- 學位論文
運用醫療失效模式與效應分析於住院給藥流程安全評估
Using Healthcare Failure Mode and Effect Analysis Tool to Review the Safety of Process of Hospitalized
摘要
近十年來國內外有關醫療疏失的研究結果發現，用藥錯誤為所有疏失中最常發生項目。風險管理是為避免未來可能發生之不願見的事件，而事先擬定方案以防止事件的發生，醫療系統得以透過風險管理之前瞻性觀念，管理醫療流程風險。 醫療失效模式與效應分析（HFMEA）為一套前瞻性檢視高風險照護流程工具，從流程圖中找出失效的模式及原因，並透過失效的嚴重度、發生機率進行危險評估、最終由決策樹以判斷是否需擬定改善措施。故本研究以HFMEA為工具，用以瞭解給藥流程中常見失效模式，及造成失效模式之主要原因，並據此提出改善給藥安全之可行方案。 研究對象為南區某區域醫院護理科，因考量某些護理單位之緊急性及特殊性，故排除加護病房、開刀房、呼吸治療、護理之家、精神科、安寧病房等護理站，最後選取五個護理站，包括了三個內科系病房及二個外科系病房共計五個病房。 研究流程包含，一、成立HFMEA小組，成員包含研究者及五個選中病房護理長共計六員。二、例用問卷調查五個選中病房之全體護理人員，以瞭解目前單位內給藥失效發生的可能性及原因；三、整合小組討論及問卷所得之結果，找出潛在失效的原因。四、透過小組成員進行風險/失效評估，以界定高風險系數失效原因。五、運用決策樹分析，以判定個案醫院是有否針對各項失效原因擬定防範措施。六、個案醫院現在未防範措施之原因，提出建議改善計劃。 研究發現住院給藥流程步驟中，共計有存在著個58個失效模式及80個潛在失效原因。其中危險系數大於8分失效模式包含在備藥階段中，未發現醫囑與電腦醫令不符、藥品分包未保持乾燥、無發現藥局給錯藥物、劑量分裝錯誤、無複誦口頭醫囑、未發現複誦錯誤、有複誦但抄寫錯誤。執行階段不知道要以那兩種方式辦識病人、護理人員施打劑量錯誤、未採一藥一核、己給藥但未核章、未能定時觀察病人反應、未記錄病人反應。 未控制潛在失效原因如下：於組織界面中，包含藥品外觀及藥品名字相似、辨識病人政策之宣導及監督不良、藥物劑量包裝差異性大、護理人員工作忙碌、醫院只針對特殊藥品給予給藥流速、液體給藥之分裝杯保存不良。護理人員與醫師之溝通界面問題來自，護理人員無對醫囑不明確項目和醫師再次確認。工作場所與護理人員界面中，護理人員作業中被打斷、藥物分包時掉落地上為主要原因。護理人員本身中，護理人員未看清楚醫令與醫囑不符、護理人員劑量計算錯誤、護理人員對藥物名稱認知不足、個人專業知識判斷錯誤導致給藥途徑錯誤、護理人員未帶章習慣、臨時醫囑單忘記核章、確認醫囑錯誤，為給藥錯主要來源。 研究建議：在組織界面中，建議增設藥物辦識系統（Bar code）、加強宣導及並教育辦識方法技巧、高危險藥物給予特殊記號、液體給藥之分裝杯，保存至所屬UD子車之藥盒裡。建議醫院統一各藥物之包裝。 給藥流程作業中建議，於給藥記錄單中，增設一欄大夜班人員核對後之檢查章、主護護士配藥前需準備乾淨的配藥盤、醫師依照病人特殊狀況及持殊藥物，書寫輸液流速、護理人員於藥物劑量及途徑用螢光筆畫圖、將執行時間點規定為以確實用藥時間記錄之、於交班記錄單上增加時間欄，間隔為一小時，由護理人員巡視病床後，立即簽章及記錄病患現況。 在護理人員考核上包含定期抽查護理人員核對醫囑正確性、對於辦識圖卡上之藥物認識，尤其是有新進人員時、不定期於給藥完成後，抽查投藥記錄單是否簽章。定期檢查護理人員章是否帶在身上、投藥記錄單核章完整性及交班記錄單記錄完整性。 最終在工作環境上，將於配藥間張貼藥物劑量換算表。護理人員教育部分，則加強給藥途徑縮寫認知。 透過人因介面模式中所呈現之錯誤並非單純來自個人問題，且運用風險管理理念於探討護理人員給藥安全評估時，在非直接承認錯誤的壓力下，將有效提昇護理人員對於討論給藥疏失問題之參與度，增加問卷結果信效度，並確實反映出現今環境中存在的風險因子。 HFMEA實施將有助於提昇高危險醫療流程之安全性，但在使用上，可因研究對象特性進行工具使用的調整，調整內容如流程篩選上評估依據、成員代表資格認定、定義風險係數評比依據、改善方案評估方式、科技運用於病人安全之注意事項，最終以期達結果更具效度。
並列摘要
Medication error has been approved to be the most frequent mistake by research related to medical error in the decade. Risk management is a process that involves making and implementing decisions that will minimize the adverse effects of accidental losses upon an organization .The medical system employs can use risk management to prevent error from medical procedures. Healthcare failure mode effect analysis (HFMEA) is a systematic approach to identify and prevent product and process problems before they occur.. Accordingly, based on HFMEA, the study aims to explore frequent failure modes and the possible reasons on medication process. Recommendations regarding to improving medication safety will be provided. The study selected five nursing stations, including 3 internal medicine wards and 2 surgery ward, from the nursing department of a community hospital down south. The ICU, operation room, RCW, nursing home, psychiatric ward, hospice ward were excluded owing to the particularity. There are six steps in the research process. 1. A HFMEA team was set up, including the researcher and 5 head nurses of the selected wards. 2. All nurses in the wards were surveyed to investigate the possibility of and the causes of medication failure. 3. The discussion of the HFMEA and the survey results were compiled to explore potential failure reasons. 4. The HFMEA team proceeded risk/failure evaluation to identify possible reasons of high risk coefficient. 5. A decision tree analysis was utilized to determine whether or not the hospital designed any preventive strategies. 6. Recommendations are offered to the hospital studied. The study found 58 failure modes and 80 potential failure causes. In preparation dimension, the failure modes with risk evaluation score larger than 8 points are wrong order, drug contamination ,wrong drug ,wrong dose ,do not re-confirm ambiguous orders ,calculate error ,don’t understand drug name ,read back oral order error。