Safe and effective genomic medicine implementation in hospitals: a scoping review.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.