Rex J H, Turnbull J E, Allen S J, Vande Voorde K, Luther K
Hermann Hospital, Houston, TX, USA.
Jt Comm J Qual Improv. 2000 Oct;26(10):563-75. doi: 10.1016/s1070-3241(00)26048-3.
Adverse drug events (ADEs) occur frequently, and serious ADEs are associated with mortality or prolonged morbidity. As many ADEs are preventable, identification and modification of systems and processes that permit ADEs has the potential to reduce the rate of ADEs.
Root cause analysis was systematically employed in a blame-free fashion to investigate the patterns of serious ADEs that occurred during a 29-month period at Hermann Hospital (Houston), and process improvements were implemented on the basis of these findings. The consistently nonpunitive responses to the results of the initial and subsequent root cause analyses was gradually seen, accepted, and ultimately embraced by the hospital staff.
The most commonly identified root causes were environmental factors (for example, increased census, increased acuity, change of shift) and staffing issues (for example, personnel new to a unit). Policy changes that led to increased use of forcing or constraining functions (for example, removal of concentrated intravenous potassium solutions from floor stocks) and better personnel support (for example, early awareness and response to localized increases in census and acuity) were particularly effective. Although limited by our lack of active surveillance and not necessarily directly due to the process changes that we implemented, the rate of voluntarily reported serious ADEs/100,000 patient days decreased during this time from 7.2 to 4.0, a decline of 45% (p < 0.001).
Systematic application of root cause analysis followed by implementation of process changes that target the underlying cause(s) of each event can be successfully implemented in a large hospital.
药物不良事件（ADEs）频繁发生，严重的药物不良事件与死亡率或延长的发病率相关。由于许多药物不良事件是可预防的，识别并改进导致药物不良事件的系统和流程有可能降低药物不良事件的发生率。
以无指责的方式系统地采用根本原因分析，以调查在休斯顿赫尔曼医院29个月期间发生的严重药物不良事件的模式，并根据这些发现实施流程改进。医院工作人员逐渐看到、接受并最终采纳了对初始和后续根本原因分析结果始终不惩罚的回应。
最常确定的根本原因是环境因素（例如，人口普查增加、病情严重程度增加、班次变化）和人员配备问题（例如，新到某科室的人员）。导致更多使用强制或约束功能的政策变化（例如，从病房库存中移除浓缩静脉钾溶液）和更好的人员支持（例如，对人口普查和病情严重程度局部增加的早期认识和应对）特别有效。尽管受到缺乏主动监测的限制，且不一定直接归因于我们实施的流程变化，但在此期间，自愿报告的严重药物不良事件/10万患者日的发生率从7.2降至4.0，下降了45%（p<0.001）。
在大型医院中，可以成功地系统应用根本原因分析，然后针对每个事件的根本原因实施流程变化。
