• Is a 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 resemble
patients 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.
• Is one component of the quality
assurance system and is part of
the performance monitoring that
occurs after a test has been
established.
• 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.
• 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 an
analytical method to detect the proportion of
individuals with the disease. It indicates the ability of
the test to generate more true-positive results and few
false negative results.
• Sensitivity (%) = 100 x # of True positives
total # of tested individuals
• DIAGNOSTIC SPECIFICIY  Is the ability of
the analytical method tto detect the proportion
of individuals without the disease.it reflects the
ability of the method to detect true negative
with very few false-positives.
• Specificity (%) 100 x # of without the disease
Total number of individuals without the disease

• It involves the analyses of
control samples together with
the patient specimens.
• It detects changes in
performance between present
operation and the “stable”
operation.
• It is important for the daily
monitoring of accuracy and
precision
• It detects both random and
systematic errors within a one-
week cycle
INTERRLAB QC
EXTERNAL QC
• 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
• The CAP proficiency programs
is the gold standard of
clinical laboratory external
QC testing.
• EQUAS  External Quality Assurance
System
• Unknown sample from reference laboratory
•12 samples annually; 1 sample/month
• REFERENCE LAB FOR CHEM AND PROVIDING
CHEM EQUAS SAMPLES  Philippine Lung
Center
• Routine Tests 20 or more requesed tests
within 24 hours; usually Glucose, TAG and
Cholesterol
 STANDARD CONTROL
• Most specific known • Resemble patient’s
sample sample
• Contain one • Contain several
component/analyte
analytes
only
• colorless • Yellow just like
serum
• Uknown samples must be tested by the
laboratorians who regularly perform
analysis of patient specimens using the
same reagents and equipment for actual
patient specimens, and the results are
submitted to the program provider,
preferably as soon as every analysis is
done.
• Results of the proficiency testing must not
be shared with other laboratories “ during
the testing period”- comparison studies
can be made after the testing cycle to
identify areas for improvement;
• Results must release monthly, including the
equipment, reagents and methods used.
• The ultimate goal of proficiency testing is
to ensure our clinicians that patient results
are accurate.
• In external QC, difference of greater than 2SD
in the results indicates that a laboratory is not in
agreement with the rest of the laboratories
included in the program.
• If I case a laboratory failed to identify or
resolve an error or discrepancy in the test
process, the facility is at risk of continous
operation and may be recommended for
closure
TO CHECK THE STABLITY OF THE
MACHINE
TO CHECK THE QUALITY OF REAGENTS
TO CCHECK TECHNICAL (OPERATOR
ERRORS
• The accuracy of a solution depends on the control
solutions, how they are originally constituted and
how they remain stable overtime.
• General Chemistry assays used 2 levels control
solutions, while immunoassays used 3 levels.
• To establish statical quality control on a new
instrument or on new lot number of control
materials, the different levels of control material
must be analysed for 20 consecutive days in
duplicates.
• For highly précised assays (with <1% CV) such as
blood gases, analysis for 5 days is adequate.
• Control limits are calculated from the mean and SD.
• The ideal control/ reference limit is between +/-
2SD
• When changing a new lot #, laboratorians use the
newly calculated mean value as the target mean
but retain the previous SD value, but when more
data are obtained, all values should be averaged
to get best estimates of the mean and SD
1. RESEMBLE HUMAN SAMPLE (HUMAN CTRL PREFERRED)
• NON-ICTERIC
• NON-HEMOLYSE
• SAME ANALYTES WITH SERUM
• HAVE THE CAPACITY OF MONITORING ANALYTICAL
ERRORS.
2. NON-INFECTIOUS
3. INEXPENSIVE AND STABLE FOR LONG PERIODS
4. NO MATRIX EFFECTS/KNOWN MATRIX EFFECTS
5. WITH KNOWN ANALYTE CONCENTRATIONS (ASSAYED
CONTROL)
6. CONVENIENT PACKAGING FOR EASY DISPENSING AND
STORAGE
• It is recommended by Westgard et al and CLIA that
40 to 100 samples be run ach method I duplicate
on the same day over 8-20 days, ideally within 4
hours, to determine its accuracy and precision.
• If only 40 samples will be measured, daily analysis
in duplicate of 2-5 specimens should be followed
for at least 8 days.
• The most important characteristic of method
evaluation is to determine if the total error
(Random and Systematic) is less than the allowable
error.
• Are errors encountered in the collection ,
preparation and measurement of samples,
including transcription and releasing of
laboratory results.
