- • Before IOM's To Err Is Human
Minnesota's initial adverse event program, if it can be categorized as such, was a horribly ambiguous program with unclear reporting standards that evolved in 1995 from the Criminal Procedure Code, Minnesota Statute §626.557, the Vulnerable Adult Act (VAA). The VAA required reporting of maltreatment of vulnerable adults, inclusive of reporting within medical facilities. Law enforcement was the primary agency to conduct investigations, although reporting to county and/or state boards or agencies that might make decisions also occurred.
- • ‘A Call to Action’
Following the IOM report in 1999, Minnesota formed the Minnesota Alliance for Patient Safety (MAPS) in 2000, which provided collaboration between a public regulatory authority and multiple private health care organizations, including its three co-founders – the Minnesota Department of Health (MDH) the Minnesota Hospital Association (MHA) and the the Minnesota Medical Association (MMA), plus a statewide safety coalition of over 50 health care organizations. MAPS served to generate a culture of patient safety by mobilizing community resources to address patient safety issues. One of the initial tasks of MAPS was the creation in November 2001 of the Patient Safety Manifesto, "Call To Action" [PDF], patterned after the Harvard Executive Session on Patient Safety.
- • Minnesota's Adverse Event Reporting Program
Minnesota's medical error reporting developed from statutes, with virtually no contribution via administrative rules. In an embrace of the IOM call for a non-punitive, mandatory reporting program and an embrace of the National Quality Forum 27 “Never Events,” the Adverse Health Care Events Reporting Act of 2003 was passed. The law was heavily endorsed by the Minnesota Department of Health (MDH), MAPS, the medical community, and the Minnesota Hospital Association (MHA), which designated it as its highest priority legislation. The bill was signed by the governor on May 27, 2003. Unfortunately Minnesota was in the midst of a major and historic budget deficit, and the law was written with language that required non-state funds to be used to fund this activity in fiscal years 2004 & 2005. Reporting of the NQF's 27 ‘Serious Reportable Events in Health Care’ [PDF] began July 1, 2003 with a ‘limited implementation’ of the program with major facilitation and managment by the MHA. Initial 2004 non-state funding for 2004 in the amount of $115,000 was raised by the MHA from 5 contributing MAPS members. Subsequent non-state funding of the MDH for an additional $135,000 led to a MDH August 6, 2004 memorandum [PDF], announcing plans to start full implementation of the Adverse Health Care Events Reporting program on December 6, 2004. The MHA, in transferring full operations for the program to the MDH, published a December 2004 Update [PDF].
The reporting program places accountability on the hospitals and outpatient surgical centers to report adverse events. The MHA ran the operation in the beginning, developing a web-based reporting tool and the personnel to collect the data. In keeping with the confidentiality and security provided in the law, the data was forwarded to the MDH for development of a report to the legislature and a report for public release. The initial reports contained only aggregate data. With full program implementation that began in December 2004, subsequent annual reports have included events by category with identification of medical facilities. Every effort has been made to avoid a ‘blame’ mentality. No physicians or other health professionals are included in adverse event reports.
The Minnesota effort is remarkable for the leadership of the private community. The adverse event reporting law might not have passed, and the reporting program certainly could not have been implemented without the support of the Minnesota Hospital Association and the major financial contributors within the MAPS community. Arguments that Patient Safety efforts are driven by regulatory efforts (see Devers KJ et al, What Is Driving Hospitals' Patient-Safety Efforts? Health Affairs (2004); 23:103-15.) have been repudiated in Minnesota where a private-public collaboration is active.