In administration dimension the failure modes with risk evaluation score larger than 8 points are identify patient error、incorrect route of drug administration、didn’t sign/stamp on occasional orders ,didn’t to observe patient reaction. The potential failure causes during the medication procedures in three dimensions. The organization dimension consists of medication physical appearance, the similarity between medication names, poor policy and supervision of patient verification, the variety of dose packages, tight schedules of nurses, medication speed equipments offered only to specialty pharmaceuticals, and the defective management of liquid medication dispensers. The main problem in the dimension of the communication is that nurses do not re-verify ambiguous orders with doctors. The dimension of working field and nurses is composed of two reasons: nurses are interrupted while working and medication is dropped onto the floor while dispensed. In addition, the sources of medication error also include that nurses do not re-confirm ambiguous orders, miscalculate dosage, lack recognition of medication names, procedure incorrect route of drug administration based on profession misjudgments and forget to sign/stamp on occasional orders. Suggestions are offered in accordance to three dimensions mentioned above. First, medication bar code, continuing education on verifying medication, specific signs high-alert medications, the liquid medication noggin maintained in the UD carts and a decrease in variety of medication packing are needed. Secondly, according to medication procedures, it is necessary to insert a column for midnight shift nurses to sign/stamp in the medication administration record (MAR). Additionally, responsible nurses need to clean medication trays. Dosage and medication routes should be highlighted. Doctors prescribe clearly liquid medication speed depending on patient’s health condition and specialty pharmaceuticals. A time column with one-hour intervals needs to be added in the shift record sheet for nurses to keep track of the actual medication time after each round. Thirdly, the performance evaluation of nurses contains regular checks of the Order whether or not, especially novice ones, verify the accuracy of orders, are able to recognize medication on the pictures, carry stamps while on duty, exactly complete shift record sheet, and stamp/sign the medication record. Finally, the conversion tables for dosage should be posted in the prescription room. Nurses need more education to distinguish the abbreviation of medication route. Using Human factors engineering on patient safety can understand the error isn’t only on personal problems ,and when also using risk management in discussion nursing staff for medication safety evaluation, under the non-direct acknowledgment wrong pressure, will be effective promotes the nursing staff regarding the discussion participating of for the medication error question, the increase questionnaire result validity, and reflected truly in the nowadays environment exists risk factor. To implement HFMEA will improve high risk medical process ,it can adjustment which the tool in uses, in adjustment content like flow screening appraised the basis, the member on behalf of the qualifications recognized , the definition risk coefficient , the improvement project evaluation way , the science and technology utilize of matters needing attention in the patient safety, finally reaches the result by the time to have the validity.