With approximately 13 billion laboratory tests conducted annually in the United States, these diagnostic procedures play a pivotal role in patient care. However, the diagnostic laboratory data ecosystem is fraught with issues that can lead to errors, making it the third-leading cause of death in the nation. In response to this, a research team from MIT’s Department of Aeronautics and Astronautics Engineering Systems Lab, in collaboration with Synensys, embarked on a year-long study.
The comprehensive study provided a rare holistic view of the diagnostic laboratory data ecosystem, encompassing not only doctors and lab technicians but also device manufacturers, health information technology (HIT) providers, and government entities. By adopting a systems-based methodology, rooted in systems theory, the MIT researchers identified six systemic factors contributing to patient hazards.
These factors include decentralization, flawed communication and coordination, insufficient focus on safety-related regulations, ambiguous or outdated standards, misperceived notions of risk, and a lack of systems theory integration. The sheer volume of potential risks, known as unsafe control actions (UCAs), led the researchers to advocate for a holistic approach, emphasizing the need for a fundamental shift in perspective and operations within the medical community.
The MIT engineers argue that despite the multitude of potential hazards, addressing these issues at the systemic level can lead to more effective change. They highlight four systemic factors that require greater oversight and accountability: decentralization, flawed communication and coordination, insufficient focus on safety-related regulations, and ambiguous or outdated standards. The remaining two systemic factors, misperceived notions of risk and a lack of systems theory integration, call for a fundamental shift in perspective and operations within the medical community.
Drawing parallels with the aviation industry, which has successfully used systems theory for decades to improve safety, the researchers propose introducing controls and error reporting mechanisms into the diagnostic laboratory data ecosystem. These controls, inspired by engineering principles, aim to solicit feedback, enabling the system to change and adapt for safer behaviours and outcomes for healthcare workers and patients alike.
The MIT team, working on behalf of the U.S. Food and Drug Administration (FDA), will continue its research with Synensys, focusing on diagnostic screenings outside the laboratory, such as those conducted at a physician’s office or at home. This ongoing initiative aims to further enhance patient safety in diagnostic processes and contribute to the broader understanding of health care as an engineered system.