1. RANDOM ERROR/ INDETERMINTE/
UNPREDICTABLE/IMPRECISION
• Is present in all measurements; it is due to
chance; variations in technique
• It is due to instrument, operator and
environmental conditions such as pipetting
error, mislabeling, temperature fluctuation, and
improper mixing of sample and reagent
• Best measured by: SD & CoV
2. SYSTEMATIC ERROR/ DETERMINATE/
PREDICTABLE/ INACCURACY
• Is an error that influences observations consistently in
one direction (constant difference)
• It is detected either + or _ bias – often related to
calibration probs, deterioration of reagents and
control materials, improperly made standard solutions,
contaminated solutions, unstable and inadequate
reagent blanks, leaky ion selevtive electrode (ISE),
failing instrumentation and poorly written procedures.
• Statistical tool to confirm: MEAN or AVERAGE
a. CONSTANT ERROR
• It refers to a difference between the target value and
the assayed value.
• It is independent of sample concentration
b. PROPORTIONAL/SLOPE/PERCENT ERROR
• It results in greater deviation from the target value
due to higher sample concentrations
• It exists when the difference between the test method
and the comparative method values is proportional to
the analyte concentration
3. CLERICAL ERROR
• IS THE HIGHEST FREQUENCY OF ERRORS
OCCURS WITH THE USE OF
HANDWRITTEN LABELS AND REQUEST
FORMS
1. IMPROPER PATIENT PREPARATION
2. MISLABELED SPECIMEN
3. INCORRECT ORDER OF DRAW
4. INCORRECT PATIENT IDENTIFICATION
5. WRONG SPCIMEN CONTAINER
6. INCORRECT ANTICOAGULANT TO BLOOD RATION
7. IMPROPER MIXING OF SAMPLES AND ADDITIVES
8. INCORRECT SPECIMEN PRESERVATION
9. INCORRECT USED OF TUBES FOR BLOOD
COLLECTION
10.MISHANDLED SPECIMEN (TRANSPORT AND STORAGE)
11.MISSED OR INCORRECTLY INTERPRETED LABORATORY
REQUESTS
1. UNAVAILABLE OR DELAYED LABORATORY
RESULTS
2. INCOMPLETE LABORATORY RESULTS
3. WRONG TRANSCRIPTION OF THE PATIENT’S
DATA AND LABORATORY RESULTS.
• INDICATORS OF ANALYTIC PERFORMANCE: INTERNAL
QC, PROFICIENCY TESTING, ACCREDITATION, QULITY
ASSURANCE MONITORING AND LABOTORY
UTILIZATION
• THE FIRST STEP IN METHOD EVALUATION IS THE
PRECISION STUDY WHICH ESTIMATES THE RANDOM
ERROR.
• TO STUDY IMPRECISION OR RANDOM ERROR:
 2 Control solutions are run twice a day in a 10-to-20
day period- by testing multiple samples on different
days, a better assessment of random error over time is
achieved.
• Non laboratory personnel were responsible for
29% of the errors within regard to laboratory
results.
• Online compute input is the most error-free
means of requesting laboratory tests.
• ALLOWABLE ERROR (Ea)  it is based on the
quantity of error that will negatively affect
clinical decisions
• the total error must be less than the Ea or fixed
limits for a method to be considered acceptable.
• MEAN  Is a measure of central tendency. It is
associated with symmetrical or normal
distribution
• Standard Deviation is a measure of the
dispersion of values from the mean. It helps
describe the curve. A measure of distribution
range.
• It is the most frequently used measure of variation
• SD is inversely proportional to precision
• COEFFICIENT OF VARIATION (CV) is the
percentile expression of the mean; an index of
precision.
• Ideal result = 2-4%
• CV = SD/ mean x 100
• Aka Total % error
• VARIANCE  Is called the SD squared; a measure
of variability. I t represents the difference between
each value and the average of the data.
• V= (SD)2
1. INFERENTIAL STATISTICS – ARE USED TO COMPARE THE MEANS
OR SD OF TWO GROUPS OF DATA
2. F-TEST- IS USED TO DETERMINE WHETHER THERE IS A
STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE SD OF 2
GROUPS OF DATA
3. MEADIAN- IT S THE MIDPOINT OF A DISTRIBUTION; 50% CENTILE.
4. MODE- IS THE MOST FREQUENT OBSERVATION; IT IS USED TO
DESCRIIBE DATA WITH TWO CENTERS (BIMODAL)
5. RANGE- IS THE SIMPLEST EXPRESSION OF SPREAD OR
DISTRIBUTION; IT IS THE DIFFERENCE BETWEEN THE HIGHEST AND
LOWEST SCORE IN A DATA.
