QUALITY CONTROL

 Is a system of ensuring accuracy and precision in the laboratory by including quality control
reagents in every series of measurements
 It is a process of ensuring that analytical results are correct by testing known samples that
resemble patient samples
 It involves the process of monitoring the characteristics of the analytical processes and detects
analytical errors during testing, and ultimately prevent the reporting of inaccurate patient test
results

PARAMETERS OF QUALITY CONTROL

1. SENSITIVITY
- Is the ability of an analytical method to measure the smallest concentration of the analyte
of interest
2. SPECIFICITY
- Is the ability of an analytical method to measure only the analyte of interest
3. ACCURACY
- Is the nearness or closeness of the assayed value to the true or target value
4. PRECISION
- Is the ability of an analytical method to give repeated results on the same sample that
agree with one another
5. PRACTICABILITY
- Is the degree by which a method is easily repeated
6. RELIABILITY
- Is 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
7. DIAGNOSTIC SENSITIVITY
- It indicates the ability of the test to generate more true-positive results and few false-
negative
TP
Sensitivity=
TP+ FN
8. DIAGNOSTIC SPECIFICITY
- It reflects the ability of the method to detect true-negatives with very few false-positive
TN
Specificity=
TN + FP
KINDS OF QUALITY CONTROL

1. INTRALAB QUALITY CONTROL

 It involves the analyses of control samples together with the patient specimens
 It detects changes in performance between the present operation and the “stable”
operation
 It is important for the daily monitoring of accuracy and precision of analytical methods
 It detects both random and systematic errors in a daily basis
 It allows identification of analytic errors within a one-week cycle
2. INTERLAB QUALITY CONTROL
 It involves proficiency testing programs that periodically provide samples of unknown
concentrations to participating clinical laboratories
 It is important in maintaining long-term accuracy of the analytical methods

TYPES OF ERROR
1. RANDOM ERROR
 Is present in all measurements; it is due to chance
 Is a type of error which varies from sample to sample
 Is the basis for varying differences between repeated measurements- variations in
technique
 It is due to instrument, operator and environmental conditions such as pipetting error,
mislabeling of samples, temperature fluctuation, and improper mixing of sample and
reagent
2. SYSTEMATIC ERROR
 Is an error that influences observations consistently in one direction (constant
difference)
 It is detected as either positive or negative bias- often related to calibration problems,
deterioration of reagents and control materials, improperly made standard solutions,
contaminated solutions, unstable and inadequate reagent blanks, leaky ion selective
electrode, failing instrumentation and poorly written procedures
 It is a measure of the agreement between the measured quantity and the true value
3. CLERICAL ERROR
  Is the highest frequency of errors; occurs with the use of handwritten labels and
request forms

STATISTICS

- Is the science of gathering, analyzing, interpreting and presenting data

1. MEAN- is a measure of central tendency. It is associated with symmetrical or normal

distribution
∑x
Mean=
n
2. STANDARD DEVIATION- is a measure of the dispersion of values from the mean. It helps
describe the normal curve. A measure of the distribution range. It is the most frequently used
measure of variation

√
2
∑ ( x-mean )
SD=
n-1
3. COEFFICIENT OF VARIATION- is a percentile expression of the mean; an index of precision
SD
CV= × 100
mean
4. VARIANCE- is called the standard deviation squared; a measure of variability. It represents the
difference between each value and the average of the data

TERMINOLOGIES

1. Inferential Statistics- are used to compare the means or standard deviations of two groups of
data
2. F- test- is used to determine whether there is a statistically significant difference between the
standard deviation of two groups of data
3. Median- is the value of the observation that divides the observations into two groups, each
containing equal number of observations. It is the midpoint of a distribution
4. Mode- is the most frequent observation; it is used to describe data with two centers
5. Range- is the simplest expression of spread or distribution; it is the difference between the
highest and lowest score in a data
6. Standard deviation index- is the difference between the value of a data point and the mean
value divided by the group’s SD
 7. T- test- is used to determine whether there is a statistically difference between the means of
two groups of data

QUALITY CONTROL CHART

 Is used to observe values of control materials over time to determine reliability of the
analytical method
 Is utilized to observe and detect analytic errors such as inaccuracy and imprecision

