IQC Rule Description of the Rule

*
13s One control measurement exceeds x̅ ± 3 SD
12s One control measurement exceeds x̅ ± 2 SD
22s Two consecutive control measurements exceed x̅ + 2 SD or x̅ − 2 SD
31s Three consecutive control measurements exceed the same limit, which is either x̅ +1 SD
or x̅ − 1 SD
41s Four consecutive control measurements exceed the same limit, which is either x̅ +1 SD
or x̅ − 1 SD
R4s The difference between the high and low control measurements within a run exceeds 4
SD
7̅x Seven consecutive control measurements fall on one side of the mean
10̅x Ten consecutive control measurements fall on one side of the mean
7T Seven consecutive control measurements trend in the same direction (i.e., progressively
higher or progressively lower)
Examples of statistical IQC rules (i.e., Westgard rules).
Abbreviations: IQC, internal quality control; SD, standard deviation; x̅ , mean of the IQC. * Some of
the statistical IQC rules presented in the medical literature are counting rules. The decision criteria
are based on counting the number of IQC results that violate a certain control limit. These types of
counting rules can be expressed by abbreviations of the form “A L”, where “A” represents the
number of control observations and “L” represents a certain control limit [9]. If “A” control
observations exceed the limits of the rule, it is determined that the measurement procedure has an
out-of-control condition
7 Principles of Quality Control in Laboratory
1. Accuracy and Precision
2. Reliability
3. Standardisation
4. Regular Calibration
5. Documentation
6. Corrective Actions
7. Continuous Improvement

Importance of Quality Control in a Clinical Laboratory

After knowing what is quality control in the laboratory, the question to dig well is why is it
significant. Let’s appreciate that.

Diagnostic Accuracy: The importance of diagnostic accuracy cannot be overemphasised

in medical labs. The entire healthcare industry is dependent on it, whether it is for faster
diagnosis or timely treatment. With QC measures, especially internal quality control in a
laboratory, like instrument calibration, testing standards, etc., medical labs will improve
diagnostic accuracy manifold.

Patient Safety: Quality control directly impacts diagnostic procedures, which have an
impact on patient health safety. QC procedures minimise the risk of errors and incorrect
treatments.

Efficiency in Healthcare Services: Efficient lab quality control processes boost

productivity, cutting down result turnaround times. Faster, more accurate results support
healthcare providers in making timely decisions for patient care.

Keeping Up with Standards: Regular QC checks to ensure high standards in testing

methodologies and calibration of various equipment used. Consistent standards are
important to uphold the quality of healthcare in the long term.

Building Trust: Strong lab quality control measures build trust among patients, healthcare
providers, laboratories, and the healthcare system overall.

Regulatory Compliance: Adhering to various local and global regulations is mandatory for
medical labs. If they want to maintain regulatory compliance, they need to follow suggested
procedures and rules, which are taken care of through quality control checks for medical
labs.
 Quality Control in a Clinical Laboratory

Quality Control (QC)

