Continuous improvement

quality improvement activities, typically conducted by health care delivery organizations, to assess processes of providing care to meet patient needs. These activities usually compare the relative effectiveness of delivering existing approved therapies or diagnostics. IOM reports in 2000 and 2001 found that most medical errors resulted from faulty processes and systems, not individuals. Quality improvement efforts to identify and correct errors and inefficiencies in the processes of delivering patient care have become common practice within health care delivery organizations. Today, the concept of continuous improvement in health care includes more than just measurements of quality and could also incorporate innovation and a strong scientific foundation to inform improvement efforts. Several workshop participants suggested that to pursue the goal of further integrating clinical research and practice, policy change or clarification be taken up that would expressly permit inclusion of routine evidence generation activities of health care organizations that pose no more than a minimal risk to patients under the concept of continuous improvement activities, which would have the effect of exempting these activities from the traditional regulatory framework applied to experimental research activities (e.g., Common Rule, HIPAA). They noted that incorporating low-risk research into the concept of continuous improvement could improve the ability of health care systems to engage in research efforts. For a discussion of the distinctions between continuous improvement—including quality and clinical effectiveness assessments—and human subjects research that requires formal oversight by an Institutional Review Board (IRB), see Selker et al., 2011.