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In our labs we use statistical process to monitor and evaluate the analytical process that produces patient results.
When a diagnostic test is performed, the outcome of the test is a result. The result may be a patient result or it may be a quality control (QC) result. The result may be quantitative (a number) or qualitative (positive or negative) or semi-quantitative (limited to a few different values).
We use the QC results obtained in our labs to validate whether the instrument is operating within pre-defined specifications, inferring that patient test results are reliable. Once the test system is validated, patient results are then be used for diagnosis, prognosis, or treatment planning.
In our labs we do testing for normal and abnormal controls for each test at least daily to monitor the analytical process. The QC statistics for each test performed in the laboratory are calculated from the QC database collected by regular testing of control products. The data collected is specific for each level of control. Consequently, the statistics and ranges calculated from this data are also specific for each level of control and reflect the behavior of the test at specific concentrations.
Besides performing QC tests on equipments and reagents, we also regularly calibrate all our instruments. The calibration is done by our NABL approved consultants who also monitors and checks our QC reports.
Our custom built MIS system has checks enabled to alert for any abnormal values. Abnormal value reports need to be reviewed before they can be printed. During the review process the doctor may cancel the test and call for a fresh sample, in which case the patient is immediately alerted. Records are maintained for all reports with abnormal values and details of action taken against each report.
We also adhere to all the NABL guidelines pertaining to quality and relevant records are maintained in our MIS. Regular NABL awareness campaigns and NABL training is held for our staff and consultants.
Every effort is made to minimize any human or machine error during testing and reporting so that we can continue to fulfill our commitment towards reliable and accurate diagnosis and reporting.