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Internal ,External
Quality Control &
(SOPs)
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Internal and External QC

Random and Systematic errors must be

detected at an early stage and then every
effort should be taken in order to minimize
them.
The strategy for their detection consists of
specific SQC methods which are divided in
two categories: Internal and External SQC

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statistical quality control (SQC)

SQC is faster and more efficient than single

checking.
“SQC is process that minimizes the variability of a
procedure” or it is “The process that focuses on
revealing any deviations from well defined standards”
.

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Internal Quality Control (IQC)

It concludes all SQC methods which are performed every

day by the laboratory personnel with the laboratory’s
materials and equipment for the continuous monitoring of
operation and the results of measurements in order to
decide whether results are reliable enough to be released.
It checks primarily the precision (repeatability or
reproducibility) of the method.

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IT involves the practical steps which depend on the use of

two strategies:
(1) Analysis of reference materials to monitor trueness and
statistical control.
(2) Duplication to monitor precision. Duplicates for IQC must
reflect as far as possible the full range of variation present in
the run. The best placing of duplicates is at random within
each run.

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Reference materials in IQC are used in combination with control

charts that allow both persistent bias and run effects to be
addressed .
Persistent bias is evident as a significant deviation of the Centre
line from the assigned value.
Internal quality control is an essential aspect of ensuring that
data released from a laboratory are fit for purpose.
Runs where performance falls outside acceptable limits, the data
produced can be rejected and, after remedial action on the
analytical system, the analysis can be repeated.

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External Quality Control (EQC).

It concludes all SQC methods which are performed periodically (i.e.

every month, every two months, twice a year) by the laboratory
personnel with the contribution of an external center (referral
laboratory, scientific associations, diagnostic industry etc.).
It checks primarily the accuracy of the laboratory’s analytical methods.
However, there are certain EQC schemes that check both the accuracy
and the precision.
External quality control or external assessment scheme (EQAS) or
proficiency testing program (PT) refer to the process of controlling
the accuracy of an analytical method by interlaboratory comparison

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The verifying accuracy of results is done by comparison to an

established value for the outside sample. An organizing agency
or laboratory sends identical specimens to all participating
laboratories for testing by methods routinely adopted by them.
The results from the participating laboratories are received by
the organizing agency and compared with a "correct" answer
retrospectively and a performance score is assigned.

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All the participating laboratories are identified by a code

and reports issued to the participants contain the
performance score of all participating laboratories
including its own score. A commonly used evaluation
criterion has been the comparison of PT test results
with those of peer groups. All values that exceed 2 SD
are unacceptable.

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An EQAS coordinator normally takes following

steps:
1. The EQAS coordinator calculates the mean
value (μ) and the standard deviation (s) of
each peer group.
2. calculates the range μ ± 3s.
3. If there are laboratory results which are over
the previous range, these results are
rejected.
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4. calculates the range μ ± 2s.

5. If there are laboratory results which are over
the previous range, these results are rejected.
6. The steps 4 – 5 are repeated until there will be
no value outside the new range μ ± 2s.

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EQAS charts and statistics

Standard Deviation Index:

EQAS has its own charts and statistics. One of the most
important statistics is the:
“Standard Deviation Index” (SDI). SDI shows the distance of
the laboratory results from the consensus mean. It
quantifies the inaccuracy of the analytical method
it is calculated by the formula:
laboratory result - Mean value of peer group
Standard deviation of peer group

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The control limits of SDI are zero ± 2 SDI. The SDI value of each
laboratory can be located on a proper chart (SDI chart) as follows:

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Precision Index and Coefficient of
Variation Ratio (CVR)

 External quality assessment schemes quite often use two

different statistics for the measurement of precision, the
Precision Index (PI) and the Coefficient of Variation Ratio (CVR).
 Standard deviation of laboratory = PI
Standard deviation of peer group
The control limits of PI are < 2.
 CV of laboratory month = CVR
CV of peer group month

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Benefits of EQA:

Assesses the overall performance of laboratory & laboratory

quality.
Establishes inter-laboratory comparison.
Serves as an early warning system for problems.
Identifies systematic kit problems.
Indicates areas towards which efforts need to be directed for
improvement of quality of results.
Identifies training needs.

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Standard Operating
Procedures (SOPs)
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SOPs are an important part of the quality

assurance programme.
SOPs help prevent mistakes rather than detecting
them.
SOP is a document, which contains detailed,
written instructions describing the stepwise
process and technique of performing a test or
procedure in the laboratory.

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 SOP helps to ensure uniformity, consistency and control over

the processes carried out. It ensures that the procedures are
done in exactly the same way each time irrespective of the
operator.
SOP should be simple and written in an easy to understand
language.
It should be titled along with version number, dated and signed
by an authorized person and updated regularly.

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It is important for the SOP document to be readily

available in the working area and is therefore also
referred to as 'laboratory bench work manual'.
SOPs are controlled documents and can be changed
only with approval of the laboratory quality manager
and/or Head of the laboratory.

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 The text of SOP for test procedure should 20
contain :

(1) Introduction
(2) Principle of method
(3) Specimen types, collection and storage
(4) Reagents, standards and control - preparation and storage
(5) Equipment, glassware and other accessories
(6) Detailed procedure
(7) Calculations, calibration curve
(8) Analytical reliabilities – (QC and Statistical assessment)

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(9) Hazardous reagents

(10) Reference range and clinical interpretation
(11)Limitations of method (e.g. interfering substances and
troubleshooting)
(12) References
(13) Date and signature of authorization
(14) (Effective date + Schedule for review)

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Thank you

Suhair Ahmed .Clinical chemistry