement
conditions
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