QUALITY CONTROL & QUALITY ASSESSMENT
MRS. R. KHAN-SANKAR
BSC. MLT, RPT
OBJECTIVES
• To define quality, quality assurance (QA) and quality control (QC).
• Understand how a QC program is implemented.
• To discuss differences between QC and QA, internal and QC.
• To understand importance of QA and QC in the lab.
• To discuss variables that affect the quality of lab results.
• Evaluate systematic and random errors
• Construct and interpret Levy-Jennings chart and understand
Westguard rules.
QA Procedures
STANDARD OPERATING PROCEDURES (SOPs) -
Each laboratory method is clearly described in standard operating procedures. These methods
are periodically reviewed for updates.
TRAINING -
Tests are performed by trained staff members. Each staff member must meet performance
criteria before performing a test.
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.
QC Samples
BLANKS -
A reagent blank is analyzed with every set of samples that are extracted or digested. This reagent blank
includes any and all reagents that are used in the analytical process and is carried through the entire
process, including extraction and filtering or digestion.
DUPLICATES -
At least ten percent of samples are analyzed in duplicate. The first, last and every tenth sample are run in
duplicate. Duplicate values typically should fall within 8% of each other for all samples unless sample
homogeneity is a problem. This information is included in the report.
STANDARD REFERENCE MATERIALS -
At least one standard reference material is analyzed with each set of samples. The values for the standard
reference materials are included in the final report. Samples run with a standard reference material that
falls outside the acceptable range are reanalyzed, including digestion or extraction if necessary.
What is Quality Assessment?
Quality Assessment (QA) is a planned, ongoing review process that observes
and evaluates the quality of all laboratory-related processes and activities.
All non-waived laboratories are required to perform quality assessment.
However, laboratories of all complexities, including waived labs, can benefit
from effective Quality Assessment since it increases the quality of the
laboratory's performance and services by identifying, evaluating, correcting, and
preventing test system problems
The basics of QA are:
• Setting goals.
• Evaluating current policies, processes, and procedures to see if they are effective and are
being followed by all staff.
• Identifying activities that have the potential for problems that can impact the quality of
lab test results.
• Detecting and keeping track of errors over time.
• Making corrections and improvements, and evaluating the effectiveness of those changes
in meeting goals.
• Reducing errors, and preventing the same errors from happening again.
• Continuous quality improvement focuses on improving processes and activities even
when no problems are identified.
Quality Systems
The updates that were made to the Clinical Laboratory Improvement Amendments (CLIA) in
2003, describe a quality systems approach to laboratory operations.
Quality systems are all of the laboratory’s policies, processes, procedures, and resources that are
needed to achieve consistently high quality testing and customer service.
The quality systems approach focuses on comprehensive and coordinated efforts to achieve
accurate and reliable test results.
Quality Assessment is an integral part of the quality systems approach, and allows you to
provide accurate and reliable test results through high quality testing while improving
patient care and customer service
Variables that affect the quality of results
• The educational background and training of the laboratory personnel
• The condition of the specimens
• The controls used in the test runs
• Reagents
• Equipment
• The interpretation of the results
• The transcription of results
• The reporting of result
Errors in measurement
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)
Sources of error
Input data required - such as standards used, calibration values, and values of
physical constants.
Inherent characteristics of the quantity being measured - e.g. CFT
(complement fixation test) and HAI (hemagglutinating inhibiting) titer.
Instruments used - accuracy, repeatability.
Observer fallibility - reading errors, blunders, equipment selection, analysis
and computation errors.
Environment - any external influences affecting the measurement.
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.
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.
LEVEY-JENNINGS
Levey– Jennings charts can help distinguish between normal variation and
systematic error.
The first QC measurements for determining whether an assay is valid or not is whether
the kit or assay is within the expiry date and that the kit/assay controls meet the stated
limits.
A Levey–Jennings chart is a graph that quality control data is plotted on to give a
visual indication whether a laboratory test is working well.
The chart should be marked with the mean and one, two and three standard
deviations above and below the mean value for easy interpretation.
Even when a control value falls within 2 SD, it can be a cause for concern. Levey–
Jennings charts can help distinguish between normal variation and systematic error.
Levey-Jennings Chart Example
A lab runs a cholesterol test. To monitor the test, they run a control daily. The control value is 250 mg/dL. The data for thirty
days is in the table below.
Table 1: Lab Test Control Data
Calculate the Mean/Average
Control Day Control Day Control
Day
1 250 11 240 21 247
2 255 12 254 22 245
3 245 13 246 23 248
4 232 14 257 24 249
5 232 15 250 25 241
6 257 16 255 26 247
7 244 17 259 27 240
8 259 18 247 28 252
9 262 19 246 29 247
10 246 20 248 30 264
The Levey-Jennings chart for this data is shown below. Each control result is plotted on the Levey-Jennings
chart. There two options for the center line on the chart. You can use the control value (as was done in this
example) or you can use the average of the results. You might want to use the average if you do not have a
control with a “known” value.
