Donnelly Lane F, Palangyo Tua, Bargmann-Losche Jessey, Rogers Kiley, Wood Mathew, Shin Andrew Y
Center for Pediatric and Maternal Value, Lucile Packard Children's Hospital - Stanford, Stanford Children's Health.
Stanford University, School of Medicine, Palo Alto, CA, USA.
Pediatr Qual Saf. 2019 Aug 7;4(5):e200. doi: 10.1097/pq9.0000000000000200. eCollection 2019 Sep-Oct.
Serious Safety Events (SSEs) are defined as events in which there is a deviation from clinically accepted performance standards, causation, and significant patient harm or death. Given the nature of SSEs, it is important that the processes for declaration of SSEs, the performance of a root cause analysis (RCA), and action plan formation occur quickly, such that the window for potential recurrence of similar events is as small as possible. This manuscript describes a process put in place to improve the timeliness of SSE determination and RCA conduction and evaluates the effect of the process change on these parameters.
A causal analysis was performed of the baseline process to determine factors contributing to long process times. A new process was created and implemented both for the SSE determination process and the RCA completion process. We calculated the mean time for the pre-implementation phase (April 2016-December 2017) and the post-implementation phase (March 2018-January 2019) for both SSE determination and RCA completion. We evaluated differences with a two-sided test assuming unequal variances.
Comparing pre- versus post- implementation phases, the mean time for SSE determination for events that met the SSE criteria decreased from 38.4 to 4.8 days ( < 0.0001), determination for events that did not meet the SSE criteria decreased from 38.4 to 3.8 days ( < 0.0001), and RCA completion time dropped from 118.0 to 26.2 days ( < 0.0001).
A targeted intervention can significantly reduce SSE determination and RCA conduction times.
严重安全事件（SSEs）被定义为偏离临床可接受性能标准、存在因果关系且对患者造成重大伤害或死亡的事件。鉴于严重安全事件的性质，重要的是严重安全事件的申报流程、根本原因分析（RCA）的执行以及行动计划的制定要迅速进行，以使类似事件潜在复发的窗口期尽可能小。本手稿描述了为提高严重安全事件判定和根本原因分析执行的及时性而实施的一个流程，并评估了流程变更对这些参数的影响。
对基线流程进行因果分析，以确定导致流程时间过长的因素。为严重安全事件判定流程和根本原因分析完成流程创建并实施了一个新流程。我们计算了实施前阶段（2016年4月 - 2017年12月）和实施后阶段（2018年3月 - 2019年1月）严重安全事件判定和根本原因分析完成的平均时间。我们使用假设方差不等的双侧检验评估差异。
比较实施前和实施后阶段，符合严重安全事件标准的事件的严重安全事件判定平均时间从38.4天降至4.8天（<0.0001），不符合严重安全事件标准的事件的判定平均时间从38.4天降至3.8天（<0.0001），根本原因分析完成时间从118.0天降至26.2天（<0.0001）。
有针对性的干预可以显著减少严重安全事件判定和根本原因分析的时间。
