根本原因分析报告表文档格式.docx

1、Age: 年龄：Gender: M F 性别：男女 MR Level: 议员级别：NR 上午十时十五分 ML 毫升 MO 莫 SV 希沃特 PR 公关 City/Town: 市/镇：Date of Event: 活动日期：Date RCA Completed: RCA的完成日期：1. 1。THE EVENT Describe what happened and any harm that resulted. 事件 - 描述发生了什么，而导致的任何损害。 Identify the proximate cause, if known. 确定近因，如果知道的话。RCA Team Members: R

2、CA的团队成员：Team Leader: 组长：2. 2。BACKGROUND & FACTORS SUMMARY Answer the following questions （brief summary only- attach supporting documents）. 背景与因素的摘要， 回答下列问题（摘要只，附上证明文件）。2.1 2.1 What was the sequence of events that was expected to take place? 什么是地方序列采取预期的事件呢？ Attach flowchart if available. 如果有附加流程图。D

3、escription: 说明：2.2 2.2 Was there a deviation from the expected sequence? 是否有一个序列偏离预期？ Yes 是 No 无 If YES, describe the deviation. 如果是，请描述的偏差。2.3 2.3 Was any deviation from the expected sequence likely to have led to or contributed to the adverse event? 在任何序列偏离预期可能导致或促成了不良事件？ NK NK细胞 If YES, describe

4、with causal statement. 如果是，请描述与因果发言。2.4 2.4 Was the expected sequence described in policy, procedure, written guidelines, or included in staff training? 预期序列是在描述的过程政策，书面指引，或包括在员工培训？If YES, cite source. 如果是，引用的来源。2.5 2.5 Does the expected sequence or process meet regulatory requirements and/or practi

5、ce standards? 是否预期的序列或过程符合要求和监管/或执业标准？ Cite references and/or literature reviewed by the team. 引用参考文献和/或文献回顾了队伍。If NO, describe deviation from requirements/standards. 如果没有，说明偏离标准要求/。2.6 2.6 Did human action or inaction appear to contribute to the adverse event? 难道人的行为或不出现不良事件做出贡献？If YES, describe th

6、e actions and how they contributed. 如果是，请描述他们的行动和如何作出了贡献。2.7 2.7 Did a defect, malfunction, misuse of, or absence of equipment appear to contribute to the event? 做了一个缺陷，故障滥用，或缺乏设备似乎有助于事件？If YES, describe what equipment and how it appeared to contribute. 如果有，请说明它是如何出现的设备和贡献。2.8 2.8 Was the procedure

7、or activity involved in the event being carried out in the usual location? 是程序或事件的活动参与了正在进行中的正常位置？If NO, describe where and why a different location was utilized. 如果没有，说明在哪里以及为什么不同的位置被利用。2.9 2.9 Was the procedure or activity being carried out by regular staff familiar with the consumer and activity?

8、 是过程或活动是由经常开展活动和工作人员熟悉的消费者？If NO, describe who was carrying out the activity and why regular staff were not involved. 如果没有，说明谁是开展活动的正式工作人员，为什么没有参与。2.10 2.10 Were involved staff credentialed/skilled to carry out the tasks expected of them? 参与资格的人员/技术开展对他们的期望的任务是什么？If NO, describe the perceived inadeq

9、uacy. 如果没有，说明知觉不足。2.11 2.11 Were staff trained to carry out their respective responsibilities? 责任的工作人员进行培训，以履行各自的？2.12 2.12 Were staffing levels considered to have been adequate at the time of the incident? 这一事件被认为具有人手已足够时间在？If NO, describe why. 如否，说明原因。2.13 2.13 Were there other staffing factors id

10、entified as responsible for or contributing to the adverse event? 是否有其他工作人员的事件的不利因素确定为负责或作出贡献？If YES, describe those factors. 如果是，请描述这些因素。2.14 2.14 Did inaccurate or ambiguous information contribute to or cause the adverse event? 难道不准确或含糊不清的信息有助于或导致不良事件？If YES, describe what information and how it c

11、ontributed. 如果是，请描述什么样的信息以及如何作出了贡献。2.15 2.15 Did a lack of communication or incomplete communication contribute to or cause the adverse event? 做了沟通缺乏沟通或不完整的促进或导致不良事件？If YES, describe who and what and how it contributed. 如果是，请描述谁和什么和如何作出了贡献。2.16 2.16 Did any environmental factors contribute to or cau

12、se the adverse event? 没有任何环境因素导致或引起的不良事件？If YES, describe what factors and how they contributed. 如果是，哪些因素，以及如何描述他们的贡献。2.17 2.17 Did any organizational or leadership factors contribute to or cause the adverse event. 没有任何组织或领导的因素促成或导致不良事件。2.18 2.18 Did any assessment or planning factors contribute to

13、or cause the adverse event? 没有任何评估或规划因素促成或导致不良事件？2.19 2.19 What other factors are considered relevant to the adverse event? 考虑什么其他因素有关的不良事件？Describe:2.20 2.20 Rank order the factors considered responsible for the adverse event, beginning with the proximate cause, followed by the most important to le

14、ss important contributory factors. 排名考虑的因素的不利事件负责，因为首先是近因，最重要其次是较少的重要成因。 Attach Contributory Factors Diagram, if available. 附加成因图，如果有的话。Was a root cause identified? 是一个根本原因确定了吗？If YES, describe the root cause. 如果是，请描述的根本原因。3. 3。RISK REDUCTION ACTIONS TAKEN List the actions that have already been tak

15、en to reduce the risk of a future occurrence of the event under consideration. 采取减少风险行动 -列出行动的代价已经采取了降低风险的下一个未来事件的发生。 Note the date of implementation. 注意实施日期。Action Taken - Description 采取的行动-描述 Date Implemented 之日起施行 4. 4。PREVENTION STRATEGIES List from highest priority to lowest priority the recomm

16、ended actions designed to prevent a future occurrence of the adverse event. 防治策略 -列出从最高到最低优先级优先不良事件的发生而设计的行动建议，以防止未来的。 Begin with a rank of 1 （highest）. 首先1级（最高）。 For each strategy or action provide an estimated cost, if known, and any additional considerations or recommendations for implementing th

17、e strategy （eg, phase-in, immediate need, triage by risk）. 对于每个策略或采取行动所提供的成本估计，如果知道，和任何其他考虑或实施战略的建议（例如，逐步实施的，迫切需要，风险分流的）。Rank 秩 Strategy 战略 Estimated Cost 估计费用 Special Considerations 特别注意事项 1 一 2 2 3 三 4 4 5 5 6 6 7 7 INCIDENTAL FINDINGS List and describe any incidental findings that should be caref

18、ully reviewed for corrective action. 偶然发现 -列出和介绍任何纠正行动偶然发现，应予以认真审查。6 . 6。APPROVAL After review of this summary report, all team members should notify the team leader of either their approval or recommendations for revision. 批准 -在本摘要报告的审查，所有团队成员应通知的任何修订小组的领导人或他们的建议批准。 Following all revisions the repo

19、rt should be signed by the team leader prior to submission. 以下所有的修订的报告，需经领队之前提交。Signature of Team Leader: 领队：Date Signed: 签署日期：The information contained in this report is confidential and is intended solely to promote safety and reduce consumer risk. 本报告中包含的信息是保密的，是唯一目的是促进安全和减少消费者的风险。Forward this report to all RCA team members and to the following individuals: 这份报告转发给所有团队成员和RCA的下列人员：Name 名称 Title 标题 Organization 组织 Address 地址 Email 电邮