Today ONC posted a final summary report on Health Information Technology Adverse Event Reporting:  Analysis of Two Databases.     

Patient safety thrives in health care organizations where reporting of adverse events, including near misses and unsafe conditions, is encouraged.  The Patient Safety and Quality Improvement Act of 2005 directed the Agency for Healthcare Research and Quality (AHRQ) to create Patient Safety Organizations (PSOs) and “Common Formats” to encourage adverse event reporting that could be aggregated across organizations to inform a learning health system for better, safer care.  AHRQ’s Common Formats include standard questions and narrative text fields about all types of adverse events, not just questions on health IT.

In an effort to better understand the role of health IT in adverse events, ONC funded analyses of adverse events reported to two PSOs — UHC and ECRI Institute (ECRI) .  These analyses began by reviewing hundreds of thousands of adverse events from all causes reported to the two PSOs, since January 2011 for UHC and October 2009 for ECRI.   Both PSOs collect information on adverse events beyond the Common Formats questions. The final report posted today summarizes findings from the analyses, which include:

• In the ECRI database, the Common Formats Yes/No question  on health IT involvement was answered only four percent of the time, requiring any learning related to health IT to be based on analysis of the narrative text and other information that may be included in the reports.   
• In the UHC database, the Common Formats Yes/No question on health IT involvement was answered approximately half the time, which provided a large enough database for further analysis using the Common Formats. The analysis found:
  • Overall, incidents involving health IT were less likely to result in harm when compared to those events that were not health IT-related.
  • The most common contributing factors to health IT-related events were communication among staff and team members (40-42 percent), staff inattention (33-34 percent), accuracy of the data (21-23 percent), and availability of data (10-12 percent). These factors were more frequently identified in health IT-related events than in events that were not health IT-related.
  • Medication-related events were the most common health IT-related event type, accounting for about one-third of these events.
  • More than half of the health IT-related events were categorized in the Common Formats “other” report category making it difficult to determine the clinical problem involved in these events from these data.
  • About 60 percent of the events involving health IT were categorized as an incident (i.e., they reached a patient although they may not have resulted in harm to the patient), 14 percent as near miss event, and 26 percent as an unsafe condition.
  • The UHC data showed that clinical documentation systems, computerized provider order entry (CPOE), and laboratory information systems are among the types of IT most commonly involved in adverse events. Health IT-related issues were common in the interfaces between different software components that make up health IT systems.
  • Comparing answers to the Common Formats question on whether an event was health IT-related to a more in-depth review of the event, UHC found that an estimated 31 percent of the events coded as health IT-related were not actually health IT-related, and over 25 percent of the events that actually were health IT-related were not coded as such.

While this report points to the need for improvements, it also confirms the value of standardized adverse event reporting across organizations using the Common Formats.  ONC and AHRQ, working together, will reach out to PSOs, health care organizations, and health IT developers to explore ways to improve reporting using the Common Formats.

Healthcare organizations and health IT developers, working with PSOs, can use evidence like this to focus their efforts to use health IT to make care safer and to continuously improve the safety of health IT.  Suggestions for how to get engaged in such efforts are available in an ONC-sponsored guide developed by ECRI Institute on “How to Identify and Address Unsafe Conditions Associated with Health IT.”  Recommended practices to optimize the safety and safe use of health IT in many of the areas identified in these analyses are available in ONC’s SAFER Guides.

Please post your reactions to the report on this blog or directly contact Kathy.kenyon@hhs.gov with comments.