In response to a congressional mandate under the Patient Safety and Quality Improvement Act of 2005 (PSQIA), the National Academies of Sciences, Engineering, and Medicine (the National Academies) was asked to review the Agency for Healthcare Research and Quality (AHRQ) draft report Strategies to Improve Patient Safety: Draft Report to Congress for Public Comment and Review by the National Academy of Medicine.1 The National Academies convened a committee of four subject-matter experts with experience in clinical patient safety, patient-safety research, health information technology, safety science, clinical medicine, and implementation science to conduct a peer review of the draft report. This committee had less than 3 months to review the AHRQ draft report and comment on additional effective strategies for improving patient safety, new evidence of effectiveness for safety strategies, potential implementation methods that were not mentioned, and any general technical corrections.
As the lead federal agency supporting patient safety for the country, AHRQ has a broad research portfolio of activities covering the topic. A major research dissemination vehicle has been the Making Healthcare Safer (MHS) series of reports, the most recent of which was released in 2020 (Hall et al., 2020; Shekelle et al., 2013; Shojania et al., 2001). These reports represent highly curated and prioritized summaries of important safety research and publications, and the AHRQ draft report includes an excellent overview of the MHS reports and their important contributions. In addition to its review of the AHRQ draft report, the committee offers several technical suggestions for enhancing the usefulness of the MHS report series.
The committee closely examined the congressional intent of the PSQIA in its establishment of two new entities, patient safety organizations (PSOs) and a Network of Patient Safety Databases (NPSD), charged with collecting and analyzing multi-organizational regional and national data. Because that was the defining reason for the PSQIA, the committee focused significant attention on reviewing the draft report’s coverage of strategies to improve patient safety involving these new entities. It has been more than 15 years since the enactment of the PSQIA. The question before Congress and the authors of the draft AHRQ report is whether the creation of PSOs and the NPSD has significantly enabled major advances in patient safety. The 2019 U.S. Department of Health and Human Services’ Office of Inspector General’s (OIG’s) report on PSOs provides valuable data about the current use of PSOs and the NPSD to improve patient safety and reduce medical errors. Although many organizations indicated that they benefited from their participation with PSOs, the OIG concluded that “the PSO program has yet to realize its promise of enabling learning and advances in patient safety on a national scale” (OIG, 2019, p. 16)—the congressional intent of the PSQIA. The committee believes the AHRQ
draft report could be strengthened significantly by focusing more attention on strategies to overcome the barriers to leveraging PSOs and the NPSD identified in the OIG report. The committee suggests that the final report consider the following additional strategies:
- Fund demonstration projects and communicate compelling evidence of the benefits of PSOs and the NPSD, both to client organizations and to patient safety researchers. Highlight the benefits of transparency and the utility of analyzing data from multiple, similar organizations for benchmarking and learning.
- Explore the use of artificial intelligence (e.g., machine learning, natural language processing) to enhance the value of the insights from large, multi-organizational datasets and to potentially reduce the burden of data collection and normalization.
- Communicate clear guidance about the legal protections afforded data submitted to PSOs and the NPSD, including privacy protecting procedures. Where protections are deemed insufficient to address health care organizations’ concerns, strategies for encouraging further regulatory or legislative actions may be required.
- Increase the use of Common Formats (e.g., definitions, data elements) as a critical intermediary step to shared learning and benchmarking. Explore inclusion of Common Formats use as part of the certification criteria for PSOs. Explore the use of natural language processing as an adjunct to gathering patient-safety information from free-text fields.
- Expand the coverage of Common Formats into ambulatory care and specialty care.
- Explore incentives and technical strategies to facilitate automated transmission of patient-safety data from electronic health record systems to PSOs to reduce the costs and burden of reporting. Include attention to data quality and completeness.
- Explore payer or regulatory incentives for reporting safety data to PSOs in a standardized format as a strategy to increase voluntary reporting that facilitates return benefits to both the reporting organizations and the systematic enhancement of patient safety for the nation.
- Include results of additional studies related to the Comprehensive Unit-Based Safety Program (CUSP) in which CUSP may not have been effective, as well as studies of approaches that can help struggling hospitals improve patient safety.
- Explore high visibility implementation strategies from other national patient safety organizations, programs, and initiatives—such as the Veterans Health Administration National Center for Patient Safety, the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System, the FDA Sentinel Initiative, the Vaccine Adverse Event Reporting System, the Centers for Disease Control and Prevention Epicenters Program, the Institute for Healthcare Improvement, and The Joint Commission, and appropriate international examples.
- Update AHRQ’s responses to the OIG report recommendations with any subsequent results.
The nation expects and deserves safer care. The PSQIA created valuable national resources as part of the tools needed for systemic change. The committee offers these additional strategies to improve patient safety for consideration in the revision of the AHRQ draft report to Congress.