Hospitals’ incident reporting systems are missing about half of Medicare patient harm events and even more infrequently investigating those events or reporting them to the government, according to a pair of reviews conducted by the Department of Health and Human Services’ Office of Inspector General (HHS OIG).
The findings build upon a prior OIG investigation of 770 Medicare patients who were discharged in October 2018, among which 299 experienced harm events.
Based on surveys covering 266 of the harm events returned by 154 hospitals in 2023, the OIG found that 49% of the harm events were absent from a hospital’s incident reporting and surveillance systems (regardless of whether the facility was initially aware of the event). It was unclear to OIG whether another 16% of patient harm events were or were not captured.
For many of the uncaptured events, staff did not make a recording because they either did not consider the event to be harm (46% of missed events) or because it wasn’t standard practice at the hospital to capture them (18%)—which OIG found “was often because hospitals applied narrow definitions of harm.”
The review also found that hospitals were no more likely to capture more severe adverse advents than they were temporary harm events and were more likely to miss patient harm stemming from surgeries or procedures. Teaching hospitals more often missed patient harm events than non-teaching hospitals in the review’s sample, which the OIG speculated could be tied to the more complex care they deliver.
The 94 harm events in the sample that were captured by hospitals’ systems were most often flagged in a medical record review (54%) or by a real-time patient monitoring system (40%), according to the report. However, among 48 for which the OIG had sufficient information, only 17 were investigated by the hospital to identify issues that may have contributed to the event. Further, only 11 of those resulted in patient safety improvements or process changes, such as staff trainings or enhanced monitoring.
“When hospitals opted not to conduct investigations, they cited reasons similar to those for not capturing events—they believed that the harm events were not preventable; the cause was immediately known and remediated; or they considered the harm events to be known complications, side effects, or risks of treatment and therefore understood and even expected,” the OIG wrote in its report.
In a companion memo reviewing the same sample of harm events, the OIG determined that 15 of the 94 harm events captured by hospitals should have been reported under Centers for Medicare & Medicaid Services (CMS) or states’ reporting requirements.
Hospitals reported only five of those required events, though another seven of the remaining unrequired events were reported voluntarily to external groups for learning purposes.
The results, though more encouraging than those the OIG found years earlier, outlined room for hospitals to improve their safety surveillance, better understand where their practices can be improved and comply with required transparency, the watchdog wrote.
The OIG also paired its reviews with recommendations for federal agencies, their partners, surveyors and states. These included better alignment of harm event definitions and the creation of a taxonomy of patient harm and prioritization of the Medicare Quality Assurance and Performance Improvement requirement during surveys. The agencies concurred with some, but not all, recommendations.
“In response to our prior work, HHS agencies took a number of actions to help hospitals improve patient safety, but our study shows that additional actions are needed,” the OIG wrote in its report.
The OIG’s patient safety event surveillance reviews were published Tuesday alongside a separate report in which the office found gaps in hospitals’ infectious disease outbreak preparedness the CMS could help address.
Specifically, the OIG found the CMS was not ensuring that surveyors were trained on key planning areas for an emerging infectious disease outbreak, did not ensure that hospitals’ emergency preparedness plans met the needs of all at-risk patient populations and did not have guidance addressing front-line staff’s mental health as part of preparedness planning.
Though it noted some limitations, the CMS concurred with all of the recommendations the OIG outlined in that report.