建立「臨床實驗室品質管制即時反饋系統」以提升醫學檢驗品管能力

Building the Real-time Feedback System in Clinical Laboratory to Improve the Medical Biotechnology Quality Control Ability

醫學檢驗數據為提供醫師診斷及治療的重要依據，準確的檢驗報告便能提升醫療品質並維護病人安全。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。目前國內醫院實驗室定量生化檢驗品質管制準則多採用Westgard multi-rules依據QS9000與ISO15189的國際規範來監控品質與製程能力，然而這些品質準則仍存在不夠嚴謹問題。本研究主要藉由導入工業界品質指標及量測系統分析（measurement system analysis, MSA）之評估準則，開發適用於臨床醫學檢驗實驗室之品質量測系統並建立行動通訊的手機APP介面，透過此量測系統自動分析檢驗樣本數據，估計品質指標Cp、Cpk 值與GR&R值，以監控全自動生化檢驗中儀器、檢驗試藥與測量人員本身或彼此間的變異，除提供品管人員進行自我評估與校正外，不同實驗室間也可透過線上數據統整與交流，評斷實驗室間品管之優劣性。本計畫在天晟醫院檢驗科實驗室、亞東技術學院、銘傳大學三方合作下，開發了檢驗科內部品管的行動APP介面，可以應用於中小型醫院的臨床病理科或醫學檢驗部門的實驗室，本研究達成了以下四個重要的成果。1.本研究成功建置一個可即時回饋每日品管數據的雲端資料庫與APP介面，可直接收集當日品管數據，應用該實驗室內部的品管準則（QC rules），即時回饋異常或提供管制圖給品質主管或實驗室主任。2.本研究實證，透過新建立的品質指標Cp、Cpk估計值與GR&R值，可有效監控全自動生化檢驗中的各種變異。3.透過此系統，匯入不同醫院使用相同機型的檢驗儀器與相同批號的品管試劑的每日品管資料，可達到同儕間平行比對的效益。4.經開發完成之系統可推廣於各中小型醫院與檢驗機構。本研究能幫助臨床實驗室提升品質管制能力並即時將每日品管數據回饋給品管醫檢師或實驗室主任，同時此系統兼具了建立同儕實驗室間比對的機制，能有效提升醫學檢驗品質，並進而提升了病人安全與整體醫療品質。 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.Quality control/assurance procedures in most hospitals are based on Westgard multi-rules supplemented by QS9000 and ISO15189 international standards. However, the traditional criteria used to determine the acceptability of analytic quality may not be objective in clinical laboratories. At the same time, using the evaluation rules of quality capacity indices and the measurement system analysis (MSA) method to improve laboratory quality is a practice that has long been well known in the manufacturing industry. This study attempts to develop a quality management system and establish Mobile communications APP platform that can be applied in clinical laboratories. The management system will use the Cp and Cpk indices, as well as gauge repeatability and reproducibility (GR&R) values, to evaluate the variances among medical machines and technicians. The developed system can be applied not only for monitoring variations in quality control, but also for revealing differences of inter-laboratory quality control capability. This project including Ten-Chen medical group Ten Chan general hospital laboratory; Oriental Institute of Technology and Ming Chuan University totally three party cooperation. It had developed the APP interface system for internal quality control in the medical laboratory. It can be applied to the clinical pathology department or medical laboratory into the small-sized or medium-sized hospital laboratories. This study has achieved four important results as the following: (1) This study successfully built a cloud database and APP interface system can real-time feedback daily QC data, which can directly collect the daily data, application of the inter-laboratory quality control (QC) rules, daily abnormal QC results or control chart in laboratory can be real-time feedback to the QC MT or the director of laboratory. (2) In this research, through the quality index “Cp, Cpk estimation value” and “GR&R value”, can effectively monitor the automatic biochemical test in various variation. (3) Through this system, the daily quality control data of the same instruments and the same batch of QC reagents with different hospital laboratories will compare into the system, it to achieve the benefit of parallel comparison among peers. (4) In the future, the developed system can be promoted to small-sized or medium-sized hospitals and medical facilitiesThis study can help clinical laboratory to improve the quality control ability and real-time feedback the daily QC data to quality medical technologist (MT) or the direct of the laboratory. In addition, this system also can be used for comparison with peer laboratories, and enhancing the total medical quality and patient safety.

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.Quality control/assurance procedures in most hospitals are based on Westgard multi-rules supplemented by QS9000 and ISO15189 international standards. However, the traditional criteria used to determine the acceptability of analytic quality may not be objective in clinical laboratories. At the same time, using the evaluation rules of quality capacity indices and the measurement system analysis (MSA) method to improve laboratory quality is a practice that has long been well known in the manufacturing industry. This study attempts to develop a quality management system and establish Mobile communications APP platform that can be applied in clinical laboratories. The management system will use the Cp and Cpk indices, as well as gauge repeatability and reproducibility (GR&R) values, to evaluate the variances among medical machines and technicians. The developed system can be applied not only for monitoring variations in quality control, but also for revealing differences of inter-laboratory quality control capability. This project including Ten-Chen medical group Ten Chan general hospital laboratory; Oriental Institute of Technology and Ming Chuan University totally three party cooperation. It had developed the APP interface system for internal quality control in the medical laboratory. It can be applied to the clinical pathology department or medical laboratory into the small-sized or medium-sized hospital laboratories. This study has achieved four important results as the following: (1) This study successfully built a cloud database and APP interface system can real-time feedback daily QC data, which can directly collect the daily data, application of the inter-laboratory quality control (QC) rules, daily abnormal QC results or control chart in laboratory can be real-time feedback to the QC MT or the director of laboratory. (2) In this research, through the quality index “Cp, Cpk estimation value” and “GR&R value”, can effectively monitor the automatic biochemical test in various variation. (3) Through this system, the daily quality control data of the same instruments and the same batch of QC reagents with different hospital laboratories will compare into the system, it to achieve the benefit of parallel comparison among peers. (4) In the future, the developed system can be promoted to small-sized or medium-sized hospitals and medical facilitiesThis study can help clinical laboratory to improve the quality control ability and real-time feedback the daily QC data to quality medical technologist (MT) or the direct of the laboratory. In addition, this system also can be used for comparison with peer laboratories, and enhancing the total medical quality and patient safety.