Quality Control In Clinical Laboratory BI-11.

16
Quality control is a statistical system for measuring the reproducibility of degree
of precision in laboratory procedures.
It is an excellent means of improving laboratory efficiency. The programme
ensures the physicians, quality results and the patients.
‘The study of the sources of variation for which laboratory is responsible and
procedures used to recognize and minimize them is defined as quality control
(QC)’.
The main emphasis of QC is to monitor the precision and accuracy of the
performances of analytical methods.
• Regulatory agencies require the use of quality control (QC) materials to
assess the validity of results in a laboratory.
• Serum controls with known normal and abnormal values should be run
routinely.
• Sensitivity: of a clinical test refers to the ability of the test to identify those
patients with the disease correctly.
A test with high sensitivity tends to capture all possible positive conditions
without missing anyone.
• Sensitivity 99%.
• Specificity: of a clinical test refers to the ability of the test to identify those
individuals without the disease correctly.
Specificity relates to the ability of the test to identify negative results.
• Specificity 99%
• Accuracy: refers to closeness of an observed value to the actual amount
(true value) of substance present in the sample.
• Precision: refers to the extent to which repeated determination on an
individual specimen varies using a particular technique and is dependent
on how rigorously the methodology is followed.
Precision denotes the amount of variability of an estimate on
repeated measurements. If you repeat a study multiple times, the variation
that arises by virtue of the way in which subjects are sampled is called
sampling variation/random variation. Precision is an indicator of random
error. It is usually represented as confidence interval.
 • The mean or average : mean is the average of the given sample or data
set. It is equal to the total of observation divided by the number of
observations. The average is the sum of all values divided by the number
of values.
• Standard deviation : This is a statistical expression of the scatter or
dispersion of values around a central average value.
• Validity: Validity is the ability to measure what it intends to measure. It
refers to a lack of systematic error. Internal validity refers to the strength
of the inferences from the study and external validity is the ability to
generalize study results to a more universal population.
Type of material used for quality control –
Frozen, pooled patient specimen,
Commercial lyophilized, freeze dried pool material.
Commercial stabilized low temperature liquid serum pools.
Evaluation of QC results – By standard deviation and coefficient of variation.
1) Standard deviation (SD) – standard deviation is a measure of the dispersion
of a set of data from its mean.
2) Coefficient of variation (CV) – CV refers to the coefficient of variation,
which describe the standard deviation as a percentage of the mean.
3) Frequency of analysis of QC sample:
4) Daily preparation and analysis of quality control sample should be a
regular feature of the laboratory.
5) Control pools used by laboratory are of
6) 1) Normal pool – it contains constituents at concentrations within the non-
diseased reference range.
2) Abnormal pool – analytes at concentration outside the reference range.
7) All tests are performed after running internal quality control daily and
verifying their results.

Monitoring QC data:
QC results are monitored by LEVY-JENNING CHART.
Plot control values each run , make decision regarding acceptability of run.
Monitor over time to evaluate the precision and accuracy of repeated
measurements.
Review charts at defined intervals, take necessary action and document.

Findings –
a) Ideally laboratory should have control values clustered about the mean (+/-
2SD) with little variation in the upward or downward direction.
b) Imprecision – large amount of scatter about the mean. Usually caused by errors
in technique.
c) Inaccuracy – may see as a trend or a shift usually caused by change in the
testing process.
d) Random error – no pattern, usually poor technique malfunctioning equipment.

Westgard Rules:
It uses a combination of control rules to judge the acceptability of an analytical
run and to decide whether an analytical run is in-control or out of control, multi
– rules are popularly known as westgard rules.
Calibration and calibration materials
 • Calibrators and controls are not the same.
• Calibrator is a material with known quantitative/qualitative characteristics
(concentration) and is used to standardize the method or instrument,
standard solution in water may be satisfactory.
Internal quality control program
Internal quality control can be maintained by the following various ways.
1.Use of standardized glassware, reagents and equipment.
2. Maintenance of a) proper analytical skill from start to finish. b) required quality
of regents. c) desired performance of the instruments.
3. Selection of accurate and precise methods
4.Routine use of various primary standards, quality control sera, reference sera,
previously analysed specimen and statistical methods to evaluate the obtained
results.
Day-to-day internal quality control program is very useful for maintenance of
consistency and precision.
Control samples prepared by laboratory e.g. pooling sera together and analysing
them.
Pooled sera, carefully mixed, dispensed into small volumes, stoppered and
preserved into small volumes, stoppered and preserved in a frozen store at -20oC.
External quality control program:
1.External QC program is designed and aimed to provide comparability of results
between all the laboratories using the same method anywhere.
2. Use of quality control serum prepared by a recognised body. In this, results of
several laboratories which analyse the same specimen are utilised to judge the
standard of the technical skill in the laboratory. The data collected from different
laboratories gives idea about the accuracy of the analysis.
3.Analysis of some specimen brought from recognised laboratories and
comparative studies of the analysed specimen.

****************************$$$$$$******************************