應用「醫療照護失效模式與效應分析」以防範腫瘤標誌檢驗錯誤報告

Healthcare failure mode and effects analysis (HFMEA) as a performance improvement tool to prevent tumor marker report errors in a radioimmunoassay laboratory

醫學檢驗數據為提供醫師診斷及治療的重要依據，準確的檢驗報告便能提升醫療品質並維護病人安全。醫療照護失效模式與效應分析，簡稱HFMEA，是近年來醫院管理廣泛運用在評估病人安全的作業流程，並改善醫療品質的一種風險評估工具。本研究執行期間為2015年6月至12月，採用美國評鑑聯合會（JCAHO）所建議的HFMEA品質改善手法，導入核子醫學檢驗實驗室的作業流程評估，探討產生錯誤血液腫瘤標誌檢驗報告的高風險操作步驟與原因。研究結果顯示，依據HFMEA五個步驟，組成跨專業的品質改善小組，經研究團隊分析腫瘤標誌檢驗的5項主流程中的23個次流程，仔細探究31項潛在失效模式與40項可能造成失效的潛在原因後發現，造成錯誤報告的主因為：檢體錯誤、檢體不足、委外代檢單位檢驗過程失誤與人工輸入報告錯誤等，具體改善對策有五項，分別為1.檢驗單上詳細註明檢體種類與檢體量並將檢驗資訊公佈於網頁上、2.定期追蹤重大異常、3.建立檢體分裝的複查核對機制、4.定期審查委外實驗室之報告錯誤率與5.建立委外報告輸入與核發雙重確認機制。研究顯示，運用HFMEA改善作業流程後，各項次流程的風險計分均已下降且未曾再發生報告異常事件，有效防範了核子醫學腫瘤標誌檢驗錯誤報告的發生，並進而提升了病人安全與醫療品質。

Healthcare failure mode and effect analysis (HFMEA), proposed by Joint Commission on Accreditation of Healthcare Organizations (JCAHO), is a proactive tool used to analyze risks, identify failures before they happen and prioritize remedial measures. Aims of this study were to evaluate the frequency, type, preventability, as well as severity of tumor marker report errors in a radioimmunoassay (RIA) laboratory of a tertiary medical center, to examine the hazards associated with the process and identify the areas needing improvement.
The HFMEA program was performed in the RIA laboratory between June 2015 and December 2015. The multidisciplinary teams including 3 nuclear physicians, 3 clinical laboratory technologists and 1 nurse practitioner and 1 HFMEA staff were trained to analyze the process of tumor markers reporting, to identify possible causes of failures and potential effects. Potential probability and severity were classified using a fourpoint scale according to the HFMEA Severity Scale. The study planned to reduce the failure risks and assessed the improvement of medical quality and patient safety.
After analyzing the 23 sub-steps from the 5 main steps in the process, errors were classified into 31 failure modes, 40 associated causes and effects were identified. The main reasons were: (1) sample errors, (2) insufficient specimen, (3) outsourcing laboratory errors, and (4) manual data input errors. The improvement procedures included: (1) to specify the information of test specimen on the website, (2) to regularly follow major outliers, (3) to double check sample aliquots, (4) to periodically review outsourcing lab reports error rate, and (5) to double confirm the outsourcing reports. The introductions of new activities in the revised process significantly reduced failure rates and severity scores.
HFMEA is an effective proactive risk-assessment tool useful to aid in identifying errors of RIA tumor marker reports, and enhancing the medical quality and patient safety.