Abstract:

Although both clinical laboratory administrators and ISO 15189 require to assess determination results from the previous batch of patient specimens after appearing internal quality control out-of-control, they do not provide the detail methods to evaluate them. In this article, we mainly investigate to assess the validity of biochemical determination results after appearing internal quality control out-of-control according to 1/2 allowable total error providing by the external quality assessment of the National Center for Clinical Laboratories (NCCL) with considering control materials, the rules of internal quality control, clinical significance and so on. The results of 33 routine biochemical items were analyzed and showed that there were 661 out-of-control cases in 2013. After the assessment, 9 cases required to withdraw the test results in the previous batch of patient specimens, accounting for 1.3% of total out-of-control cases. How to set rational quality control standard and save resources in accordance with the actual situation of the laboratory is worth thinking for clinical laboratory administrators.

Key words: Quality management, Internal quality control, Out-of-control, Determination result, Assessment