個別化品質管制計畫導入臨床微生物實驗室之實務探討

Individualized Quality Control Plan (IQCP) Implementation for a Clinical Microbiology Laboratory

目的：藉由實驗室個別化品質管制計畫（Individualized Quality Control Plan，IQCP），描述執行IQCP之經驗，提供實驗室品質管理與提升的重要資訊。材料與方法：依據美國病理學會（College of American Pathologists，CAP）規範及台灣醫事檢驗學會指引，針對風險管理作業指引進行危害風險評估，依據發生頻率及影響程度面向，試算風險係數並產出量化風險鑑別結果。結果：以抗生素敏感性試驗執行IQCP評估，經過風險評估結果，以『檢體識別』及『並非單一菌落』風險較高，其風險矩陣的風險係數為16分，風險評價為不可接受，針對不可接受的項目需在實驗室的品管計畫中說明如何預防這個風險的發生，提出有效的改善或預防機制。結論：利用IQCP所建立的規範，打造一套實驗室量身訂做的品管計畫，以確保每一份報告的正確性。 Objective: Individualized Quality Control Plan (IQCP) implementation provides important information for laboratory quality management and enhancement. Materials and Methods: According to the regulations of the College of American Pathologists and the guidelines of the Taiwan Society of Laboratory Medicine, risk level is determined by combining the frequency of occurrence and severity of harm to the patient. Results: In this study, the IQCP was implemented for antibiotic susceptibility testing. After risk assessment, the factor of the matrix for 'specimen identification' and 'not pure isolate' showed a higher score of 16; therefore, the result of risk assessment was 'unacceptable'.Risk identified as 'not acceptable' must be included in an IQCP to explain how to prevent the occurrence of the risk and indicate the effectiveness of the improvement or prevention mechanism. Conclusion: IQCPs tailor a laboratory-specific tailored quality control plan to ensure the accuracy of each report.