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MLS Process Control
MLS Process Control
1
Learning Objectives
At the end of this module, participants will
be able to:
◼ Differentiate accuracy and precision.
◼ Select control material for the laboratory.
◼ Establish acceptable control limits for a
method when only one level of control
material is available.
◼ Explain the use of a Levey-Jennings chart.
◼ Describe how to correct “out of control”
problems.
Quantitative QC - Module 7 2
The Quality Management System
Documents Occurrence
& Assessment
Management
Records
Quantitative QC - Module 7 3
Process control
Quantitative QC - Module 7 8
Implementation steps
◼ establish policies and procedures
◼ assign responsibility, train staff
◼ select high quality controls
◼ establish control ranges
◼ develop graphs to plot control values -
Levey-Jennings charts
◼ monitor control values
◼ develop procedures for corrective action
◼ record all actions taken
Quantitative QC - Module 7 9
What is a Control?
Quantitative QC - Module 7 10
Calibrators vs. Controls
Quantitative QC - Module 7 11
Calibrators Controls
A substance with a specific A substance similar to
concentration. patients’ samples that
has an established
Calibrators are used to set concentration.
(calibrate) the measuring
points on a scale. Controls are used to ensure
the procedure is working
1 2 3 4 5 properly.
1 2 3 4 5
Quantitative QC - Module 7 12
Characteristics of Control Materials
◼ appropriate for the diagnostic
sample
◼ values cover medical decision
points
◼ similar to test sample (matrix)
◼ available in large quantity;
ideally enough for one year
◼ can store in small aliquots
Quantitative QC - Module 7 13
Types of Control Materials
Quantitative QC - Module 7 14
Sources of Controls Materials
◼ commercially prepared
◼ made “in house”
◼ obtained from another laboratory,
usually central or reference
laboratory
Quantitative QC - Module 7 15
Control Materials
Target value predetermined
ASSAYED
Verify and use
Quantitative QC - Module 7 16
Choosing Control Materials
◼ values cover medical decision points
◼ similar to the test sample
◼ controls are usually available in high, normal,
and low ranges
Quantitative QC - Module 7 17
Preparation and Storage of
Control Material
◼ adhere to manufacturer’s
instructions
◼ keep adequate amount
of same lot number
◼ store correctly
CONTROL
Quantitative QC - Module 7 18
Steps in Implementing Quantitative QC
Mean
1SD
2SD
Quantitative QC - Module 7 3SD 19
Measurement of Variability
Variability is a normal occurrence
when a control is tested repeatedly
Affected by:
Performance
Operator Environmental characteristics
technique conditions of the
measurement
F
r
e
q
u
e
n
c
y
Measurement
Quantitative QC - Module 7 21
Measures of Central Tendency
Quantitative QC - Module 7 22
Not all central values are the same
Mean Mode
F Median
r
e
q
u
e
n
c
y
Measurement
Quantitative QC - Module 7 23
Symbols Used in Calculations
Quantitative QC - Module 7 24
Calculation of Mean
X 1 + X 2 + X 3 ... X n
X=
n
X = Mean
X1 = First measurement
X2 = Second measurement
Xn = Last measurement in series
n = Total number of measurements
Quantitative QC - Module 7 25
Example
Quantitative QC - Module 7 26
Data showing outlier
1. 192
mg/dL 11. 204 mg/dL
2. 194
mg/dL 12. 208 mg/dL
3. 196
mg/dL 13. 212 mg/dL
4. 196
mg/dL 14. 198 mg/dL
5. 185
mg/dL 15. 204 mg/dL
6. 196
mg/dL 16. 208 mg/dL
7. 200
mg/dL 17. 212 mg/dL
8. 200
mg/dL 18. 198 mg/dL
9. 202
mg/dL 19. 192 mg/dL
10. 270 mg/dL 20. 196 mg/dL
Quantitative QC - Module 7 27
Normal distribution
◼ all values symmetrically distributed
around the mean
◼ characteristic “bell-shaped” curve
◼ assumed for all quality control
statistics
Frequency
mean
Quantitative QC - Module 7 28
Quality Control is used to monitor
the accuracy and the precision
of the assay.
