Voluntary Adverse Event Reporting Part of ONC's Draft Patient Safety Plan

by Helen R. Pfister and Susan R. Ingargiola, Manatt Health Solutions


In response to the Institute of Medicine's 2011 report -- titled, "Health IT and Patient Safety: Building Safer Systems for Better Care" -- on how the government and the private sector can maximize the safety of health IT-assisted care, the Office of the National Coordinator for Health IT released a draft Health IT Patient Safety Action and Surveillance Plan on Dec. 21, 2012. 

Two of the plan's key goals are to:

  • Make it easier for clinicians to report adverse events and risks related to use of health IT tools (e.g., treatment errors due to incomplete or inaccurate data in an electronic health record, or due to unclear information display); and
  • Enable the aggregation and analysis of the adverse event and risk information that clinicians report in an effort to prevent future health IT-related errors. 

To achieve these goals, ONC proposes to leverage the voluntary adverse event reporting system that the Agency for Healthcare Research and Quality oversees pursuant to the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). 

Overview of Voluntary Adverse Event Reporting System

In its 1999 report, titled "To Err Is Human," IOM noted that health care providers often are reluctant to report their medical errors out of fear of incurring legal liability or professional sanctions. Congress passed the Patient Safety Act to encourage health care providers to voluntarily report adverse event information (e.g., medication dosing errors, surgery-related errors and similar issues) and to facilitate the development of strategies to improve patient safety.

Patient Safety Organizations

The Patient Safety Act directed AHRQ to authorize public or private organizations, known as Patient Safety Organizations (PSOs), to serve as independent patient safety experts and to receive data regarding patient safety events. The data are considered privileged and confidential; the Patient Safety Act excludes the use of patient safety data in civil lawsuits, such as those involving malpractice claims, and in disciplinary proceedings against a health care provider.

PSOs analyze data, provide feedback to specific providers, and develop and disseminate general information on ways providers can improve patient safety. By serving multiple providers and aggregating patient safety event data, PSOs help providers better understand the underlying causes of patient safety events and develop strategies to prevent them or reduce their frequency.

To support PSOs and health care providers, AHRQ created a network of patient safety databases (NPSD) that collects and aggregates non-identifiable patient safety event data. AHRQ uses data from the NPSD to analyze national and regional statistics, including trends and patterns in patient safety events, and to report on effective strategies for reducing patient safety events and increasing patient safety.

AHRQ's 'Common Formats' for Event Reporting

The Patient Safety Act authorized AHRQ to develop common formats for health care providers to use when reporting patient safety data. While most U.S. hospitals have some type of internal reporting system for collecting data on patient safety events, they often have varying ways of collecting and organizing their data. This variation makes it difficult to accurately compare patient safety events across health care providers and can be a barrier to developing strategies to improve patient safety. If providers or PSOs submit patient safety data to the NPSD, AHRQ requires that these data follow the "Common Formats" so that it can be aggregated and analyzed to identify lessons learned and best practices.

To date, AHRQ has developed Common Formats for two settings of care: acute care hospitals and skilled nursing facilities. Common Formats include data elements that are structured as well as narrative (free text). The structured data permit sorting of patient safety incidents and near misses for event analysis, as well as for pattern analysis and trending at all levels of the health care system. While the narrative data cannot be aggregated, they provide the richness of detail about an individual event or condition necessary to understand patient safety concerns at the provider or PSO levels and to act to reduce risk to patients.