is carried out in the
laboratory to nd out
and reduce
the errors in the
analytical phase of
the testing system
prior to the release of
reports of the
patients. High quality
laboratory results
involve commitment
to all phases of
testing system
including pre-
analytical, analytical
and post-
analytical phases.
Pre-analytical phase
includes those factors
which aect
the laboratory results
prior to the handling
of the sample in the
clinical labo-
ratory. Post-analytical
factors are those
which aect the
results after the an-
alytical phase is
complete. Quality
control involves
implementation of
both
Internal Quality
Control (IQC) and
External Quality
Control (EQC) which
is known as
Prociency Testing
(PT). Internal quality
control is performed
daily in the
laboratory using
controls whose
values are known,
where as
external quality
control includes the
participation of the
laboratory in an
external quality
assessment scheme
which is used as a
test of competency.
The interpretation of
quality control data is
done with the help of
both graph-
ical and statistical
tools. Quality control
data is most
commonly visualized
with the help of
Quality Control (QC)
charts which include
Levey-Jennings
(LJ) Charts and
Westgard Rules. Both
are useful in
detecting trends or
shifts
observed from the
average target value.
Corrective and
Preventive Action
(CAPA) is an
important path
towards
improvement and
eectiveness of
quality management
system in a
laboratory. The root
cause analysis of any
problem or
deviation can be
easily done by
implementing CAPA
in the
Quality Control (QC)
is carried out in the
laboratory to nd out
and reduce
the errors in the
analytical phase of
the testing system
prior to the release of
reports of the
patients. High quality
laboratory results
involve commitment
to all phases of
testing system
including pre-
analytical, analytical
and post-
analytical phases.
Pre-analytical phase
includes those factors
which aect
the laboratory results
prior to the handling
of the sample in the
clinical labo-
ratory. Post-analytical
factors are those
which aect the
results after the an-
alytical phase is
complete. Quality
control involves
implementation of
both
Internal Quality
Control (IQC) and
External Quality
Control (EQC) which
is known as
Prociency Testing
(PT). Internal quality
control is performed
daily in the
laboratory using
controls whose
values are known,
where as
external quality
control includes the
participation of the
laboratory in an
external quality
assessment scheme
which is used as a
test of competency.
The interpretation of
quality control data is
done with the help of
both graph-
ical and statistical
tools. Quality control
data is most
commonly visualized
with the help of
Quality Control (QC)
charts which include
Levey-Jennings
(LJ) Charts and
Westgard Rules. Both
are useful in
detecting trends or
shifts
observed from the
average target value.
Corrective and
Preventive Action
(CAPA) is an
important path
towards
improvement and
eectiveness of
quality management
system in a
laboratory. The root
cause analysis of any
problem or
deviation can be
easily done by
implementing CAPA
in the
Quality Control (QC)
is carried out in the
laboratory to nd out
and reduce
the errors in the
analytical phase of
the testing system
prior to the release of
reports of the
patients. High quality
laboratory results
involve commitment
to all phases of
testing system
including pre-
analytical, analytical
and post-
analytical phases.
Pre-analytical phase
includes those factors
which aect
the laboratory results
prior to the handling
of the sample in the
clinical labo-
ratory. Post-analytical
factors are those
which aect the
results after the an-
alytical phase is
complete. Quality
control involves
implementation of
both
Internal Quality
Control (IQC) and
External Quality
Control (EQC) which
is known as
Prociency Testing
(PT). Internal quality
control is performed
daily in the
laboratory using
controls whose
values are known,
where as
external quality
control includes the
participation of the
laboratory in an
external quality
assessment scheme
which is used as a
test of competency.
The interpretation of
quality control data is
done with the help of
both graph-
ical and statistical
tools. Quality control
data is most
commonly visualized
with the help of
Quality Control (QC)
charts which include
Levey-Jennings
(LJ) Charts and
Westgard Rules. Both
are useful in
detecting trends or
shifts
observed from the
average target value.
Corrective and
Preventive Action
(CAPA) is an
important path
towards
improvement and
eectiveness of
quality management
system in a
laboratory. The root
cause analysis of any
problem or
deviation can be
easily done by
implementing CAPA
in the
Quality Control (QC)
is carried out in the
laboratory to nd out
and reduce
the errors in the
analytical phase of
the testing system
prior to the release of
reports of the
patients. High quality
laboratory results
involve commitment
to all phases of
testing system
including pre-
analytical, analytical
and post-
analytical phases.
Pre-analytical phase
includes those factors
which aect
the laboratory results
prior to the handling
of the sample in the
clinical labo-
ratory. Post-analytical
factors are those
which aect the
results after the an-