1. GAUSSIAN CURVE (BELL-SHAPED CURVE)

 It occurs when the data set can be accurately described by the SD and the mean
 It is obtained by plotting the values from multiple analyses of a sample
 It is a population probability distribution that is symmetric about the mean
 It occurs when data elements are centered around the mean with most elements close
to the mean
 It focuses on the distribution of errors from the analytical method rather than the
values from a healthy or patient population
2. CUMULATIVE SUM GRAPH
 It calculates the difference between QC results and the target means
 It identifies consistent bias problems; it requires computer implementation
 This plot will give the earliest indication of systematic errors and can be used with the
13s rule
 It is very sensitive to small, persistent errors that commonly occur in the modern, low-
calibration-frequency analyzer
 Results are out of control when the slope exceed 45º or a decision (±2.7SD) is
exceeded
3. YOUDEN/ TWIN PLOT
 It is used to compare results obtained on a high and low control serum from different
laboratories
 It displays the results of the analyses by plotting the mean values for one specimen on
the ordinate and the other specimen on the abscissa
 The points falling from a center but on the 45º line suggest a proportional error, and
points falling from the center but not on the 45º line suggest a constant error
4. SHEWHART LEVEY- JENNINGS CHART
  It is the most widely used QC chart in the clinical laboratory
 It allows the laboratorians to apply multiple rules without the aid of a computer
 It is a graphic representation of the acceptable limits of variation in the results of an
analytical method
 It easily identifies random and systematic errors

ERRORS WHICH CAN BE OBSERVED IN LEVEY- JENNINGS CHART

A. TREND
 Is formed by control values that either increase or decrease for six consecutive days
 Main cause: deterioration of reagents
B. SHIFT
 Is formed by control values that distribute themselves on one side or either side of the
mean for six consecutive days
 Shift in the reference range is due to transient instrument differences
 Main cause: improper calibration of the instrument
C. OUTLIERS
 Are control values that are far from the main set of values
 Are highly deviating values
 Are caused by random or systematic errors
5. WESTGARD CONTROL CHART
 It recognized that the use of simple upper and lower control limits is not enough to
identify analytical problems
 In measuring systematic error or inaccuracy, westgard recommend that at least 40
samples, and preferably 100 samples be run by comparison-of-methods experiment
 The combination of the control rules used in conjunction with a control chart has been
called the Multirule Shewhart procedure

WESTGARD CONTROL RULES:

12S- it is used as a rejection or warning rule wh en one control result exceeds the mean ± 2SD; for
screening purposes

13S- one control result exceeds the mean ± 3SD; it is effective in determining random error

22S- 2 results from the same run exceed either the mean ± 2SD; respond most often to systematic
errors
41S- any four consecutive control results exceed either mean ± 1SD; respond to systematic errors

R4S- the range or difference between the highest and lowest control result within an analytical run
exceed 4SD; respond to random errors or increased imprecision

10X- ten consecutive results are on the same side of the target mean; systematic error

GENERAL INTERPRETATION OF QC RESULTS:

 The acceptable reference limit is set at ± 2SD

 A control value between 2s and 3s is a sign of a potential problem
 A control value outside the 3s would require corrective action
 Some laboratories use the 2s as a warning limit and the 3s as an error limit

TERMINOLOGIES:

1. Analytical run- is a set of control and patient specimens assayed, evaluated and reported
together
2. Delta check- is the difference between two consecutive measurements of the same analytes
on the same individual
3. Interference experiments- are used to measure systematic errors or inaccuracy caused by
substances other than the analyte
4. Linear range/ dynamic range- is the concentration range over which the measured
concentration is equal to the actual concentration without modification of the method
5. Physiologic limit- it helps detect sample contamination or dilution, inadequate sample volume,
inadequate reagent volumes, sudden major problems with the method, or incorrect recording
or transmission of the result
6. Point of care testing(POCT)- is a type of analytical testing performed outside the confines of
the central laboratory, usually by nonlaboratorian personnel
7. Quality assurance- is a systematic action necessary to provide adequate confidence that
laboratory services will satisfy the given medical needs for patient care; its primary goal is to
deliver quality services and products to customers
8. Quality patient care- it includes effective test request forms, clear instruction for patient
preparation and specimen handling, appropriate turn-around time for specimen processing,
testing and result reporting, appropriate reference ranges and intelligent result reports
9. Recovery experiment- it shows whether a method measures all the analytes or only part of it;
it estimates inaccuracy or systematic error
10.Predictive value- it depends on sensitivity, specificity, and prevalence of the disease being test
a. Positive predictive value- is the probability that a positive test indicates disease; it is the
proportion of persons with a positive test who truly have the disease
b. Negative predictive value- is the probability that a negative test indicates absence of
disease; it is the proportion of persons with a negative test who are truly without disease
11.Reference limit/reference value- is the usual values for a healthy population that represents
95% central tendency