Department of Pharmacy, Georges Pompidou European Hospital, 20 rue Leblanc, 75015 Paris, France.
BMJ Qual Saf. 2011 Aug;20(8):698-703. doi: 10.1136/bmjqs.2010.048074. Epub 2011 Mar 8.
In order to improve its quality-assurance programme based on ISO 9001, the Central Sterile Supply Department of a public university hospital has performed a prospective risk analysis using the Preliminary Risk Analysis method (PRA). The objectives were the achievement of a global risk mapping related to the whole process of sterilising medical devices, and second, the implementation of corrective measures to reduce identified risks.
A multidisciplinary team, formed in January 2008, validated results at each step of the study. During the analysis, 416 hazardous situations were identified, among which 81 were quoted first in priority and led to the description of 141 risk scenarios. The PRA team assessed 42 scenarios with risk ranking assessed as 'acceptable under control' or 'unacceptable.' They adopted 23 follow-up actions measures and 13 safety parameters.
The PRA constitutes an appropriate tool for assessing quality-improvement policy and safety in healthcare facilities that can be easily integrated into standard quality-management systems.
为了改进基于 ISO 9001 的质量保证计划，某公立医院中心供应室采用初步风险分析（PRA）方法进行了前瞻性风险分析。目的是实现与医疗器械消毒全过程相关的整体风险映射，其次是实施纠正措施以降低已确定的风险。
一个多学科团队于 2008 年 1 月成立，在研究的每个步骤都验证了结果。在分析过程中，确定了 416 种危险情况，其中 81 种情况被优先引用，导致 141 种风险情况的描述。PRA 团队评估了 42 种风险情况，风险等级评估为“控制下可接受”或“不可接受”。他们采取了 23 项后续行动措施和 13 项安全参数。
PRA 是评估医疗保健设施质量改进政策和安全性的合适工具，可轻松集成到标准质量管理系统中。