alytical phase is
complete. Quality
control involves
implementation of
both
Internal Quality
Control (IQC) and
External Quality
Control (EQC) which
is known as
Prociency Testing
(PT). Internal quality
control is performed
daily in the
laboratory using
controls whose
values are known,
where as
external quality
control includes the
participation of the
laboratory in an
external quality
assessment scheme
which is used as a
test of competency.
The interpretation of
quality control data is
done with the help of
both graph-
ical and statistical
tools. Quality control
data is most
commonly visualized
with the help of
Quality Control (QC)
charts which include
Levey-Jennings
(LJ) Charts and
Westgard Rules. Both
are useful in
detecting trends or
shifts
observed from the
average target value.
Corrective and
Preventive Action
(CAPA) is an
important path
towards
improvement and
eectiveness of
quality management
system in a
laboratory. The root
cause analysis of any
problem or
deviation can be
easily done by
implementing CAPA
in the
Quality Control (QC)
is carried out in the
laboratory to nd out
and reduce
the errors in the
analytical phase of
the testing system
prior to the release of
reports of the
patients. High quality
laboratory results
involve commitment
to all phases of
testing system
including pre-
analytical, analytical
and post-
analytical phases.
Pre-analytical phase
includes those factors
which aect
the laboratory results
prior to the handling
of the sample in the
clinical labo-
ratory. Post-analytical
factors are those
which aect the
results after the an-
alytical phase is
complete. Quality
control involves
implementation of
both
Internal Quality
Control (IQC) and
External Quality
Control (EQC) which
is known as
Prociency Testing
(PT). Internal quality
control is performed
daily in the
laboratory using
controls whose
values are known,
where as
external quality
control includes the
participation of the
laboratory in an
external quality
assessment scheme
which is used as a
test of competency.
The interpretation of
quality control data is
done with the help of
both graph-
ical and statistical
tools. Quality control
data is most
commonly visualized
with the help of
Quality Control (QC)
charts which include
Levey-Jennings
(LJ) Charts and
Westgard Rules. Both
are useful in
detecting trends or
shifts
observed from the
average target value.
Corrective and
Preventive Action
(CAPA) is an
important path
towards
improvement and
eectiveness of
quality management
system in a
laboratory. The root
cause analysis of any
problem or
deviation can be
easily done by
implementing CAPA
in the
Quality Control (QC)
is carried out in the
laboratory to nd out
and reduce
the errors in the
analytical phase of
the testing system
prior to the release of
reports of the
patients. High quality
laboratory results
involve commitment
to all phases of
testing system
including pre-
analytical, analytical
and post-
analytical phases.
Pre-analytical phase
includes those factors
which aect
the laboratory results
prior to the handling
of the sample in the
clinical labo-
ratory. Post-analytical
factors are those
which aect the
results after the an-
alytical phase is
complete. Quality
control involves
implementation of
both
Internal Quality
Control (IQC) and
External Quality
Control (EQC) which
is known as
Prociency Testing
(PT). Internal quality
control is performed
daily in the
laboratory using
controls whose
values are known,
where as
external quality
control includes the
participation of the
laboratory in an
external quality
assessment scheme
which is used as a
test of competency.
The interpretation of
quality control data is
done with the help of
both graph-
ical and statistical
tools. Quality control
data is most
commonly visualized
with the help of
Quality Control (QC)
charts which include
Levey-Jennings
(LJ) Charts and
Westgard Rules. Both
are useful in
detecting trends or
shifts
observed from the
average target value.
Corrective and
Preventive Action
(CAPA) is an
important path
towards
improvement and
eectiveness of
quality management
system in a
laboratory. The root
cause analysis of any
problem or
deviation can be
easily done by
implementing CAPA
in the
Quality Control (QC)
is carried out in the
laboratory to nd out
and reduce
the errors in the
analytical phase of
the testing system
prior to the release of
reports of the
patients. High quality
laboratory results
involve commitment
to all phases of
testing system
including pre-
analytical, analytical
and post-
analytical phases.
Pre-analytical phase
includes those factors
which aect
the laboratory results
prior to the handling
of the sample in the
clinical labo-
ratory. Post-analytical
factors are those
which aect the
results after the an-
alytical phase is
complete. Quality
control involves
implementation of
both
Internal Quality
Control (IQC) and
External Quality
Control (EQC) which
is known as
Prociency Testing
(PT). Internal quality
control is performed
daily in the
laboratory using
controls whose
values are known,
where as
external quality
control includes the
participation of the
laboratory in an
external quality
assessment scheme
which is used as a
test of competency.
The interpretation of
quality control data is
done with the help of
both graph-
