Systems Engineering and Point of Care Testing: Report from the NIBIB POCT/Systems Engineering Workshop.
The first part of this manuscript 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 whole. Systems are sets of interconnected elements which interact with each other, are dynamic, change over time and are subject to complex behaviors. The second part of this paper reports on the results of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) workshop exploring the future of point of care testing 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 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 three major National Institutes of Health (NIH) funded efforts in the areas the Centers for POCT for sexually transmitted disease, POCT for the future of Cancer Care, 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: 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. While 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 point of care testing and treatment, these are: Time, Location, Interpretation and Tempo. A framework is presented in this paper. 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) Workflow and implementation, 7) Maintenance/Cost, and 8) Quality Control. Definitions of these challenge areas and recommendations to address them are provided.
Division of General Medicine, Medicine, MGH-Institute for Technology Assessment, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
James E
JE
Stahl
Division of General Medicine, Medicine, MGH-Institute for Technology Assessment, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
Heather
H
McGowan
Division of General Medicine, Medicine, MGH-Institute for Technology Assessment, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
Ellen
E
DiResta
Division of Infectious Diseases, Medicine, Johns Hopkins University Baltimore MD.
Charlotte A
CA
Gaydos
Boston University, Center of Future Technologies in Cancer Care.
Catherine
C
Klapperich
Center for Integration of Medicine and Innovative Technology (CIMIT).
John
J
Parrish
National Institute of Biomedical Imaging and Bioengineering, Point-of-Care Technology Research Network; Division of Discovery Science and Technology.
Brenda
B
Korte