quality assurance in relation to medical laboratory accreditation
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Quality Assurance in relation to
Medical Laboratory
Accreditation
Dr. T.A. Varkey
Medilab Specilaity Laboratories India Pvt. Ltd., Kochi,
Mobile: 9447031471
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
QUALITY
The ISO 9000 definition of quality
is ―
the degree to which a set of
inherent characteristic fulfils
requirements.
Fundamentals of Measurement
QUALITY
ACCURACY PRECISION REPRO
DUCEBILITY RESOLUTION
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.
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
Precise but not Accurate
Accurate but not Precise
Precise and Accurate
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
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The Quality Assurance Cycle
•Data and Lab
Management
•Safety
•Customer
Service
Patient/Client Prep
Sample Collection
Sample Receipt
and Accessioning
Sample Transport Quality Control
Record Keeping
Reporting Personnel Competency
Test Evaluations
Testing
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.
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
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.
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.
• Improve quality
• Demonstrate commitment to quality
• Comply with International Standards
• Harmonisation of working processes
• Control of Laboratory Services
• Rationalisation of Services
Why Accreditation
• 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.
Formal recognition of competence of laboratory by Accreditation body has many advantages
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
* 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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