OBJECTIVES: Our main goal is to utilize health technology assessment (HTA) methods to accurately assess emerging laboratory diagnostic tests to assist the Department of Laboratory Medicine in incorporating tests with strong measures of validity and reliability, that add clinical value, and are cost-effective.

METHODS: UW Medicine recently implemented a hospital-based (Hb-) HTA program called Smart Innovation. Smart Innovation has reviewed multiple new and emerging health technologies including five tests specific to Laboratory Medicine. Smart Innovation has established a decision-making process to review new technologies that leverages HTA best practices and includes nine dimensions of evidence which are reviewed as part of a comprehensive HTA report for each evaluation. For Laboratory Medicine, the HTA report is reviewed by UW Medicine’s multi-disciplinary Laboratory Formulary Committee for adoption consideration. Each HTA report includes a fiscal impact assessment and a robust evidence review using published research to assess each clinical laboratory test’s value.

RESULTS: Among the five tests we reviewed, one was not adopted, one was added to the formulary with conditions, one resulted in the development of an ordering algorithm that incorporates clinical guidance, one was added to the formulary with the understanding that utilization is being evaluated by the Center for Medicaid and Medicare Services (CMS), and one remains under review. The current estimated cost savings is $1.55 million dollars, based on projections and review of test orders since implementation.

CONCLUSIONS: Laboratory medicine is a critical part of delivering high quality medical care. Diagnostics and testing are used in 40-70% of all clinical decision making, With the advent of precision medicine approaches, the development of new, complex, and often expensive testing methods has accelerated. Smart Innovation has allowed UW Medicine to integrate HTA into laboratory medicine to assist in stewardship of precious healthcare resources.