1.Quality assurance of computerized system for GLP laboratory
Hong LI ; Chunqi WU ; Gang HAN ; Yansheng DONG ; Qiaozhen GUO ; Jianjing WANG ; Shufang WAN ; Huazhi MA ; Quanjun WANG
Drug Evaluation Research 2017;40(4):433-436,491
In view of the characteristics of the computerized system,the key points in the quality assurance (QA) of the computerized system was discussed and summarized combined with the requirements of the GLP laboratory in Europe and America.The validation of computerized system,the control during the use of computerized system,period maintenance and safety protection of computerized system,archives of electronic data was discussed,expecting to provide reference for the management of computerized system in Chinese GLP laboratory which is generally not high currently.The experiences were obtained as follow:Through repeated inspection and review,the problem was found and set as the risk point;a targeted QA inspection plan was made focusing on the risk-based inspection and the QA inspection plan was timely adjusted according to the problems,which ensures the pertinence and validity of the QA inspection.
2.The role of transbronchial needle aspiration in the staging of bronchogenic carcinoma.
Rui WANG ; Jianjing HAN ; Jifang YAO ; Zenglin WANG
Chinese Journal of Lung Cancer 2002;5(4):284-286
BACKGROUNDTo explore the role of transbronchial needle aspiration (TBNA) in the staging of bronchogenic carcinoma.
METHODSTo 42 cases of primary bronchogenic carcinoma with suspected lymph node metastasis by X-ray and CT scan of chest, the TBNA was performed before operation. The cytological results and c-TNM by TBNA were compared with the pathological ones and p-TNM after operation.
RESULTSThe diagnosis of 10 cases with N₂ metastasis was completely corresponding by TBNA and pathological examination after operation. Nineteen out of 22 cases with N₁ metastasis were confirmed by TBNA, and the false negative results ocurred in 3 cases. The results of TBNA in lymph nodes' size from 2 to 3 cm was completely accordant with pathological ones after operation. For 1 to 2 cm lymphnodes, the accurate rate of TBNA was 88.5% (23/26). The overall accurate rate of c-TNM by TBNA was 85.7% (36/42) compared with p-TNM. A small amount of hemoptysis ocurred in 3 cases, no pneumothorax and other serious complications were observed.
CONCLUSIONSThe TBNA for staging of bronchogenic carcinoma is a simple and economic method with high correct rate and high clinical applicable value.
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