Patient safety and health policy: a history and review.

Policy initiatives on many fronts have converged to improve patient safety. A major tension that characterizes this process is the attempt to achieve a balance between learning and control in complex systems with technical, social, and organizational components. Efforts to improve learning are marked by better information flow, discovery, flexibility in thinking, embracing of failures as learning opportunities, and core incentives to promote voluntary participation of all stakeholders in the process. Efforts to improve accountability are traditionally marked by public disclosure, meeting of certain widely disseminated standards, availability of performance measures, exposure to legal liability, and compliance with mandated directives (statutes, regulations, accreditation requirements). In some sense, these directions are mutually exclusive. Although a more collaborative regulatory-improvement model would be helpful in creating an industrywide safety culture, it is likely that learning and accountability functions will follow separate tracks. An exception would be policy that stimulates organizations to comply with regulation by showing how well and by what methods they are learning and how others can profit from these experiences. Any approach to improving patient safety should, at a minimum, include a nonpunitive in-depth mechanism for reporting incidents, postincident evaluations for identification of system changes to prevent subsequent occurrences, and state-guaranteed legislative protection from discovery for all aspects of information gathered to improve patient safety. Nonpunitive approaches have yielded useful results in other industries [43]. State and federal courts, state licensing boards, and accrediting bodies such as JCAHO all function to maintain accountability and standards; however, the very fear of existing legal liability or its misapplication are the greatest hurdles to pioneering patient-safety efforts. The health care system needs to transform the existing culture of blame and punishment that suppresses information about errors and adverse events into a culture of safety that focuses on openness and information sharing to improve health care and prevent adverse outcomes. Education and leadership will be most important to creating and sustaining a strong safety culture and arguably the most important defense against preventable harms. Safety culture cannot be legislated, just as the old adage states that it is easier to pull rather than push a piece of spaghetti. Given the imbalances and inefficiencies of market forces in health care, perverse incentives that have strengthened resistance to change, and secrecy when it comes to adverse event information, however, it is likely that policy initiatives will continue to play an important role in the transformation of the industry to more highly reliable, safer levels of care.