No state in America has more activity and resources per capita addressing medical errors and patient safety than does the Commonwealth of Massachusetts.
- • Three Regulatory Reporting Programs
Massachusetts maintains two mandatory parallel incident reporting programs and a mandatory outcome reporting program focused on cardiac care.
- ◊ Division of Health Care Quality (DHCQ) Program
The regulatory milieu of Massachusetts was well established in the mid-1980s when the Massachusetts Department of Public Health (MDPH) established rules requiring the reporting of “serious incidents” by all hospitals to the Division of Health Care Quality (DHCQ). The DHCQ hospital reporting program lacks confidentiality protections. Individual facilities are not identified to the public, and there is no annual report issued by the DHCQ regarding “serious incidents,” but these data are open to Public inspection.
- ◊ Board of Registration in Medicine (BORIM)
In addition, in 1986, the Massachusetts Legislature passed the Medical Malpractice Reform Act in response to a reported increase in the number of medical malpractice claims against physicians. The Act contained several sections implementing a number of medical malpractice reforms, one of which gave the Medical Board responsibility for oversight of risk management activities at health care facilities where physicians practice. In 1987 the Massachusetts Board of Registration in Medicine (BORIM), which at that time was independent of the MDPH, established separate regulations requiring physician practitioners to work only in health facilities (i.e., hospitals, nursing homes, HMOs, and physician offices) that complied with Patient Care Assessment (PCA) Program regulations and with mandatory reporting of “major incidents”. Unlike the DHCQ program, the BORIM PCA program includes confidentiality protections.
The PCA program releases no facility-identified information to the public. However, since 2003 BORIM has added resources to the evaluation of reported “major incidents” and provides annual reports of aggregate data that is available to the public. In addition, BORIM's physician profile program provides the public with physician-specific credentialling, criminal, and malpractice information for public consumption.
Both BORIM and the DHCQ are now housed within the MDPH, and both reporting programs are active, but not necessarily collaborative.* Massachusetts does not require a formalized ‘Root Cause Analysis’ (RCA) or action plans as advocated by JCAHO and used by some other States's programs. Facility-identified data is not reported as part of either reporting program. Hence, the elements of the Commonwealth's patient programs are spread across two agencies within a single department, creating substantial overlap and duplication with respect to mandatory incident reporting, but with no statutory or regulatory requirement for coordination of programs.
* The complementary roles of the two programs is summarized in 2000 by Dr. Paul Barach in ‘Medical Errors and Patient Safety in Massachusetts: What is the Role of the Commonwealth?’ [PDF, p15]
"While the two agencies have very similar requirements for their incident reporting systems, they play different roles. The DPH is the licensing authority for hospitals, and as such is the state's enforcement authority for hospitals. It uses its incident reporting system to monitor compliance with quality standards and regulatory requirements as part of its enforcement apparatus. The Medicine Board, not being responsible for hospital care, is able to segregate its Patient Care Assessment function, including its incident reporting system, from its enforcement function and play a more educational, monitoring role. The difference, however, is one of emphasis. The DPH looks to identify system issues from its incident reporting database, and the Medicine Board is very much focused on compliance with its program requirements for hospitals."
- ◊ MASS-DAC Cardiac Outcome Reporting
Although facility-identified information is not available in event-reporting programs, 2000 legislative measures established mandatory public reporting of risk-adjusted outcomes (mortality and volume) for the 14 hospitals performing cardiac surgery and percutaneous coronary interventions. Mandatory performance measurement programs for cardiac surgery and coronary angioplasty were started with a new data analysis center (MASS-DAC) created within the Department of Health Care Policy in the Harvard Medical School, which administers it. Annual reports for 2002 and 2003 have been released through July 2006.
Links to MASS-DAC reports are provided at the DHCQ website.
- ◊ Division of Health Care Quality (DHCQ) Program
- • Sentinel Event to Center for Patient Safety
The regulatory environment was bolstered in 1994 by a sentinel event that achieved great public notoriety. Betsy Lehman, a 39 yo health care reporter for the Boston Globe, died as the result of a medical drug administration error, and this event helped to catapult medical error reporting to the forefront of public scrutiny.
In 1998, an independent Massachusetts Coalition for the Prevention of Medical Errors was created in her memory with extremely broad professional, business, and public support. This Patient Safety Coalition was the first of its kind in the United States. The original list of medication safety practices for hospitals developed by the Massachusetts Coalition for the Prevention of Medical Errors was disseminated in 1999 and later adopted by the American Hospital Association.
A Lehman Center for Patient Safety was created within the MDPH in January 2004 as the result of 2002 legislation [6A MGL § 16E] that mandated its creation. The Massachusetts Coalition for the Prevention of Medical Errors serves as the advisory board to the Lehman Center, but the Lehman Center and the Bureau of Health Quality Management (BHQM) share the same director, and their functional distinction within the MDPH and the Executive Office of Health and Human Services (EOHHS) is not apparent.
- • Major Center of Health Policy Research
Massachusetts has also enjoyed the benefits of support of a health policy expert community unequaled within the United States. The research institutions and the individual experts have brought focus upon Massachusetts' medical error reporting programs, and it has brought in federal money. In 2001, the MDPH in collaboration with the Harvard School of Public Health, the Massachusetts Hospital Association and the Massachusetts Coalition for the Prevention of Medical Errors, began a 3-year, $4.5 million grant from AHRQ to study the root causes of medical errors and to devise appropriate strategies for prevention.
Massachusetts, on a per error basis, arguably has more researchers, more experts , more regulation, and more private coalition group support than any other state in the United States. Added onto this fact is the observation that Massachusetts has received more federal money (thanks to the AHRQ grant) than almost any other state. Other than states like New York that have received comparable federal funding, It is virtually unthinkable that the Massachusetts experience with medical errors will ever be replicated in other states.