Topic Areas and Issues

1. Epidemiology of Patient Safety Risks and Hazards

Definition of Topic Area
Identification of medical errors and causes of patient injury in health care delivery, with a focus on populations that are vulnerable because they are compromised in their ability to function as an engaged patient during health care delivery.

• Assess knowledge on epidemiology by different patient populations, such as children, the terminally ill, the mentally ill, and those with other chronic illnesses.
• A focus should be given to issues for patients who are unable to function effectively as engaged patients in their health care delivery;
• Consider the roles of private and public reporting systems to achieve and sustain knowledge on patient safety epidemiology.
• Consider the need for and implications of developing national-level data on the epidemiology of patient safety risks and hazards.

2. Effective Practices and Tools

Definition of Topic Area
Development and field testing of patient safety practices to identify practices that are effective, appropriate, and feasible for health care organizations to implement, taking into account the level of evidence needed to assess patient safety practices.

• Examine possible approaches for establishing and maintaining current information on the effectiveness of practices to improve patient safety, as the information emerges from ongoing research (e.g., evidence reports, the NQF list of practices).
• Assess what level of evidence is necessary to establish the effectiveness of a patient safety practice, considering differences in these practices from clinical interventions, for which evidence is established through randomized clinical trials.
• Consider what needs to be provided to health care organizations to help them identify effective practices that are appropriate for their use, feasible to implement, and cost effective, and assess the extent to which this information is being provided by current research.

3. Infrastructure for Effective Practices

Definition of Topic Area
Establishment of the health care structural and environmental elements needed for successful implementation of effective patient safety practices, including an organization's commitment and readiness to improve patient safety (e.g., culture, information systems), hazards to safety created by the organization's structure itself (e.g., physical configurations, procedural requirements), and effects of the macro-environment on the organization's ability to act (e.g., legal and payment issues).

• Address aspects of the nature of the organization structure itself that represent patient safety risks and hazards.
• Consider various elements of the macro-environment such as medical liability and HIPAA effects on reporting, incentives or barriers created by payment structures, and effects of federal and state regulations on an organization's procedures.
• Consider how patient safety is being addressed in the education of health professionals, including implications of the attitudes of those doing the teaching toward patient safety practices.

4. Broader Adoption of Effective Practices

Definition of Topic Area
The adoption, implementation, and institutionalization of patient safety practices to achieve sustainable improvement in patient safety performance across the health care system.

• Address the separate steps of (1) dissemination of knowledge to health care organizations about effective patient safety practices and (2) their actions to adopt new practices drawing upon that knowledge.
• Consider the role of patient safety performance requirements established by external entities such as accreditation organizations or purchasers, with a focus on the relative merits of achieving compliance with such requirements versus internal motivation to adopt improved practices.
• Address the need for technical assistance for small and ambulatory providers to apply available knowledge and information in their own setting.
• Explore issues involved in moving from adoption (early acceptance of a practice), to implementation (initial use of the practice), to institutionalization (ultimate state where a practice has become an integral part of the organization's operation).

5. Monitoring Progress and Maintaining Vigilance

Definition of Topic Area
Establishment and monitoring of indicators to assess performance improvement progress for key patient safety processes or outcomes, while maintaining continued vigilance to ensure timely detection and response to issues that represent patient safety risks and hazards.

• Consider the types of process or outcome performance measures that are appropriate for monitoring patient safety performance, including implications for setting standards for performance (e.g., minimum acceptable level or benchmark comparisons).
• Assess the merits of different options for doing performance measurement, including use of trending, benchmarking, and public versus private reporting.
• Consider the roles of statewide patient safety reporting systems in public reporting of progress in patient safety performance.
• Explore implications for federal roles in establishment of measures, defining standards for reporting systems, and reporting processes.