6. SD 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 DETERMNE WHETHER THERE IS STATISTICALLY
SIGNIFICANT DIFFERENCE BETWEEN THE MEANS OF TWO
GROUPS OF DATA
• PARAMETRIC TESTS= t-test and ANOVA
• 3 measures of spread of distribution: CV, SD &
Range
• The acceptable range is 95% confidence limit,
which is equivaleent to + 2SD
• Degree of freedom  indicates the number
quantities free to vary.
• + 1 SD = 68% + 2 SD = 95%
• + 3 SD= 99%
• Is used to observe values of control
materials over time to determine
reliability of the analytical method.
• Is utilized to detect and observe
analytic errors such as inaccuracy and
imprecision
• AKA Bell-Shaped Curve, Normal Distribution Curve
• It occurs when the data set can be accurately
described by the SD and the mean.
• It occurs when data elements are centered around
the mean with most elements close to the mean.
• It focuses on the distribution errors from the
analytical method rather than the values from a
healthy or patient population.
• Can identify both random and systematic error.
• It calculates the difference between QC results
and the target means.
• Common method: V mask
• It identifies consistent bias problems; it requires
computer implementation
• This plot will give the earliest indication of
systematic errors (trend) and can be used with
the 13s rule.
• Results are out of control when the slope exceeds
45o or a decision (+ 2.7 SD) is exceeded.
• Will identify systematic error
• 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 (y axis) and thee other
specimen on the abscissa (x-axis)
• Aka Dot Chart
• It is the most widely used QC chart in the
lab
• 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
1. TREND  Is formed by control values that
either has gradual increase of decrease for
6 consecutive days;
 Main cause: deterioration of reagents
2. SHIFT  Is formed by control values that
distribute themselves on one side or either side
of the mean for 6 consecutive days; Accuracy
problem; Systematic; Sudden change
Main cause: improper calibration of the
instrument, change in reagent formulation/lot#,
failuure in the sampling & dispense system
3. OUTLIERS  Are control values that are
far from the main set of values
are highly deviating values
are caused by random or systematic
errors (pipetting error)
• Multiple rules
• It recognized that the use of simple upper
and lower limits is not enough to identify
analytical problems
• The combination of the control rules used
in conjunction with a control chart has been
called the Multirule Shewhart procedure
• Warning rule
• For screening
purposes
• One ctrl result
exceeds the mean
+ 2SD
• Rejection rule
• Random error
determination
• One ctrl result
exceeds the mean
+ 3SD
• Rejection rule
• Respond most often
to systematic error
• The last two ctrl
results exceed
either the mean +
2SD
• Respond most often
to systematic error
• The last four ctrl
results exceed
either the mean +
1SD
• Respond most often
to random error
• The range or
difference between
the highest and
lowest ctrl result
exceeds 4SD
• Systematic error
• Ten consecutive
results are on the
same side of the
target mean; either
higher or lower
mean
• The acceptable reference limit is set at + 2SD.
• The upper and lower reference limit define a specified
percentage, usually 95%, of the values of a certain
group of population, hence, 5% of the population will
fall outside the reference interval/limit in the absence
of an abnormality of disease.
• If the analytical test results are not within the +2SD,
run a new set of control and repeat specimen testing.
• A control value outside the 3s would require corrective
action such as running a new set of control
 Is the most commonly used
 Is a set of patient based-QC technique
control and patient It requires computerization
specimens assayed, of test data so that current
evaluated and results can be compared
with past results
reported together Is the difference between
two consecutive
measurements of the same
analytes on the same
individual.
 Are used to  is the concentration
measure systematic range over which the
errors or inaccuracy measured
concentration is equal
caused by
to the actual
substances other concentration without
than the analyte modification of the
method.
Sometimes
referred to as
 is a type of
absurd value analytical testing
It helps detect performed outside the
sample confines of the central
contamination or laboratory, usually by
dilution, non laboratorian
inadequate personnel (e.q. nurses)
sample value, etc.
 It can be  it depends on sensitivity,
envisioned as a specificity and prevalence
tripod with of the disease being test.
program Baye’s theorem
development, (predictive value theory)
assessment and describes the relationship
monitoring, and bet. Posttest and pretest
quality probability of disease or
improvement no disease and based on
forming the three the sensitivity and
legs. specificity of the test.