Dr. TA Varkey PhD, Managing Director, Medilab Speciality Laboratories, Kochi explains the need of Quality Control in Clinical Laboratories and how Quality assurance can be made on various procedures done.

1. Quality Assurance
in relation to
Medical Laboratory
Accreditation
Dr. T.A. Varkey
Medilab Specilaity Laboratories India Pvt. Ltd., Kochi,
Mobile: 9447031471

2. QUALITY
“ Quality is never an accident;
it is always the result of high intention,
sincere effort,
intelligent direction and skilful execution;
it represents the wise choice of many
alternatives.”
William A. Foster

3. QUALITY
The ISO 9000 definition of quality
is ―
the degree to which a set of
inherent characteristic fulfils
requirements.

5. Fundamentals of Measurement
QUALITY
ACCURACY
PRECISION
REPRO
DUCEBILITY
RESOLUTION

6.  Accuracy
is the closeness of agreement
between the result of measurement and
the true value of the measurand
 Precision is the closeness of agreement
between the results of successive
measurements of the same value of a
quantity carried out under identical
conditions at short intervals of time.

7.  Resolution
is the smallest difference
between indications of a displaying device
that can be meaning fully distinguished
 Reproducibility is the closeness of
agreement between corrected results of
measurement of the same value of a
quantity when measurements are made
under different conditions

8.  Precise
but not Accurate

9.  Accurate
but not Precise

10.  Precise
and Accurate

11. Quality Assurance

Quality Assurance encompasses all measures
taken to ensure the reliability of investigations to
give the best patient care
 Quality assurance includes the evaluation of
patient preparation and specimen collection, as
well as the pre analytical, analytical, and post
analytical phases of laboratory testing.
 Quality assurance measures are implemented to
detect irregularities in analytical results

12. The Quality Assurance Cycle
Patient/Client Prep
Sample Collection
Reporting
•Data and Lab
Management
•Safety
•Customer
Service
Personnel Competency
Test Evaluations
Sample Receipt
and Accessioning
Record Keeping
Quality Control
Sample Transport
Testing
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13. Internal Quality Control( I.Q.C)

IQC is the action of detecting errors that would
invalidate the medical usefulness of laboratory
results. IQC enables the detection of Day-to Day
performance problems and assures the
precision of clinical laboratory tests. An IQC
system requires results from two levels of quality
control sera on 20 consecutive days. The mean
and 2SD limits are established for each analyte
at both levels. SD values are then plotted on a
Levey Jennings chart and the SDI is used to
observe the deviations from the mean.

14. External Quality Assessment( E.Q.A)
 External
quality assessment schemes
allow laboratories to monitor their
accuracy and compare performance with
other laboratories.
 The laboratory is unaware of the
parameter values, this is known as „blind
analysis‟ of an EQA sample

15. Medical Laboratory Accreditation
• Credibility of test results is extremely
important where diagnosis depends on
these results. Laboratory results must be
reliable.
• For the reliable test results, the data must
be accurate, precise & reproducible.

16. Concept of Laboratory Accreditation
• This is possible only when the laboratories
performing these tests are competent.
• The concept of Laboratory Accreditation
was developed to provide a means for
third-party certification of the competence
of laboratories.

17. Why Accreditation
•
•
•
•
•
•
Improve quality
Demonstrate commitment to quality
Comply with International Standards
Harmonisation of working processes
Control of Laboratory Services
Rationalisation of Services

18. Formal recognition of competence of laboratory
by Accreditation body has many advantages
• Potential increase in business due to enhanced
customer confidence and satisfaction
• Savings of time and money due to reduction or
elimination of re-testing
• Better control of laboratory operations due to
in-built Quality Assurance System and
competent man-power
• Increased Confidence in test results and
personnel performing work.

19. Formal recognition of competence of laboratory by
Accreditation body has many advantages
• Customers can identify Accredited
Laboratories from directory of Accredited
Laboratories.
• Users of Accredited Laboratories enjoy greater
access in Domestic and International market
• Improved medical tourism through reliable &
acceptable Medicare as per International
Standards

20. * NABL *
In India, laboratory accreditation scheme
is operated by the National Accreditation
Board for Test & Calibration Laboratories
(NABL), an autonomous society under the
Department of Science & Technology,
Govt. of India.

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