Quality Assurance vs.

Quality Control
Quality Assurance Quality Control
An overall A series of
management analytical
plan to measurements used
guarantee the
to assess the
integrity of
quality of the
data
analytical data
(The “system”)
(The “tools”)
True Value vs. Measured Value

True Value Measured Value

The known, The result of an
accepted value individual’s
of a measurement
quantifiable
of
a quantifiable
property
property
Quality Assurance
• This is a systemic laboratory program,
encompassing preanalytical, analytical, and
postanalytical factors.
• Monitors excessive variation in
• specimen acceptability
• test methodologies
• Instruments
• Reagents
• quality control
• personnel competencies
 Three phases of Quality Assurance

• Pre-analytical phase
• Analytical Phase
• Post-Analytical Phase
Sensitivity

• The ability of a method to detect and measure even

the smallest amount of the particular substance
tested for.
• Analytical sensitivity – able to measure minute
concentration of the analyte
• Diagnostic sensitivity – the test must always give a
(+) result in the presence of the disease
True (+)
= ------------------------------- x 100
True (+) + False (-)
Specificity

• The ability of a method to measure only the

component desired without the interference of
some other substances present in the same
sample.
• Analytical specificity – able to measure only one
unknown substance
• Diagnostic specificity – the test must always give a
negative result in the absence of disease
True (-)
= ------------------------------- x 100
True (-) + False (+)
Accuracy
•The ability of a method to determine the
exact value of the substance of interest in the
sample.
 Precision/ Reproducibility

• The ability of a method to give repeated results

on the same sample that agrees with one
another.
Practicability

•The degree by which a method is

easily repeated.
Reliability
•The ability of an analytical method to
maintain accuracy and precision over an
extended period of time during which
equipment, reagents and personnel may
change.
Quality control (QC)

•A system used to monitor the analytical

process to detect and prevent errors that
would impact on the accuracy and precision
of laboratory test results; includes both
statistical and nonstatistical parameters.
 Types of Quality Control Program
• External Quality Control program
• Proficiency testing
• Unknown specimen from a reference laboratory
• Internal Quality Control program or Intralaboratory Quality Control
program – establish reference values in the laboratory
- Daily monitoring of accuracy and precision
- Daily or per test monitoring
 Other purposes of Quality Control

• To check the stability of the machine

• To check the quality of reagents
• To check for technical error if any was committed by the
operator
 BENEFITS OBTAINED FROM A QC PROGRAM

• Provision of a continuous record of reliability of

laboratory results
• Permits valid judgments on the accuracy of results by
monitoring precision and permitting comparisons assay
values on known control sera with stated values.
• Gives early warning of trends and shifts in control results
so that remedial actions may be taken before serious loss
of precision.
• Monitors the performance and stability of equipment
used on the assay.
• Allows a comparison between different techniques for
the assay of a substance, and thus, derive a choice
between methods
• Establish confidence on the part of the technologist
when making a report on the result.
 PRACTICAL CONSIDERATIONS IN QUALITY
CONTROL PROGRAM:
• Specimen collection and handling
• Reagents and equipment
• Methods and procedures
• Standards and controls
• Qualified personnel
Tools of Quality Assurance and Quality
Control
Standard Solution

• For accuracy
• A solution of known characteristics and of known
value or whose concentration is accurately known
• It is composed of one known constituent only and
used as a basis of reference for the calculation of
the value of the unknown.
• 100% pure
• Serve as a reference for unknown
• Choose the standard nearest to the unknown
Control solution
• For accuracy and precision
• A solution (either commercially or non-
commercially prepared) composed of several
known constituents which can be run
simultaneously with the test to check the
accuracy of the results.
• Derived from human blood
• Pooled serum (1yr)
Characteristics of an Ideal QC Material

• Resembles human sample

• Inexpensive and stable for long period of time
• No communicable disease
• No matrix effects/ unknown effects
• With known analyte concentration
• Convenient packaging for easy dispensing and storage
Blank

• Solution without the specimen

• With reagent
• Set the reading to zero
• For accuracy
Two kinds of Quality Control reagents
• Commercially prepared
• Manufactured by different companies
which may come in the lyophilized
(pulverized, dried or powdered) and the
non-lyophilized (liquid) form
• Types:
• Assayed –values are known and
given
• Unassayed – values are known but
not given
• Non-commercially prepared
• Sources for the preparation of non-
commercially prepared QC reagents
• Left-over sera (pooled sera)
STATISTICAL CONCEPTS DEALING WITH MOST PROBLEMS
OF VARIATIONS
• Arithmetic Value or Mean or average (x)
• The mathematical result when the summation of data is
divided by the total number of data
• Standard Deviation (SD)
• It is the statement of the extent of variation in any series of
measurement
• It is a measure of the distribution range of values around the
mean value or average
• Coefficient of Variation (CV)
• It is the percentile expression of the mean which is a measure
of the relative magnitude of variability.
• It is the ratio of the standard deviation over the mean
expressed in percent
• Variance (V)
• It is a statement of variability and measures the significant
differences between groups of data.
Terminologies
Mean
• The value of observation that divides the observation into two
group, the midpoint of the distribution
Mode
• Most frequent observation
Inferential Statistics
• Used to compare the means or standard deviations of two groups of
data
T-test
• Used to determine whether there is a statistically significant
difference between the means of two groups of data
F-test
• Used to determine whether there is a statistically significant
difference between the standard deviation of two groups of data
Quality Control Charts

Gaussian Curve (Bell-shaped curve)

