Clucas Luisa, Kelly Cate, Do Trang Thu, Beadell Inez, Dawson-McClaren Belinda, Gaff Clara L
Melbourne Genomics Health Alliance, Melbourne, Victoria, Australia.
The Royal Children's Hospital, Parkville, Victoria, Australia.
BMJ Open Qual. 2025 Sep 21;14(3):e003359. doi: 10.1136/bmjoq-2025-003359.
Genomic medicine is rapidly changing routine clinical care in a range of specialties. Effective clinical governance is essential for safe implementation of emerging clinical practice, including genomic medicine. Frameworks exist for national implementation of genomics but lack the granularity needed by hospitals to guide local implementation of national policy.We aimed to identify if a framework suitable to support the safe, effective implementation and use of genomic medicine at a hospital level exists.
A systematic search using scoping review methodology was performed, searching three databases (Medline, Embase and PubMed), from 2009 to 2022, to identify structured approaches to the clinical governance of genomics at a meso (hospital/hospital consortia) level.
No frameworks were identified that provided a holistic clinical governance approach to hospital-level implementation of genomics. Eight publications included components relevant to the implementation of genomics. While the clinical governance components included in the eight publications varied, all identified one or more of the following as important to effective implementation: optimal leadership of genomic care; ensuring an effective workforce; ensuring safe, effective clinical practice; the importance of quality metrics and the criticality of consumer partnerships. No publication explicitly discussed risk management, but all identified processes which would serve to minimise risk.
Institutional-level change is essential for the implementation of genomic medicine throughout a health system. Yet, there is a lack of evidence-based frameworks to support integrated clinical governance of genomic medicine and its implementation by hospitals and their executive leaders. Our results can contribute to the design of an approach which supports hospital planning and decision-making by integrating all elements of clinical governance. Without this, implementation will be piecemeal, access to genomic medicine across a health system inequitable, and patients may receive inefficient, ineffective, slow and potentially unsafe care.
基因组医学正在迅速改变一系列专科的常规临床护理。有效的临床治理对于包括基因组医学在内的新兴临床实践的安全实施至关重要。虽然存在国家层面实施基因组学的框架，但缺乏医院所需的详细程度来指导国家政策的地方实施。我们旨在确定是否存在适合在医院层面支持基因组医学安全、有效实施和使用的框架。
采用范围综述方法进行系统检索，检索2009年至2022年的三个数据库（Medline、Embase和PubMed），以确定中观（医院/医院联盟）层面基因组学临床治理的结构化方法。
未发现为医院层面实施基因组学提供全面临床治理方法的框架。八篇出版物包含了与基因组学实施相关的内容。虽然这八篇出版物中包含的临床治理内容各不相同，但都确定了以下一项或多项对有效实施至关重要：基因组护理的最佳领导；确保有效的劳动力；确保安全、有效的临床实践；质量指标的重要性以及消费者伙伴关系的关键性。没有出版物明确讨论风险管理，但都确定了有助于将风险降至最低的流程。
机构层面的变革对于在整个卫生系统中实施基因组医学至关重要。然而，缺乏基于证据的框架来支持基因组医学的综合临床治理及其由医院及其行政领导实施。我们的结果有助于设计一种通过整合临床治理的所有要素来支持医院规划和决策的方法。没有这一点，实施将是零碎的，整个卫生系统获得基因组医学的机会将不平等，患者可能会接受低效、无效、缓慢且可能不安全的护理。