What are
accuracy and
precision?
Quantitative QC - Module 7 29
Definitions
Quantitative QC - Module 7 30
Accuracy and Precision
Accurate Precise
and Precise but Biased Imprecise
Frequency
random measurement
will fall within:
68.2%
Quantitative QC - Module 7 32
Standard Deviation (SD)
(x1 − x )
2
SD = n −1
Standard Deviation – Statistical Formula
Quantitative QC - Module 7 33
Coefficient of Variation
The coefficient of variation (CV) is the SD
expressed as a percentage of the mean.
SD
CV = x 100 %
mean
◼ CV is used to monitor precision
◼ CV is used to compare methods
◼ CV ideally should be less than 5%
Quantitative QC - Module 7 34
Levey-Jennings Chart
Quantitative QC - Module 7 35
Statistics for Quantitative QC
Quantitative QC - Module 7 36
Draw lines for Mean and SDs
(calculated from 20 controls)
196.5 +3SD
194.5 +2SD
192.5 +1SD
190.5 MEAN
188.5 -1SD
186.5 -2SD
184.6
-3SD
Days
Quantitative QC - Module 7 37
Levey-Jennings Chart
196.5
+3SD
194.5 +2SD
192.5 +1SD
190.5 MEAN
188.5 -1SD
186.5 -2SD
184.6 -3SD
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19
Days
Quantitative QC - Module 7 38
Number of Controls
Interpretation depends on number of
controls run with patients’ samples.
Quantitative QC - Module 7 39
Detecting error
◼ random error: variation in QC
results with no pattern- only a cause
for rejection if outside 2SDs.
◼ systematic error: not acceptable,
correct the source of error
Examples:
shift–control on one side of the mean 6
consecutive days
trend–control moving in one direction–
heading toward an “out of control” value
Quantitative QC - Module 7 40
Levey-Jennings Chart
Shift
196.5 +3SD
194.5 +2SD
192.5 +1SD
190.5 MEAN
188.5 -1SD
186.5 -2SD
184.6
-3SD
Days
Quantitative QC - Module 7 41
Levey-Jennings Chart
Trend
196.5 +3SD
194.5 +2SD
192.5 +1SD
190.5 MEAN
188.5 -1SD
186.5 -2SD
184.6
-3SD
Days
Quantitative QC - Module 7 42
Measurement Uncertainty
Quantitative QC - Module 7 43
If QC is out of control
◼ STOP testing
◼ identify and correct problem
◼ repeat testing on patient
samples and controls after
correction
◼ Do not report patient
results until problem is solved
and controls indicate
proper performance
Quantitative QC - Module 7 44
Solving out-of-control problems
◼ identify problem
◼ refer to established
policies and procedures
for remedial action
Quantitative QC - Module 7 45
Possible Problems
◼ degradation of reagents or kits
◼ control material degradation
◼ operator error
◼ failure to follow manufacturer’s
instructions
◼ an outdated procedure manual
◼ equipment failure
◼ calibration error
Quantitative QC - Module 7 46
Summary
A quality control program for quantitative tests is
essential. It should:
◼ monitor all quantitative tests
◼ have written policies and procedures, followed by
laboratory staff
◼ have a quality manager for monitoring and
reviewing QC data
◼ use statistical analysis, provide for good records
◼ provide for troubleshooting and corrective action
Quantitative QC - Module 7 47
Key Messages
◼ A QC program allows the laboratory to
differentiate between normal variation and
error.
◼ The QC program monitors the accuracy and
precision of laboratory assays.
◼ The results of patient testing should never
be released if the QC results for the test
run do not meet the laboratory target
values.
Quantitative QC - Module 7 48
Organization Personnel Equipment
Questions?
Purchasing Process Information
Comments?
& Control Management
Inventory
Documents Occurrence
& Assessment
Management
Records
Quantitative QC - Module 7 49