• Occurs when the data can be accurately described by the SD and the
mean
• Obtained by plotting values from multiple analyses of a sample
• It occurs when data elements are centered around the mean with
most element close to the mean
• Focuses on the distribution of errors from the analytical method
Gaussian Curve
Quality Control Charts

Cumulative Sum Graph (CUSUM)

• It calculates the difference between QC results and the target
means
• Most common method is the V-mask, it requires computer
implementation
• Identifies continuous bias
• Give the earliest indication of systematic errors and
can be used within the 13s rule
• Very sensitive to small, persistent errors
• Results are out of control when the slopes exceeds 45°
Cumulative Sum Graph
Quality Control Charts

Youden/ Twin Plot

• Used to compare results obtained on high and low control serum
from different laboratories
• Displays the result of the analyses by plotting the mean values for
one specimen on the ordinate and abscissa
Youden Plot
Quality Control Charts

Shewhart Levey-Jennings Chart

• Most commonly used
• Allows laboratorian to apply multiple rules without the aid of
computer
• A graphic representation of the acceptable limit of variations
Shewhart-Levey Jennings Chart
 INTERPRETATION OF RESULTS:

• In control – when the values of the control fall within the

confidence limit
• Out of control – when the values of the control fall outside the
confidence limit.
 Types of Out of Control Charts

• Trend
– It is formed by the control values that continue either to
increase or decrease for a period of six (6) consecutive days by
passing the mean.
– Main Cause: deteriorating reagent
changes in the concentration of standards.
• Shift
– It is formed by the control values that distribute themselves on
one side of the mean for a period of six (6) consecutive days.
– Main Cause: deterioration of standard
improper calibration of instruments
• Outliers
– Are values which are far from the main set of values due to wild
errors
– Main Cause: Random or systematic errors
– 1 outlier in 20 days (in control)
– 2 or more outlier in 20 days (out of control)
TYPES of VARIATION

• Random / Indeterminate Error

• Due to unpredictable cause / origin is not possibly determined (
affects the precision of results )
1. Inherent Random Error
( Inherent to the equipment )
ex.: fluctuation in temperature,
slight variation in function of instrument
TYPES:

• Random / Indeterminate Error

• 2. Limited Random Error
( limitations of observation )
ex.: fatigue of the eye of the observer

CORRECTION OF RANDOM ERRORS:

1. Use of high grade equipment
2. Careful use of the equipment
• Determinate/ Residual/ Systematic Error
- Magnitude can be determined, tangible
1. Personal Error
( Due to carelessness, prejudice and
color acuity problems )
ex.: Use of dirty apparatus
Improper calibration
Poor sample preparation
Misreading of data
Personal Bias
Improper calculations
Incorrect listing of weights
Overtitration

CORRECTION OF PERSONAL ERRORS:

- Proper training and experience
• Determinate/ Residual/ Systematic Error
2. Methodic Error
( Due to the method which cannot be eliminated
unless a change is made with it )
ex.: Co- precipitation of impurities
impurities of reagent
unstable specimen
side reactions
slow or incomplete reactions
CORRECTIONS OF METHODIC ERRORS:
- Proper method development / procedural
changes
• Determinate/ Residual/ Systematic Error
3. Instrumental Error
( Due to the instrument itself )
ex.: Variation in temperature
Contamination of equipment
Power fluctuations
Component failure
Damaged parts of the instrument
CORRECTIONS OF METHODIC ERRORS:
- Calibration
- Proper instrument maintenance
• Gross Error / Blunders
• Lead to the formation of outliers / requires statistical techniques to
be rejected
ex.: Spilling of small portions of sample
during the transfer of liquids to the
container
instrument breakdown
loss of crucial sample
Westgard Control Rules
A rejection or warning rule used to identify /
indicate if the analytical process is out of
control.

Westgard Control Rules:

12s = rejection warning when one control result exceeds the mean +
2SD ( due to random error )

13s = rejection warning when one control result exceeds the mean +
3SD ( due to random error )

2-2s = rejection warning when the last two control result exceeds
the mean +2SD (due to systematic error)
Westgard Control Rules
4-1s
= rejection warning when the last four consecutive
control results exceed the mean + 1SD ( due to
systematic error )

R-4s
= rejection warning when one control exceeds the
mean by -2SD and the other control exceeds the
mean by +2SD (due to random error or increased
imprecision )

10x
= rejection when 10 consecutive results are on the
same side of the target mean
 Levey-Jennings Control Chart

100

95
Mean = 90

Control
90
Range =

85-95
85

80

1 3 5 7 9 11 13

Days or Runs
Five factors to be considered when
establishing reference intervals

• The composition of the reference population

• Criteria used
• Physiologic and environmental conditions of the reference
population
• The specimen-collection procedure
• The analytical method used
Compute for the Standard Deviation
Your lab manager asks you to create the new control range for the
new lot of Chloride control level. The following 20 Chloride values
are gathered to determine the control limits. Using a calculator,
calculate and record the mean, the standard deviation, and the
95% confidence interval for this set of values.
 Unit: mmol/L
106 108
111 109
104 83
106 119
112 105
110 106
115 108
127 114
83 120
110 100
Compute for the mean
Compute for the SD
Confidence Limit
Compute for the Confidence Limit
THANK YOU!!

• REFERENCES:
• Bishop, M.L., Fody, E.P., & Schoef, L.E. (2018). Clinical Chemistry
Principles, Techniques, and Correlations
• Kimberly Ann Pulga, RMT, MPH. Clinical Chemistry 1 Lecture. Our
Lady of Fatima University. Valenzuela City.
• Sherine Z. Felipe, RMT, MSMT, MLS (ASCPi)CM. Clinical Chemistry 1
Lecture. Our Lady of Fatima University.
• Valenzuela City.