Department of Radiation Medicine, North Shore-Long Island Jewish Health System, New Hyde Park, New York.
Department of Radiation Medicine, North Shore-Long Island Jewish Health System, New Hyde Park, New York.
Pract Radiat Oncol. 2012 Apr-Jun;2(2):86-96. doi: 10.1016/j.prro.2011.06.010. Epub 2011 Aug 6.
The purpose of this work was to develop and implement six sigma practices toward the enhancement of patient safety in an electronic, quality checklist-driven, multicenter, paperless radiation medicine department.
A quality checklist process map (QPM), stratified into consultation through treatment-completion stages was incorporated into an oncology information systems platform. A cross-functional quality management team conducted quality-function-deployment and define-measure-analyze-improve-control (DMAIC) six sigma exercises with a focus on patient safety. QPM procedures were Pareto-sorted in order of decreasing patient safety risk with failure mode and effects analysis (FMEA). Quantitative metrics for a grouped set of highest risk procedures were established. These included procedural delays, associated standard deviations and six sigma Z scores. Baseline performance of the QPM was established over the previous year of usage. Data-driven analysis led to simplification, standardization, and refinement of the QPM with standard deviation, slip-day reduction, and Z-score enhancement goals. A no-fly policy (NFP) for patient safety was introduced at the improve-control DMAIC phase, with a process map interlock imposed on treatment initiation in the event of FMEA-identified high-risk tasks being delayed or not completed. The NFP was introduced in a pilot phase with specific stopping rules and the same metrics used for performance assessments. A custom root-cause analysis database was deployed to monitor patient safety events.
Relative to the baseline period, average slip days and standard deviations for the risk-enhanced QPM procedures improved by over threefold factors in the NFP period. The Z scores improved by approximately 20%. A trend for proactive delays instead of reactive hard stops was observed with no adverse effects of the NFP. The number of computed potential no-fly delays per month dropped from 60 to 20 over a total of 520 cases. The fraction of computed potential no-fly cases that were delayed in NFP compliance rose from 28% to 45%. Proactive delays rose to 80% of all delayed cases. For potential no-fly cases, event reporting rose from 18% to 50%, while for actually delayed cases, event reporting rose from 65% to 100%.
With complex technologies, resource-compromised staff, and pressures to hasten treatment initiation, the use of the six sigma driven process interlocks may mitigate potential patient safety risks as demonstrated in this study.
本研究旨在开发和实施六西格玛实践，以提高电子病历、质量检查表驱动、多中心、无纸化放射医学部门的患者安全性。
将质量检查表流程图（QPM）分层为咨询至治疗完成阶段，纳入肿瘤信息系统平台。一个跨职能质量管理团队进行了质量功能部署和定义-测量-分析-改进-控制（DMAIC）六西格玛练习，重点关注患者安全。QPM 程序按降低患者安全风险的顺序进行帕累托排序，采用失效模式和影响分析（FMEA）。对一组最高风险程序建立了定量指标。这些指标包括程序延迟、相关标准差和六西格玛 Z 分数。QPM 的基线性能是在前一年的使用中建立的。数据驱动分析导致 QPM 的简化、标准化和完善，目标是降低标准差、减少滑动天数和提高 Z 分数。在改进-控制 DMAIC 阶段引入了患者安全的禁飞政策（NFP），如果 FMEA 确定的高风险任务延迟或未完成，则在启动治疗时强制使用流程图联锁。NFP 在试点阶段引入了具体的停止规则，并使用相同的指标进行绩效评估。部署了自定义根本原因分析数据库来监测患者安全事件。
与基线期相比，在 NFP 期间，风险增强 QPM 程序的平均滑动天数和标准差提高了三倍以上。Z 分数提高了约 20%。观察到主动延迟而不是被动硬停止的趋势，NFP 没有不利影响。每月计算的潜在禁飞延迟数从 60 降至 520 例中的 20。在 NFP 合规性延迟的潜在禁飞病例中，计算的潜在禁飞病例的比例从 28%上升到 45%。主动延迟上升到所有延迟病例的 80%。对于潜在的禁飞病例，事件报告从 18%上升到 50%，而对于实际延迟的病例，事件报告从 65%上升到 100%。
在复杂的技术、资源受限的员工和加快治疗启动的压力下，本研究证明，使用六西格玛驱动的流程联锁可以降低潜在的患者安全风险。
