Babiker Amir, Amer Yasser S, Osman Mohamed E, Al-Eyadhy Ayman, Fatani Solafa, Mohamed Sarar, Alnemri Abdulrahman, Titi Maher A, Shaikh Farheen, Alswat Khalid A, Wahabi Hayfaa A, Al-Ansary Lubna A
Pediatrics Department, College of Medicine, King Saud University, Riyadh, Saudi Arabia.
King Abdullah Specialized Children's Hospital, King Saud Bin Abdulaziz University for Health Sciences, National Guard Health Affairs, Riyadh, Saudi Arabia.
J Eval Clin Pract. 2018 Feb;24(1):206-211. doi: 10.1111/jep.12873. Epub 2017 Dec 29.
RATIONALE, AIMS, AND OBJECTIVES: Implementation of clinical practice guidelines (CPGs) has been shown to reduce variation in practice and improve health care quality and patients' safety. There is a limited experience of CPG implementation (CPGI) in the Middle East. The CPG program in our institution was launched in 2009. The Quality Management department conducted a Failure Mode and Effect Analysis (FMEA) for further improvement of CPGI.
This is a prospective study of a qualitative/quantitative design. Our FMEA included (1) process review and recording of the steps and activities of CPGI; (2) hazard analysis by recording activity-related failure modes and their effects, identification of actions required, assigned severity, occurrence, and detection scores for each failure mode and calculated the risk priority number (RPN) by using an online interactive FMEA tool; (3) planning: RPNs were prioritized, recommendations, and further planning for new interventions were identified; and (4) monitoring: after reduction or elimination of the failure mode. The calculated RPN will be compared with subsequent analysis in post-implementation phase.
The data were scrutinized from a feedback of quality team members using a FMEA framework to enhance the implementation of 29 adapted CPGs. The identified potential common failure modes with the highest RPN (≥ 80) included awareness/training activities, accessibility of CPGs, fewer advocates from clinical champions, and CPGs auditing. Actions included (1) organizing regular awareness activities, (2) making CPGs printed and electronic copies accessible, (3) encouraging senior practitioners to get involved in CPGI, and (4) enhancing CPGs auditing as part of the quality sustainability plan.
In our experience, FMEA could be a useful tool to enhance CPGI. It helped us to identify potential barriers and prepare relevant solutions.
原理、目的和目标：临床实践指南（CPG）的实施已被证明可减少实践中的差异，提高医疗质量和患者安全。中东地区在CPG实施（CPGI）方面的经验有限。我们机构的CPG项目于2009年启动。质量管理部门进行了失效模式与效应分析（FMEA）以进一步改进CPGI。
这是一项定性/定量设计的前瞻性研究。我们的FMEA包括：（1）对CPGI的步骤和活动进行流程审查和记录；（2）通过记录与活动相关的失效模式及其影响进行危害分析，确定所需行动，为每个失效模式指定严重程度、发生概率和检测分数，并使用在线交互式FMEA工具计算风险优先数（RPN）；（3）规划：对RPN进行优先级排序，确定建议和新干预措施的进一步规划；（4）监测：在减少或消除失效模式之后。计算出的RPN将与实施后阶段的后续分析进行比较。
使用FMEA框架对质量团队成员的反馈数据进行了审查，以加强29项适配CPG的实施。确定的RPN最高（≥80）的潜在常见失效模式包括意识/培训活动、CPG的可获取性、临床倡导者的支持较少以及CPG审核。采取的行动包括：（1）组织定期的意识活动；（2）提供CPG的印刷版和电子版；（3）鼓励资深从业者参与CPGI；（4）加强CPG审核，作为质量可持续性计划的一部分。
根据我们的经验，FMEA可能是加强CPGI的有用工具。它帮助我们识别潜在障碍并准备相关解决方案。
