Quality Control: Theory and
Practice in the Clinical
Laboratory
Presented by:
Ma.Gladys Bautista
QUALITY
◼ Doing the right thing right, the first time and
every time.
◼ Is fitness for use “Juran”. A service which is
free from deficiencies and meets customer
need
◼ It’s invisible when GOOD and impossible to
ignore when BAD
Quality Control
◼ Quality control in the medical laboratory is a
statistical process used to monitor
and evaluate the analytical process that
produces patient results.
QA/QP
◼ QA- the system used to verify that the entire
analytical process is operating within
acceptable limits (proactive)
◼ QC- the mechanisms established to measure
non-conforming method performance
(reactive)
Quality Assurance
◼ QA involves the planned and systematic
actions necessary to provide confidence in
each analytical result.
◼ It’s the overall program that ensures that the
final results reported by the laboratory are
correct. It 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.
QA Procedures
◼ Standard Operating Procedures (SOP)
Each laboratory method is clearly described
in standard operating procedures. These
methods are periodically reviewed for
updates.
QA Procedures
◼ TRAINING
◼ Tests are performed by trained staff
members. Each staff member must meet
performance criteria before performing a test.
QA Procedures
◼ RELIABLE AND WELL-MAINTAINED
EQUIPMENT
◼ Each instrument is operated by trained staff
members. Maintenance logbooks are kept for
each instrument. The instruments are
calibrated according to manufacturer
guidelines and in accordance to the relevant
SOPs. Balances, pipettes and other
measuring devices are calibrated frequently.
QA Procedures
◼ TRACEABILITY
◼ Analytical standards used are traceable to
certified reference materials. Internal
reference materials are checked as far as is
technically and economically practicable.
QA Procedures
◼ ANNUAL REVIEW OF QC RESULTS
◼ The results of proficiency testing and QC
results are annually evaluated for trends. A
system of control chart is used to determine if
the system is in a state of statistical control
and examine the relative variability of
repetitive data.
Terminology
Systematic Error
◼ Systematic error is evidenced by a change in
the mean of the control values. The change
in the mean may be gradual and
demonstrated as a trend in control values or
it may be abrupt and demonstrated as a shift
in control values.
Test Potassium Normal Control Abnormal Patient Results
Control
3.7- 4.3 mmol/L 6.7 – 7.3
mmol/L
Nov. 1 4.0 7.0 4.2, 4.0, 3.8, 5.0,
5.8, 4.2
Nov. 2 4.1 7.0 3.8, 4.4, 4.6, 3.9,
4.8, 4.4, 3.9
Nov. 3 4.0 6.9 4.4, 3.9, 3.7, 4.7
Nov. 4 4.2 7.1 4.7, 5.6, 4.2, 3.7,
4.3
Nov. 5 4.1 7.0 4.2, 4.3, 4.1, 4.3
Nov. 6 4.1 7.0 4.6, 4.4, 5.5, 3.8,
3.2
Nov. 7 4.2 8.0 2.8, 4.6, 4.2, 3.2,
Mean = 4.1 3.9, 4.1, 6.0, 4.3
Calculations and Use of QC Statistics
◼ QC statistics for each test performed in the
laboratory are calculated from the QC
database collected by regular testing of
control products.
◼ The data collected is specific for each level
of control.
◼ The most fundamental statistics used by the
laboratory are the mean [ x ] and standard
deviation [s]
Calculating a Standard Deviation
◼ Standard deviation is a statistic that quantifies how
close numerical values (i.e., QC values) are in
relation to each other.
◼ The term precision is often used with standard
deviation.
◼ It provides the laboratory an estimate of test
consistency at specific concentrations.
◼ The repeatability of a test may be consistent (low
standard deviation, low imprecision) or inconsistent
(high standard deviation, high imprecision).
Calculating a Standard Deviation
◼ Standard deviation may also be used to
monitor on-going day-to-day performance.
For instance,
◼ if during the next week of testing, the
standard deviation calculated in the example
for the normal
◼ potassium control increases from .08 to 0.16
mmol/L, this indicates a serious loss of
precision. This instability may be due to a
malfunction of the analytical process.
Investigation of the test system is
necessary and the following questions
should be asked:
◼ Has the reagent or reagent lot changed
recently?
◼ Has maintenance been performed routinely
and on schedule?
◼ Does the potassium electrode require
cleaning or replacement?
◼ Are the reagent and sample pipettes
operating correctly?
Formula for Calculation of Standard
Deviation
◼ Formula:
◼ Normal Control Mean = 4.1
◼ Standard Deviation N Control = 0.1mmol/L
Creating A Levy- Jennings Chart
◼ Standard deviation is commonly used for
preparing Levey-Jennings (L-J or LJ) charts.
◼ The Levey-Jennings chart is used to graph
successive(run-to-run or day-to-day) quality
control values.
◼ A chart is created for each test and level of
control.
◼ The first step is to calculate decision limits.
Creating A Levy- Jennings Chart
◼ These limits are ±1s, ±2s and ±3s from the
mean.
◼ The mean for the Level I potassium control in
Table 1 is 4.1 mmol/L and the standard
deviation is 0.1 mmol/L.8
Mean = 4.1 mmol/L
SD = 0.1 mmol/L
◼ ±1s range is 4.0 to 4.2 mmol/L
◼ ±2s range is 3.9 to 4.3 mmol/L
◼ ±3s range is 3.8 to 4.4 mmol/L
Why use 2SD
◼ When an analytical process is within control,
◼ approximately 68% of all QC values fall within
◼ ±1 standard deviation (1s).
◼ Likewise 95.5% of all QC values fall within ±2
standard deviations (2s) ofthe mean. About
4.5% of all data will be outsidethe ±2s limits
when the analytical process is in control.
Why use 2SD
◼Approximately 99.7% of all QC values are
found to be within ±3 standard deviations (3s)
of the mean. As only 0.3%, or 3 out of 1000
points, will fall outside the ±3s limits, any
value outside of ±3s is considered to be
associated with a significant error condition
and patient results should not be reported.
Other statistics used in Clin Lab
◼ 1. CVR
◼ 2. SDI
◼ 3. Deming regression analysis
◼ 4. Paired t- test
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