ical and statistical
tools. Quality control
data is most
commonly visualized
with the help of
Quality Control (QC)
charts which include
Levey-Jennings
(LJ) Charts and
Westgard Rules. Both
are useful in
detecting trends or
shifts
observed from the
average target value.
Corrective and
Preventive Action
(CAPA) is an
important path
towards
improvement and
eectiveness of
quality management
system in a
laboratory. The root
cause analysis of any
problem or
deviation can be
easily done by
implementing CAPA
in the
Quality Control (QC)
is carried out in the
laboratory to nd out
and reduce
the errors in the
analytical phase of
the testing system
prior to the release of
reports of the
patients. High quality
laboratory results
involve commitment
to all phases of
testing system
including pre-
analytical, analytical
and post-
analytical phases.
Pre-analytical phase
includes those factors
which aect
the laboratory results
prior to the handling
of the sample in the
clinical labo-
ratory. Post-analytical
factors are those
which aect the
results after the an-
alytical phase is
complete. Quality
control involves
implementation of
both
Internal Quality
Control (IQC) and
External Quality
Control (EQC) which
is known as
Prociency Testing
(PT). Internal quality
control is performed
daily in the
laboratory using
controls whose
values are known,
where as
external quality
control includes the
participation of the
laboratory in an
external quality
assessment scheme
which is used as a
test of competency.
The interpretation of
quality control data is
done with the help of
both graph-
ical and statistical
tools. Quality control
data is most
commonly visualized
with the help of
Quality Control (QC)
charts which include
Levey-Jennings
(LJ) Charts and
Westgard Rules. Both
are useful in
detecting trends or
shifts
observed from the
average target value.
Corrective and
Preventive Action
(CAPA) is an
important path
towards
improvement and
eectiveness of
quality management
system in a
laboratory. The root
cause analysis of any
problem or
deviation can be
easily done by
implementing CAPA
in the
Quality Control (QC)
is carried out in the
laboratory to nd out
and reduce
the errors in the
analytical phase of
the testing system
prior to the release of
reports of the
patients. High quality
laboratory results
involve commitment
to all phases of
testing system
including pre-
analytical, analytical
and post-
analytical phases.
Pre-analytical phase
includes those factors
which aect
the laboratory results
prior to the handling
of the sample in the
clinical labo-
ratory. Post-analytical
factors are those
which aect the
results after the an-
alytical phase is
complete. Quality
control involves
implementation of
both
Internal Quality
Control (IQC) and
External Quality
Control (EQC) which
is known as
Prociency Testing
(PT). Internal quality
control is performed
daily in the
laboratory using
controls whose
values are known,
where as
external quality
control includes the
participation of the
laboratory in an
external quality
assessment scheme
which is used as a
test of competency.
The interpretation of
quality control data is
done with the help of
both graph-
ical and statistical
tools. Quality control
data is most
commonly visualized
with the help of
Quality Control (QC)
charts which include
Levey-Jennings
(LJ) Charts and
Westgard Rules. Both
are useful in
detecting trends or
shifts
observed from the
average target value.
Corrective and
Preventive Action
(CAPA) is an
important path
towards
improvement and
eectiveness of
quality management
system in a
laboratory. The root
cause analysis of any
problem or
deviation can be
 easily done by
implementing CAPA
in the
Quality Control (QC) is carried out in the laboratory to find out and
reduce the errors in the analytical phase of the testing system prior
to the release of reports of the patients. High quality laboratory
results involve commitment to all phases of testing system
including pre-analytical, analytical and post- analytical phases. Pre-
analytical phase includes those factors which affect the laboratory
results prior to the handling of the sample in the clinical laboratory.
Post-analytical factors are those which affect the results after the
an-alytical phase is complete. Quality control involves
implementation of both Internal Quality Control (IQC) and External
Quality Control (EQC) which is known as Proficiency Testing (PT).
Internal quality control is performed daily in the laboratory using
controls whose values are known, where as external quality
control includes the participation of the laboratory in an
external quality assessment scheme which is used as a test of
competency.The interpretation of quality control data is done with
the help of both graph-ical and statistical tools. Quality control
data is most commonly visualized with the help of Quality Control
(QC) charts which include Levey-Jennings (LJ) Charts and Westgard
Rules. Both are useful in detecting trends or shifts observed from
the average target value. Corrective and Preventive Action (CAPA)
is an important path towards improvement and effectiveness
of quality management system in a laboratory. The root cause
analysis of any problem or deviation can be easily done by
implementing CAPA in the