Background on Minnesota's Adverse Health Events Reporting Law

In 2003, Minnesota became the first state in the nation to establish a mandatory adverse health event reporting system that included 27 “never events’ identified by the National Quality Forum (NQF) and a public report that identified adverse events by facility. The law covers Minnesota hospitals, freestanding outpatient surgical centers, and regional treatment centers. The law was modified in 2007 to include a 28th event, after the NQF expanded its list.

A number of factors helped to shape Minnesota's reporting system:

• The IOM report “To Err is Human” in 2000 revealed that preventable errors could contribute to the deaths of up to 98,000 people per year.
   
• Public and media attention after the report's publication helped start a national conversation about the reasons why such errors occur. A primary focus of the discussions was the concept that most errors happen not because of the actions of one provider, but because of a failure of complex systems and process in health care.
   
• A desire to create a transparent system that balanced quality improvement and accountability, and develop opportunities for providers to learn from each other about how to prevent adverse events.
   
• A strong collaborative organization, the Minnesota Alliance for Patient Safety, that wanted to take a stand on safety and make Minnesota a leader on this issue.

The Adverse Health Events Review Process

The Adverse Health Events Reporting Law requires MDH to track, assess, and analyze all incoming reports of adverse events, along with the accompanying root cause analyses and corrective action plans. This process is as follows:

• A hospital or ambulatory surgical center discovers that one of the 28 reportable events has occurred. Within 15 days, they must report the details of the event into a secure, password-protected Web-based registry.

• The facility is required to convene an internal team to conduct a Root Cause Analysis (RCA), which involves investigating the role of various factors that may have contributed to the event, including communication, equipment, staffing/fatigue, training, policies/procedures, and organizational culture.

• Within 60 days of the events discovery, facilities are required to submit the findings of their RCA and corrective action plan(s).

• A team of clinical and quality improvement experts reviews each event, to ensure that the RCA and corrective action plan meet all criteria, and that the facility is taking strong enough steps to reduce the risk of a future event.
   
• The facility gets feedback from the review team, and must submit responses and modifications to their plan until all review criteria are met. Each event can go through up to three reviews.

Sharing Information

Along with providing feedback to individual facilities about their root cause analyses and corrective action plans, MDH is also responsible for determining patterns of system failure and successful methods for addressing them, and for sharing this information with facilities. This information sharing takes many forms:

• Information about patterns in root causes and best practices is regularly shared with facilities through newsletters, safety alerts, presentations and meetings.
   
• Many hospitals choose to participate in a data-sharing agreement, through the Minnesota Hospital Association, whereby they can learn directly from other hospitals experiences with similar events.

• The majority of hospitals participate in one or more statewide Calls to Action, campaigns designed to reduce the incidence of the four most common types of adverse events. These campaigns have their roots in analysis of adverse events data and the development of best practices based on trends.

Ensuring Accountability

MDH implemented the Adverse Health Events Reporting Law as a quality improvement and accountability initiative rather than as a regulatory tool. However, MDH is still authorized and required to investigate complaints and enforce licensing and certification standards for certain health care facilities. Adverse health event reporting does not replace these regulatory requirements. The policy goals of the Adverse Health Events reporting system are balanced with the regulatory obligations of the department to hold facilities accountable through multiple channels:

• Adverse health events that are submitted in compliance with the Adverse Health Events Reporting Law are reviewed solely under that law following the procedure described above. However, if an adverse health event is discovered that has not been submitted within the time frame required by statute, the facility would be subject to investigation by MDH under the Vulnerable Adult Act (VAA) or the Maltreatment of Minors act.

• If MDH's Office of Health Facility Complaints receives a complaint about a potential incident, the facility may be subject to an investigation whether or not the event was reported through the adverse health events reporting system. A facility may be subject to state or federal sanctions depending on the findings of the investigation, and information may also be provided to the appropriate professional boards. Findings of complaint investigations are also made public.

• Four of the 28 reportable adverse events are criminal events. Facilities must still report these events under the VAA or Maltreatment of Minors requirements, along with events that fall outside of the 28 reportable adverse events but meet the reporting requirements of the VAA, the Maltreatment of Minors Act, or other state, federal or accreditation reporting requirements.

• The licensing boards that regulate physicians, physician assistants, nurses, pharmacists and podiatrists are also required to report to MDH when events come to their attention that may qualify as adverse health events.

Other Resources

A Better System for Monitoring and Preventing Medical Errors
Minnesota Medicine article, April 2004.