QUALITY

CONTROL
Quality Control
◦ Is as system of ensuring accuracy and precision in the laboratory by including quality control reagents in every series
of measurements.
◦ Is a process of ensuring that analytical results are correct by testing known samples that resembles patient sample
◦ 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.
◦ Is one component of the quality assurance system, and is part of the performance monitoring that occurs after a test has
been established.
Parameters of Quality Control
Sensitivity
◦ Is the ability of an analytical method to measure the smallest concentration of
the analyte of interest.
Specificity
◦ Is the ability of an analytical method to measure only the analyte of interest.
Accuracy
◦ Is the nearness or closeness of the assayed value to the true or target value.
◦ It is estimated using 3 types of studies: recovery, interference, recovery, interference, recovery,
interference, and patient sample comparison.
◦ Recovery study determines how much of the analyte can be identified in the sample; interference study
determines if the specific compounds affects the laboratory tests like hemolysis, turbidity, and icteric;
sample comparison study is used to assess presence of error (inaccuracy) in actual patient sample.
Precision or reproducibility
◦ Is the ability of an analytical method to give repeated results on the same sample that agree
with one another.
Practicability
◦ Is the degree by which a method is easily repeated.
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.
Diagnostic sensitivity
◦ is the ability of the analytical method to detect the proportion of individuals with the disease.
◦ It indicates the ability of the test to generate more tru-positive results and few false-negatives.
◦ Screening tests requires high sensitivity so that no case is missed.
◦ Sensitivity(%)=100 x the number of diseased individuals with positive test/total number of diseased
individuals tested.
Diagnostic specificity
◦ Is the ability of the analytical method to detect the proportion of individuals without the disease.
◦ It reflects the ability of the method to detect true-negatives with very few false-positives.
◦ Confirmatory tests requires high specificity to be certain of the diagnosis.
◦ Specificity(%)= 100 x the number of individuals without the disease with a negative test/total number of
individuals tested without the disease
◦ 100% sensitivity and specificity indicate that the test or method detects every patient with the disease and
that the test is negative for every patient without the disease.
Kinds of Quality Control
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.
Interlab Quality Control (External QC)
◦ It involves proficiency testing programs that periodically provides samples of unknown concentrations to participating clinical
laboratories.
◦ It is important in maintaining long-term accuracy of the analytical methods.
Rationale of the External QC/Proficiency
testing
The ultimate goal of proficiency testing is to ensure our clinicians that patient results are accurate.
Objectives of Quality Control
◦ To check the stability of the machine.
◦ To check the quality of the reagents.
◦ To check technical (operator) errors.
Control Limits (Control Values)
◦ These are expected values represented by intervals of acceptable values with upper and lower limits.
◦ If the expected (control) values are within the desired control limits, the clinicians are assured that the test results are accurate
and precise.
Control materials (“QC material” Control Solutions)
◦ The accuracy of any assay depends on the control solutions, how they are originally constituted and how they remain stable
over time.
Characteristics of an Ideal QC Material
◦ Resembles human sample
◦ No communicable diseases
◦ Inexpensive and stable for long periods
◦ No matrix effects/known matrix effect
◦ With known analyte concentrations (assayed control)
◦ Convenient packaging for easy dispensing and storage.
Variations
◦ Are errors encountered in the collection, preparation, and measurement of samples, including transcription and releasing of
laboratory results.
Types of Error:
1. Random Error
◦ Is present in all instruments; 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, (variation in techniques) 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.
a. Constant Error
◦ It refers to a difference between the target value and the assayed value
◦ Independent of sample concentration
b. Proportional/ slope/ percent error
◦ Exists when the difference between the test method and the comparative method values is proportional to the analyte
concentration.
◦ 3. Clerical error- perfect.
Examples of pre-analytical errors
1. Improper patient preparation
2. Mislabeled specimen
3. Incorrect order of draw
4. Incorrect patient identification
5. Wrong specimen container
6. Incorrect anticoagulant to blood ratio
7. Improper mixing of samples and additives
8. Incorrect specimen preservation
9. Incorrect use of tubes for blood collection
10. Mishandled specimen (logistics, storage)
11. Missed or incorrectly interpreted laboratory reauests
Post-analytical Errors
◦ Unavailable or delayed laboratory results.
◦ Incomplete laboratory results.
◦ Wrong transcription of the patient’s data and laboratory results.
Statistics
◦ The science of gathering, analyzing, interpreting, and presenting data.
1. Mean – is a measure of central tendency.
-associated with symmetrical or normal distribution.
Mean=sigma x/ 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.
3. Coefficient of variation- is a percentile expression of the mean; an index of precision.
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.
Other terminologies
◦ inferential statistics- are used to compare the means or standard deviations of two groups of data.
◦ f-test-is used to determine whether there is a statistically significant difference between the standard deviations of two groups
of data.
◦ 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; 50 th centile.
◦ Mode- is the most frequent observation; it is used to describe data with two centers (bimodal).
◦ Range-is the simplest expression of spread or distribution; it is the difference between the highest and lowest score in a data.
◦ T-test- is used to determine whether is a statistically significant difference between the means of two groups of data.
Notes to Remember
◦ Statistical analyses are used to determine the types and quantity of error that a method has, and to decide whether the test is
still valid or unacceptable to make clinical decisions.
◦ Parametric tests: t-test and analysis of variance (ANOVA).
◦ 3 measures of spread or distribution: CV, SD and range
◦ The acceptable range is 95% confidence limit which is equivalent to +/- 2SD.
◦ SD describes the distribution of all values around the mean.
◦ SD and variance represents the average distance from the center of the data (mean) and every value in the data set.
◦ CV allows a laboratorian to compare SDs with different units.
◦ The CV of analyzers described as having reproducible test results can be lower that 1%.
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