Quality Control and Quality Assurance

5:16 AM

When a diagnostic test is performed in the medical laboratory, the outcome of the test is a result. The result may be a patient result or it may be a quality control result. The result may be quantitative or qualitative or semi-quantitative. Quality control results are used 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 can then be used for diagnosis, prognosis, or treatment planning. 

 For example, when a patient’s serum is assayed for potassium, the test result tells us how much potassium is present in the blood. This result is then used by the physician to determine whether the patient has a low, normal or high potassium.

The maintenance of a quality management system is crucial to a laboratory for providing the correct test results every time. Some important elements of quality assurance are: SOPs (standard operation procedure), documentation, quality control samples, EQAS (external quality assessment scheme).

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