應用進階品管指標以提升臨床生化檢驗品質

Application of Advanced Quality Control Indicators to Improve the Quality of Clinical Biochemistry Tests

為了使臨床醫師能夠正確的診斷與治療處置疾病，實驗室的臨床醫檢師須持續提升的品質管制能力，以確保檢驗報告之正確性並降低量測的不確定度。有別於傳統量測不確定度的品管指標，本研究將工業品管製程指標Cpk應用於臨床生化實驗室，並與傳統指標如CV、bias及TE進行品管鑑別度比較。本研究於2015年1月至12月期間收集一家區域教學醫院之臨床實驗室每日生化檢驗項目（包含GLU、BUN、CRE、AST、ALT、NA、K）高低濃度（Level-1、Llevel-2）的品管數據，經由運算所得之品質製程能力指標Cpk進行品管能力的鑑別與判讀，同時也與傳統指標分析比較。研究結果發現該實驗室在1月至11月期間，NA、K與CRE以同儕品管數值所運算出的Cpk指標出現了多個傳統指標無法鑑別的偏移現象透過事後回溯分析可進一步找到造成偏移的可能原因。本研究結論Cpk指標相較於傳統CV、bias及TE等品管指標更具鑑別度，有助於實驗室量測不確定度之管制能力的提升，該指標同時也兼具同儕實驗室間比對的價值。

In order to enable clinical doctors to accurately diagnose and treat diseases, the clinical medical technologists at laboratories have to continue to improve quality control ability to ensure the accuracy of test reports and reduce the uncertainty of measurement. Different from the quality control indicators for traditional measurement of uncertainty, this study applied industrial quality control process indicator, Cpk, to clinical biochemical laboratory, and performed the comparison on identification of quality control between it and traditional indicators such as CV; bias and TE. This study collected the quality control data of high and low concentrations of daily biochemical test items (including GLU, BUN, CRE, AST, ALT, NA, K) of a clinical laboratory in a metropolitan teaching hospital from January to December 2015. After the calculations, this study obtained the quality control process indicator, Cpk, for identification and interpretation. Moreover, this study also performed analysis and comparison between it and traditional indicators. The research results showed that, from January to November, deviation in Cpk indicator of NA, K, and CRE calculated using peer quality control values that could not be identified using multiple traditional indicators were discovered in the laboratory. This study performed ex post facto analysis to further find out the possible reasons for deviation. This study concluded that, compared with traditional quality control indicators, such as CV, bias, and TE, the identification of Cpk indicator was higher. Cpk can help improve the ability to control uncertainty of laboratory measurements. In addition, this indicator also can be used for comparison with peer laboratories.