There are two types of Common Formats: generic and event-specific. Generic Common Formats contain data elements that apply to all patient safety concerns (e.g., harm, reporter and location). Event-specific Common Formats pertain to specific types of patient safety events (e.g., falls and health care-associated infections). The current version of the Common Formats (Version 1.2) for acute care hospitals includes three generic and nine event-specific forms. The three generic forms are:

  • The Healthcare Event Reporting Form (HERF). The HERF is designed to be completed by the individual who witnessed, first discovered or is most familiar with the details of the patient safety event. The HERF captures information on incidents, near misses and unsafe conditions. This form is analogous to incident reports commonly used in hospitals today. It contains structured questions and allows for a brief narrative to document the precise details of the event or unsafe condition. The HERF solicits only the most basic information about an event or unsafe condition and is intended to start a reporting process that is completed using other generic and event-specific forms.
  • Patient Information Form (PIF). The PIF supplements the HERF in cases where an "incident" (i.e., an event that reached the patient) occurred; it is not used for near misses or unsafe conditions. The PIF provides for collection of demographic information as well as additional information about the impact of the event on a patient (e.g., level of harm). 
  • Summary of Initial Report (SIR). The SIR is completed for all incidents, near misses and unsafe conditions reported on a HERF. It represents everything that is known about the event or unsafe condition at the time the initial report is completed. Contributing factors and risk factors that are general in nature are reported on the SIR. As with the HERF, it includes structured questions and allows for a final narrative comment. Certain data elements on the SIR are used to confirm the information originally captured by the initial reporter on the HERF (e.g., location, reporter title). The SIR also allows the user to indicate if the event is a serious reportable event as defined by the National Quality Forum.

The nine event-specific forms cover the following topics:

  • Blood or blood product;
  • Device or medical/surgical supply, including health IT;
  • Fall;
  • Health care-associated infection;
  • Medication or other substance;
  • Perinatal;
  • Pressure ulcer;
  • Surgery or anesthesia; and
  • Venous thromboembolism.

The event-specific forms are intended to supplement the information collected on the HERF, PIF and SIR. Additional structured information is collected about the event itself, as well as information about the use or employment of measures designed to prevent the occurrence of the event.

While AHRQ makes paper versions of the Common Formats available, they are intended to be completed and transmitted electronically.

Role of Adverse Event Reporting and Analysis in ONC's Draft Plan

According to ONC, clinician reporting of adverse events and risks associated with health IT provides the raw data necessary for developers, providers, researchers and policymakers to understand the root causes of the events and to subsequently improve the safety of health IT. To make data about health IT-related adverse events and risks more widely available and actionable, ONC is proposing a number of different steps. 

First, ONC is proposing to require that electronic health records facilitate reporting of safety events using AHRQ's Common Formats. Specifically, ONC is proposing to include the ability to facilitate reporting in AHRQ's Common Formats as a required element for EHR certification under the Medicare and Medicaid EHR Incentive Programs. The Common Formats are designed to support this use. 

Next, to help inform ONC's development of EHR standards and certification criteria related to patient safety, AHRQ will support research that will test the extraction of data elements both identical to and related to AHRQ's Common Formats from multiple established EHR implementations, as well as the exportation of this data to hospital incident reporting systems.

ONC also is proposing to leverage AHRQ's PSOs in an effort to aggregate and analyze information from providers' health IT-related adverse event reports. AHRQ will encourage PSOs to help health care providers use the Common Formats, which will allow the PSOs to more efficiently identify, aggregate and analyze the health IT-related patient safety events. AHRQ's NPSD will analyze these health IT-related patient safety events, and HHS will publish a report of its findings.

Reactions to ONC's Proposed Safety Plan

Voluntary adverse event reporting by health care providers is just one part of ONC's proposed plan for ensuring the safety of health IT. Other parts of ONC's plan include a code of conduct for health IT developers, the incorporation of health IT safety in post-market surveillance of EHRs through ONC-Authorized Certification Bodies and the inclusion of health IT safety in medical education and training, among other things.

The November 2011 IOM report that spurred development of ONC's plan also suggested creating an independent body to investigate problems with health IT and to recommend fixes, similar to how the National Transportation Safety Board investigates aviation accidents, but ONC chose not to adopt that recommendation.

Reactions to ONC's proposed plan are only beginning to filter in. Some stakeholders are suggesting it doesn't go far enough, while others are calling the proposal a necessary step in the right direction. The public has until Feb. 4 to comment on the proposal, including whether they think a more robust, mandatory patient safety program is warranted.

to share your thoughts on this article.