Figure 1: Levey-Jennings Chart for Lab Test Control Data
On each side of the results, there are three lines. The LCL and UCL are three
standard deviations from the center line.
The other two lines represent distances of one and two standard deviations
from the average.
The standard deviation is either a known standard deviation from previous
measurements or the standard deviation of the results. In this example, it is
the standard deviation of the results.
The red points in the chart above are “out of control.” When this is the case,
the lab tests since the last control was run are suspect.
Days 4 and 5 are out of control.
They fail a test that says two consecutive points beyond 2 standard
deviations from the average (or control value) are out of control.
This condition indicates that the accuracy of the lab test is significantly
different for those two points. Days 17 to 27 also represent an out of control
situation. This is a run of 8 or more below the average and indicates that the
accuracy of the lab test has shifted.
How to Construct a Levey-Jennings Chart
The steps in constructing a Levey-Jennings chart are shown below. It is assumed that the proper
control has been selected. These steps relate just to how the Levey-Jennings is made.
1. Decide if you will use the control value for the center line on the Levey-Jennings chart or if you
will use the average calculated from the results of running the control in the lab test.
2. Decide if you have a known standard deviation for the lab test or if you will use the calculated
standard deviation from the results from running the control in the lab test.
3. Select the frequency with which the data will be collected (e.g., before each test or daily). Data
should be collected in the order in which they are generated.
4. Select the number of data points (k) to be collected before control limits are calculated (at least
twenty). You can start the chart with as little as six points. Recalculate the control limits until you
have twenty or more points. The more data points you have, the better the estimate of the variation
in the lab test.
5. Run the control in the lab test and record the individual results.
6. Plot the results (X) on the Levey-Jennings chart.
7. Calculate the overall process average (if the control value is not being used for the center line):
where k is the number of control samples run.
8. Calculate the standard deviation (if a known standard deviation is not being used):
You can easily calculate this in Excel using the STDEV function.
9. Calculate the upper control limit (UCL) and the lower control limit (LCL).
10. Plot the center line as a sold line on the Levey-Jennings chart and label. Plot the control limits on the
Levey-Jennings chart and label. If you are using the Westgard rules (described below), you will also need to
plot the lines at +1s, +2s, -1s and -2s from the center line.
11. Interpret the chart – what is it telling you about the lab test?
Westgard Rules
The Levey-Jennings charts can be interpreted using the Westgard rules. These are really
multirole quality control procedures that are designed to minimize false rejections and
maximize error detection.
The rules below assume that one control is being run. Each test is designed to send a signal
that something in the lab test has shifted.
•12s: This test sends a signal if there is a point beyond +/- 2 standard deviations. In the original
Westgard multirule QC procedure, this test was used as a warning signal to carefully inspect
the data.
It is really not too useful a rule since computers make it easy to do charts now. If you use this
test, remember that 5% of the points in a normal distribution will be beyond +/- 2 standard
deviations from the center line. This means that you will have a large number of false
rejections compared to using the rules below.
13s: This test sends a signal when a point exceeds +/- three standard deviations.
22s: This test sends a signal if two consecutive points are beyond + 2 standard
deviations from the mean or beyond -2 standard deviations from the mean.
R4s: This test sends a signal when one point is beyond +2 standard deviations and the
following point is beyond -2 standard deviations or vice-versa.
41s: This test sends a signal when 4 consecutive points exceed +1 standard deviation or 4
consecutive points exceed -1 standard deviation.
10x: This test sends a signal when 10 consecutive control measurements fall on one side of
the centerline. Other common values used include 8 and 12.
Temperature and humidity in your lab can influence many aspects: Research
quality: Even slight variations can affect chemical reactions, cell culture growth,
reagent stability, and instrument precision.
To maintain the validity of any research being done, you need consistent protocols
across all of the laboratory testing and equipment. This starts with recording the
laboratory temperature and humidity. From there, it expands to knowing variables that
explain out-of-range results.
Best practices for lab equipment maintenance and calibration
In the world of scientific research, where precision and accuracy are crucial, laboratory
equipment plays a huge role.
From cutting-edge analyses to groundbreaking discoveries, these tools are the backbone of
modern science, serving as the link between hypotheses and conclusions.
However, the true power of these instruments lies not solely in their capabilities, but also
in the meticulous care and handling they require.
This is where maintenance and calibration come into play - the two pillars that ensure the
integrity of research outcomes and pave the way for scientific advancements.
Why maintenance and calibration matter
The dynamic connection between maintenance and calibration forms the core of the
reliability of research results.
Regular maintenance protects instruments from wear and tear, sustaining their functionality
and performance over time so that they operate at their best, while calibration fine-tunes
instruments to standardized benchmarks, making sure they run and measure correctly.
Together, maintenance and calibration make sure that the data collected during experiments is
not only correct but also easily reproducible, making sure researchers can trust the results of
their discoveries.