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Ever since the Institute of Medicine (IOM) published its report on medical errors last year, states have been struggling to develop the best way to approach the concern.
The IOM called on each state to create a mandatory reporting system, beginning with hospitals, to collect information about adverse events that cause death or serious harm. It suggested that state-based mandatory reporting would protect the public by assuring that errors are reported and responded to, and would encourage providers to invest in and improve patient safety. In the institute’s view, mandatory reporting would be complemented by voluntary reporting systems to identify system weaknesses before serious harm occurs.
In the months since the IOM report was issued, the National Academy for State Health Policy (NASHP) in Portland, ME, has been working with states to address the Institute’s recommendations.
The Academy first looked at eight states (Colorado, Florida, Kansas, Massachusetts, New York, Pennsyl-vania, South Carolina, and Washing-ton), which have mandatory reporting programs that had been developed before the IOM report was written and were not designed specifically to address medical errors. The academy found that each state defined reportable events somewhat differently and there were other significant differences in how data are gathered and used.
Underreporting was found to be a problem in all states, and no reliable method was identified for determining an anticipated number of reports. Neither was there consensus among states on what information is disclosed and when and how to protect information from disclosure.
Most states surveyed said they use the data collected to trigger on-site investigations and plans for correction. Some states aggregated information; three sent out alerts to hospitals when trends are seen; others publish newsletters, made web-based reports, report to advisory groups, and share information with other state agencies.
As a result of that initial work, the academy turned its attention to what other things states could be doing and how they could organize their work. "We’ve been looking into the roles states play and what’s happening between states and the federal government that could provide models other states could follow," Jill Rosenthal, NASHP policy analyst, tells State Health Watch. "Our latest publication looks at possible state roles and raises a series of questions for states to consider in addressing the issue."
The issue for states to consider is how to estimate the size of the problem in their states. NASHP’s report, Patient Safety and Medical Errors: A Road Map for State Action, points out that state data agencies and purchasers have hospital discharges, claims, and other sources of data that can be used to help estimate how many reported deaths in a state are likely to be due to medical errors. By working with the state data agencies, hospitals and their associations, and researchers, states can identify means of estimating the number of medical errors.
Assigning responsibility for patient safety in state government can be an issue because many governmental agencies typically have a role to play. For instance, health departments protect public health; licensing and certification agencies have an oversight responsibility; a number of state and private parties purchase health care and are concerned about outcomes and quality; data agencies collect information; and insurance departments oversee health insurance and health plans.
"In general," the report states, "there is no vehicle around which to organize state activities on patient safety, although at least one state has created a Center on Patient Safety to coordinate fragmented state activities. Other states have created task forces and commissions to craft coordinated strategies."
As states search for ways to organize their efforts, Ms. Rosenthal says, privacy has become one of the most controversial issues to be dealt with. Should the information obtained through reporting systems be made available to the public or should it be kept confidential?
There are strong arguments made on either side. "Consumers want to have information available," Ms. Rosenthal tells SHW.
"States say the information needs to be made public so they can hold facilities accountable. But providers say that if information is made public, it could lead to less reporting of errors and thus less information on which to base a realistic assessment of the nature and magnitude of the problem and develop sound new policies and procedures," she says.
Ms. Rosenthal says one thing that has been found in visits to states is that underreporting is a problem both when the data are made public and when they are kept confidential. So it may be that provider fears that public reporting of data could lead to more underreporting are not valid.
"Deciding whether and how to protect system data from public disclosure and legal discovery involves balancing the public’s need and uses for the information with provider concerns about the legal consequences of making information public," the NASHP report says.
"Several strategies for protecting mandatory reporting system data are available, should policy-makers decide that such protections are needed. System design features, such as de-identifying data and receiving reports anonymously, may reduce the need for legal protections by making it difficult to link specific incidents to individuals or institutions. This approach may make it more difficult for state officials to conduct important follow-up activities to ensure compliance with reporting requirements," according to the report.
The academy says that exempting mandatory reporting system data from public disclosure laws provides limited protection, while combining public disclosure exemptions with other statutory protections is a useful strategy for strengthening their effectiveness for protecting data.
Strong protections needed
"Special confidentiality statutes and statutory peer review protections may provide the strongest protections from disclosure for mandatory reporting system data if their statutory language is explicit, expressing a clear legislative intent that the information not be disclosed," according to the report.
The academy report adds that while each strategy has strengths and weaknesses, they all are helped when their language explicitly references reporting system data, they are used in combination, and each references the other, making it clear that reporting system data are protected by each of them.
Ms. Rosenthal says that while some federal guidance in terms of definitions could be helpful, this issue needs a state-by-state resolution because states vary in terms of peer review and licensing.
"States are looking for federal leadership, but want the ability to adapt what comes out," Ms. Rosenthal adds. Meanwhile, NASHP will continue helping states share information on specifics and developing best-practices models.
[Contact Ms. Rosenthal at (207) 874-6524.]