Harvard Medical School

Patient Care - Safety and Risk Initiatives

Medical errors and patient safety have been highlighted by two Institute of Medicine reports (Institute of Medicine, 2000; 2001). The second report, Crossing the Quality Chasm: A New Health System for the 21st Century, recommended a deeper understanding of risk, and a fundamental redesign of the health system with a focus on reliability, safety, effectiveness, and efficiency in the delivery of care. In 2001, Tommie Thompson, then Secretary at the US Department of Health and Human Services gave the healthcare industry a mandate ".to enhance the knowledge base about safety; to identify and learn from medical errors." Given that we have been in the practice of medicine for a long time, why is our current state of knowledge about medical risk and adverse events so impoverished? At this point, hospitals lack the tools necessary to efficiently and routinely assess the risks associated with new clinical processes and invasive procedures.

Dr. Meghan Dierks, Assistant Professor at the Harvard Medical School, and Director of Clinical Systems Analysis at Harvard's Beth Israel Deaconess Medical Center in Boston, in partnership with Item Software, have been working to remedy this through the use of the software tool - Quantitative Risk Assessment System ( QRAS ).

The major aim of this work is to:

  • Establish the technical merit and feasibility of using formal Probabilistic Risk Analysis to model system-based risk in high-priority, high-risk areas of clinical care
  • Identify those aspects of healthcare to which Probabilistic Risk Assessment is most applicable for quality and safety monitoring
  • Incorporate this analysis into hospital policy, planning and prioritization for safety interventions or procedures

The team has identified two areas that have been particularly well-suited for PRA, and that have been modeled effectively using the QRAS . They are:

1. Safety assessment prior to the introduction of new technologies, equipment and procedures into the clinical environment

2. Risk assessment in technology-dependent procedural areas such as the operating room, the intensive care unit, the cardiac catheterization unit and the interventional radiology unit

Previously the innovative appeal of procedures and practice tended to drive rapid introduction and deployment in many institutions without formal evaluation of the 'hidden' risks associated with these new technologies. The modeling environment offered by QRAS has proven useful in analyzing safety issues relating to new technologies and procedures prior to their introduction into the patient environment. Dr. Dierks is working with leadership at the Beth Israel Deaconess Medical Center to incorporate PRA into the pre-procurement analysis and assessment process. For the first time, the safety and risks of a new technology will be incorporated, along with the standard cost-analysis, prior to procurement of these devices.

In the second area of focus, use of the QRAS has been very effective in understanding the risks associated with invasive procedures. Until now, our understanding of what can go wrong in the high-risk 'surgical' environment focused almost exclusively on patient factors (e.g., co-morbidities such as cardiovascular disease or diabetes) or the technical and anatomic aspects of the clinical procedure. Absent from such models were important system factors, including resource availability, scheduling constraints, access to and quality of information for real-time decision-making, and human performance issues such as response time to alarms and critical events. Another important aspect missing from the risk equation has been the variation in risk across different phases of care - i.e., from the pre-operative or pre-procedure planning phase, through the post-operative recovery phase.

Here, Dr Dierks and colleagues have found the Mission-phase modeling capabilities in QRAS to be particularly applicable, and are modeling phases of clinical care in a manner similar to the 'mission phases' use by the Aerospace and Defense industries. Physicians are no longer dependent on the traditional models that tend to treat surgical and interventional procedural risk as uniform across all phases of care. For the first time, decision-makers can visualize how the dominance of risk factors varies across different phases of surgical care. This is proving useful in identifying phase-specific vulnerabilities, and prioritizing interventions.

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