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歷 年 稿 件 內 容
 
*類別：
* 姓名： 林聰義
投稿種類： 壁報
*中文投稿標題： Near miss management and problem solving strategy of a hematology autoanalyzer
*中文作者姓名列：
*中文服務單位：
*英文投稿標題：
*英文作者姓名列：
*英文服務單位：
* 投稿摘要： Risk management has been a major policy of our lab department. It is a very useful and effective means for laboratory supervisors to evaluate, reduce and most of all, to eradicate the potential laboratory errors. We enjoyed the fame being an accredited laboratory for years, but frustrated to find that some of the laboratory errors may happen again and again. Thus we need to trace back to the real causes of these QC dilemmas as to carry out the preventive action against the unexpected recurrence. We learned that some of the QC dilemmas are originated from the imperfect design of the instrument although it is a cutting edge product. Hence, we invited the engineer of the manufacturer to join our near miss task force. We found three imperfect design or defective material in use may cause QC problems. So we redesign the near miss QC flow chart and start from the very beginning of QC chain that is from the manufacturer’s end. We collect, sort, analyze data and work it out with engineers to eliminate frequent laboratory errors that happened in the past three years. The algorithm is as follow: 1. Risk assessment by FMEA, FTA. 2. Explore the risk factors on root-cause basis. 3. Develop and set up “risk surveillance points” for near miss warming. 4. Validate the outcome of risk management by FRACAS. We set eight risk surveillance enforcements as follow：1. A 1SD QC acceptance criterion for the returned use of instrument after the maintenance. 2. A 2SD QC proactive checking for routine analyses. 3. Clean manual and closed mode trice before the start of daily measurements. 4. Rinse flow cell twice, on weekly basis. 5. Monitor the quality of staining solution in use on weekly basis. 6. Demand the engineer to clean the reaction cuvette and its tubing on half-month basis 7. Demand the engineer to clean the IMI channel on half-month basis; furthermore our staffs will execute auto rinse at each noon on daily basis. 8. Check the alignment of the two pushing rods in rack processing. The outcome is desirable, we found that Baso channel’s problems reduced from once per 45 days to once per 150 days, pushing rod’s problem reduced from 30/d to never happened again, IMI channel’s problem from once per 50 days to once per 120 days. We have drawn a comprehensive picture of “dynamic risk profile” for the surveillance of potential errors of a hematology auto-analyzer. The laboratory risk profiles thus constructed were revised on quarterly basis in the risk reduction plan.
*關鍵字1 ： near miss
*關鍵字2 ： risk management
*關鍵字3 ： problem solving strategy
*關鍵字4 ： risk reduction plan
*關鍵字5 ： dynamic risk profile
* 服務機關：
* 第一作者： 高志鵬
* 身分字號： *****61512
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