Errors types

(Lecture 2)

Dr. Omar Abuyaman

Faculty of Allied Health Sciences

Department of Laboratory Medical Sciences
The Hashemite University
Jordan
QC , overview

• Quality Control - QC refers to the measures that must be included during each assay run to verify that

the test is working properly. (the process of detecting errors).

• Quality Assurance - QA is defined as the overall program that ensures that the final results reported by

the laboratory are correct. (the systems or procedures in place to avoid errors occurring)

• “The aim of quality control is simply to ensure that the results generated by the test are correct. However,

quality assurance is concerned with much more: that the right test is carried out on the right specimen,

and that the right result and right interpretation is delivered to the right person at the right time”.
QC , overview

• Quality Assessment - quality assessment (also known as proficiency testing) is a

means to determine the quality of the results generated by the laboratory. Quality

assessment is a challenge to the effectiveness of the QA and QC programs.

• Quality Assessment may be external or internal, examples of external programs

include NEQAS, HKMTA, and Q-probes.

QC , overview

• True value - this is an ideal concept which cannot be achieved.

• Accepted true value - the value approximating the true value, the difference
between the two values is negligible.

• Error - the discrepancy between the result of a measurement and the true (or
accepted true value).
QC , overview

Unreliable Performance ?
• Potential consequences include:-
• patient misdiagnosis
• delays in treatment
• increased costs
• avoidable retests cost US 200million USD per year
• Even a small calibration bias can effect treatment rates:
• 1% +ve bias in cholesterol result
 5% increase in patients exceeding the treatment cut-off
• 3% +ve bias
 15% increase in patient treatment.
QC , overview

Random Error
• An error which varies in an unpredictable manner, in magnitude and sign, when a large
number of measurements of the same quantity are made under effectively identical
conditions.
• Random errors create a characteristic spread of results for any test method and cannot be
accounted for by applying corrections. Random errors are difficult to eliminate but
repetition reduces the influences of random errors.
• Examples of random errors include errors in pipetting and changes in incubation period.
Random errors can be minimized by training, supervision and adherence to standard
operating procedures.
QC , overview

Random Errors
x

x x
x x
True x x x x
Value x x x
x x x
x
x

x
QC , overview

Systematic Error
• An error which, in the course of a number of measurements of the same value of a
given quantity, remains constant when measurements are made under the same
conditions, or varies according to a definite law when conditions change.
• Systematic errors create a characteristic bias in the test results and can be accounted for
by applying a correction.
• Systematic errors may be induced by factors such as variations in incubation
temperature, blockage of plate washer, change in the reagent batch or modifications in
testing method.
QC , overview

Systematic Errors

x
x x x x x x x
True x
Value
QC , overview

Error Classification..
• Pre-analytical:-
– errors before the sample reaches the laboratory
• Analytical:-
– errors during the analysis of the sample
• Post-analytical:-
– errors occurring after the analysis
QC , overview

Pre - Analytical Errors..

• Improper preparation of the patient:-
– patient fasting
• glucose test
– stress and anxiety
• urinary protein
QC , overview

Pre - Analytical Errors..

• Improper preparation of the patient
• Improper collection of the blood sample:-
– sample haemolysis
• LDH, potassium or inorganic phosphate
– insufficient sample volume
• unable to carry out all requested tests
– collection timing
• 24 hour urine
QC , overview
Analytical Errors..
• The sample:
– labelling
• barcoding / aliquoting
– preparation
• centrifugation / aspiration
– storage temperature
• short –term refrigeration
• medium term freezing at –20oC
• long term freezing at -80oC
– correct test selection
• Laboratory Information Management System (LIMS)
QC , overview

Post - Analytical Errors..

• The prompt and correct delivery of the correct report
on the correct patient to the correct Doctor.

• How the Clinician interprets the data to the full benefit

of the patient.
QC , overview

How can Analytical Quality be Controlled ?

• Internal Quality Control (IQC).

• daily monitoring of quality control sera

• External Quality Assessment (EQA).

• comparing of performance to other laboratories.
Pre-Analytical & Analytical Causes of Error

30
Post- Analytical Causes of Error
• Incorrect reference values
• Incorrect data entry of lab result

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Random Analytical Error (RE)
Factors contributing to random analytical error (RE) are those that
affect the reproducibility of measurement. These include:
• instability of the instrument,
• variations in the temperature,
• variations in the reagents and calibrators (and calibration-curve
stability),
• variability in handling techniques such as pipetting, mixing, and
timing, and
• variability in operators.
These factors superimpose their effects on each other at different
times. Some cause rapid fluctuations, and others occur over a longer
time. Thus RE has different components of variation that are related
to the actual laboratory setting.
Systematic error
• Systematic change in the test system resulting in a displacement of
the mean from the original value
• Systematic error of an analytic system is predictable and causes shifts
or trends on control charts that are consistently low or high

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Causes of Systematic Error
• Change in reagent or calibrator lot numbers
• Wrong calibrator values
• Improperly prepared reagents
• Deterioration of reagents or calibrators
• Inappropriate storage of reagents or calibrators
• Variation in sample or reagent volumes due to pipettor misalignments
• Variation in temperature or reaction chambers
• Deterioration of photometric light source
• Variation in procedure between technologists

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Shifts and Trends
• Shift
• QC data results are distributed on one side of the mean for 6-7 consecutive
days

 Trend
• Consistent increase or decrease of QC data points over a period of 6-7 days

40
Random Error
• Imprecision of the test system causing a scatter or spread of control
values around the mean

42
Causes of Random Error
• Air bubbles in reagent
• Improperly mixed reagents
• Reagent lines, sampling, or reagent syringes
• Improperly fitting pipette tips
• Clogged or imprecise pipetter
• Fluctuations in power supply

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Random Analytical Error (RE) Components

• Within-run component of variation (wr)

• Within-day, between-run variation (br)

• Between-day component of variation (bd)

 Within-run component of variation (wr)

is caused by specific steps in the procedure:

1. sampling

2. pipetting precision

3. short-term variations in temperature and

4. stability of the instrument.

 Within-day, between-run variation (br)

is caused by:
1. instability of calibration curve
2. differences in recalibration that occur throughout the day,
3. longer term variations in the instrument,
4. small changes in the condition of the calibrator and reagents,
5. changes in the condition of the laboratory during the day, and
6. fatigue of the laboratory staff.
Between-day component of variation (bd)
is caused by:

1. daily variations in the instrument,

2. changes in calibrators and reagents (especially if
new vials are opened each day), and
3. changes in staff from day to day.
Total Variance of a Method (t2)

t2 = wr2 + br2 + bd2

RE = t