Clinical Chemistry Part Ii

QUALITY CONTROL IN CLINICAL LABORATORY
Quality control in clinical biochemistry laboratory refers to the reliability of investigative

service. Any error in the laboratory will jeopardize the lives of patients. lt is therefore utmost
important that the laboratory errors are identified and rectified.
Quality control comprises of four interrelated factors namely precision, accuracy, specificity
and sensitivity.
Precision refers to the reproducibility of the result when the same sample is analysed on
different occasions (replicate measurements) by the same person. For instance, the precision
is good, if the blood glucose level is 78, 80 and 82 mg/dl on replicates.
Accuracy means the closeness of the estimated result to the true value e.g., if true blood urea
level is 50 mg/dl, "the laboratory reporting 45 mg/dl is more accurate than the one reporting
35 mg/dl.
(A) Imprecise;
(B) Precise but inaccurate;
(C) Precise and accurate.
Specificity refers to the ability of the analytical method to specifically determine a particular
parameter e.g., glucose can be specifically estimated by enzymatic glucose oxidase method.
Specificity of a reaction denotes that only one substance will answer that particular test.
Specificity is determined by the method of the analysis.
Sensitivity deals with the ability of a particular method to detect small amounts of the
measured constituent. It indicates that whether the method could be utilized to test a very
dilute solution. The sensitivity of an assay is the fraction of those with a disease that the assay
correctly predicts. A test should be both sensitive and specific.
Levey Jennings chart

The quality control material is usually run daily and the values are plotted on levey Jennings
chart. In Levey Jennings chart, the concentration is plotted on the y-axis (ordinate) and the
days are plotted on x-axis (abscissa). The values should be within 2 SD of the mean values to
consider the test result is ‘under control’. If any deviation occurs beyond 2 SD, the test is
considered ‘out of control’. If the result is out of control, the type of error causing the
variation in test result should be traced.
Levey Jennings chart

All laboratories should operate a quality assurance system, which includes
1. Internal quality control procedures,
2. Participation in proficiency testing schemes,
3. Use of reference standards and
4. Accreditation
METHODS OF QUALITY CONTROL
Internal quality control

Refers to the analysis of the same pooled sample on different days in a laboratory the results
should vary within a narrow range.
Control samples Although quality control material may be prepared in the laboratory itself
by using pooled sera, commercial preparations are widely used at present because of the
quality and availability of the samples.
The commercially available materials are available in different levels of values such as
normal range materials, abnormally low range (low QC control) and high range values (high
QC control).
Laboratory should perform IQC

 Every day before the samples are analysed
 Every time the tests are run in case of infrequently used test
The tolerance range is taken as any value which falls between mean -2SD to +2SD
Value obtained each day plotted in LJ chart

If the analysis is satisfactory, the points will be scattered evenly on either side of the mid-line
within 1SD shows acuracy is maintained
values at 2SDwarning limit
values at 3SD Action limit
when the six consecutive values falls above or below the mean line it shows that the
assay is out of control.
WESTERGARD MULTIRULE CHART are applied in interpreting daily QC values.
both control values are within 2s Acceptable

single value exceeds +/- 2S WARNING
One value exceeds +/- 3S Random error is detected
two value exceeds +/- 2S sensitive to Systematic error
four value exceeds +/- 1SDsensitive to systematic error
Proficiency testing program

 Refers to comparison of laboratory test results of one laboratory with another
laboratory with similar reagents and analytical instrumentation.
 External quality control is usually performed as a proficiency testing program.
 The program is administered by a laboratory or agency approved by the authority
services such as Department of Health and Human Services or Ministry of Health.
 The agency complies the data and calculates the mean and SD from all the results
provided by the participating laboratories using the same definitive method.
External Quality Control
It is a system in which the performance of the laboratory is assessed periodically and

retrospectively by an independent external agency to indicate to the laboratory staff of
any shortcomings in performance.
It indicates a need for improving or changing internal quality control procedure.
Deals with the analysis of a sample received from outside, usually from a national or regional
quality control centre. The results obtained are then compared
 Refers to evaluation of the test results of the participating laboratory by the reference
laboratory that supplies the quality control material.
 The sample is analysed without knowing the values.
 The results will be evaluated by the reference laboratory and the evaluation Result is
sent back to the participating laboratory.
 There are different methods of evaluating the results.
One method is variance index score (VIS).
BENEFITS OF EQAS
 Assess the overall performance of the laboratory.

 Establish interlaboratory comparison.
 Serves as early warning system for problems.
 Identifies systematic kit problems.
 Provides objective evidence of laboratory quality.
 Identifies training needs.
 Indicates areas towards which efforts need to be directed for improvement of results.
Quality Assurance - QA is defined as the overall program that ensures that the final results
reported by the laboratory are correct.
QC programs ensure that information generated by the laboratory is accurate, reliable, and
reproducible.
Accreditation : is a progressive and time-proven way of helping institutions evaluate and

improve their overall performance.
Benefits of accreditation
 Building Trust.
Customers will have the confidence in the quality of products and services that you
provide.
 Minimises risk
Accredited organisations reduce the risk of providing unreliable test results, services
and products

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QUALITY CONTROL IN CLINICAL LABORATORY

Quality control in clinical biochemistry laboratory refers to the reliability of investigative

Levey Jennings chart

Levey Jennings chart

METHODS OF QUALITY CONTROL

Internal quality control

Laboratory should perform IQC

Value obtained each day plotted in LJ chart

both control values are within 2s Acceptable

Proficiency testing program

External Quality Control

It is a system in which the performance of the laboratory is assessed periodically and

 Assess the overall performance of the laboratory.

Accreditation : is a progressive and time-proven way of helping institutions evaluate and

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