Systems Engineering and Point-of-Care Testing: Report from the NIBIB POCT/Systems Engineering Workshop

摘要

The first part of this article is an introduction to systems engineering and how it may be applied to health care and point-of-care testing (POCT). Systems engineering is an interdisciplinary field that seeks to better understand and manage changes in complex systems and projects as a whole. Systems are sets of interconnected elements that interact with each other, are dynamic, change over time, and are subject to complex behaviors. The second part of this article reports on the results of the National Institute of Biomedical Imaging and Bioengineering workshop exploring the future of POCT and technologies and the recognition that these new technologies do not exist in isolation, that they exist within ecosystems of other technologies and systems, and that these systems influence their likelihood of success or failure and their effectiveness. In this workshop, a diverse group of individuals from around the country, from disciplines ranging from clinical care, engineering, regulatory affairs, and many others to members of the 3 major National Institutes of Health-funded efforts in the areas such as the Centers for POCT for sexually transmitted disease, POCT for the future of Cancer Care, and POCT primary care research network, gathered together for a modified deep dive workshop exploring the current state of the art, mapping probable future directions and developing longer term goals. The invitees were broken up into 4 thematic groups as follows: home, outpatient, public/shared space, and rural/global. Each group proceeded to explore the problem and solution space for point-of-care tests and technology within their theme. Although each thematic area had specific challenges, many commonalities also emerged. This effort thus helped create a conceptual framework for POCT as well as identifying many of the challenges for POCT going forward. Four main dimensions were identified as defining the functional space for both POCT and treatment, these are the following: time, location, interpretation, and tempo. A framework is presented in this study. There were several current and future challenges identified through the workshop. These broadly fall into the categories of technology development and implementation. More specifically, these are in the areas of (1) design, (2) patient-driven demand and technology, (3) information characteristics and presentation, (4) health information systems, (5) connectivity, (6) work flow and implementation, (7) maintenance/cost, and (8) quality control. Definitions of these challenge areas and recommendations to address them are provided.