Abstract:
Ensuring the validity of laboratory results is one of the general requirements for the competence to carry out tests. The results provided by the laboratory should be satisfied as far as possible/where relevant with the quality of the measurements, statement of conformity with standard requirements or specifications. A laboratory performing testing should have a procedure for monitoring the validity of its results.
To ensure the validity of laboratory results as required or deemed appropriate for monitoring laboratory performance, a procedure for monitoring the validity of results was established. The activities that are required to fulfil validity of results based on analytical method performance characteristics were identified, analyzed, evaluated, monitored and reviewed. To assure the validity of the results, statistical techniques were applied to the monitoring and reviewing of the performance characteristics resulting data. Specificity, selectivity, linearity, acceptance limits, intermediate checks on measuring equipment, precision and accuracy, of the developed method (Ethanol analysis in blood by Headspace/GC/FID) were monitored using reference materials and positive blood control sample. The present study, assist the analyst to maintain a high level of test performance, reduces variation in test results, improves the confidence of testing results, able to translate the data into answers, which directly relate to solving the customer’s problem.