In a follow-up study to the landmark Institute of Medicine (IOM) reports To Err Is Human (IOM, 2000) and Crossing the Quality Chasm (IOM, 2001), the IOM published the report Patient Safety: Achieving a New Standard for Care in 2004 (IOM, 2004). In it, the IOM called for the Agency for Healthcare Research and Quality (AHRQ) to develop Common Formats for reporting adverse events and near misses1 to a national patient-safety database. In 2005, Congress passed the Patient Safety and Quality Improvement Act (PSQIA), which established patient safety organizations (PSOs) and a Network of Patient Safety Databases (NPSD). Under the PSQIA2 AHRQ was tasked with implementing the NPSD to provide an interactive, evidence-based management resource for health care providers and other entities. The NPSD was established to enable analysis of national and regional statistics, including trends and patterns of patient-safety events, and to promote interoperability among reporting systems by using Common Formats (e.g., definitions, data elements). In addition, the PSQIA specifies the role of PSOs, which collect, aggregate, and analyze confidential information reported by health care providers.
The PSQIA also requires AHRQ to generate a draft report to Congress on effective strategies for reducing medical errors and increasing patient safety and to submit the draft report to the National Academies of Sciences, Engineering, and Medicine (the National Academies) for peer review.3 The AHRQ draft report was to include methods to encourage the appropriate use of such strategies, including in any federally funded programs. The report’s release was concurrent with the 18-month anniversary of the operationalization of the NPSD (June 2019). The final AHRQ report will be submitted to Congress by December 2021.
In January 2021, the National Academies convened a committee of four subject-matter experts with experience in clinical patient safety, patient-safety research, health information technology, clinical medicine, safety science, and implementation science. In its review of the AHRQ draft report Strategies to Improve Patient Safety: Draft Report to Congress for Public Comment and Review by the National Academy of Medicine, the committee considered the four questions posed by AHRQ, which are listed in the committee’s Statement of Task (see Box 1). These questions focus on additional effective strategies for improving patient safety, new evidence of effectiveness for safety strategies, implementation methods not mentioned in the original report, and any technical comments or corrections to the draft report.
1 A “near miss” is “an act of commission or omission that could have harmed the patient but did not cause harm as a result of chance, prevention, or mitigation” (IOM, 2004, p. 34).
2 42 U.S.C. § 299b-22(j).
3 The review was carried out by the Health and Medicine Division of the National Academies.
The committee met four times over 3 months to review AHRQ’s draft report and reach consensus with regard to its Statement of Task. The committee approached its task by reviewing the report, reviewing the PSQIA, conducting a literature review, and reading supplementary AHRQ and U.S. Department of Health and Human Services (HHS) materials, including the Making Healthcare Safer (MHS) series of reports, from which the AHRQ draft drew much of its data, and the HHS Office of Inspector General’s (OIG’s) report Patient Safety Organizations: Hospital Participation, Value, and Challenges (OIG, 2019). The PSQIA also requires that the AHRQ draft report be available to the public and open for comment. The committee did not have access to the public comments.
After reviewing the AHRQ draft report and considering the questions posed in the Statement of Task, a number of pertinent questions arose regarding additional strategies that could be employed to improve patient safety, with special attention to leveraging the benefits of PSOs and the NPSD as envisioned in the PSQIA. One of the reasons for the committee’s focus on PSOs and the NPSD is because at the time the PSQIA was passed, only 4 percent of American physicians used a comprehensive electronic health record (EHR) (DesRoches et al., 2008). Now, 16 years later, more than 90 percent of physicians and more than 95 percent of hospitals routinely collect data in an EHR. This development fundamentally changes what is feasible and practical, and the committee believes it should heavily influence strategies to improve patient safety going forward.
In the following chapter, the committee responds directly to the Statement of Task in four sections, which include the additional strategies that the committee suggests AHRQ consider in the final version of its report.
- Section 1: Additional effective strategies or practices for reducing medical errors and increasing patient safety not mentioned in the draft.
- Section 2: Significant additional or new evidence regarding the effectiveness of particular strategies or practices for reducing medical errors and increasing patient safety.
- Section 3: Additional methods for encouraging effective adoption and sustained implementation of effective strategies for reducing medical errors and increasing patient safety.
- Section 4: Technical comments and corrections to the draft report.
The committee believes that the timing of the AHRQ report’s retrospective review of what has been accomplished using PSOs and the NPSD represents a unique opportunity to look forward and propose strategies to strengthen the role and impact of aggregate data analysis in patient safety. The committee finds the goal of learning from multi-organizational experiences compelling, and even more feasible today than it was in 2005.