Two Institute of Medicine (IOM) reports, To Err Is Human (1999) and Crossing the Quality Chasm (2001), moved public and health care industry concerns about quality, patient safety, and hazard analysis to greater visibility. As patient safety and hazard analysis concerns rise, health industry leaders have sought tools to address these challenges more effectively. Many tools exist; the quality improvement and hazard analysis models that offer methodologies to make medicine safer include Six Sigma, Hazard Analysis and Critical Control Points (HACCP), Failure Mode and Effect Analysis/ Healthcare Failure Mode and Effect Analysis (FMEA/HFMEA™), Toyota Production System (TPS), Hazard and Operability Studies (HAZOP), Total Quality Management/Continuous Quality Improvement (TQM/CQI), Root Cause Analysis (RCA), and Probabilistic Risk Assessment (PRA).

Each approach has champions, supported by consultants ready to train managers and frontline workers in the rollout of each. Competing terms, acronyms, symbols, and techniques suggest a Tower of Babel—health leaders speaking different languages and using tools that do not resemble each other. As demands for improvements in patient safety escalate, the IOM’s Patient Safety Data Standards Committee seeks a framework to understand these approaches to identify principles necessary for any quality improvement (QI) or proactive hazard analysis (PHA) methodology to succeed.

This paper provides an overview of key features of prominent methodologies, offers a framework to understand each, and shows how each relates to others. We outline principles to create effective hazard analysis in health care organizations, and we identify conceptual and methodological considerations in design and evaluation of risk/hazard identification. We relate hazard analysis to adverse event prevention and discuss strategies to apply this approach to health care. Finally, we discuss data requirements and measurement tools to support this approach.

As a caveat, we recall the words of Avedis Donabedian, who devised our modern framework for understanding quality in health care: “If we are truly committed to quality, almost any mechanism will work. If we are not, the most elegantly constructed of mechanisms will fail.” While today’s quality leaders dispute the first sentence, all affirm the validity of the second. While QI and PHA tools can assist any health care organization’s commitment to making health care safer, none will succeed in the absence of deep and sustained leadership commitment.

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