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Documented Procedures For The Validation of Laboratory Results Prior To Reporting

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104 views

Documented Procedures For The Validation of Laboratory Results Prior To Reporting

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bdgh.laboratory
Copyright
© © All Rights Reserved
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BAUAN DOCTORS GENERAL HOSPITAL

BAUAN MULTI-PURPOSE COOPERATIVE


BAUAN, BATANGAS Tel. No. 727-4019/727-352

Documented Procedures for the Validation of Laboratory Results Prior to


Reporting

Purpose:

 Laboratory Validation is to ensure that laboratory test data and results are consistent,
accurate and precise.
 validation eliminates error in test results which is important from the view point of both
patients, as well as of professional and regulatory bodies in the health care domain

Policy:

 Bauan Doctors General Hospital requires that performance for any new method be
“verified” prior to reporting patient’s test results. Precision and accuracy are specifically
identified, along with analytical sensitivity, analytical specificity, reportable range,
reference values, and any other applicable characteristic.

Following steps were taken to validate test results:

Verification or Establishment of Reference Intervals

 It is very useful to be able to transfer a reference interval from one laboratory to another
by some process of validation which is less costly and more convenient .
 One can adopt reference limits from any of the following sources: manufacturer
suggested, reference laboratory, published articles, neighbouring laboratory or previous
reference limits in the same laboratory.

Verification of Analytic Accuracy:

 Agreement between test result and “true” result was done in mainly two ways: (i)
comparison of results between new method and “reference” method (ii) Results using
new method on certified reference materials (recovery).

Verification of Precision

 Precision implies repeatability, which means, analyze repeatedly to determine variation.


 Imprecision is quantified by calculating the mean, standard deviation (SD), and
coefficient of variation (CV) of data collected from an analytical run:
CV= (SDX100)/mean
BAUAN DOCTORS GENERAL HOSPITAL
BAUAN MULTI-PURPOSE COOPERATIVE
BAUAN, BATANGAS Tel. No. 727-4019/727-352

Analytical Sensitivity:

 It is the ability of an analytical method to assess small variations of the concentration of


analyte. This is often expressed as the slope of the calibration curve. The steeper the
slope of the calibration curve, the assay is more sensitive. In reality, analytical sensitivity
depends on the precision of the method.

Verification of Analytic Interferences:

 Most commonly, this involves listing stated interferences from manufacturer, and
evaluating samples in correlation studies for differences (outliers), investigating causes
of interference. It is often difficult to determine exact cause of interference, except for
common causes, like, hemolysis, lipemia, icterus, related compounds, drugs, dietary
substances, sample additives etc.

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