隨著民眾知識水準的提高，社會健康意識的抬頭，對於疾病的認知不再停留於診斷後的治療，預防醫學的概念漸漸蔚為風尚。近年來，基因檢測技術與醫療科技進步，人們獲得基因數據能力也已迅速在臨床上實施，帶動個人化醫療趨勢。國內各大醫院、檢驗中心以及生技公司無不踏入基因檢測的行列。然而，報告結果決定受試者的一生，因此每項實驗失誤都不可忽視，檢測品質仰賴臨床實驗室檢驗流程的嚴謹度。欲達到精準檢測，實驗室必須藉由更完善的風險評估工具探討關鍵失效因子，再對其進行品質改善，才能提供管理者最正確的判斷，最終達成精準醫療之目的。
本研究結合模糊理論(Fuzzy Theory)及失效模式與效應分析(FMEA)，提出一適用於臨床實驗室的風險評估模式。將FMEA風險因子：嚴重程度(S)、發生頻率(O)、檢測程度(D)模糊化，與專家討論其相對關係設計風險規則庫，完成Fuzzy邏輯系統建構。以基因檢測實驗室為例，將流程分為檢測前、檢測中、檢測後，與專家歸類各階段之失效模式、原因、效應建立FMEA表格；接著將各失效因子之S、O、D導入模糊邏輯系統得出FRPN值。最後，根據FRPN值判斷流程高風險流程因子並給予建議。
本研究以一個案進行分析，發現基因檢測流程中，高風險因子以檢測前階段最高為「樣本混淆」、「樣本標示錯誤」。顯示實驗室管理者較難對樣本採樣、樣本辨別進行品質管制。綜觀檢測前、中、後實驗流程階段，檢測前階段的實驗錯誤除了發生頻率、檢測程度最高外，其風險程度最高。意味著實驗室管理者評估實驗室風險僅確保實驗內部流程，而忽略了來源檢體之品質控管是不夠的。管理者不僅要確保內部品質，還需考量實驗室外部品質管控。最後，針對基因檢測之高風險流程提出改善建議，供實驗室管理者改善流程風險參考，並彙整此風險評估模式於實務上的參考價值。

Owing to advances in genetic testing and medical technology, genetic data can now be used to support clinical decisions. Since the test results can affect the diagnosis and treatment of patients, the quality of laboratory testing, which highly depends on the rigor of the testing process, should be enhanced. Therefore, a comprehensive risk assessment model for clinical laboratories should be in place in order to identify the high risk process and to prevent the potential errors. A risk assessment model is proposed in this study, which integrates Failure Mode and Effect Analysis (FMEA) and fuzzy logic system (FLS), with a clinical rules based on experts’ experience and judgement. Laboratory managers could better identify high risk factors for pre-analytical phase, analytical phase, and post-analytical phase during laboratory testing process using the proposed model.
The proposed indicator, fuzzy risk priority number (FRPN) rating, was highest in the pre-analytical phase, and should be the focus to reduce risk, applying the proposed model. It is further found out that “specimen misidentification” and “incorrect data entry”, which incurred at the pre-analytical phase, are the major risk errors, and the laboratory managers should be cautious on “sample collection” and “specimen identification” periods. That is, external quality assessment and control are critical in the genetic testing laboratories. The proposed assessment model is shown to be effective on case laboratory, while its practicability requires further study.

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