Federal officials for the first time want to funnel medical-error data into a new government database. Healthcare providers say they like the potential for easier reporting and earlier detection of patient-safety problems, but they say they're worried about who else might get to look at their mistakes.
Last week, HHS announced a plan to create a new super-database that would integrate the patient-safety data collected by four federal agencies and possibly roll in state and private systems' data later. The benefits, according to HHS Secretary Tommy Thompson, would be to streamline the incident reporting required of caregivers and to let the government better analyze and share emerging patient-safety trends with providers.
But providers-including some of the 300 participants in a national summit on patient-safety data collection and use held last week in Virginia-worry that the absence of federal protection of peer-review data would leave them open to everything from malpractice suits to public humiliation.
One executive said some state government representatives at the summit expressed an interest in using the medical-error data to assist with their provider licensing functions.
"It was a message that we heard loud and clear from the providers at the data summit: They are concerned about the confidentiality of the data," said a spokeswoman for the Agency for Healthcare Research and Quality.
AHRQ Director John Eisenberg, M.D., is leading the task force charged with developing the database. Other federal agencies involved include HFCA, the Food and Drug Administration, and the Centers for Disease Control and Prevention. Collectively, the agencies have 10 medical databases that will be linked in the first phase of the project.
How providers' concerns about confidentiality will be addressed is still up in the air. Eisenberg and other project leaders said key details, such as whether data collection will be mandatory or voluntary and whether records will have all specific patient and provider information removed, haven't been determined.
Some details of the database may be affected by pending legislation. Sen. James Jeffords (R-Vt.) is crafting bipartisan legislation on patient safety, said Joseph Karpinski, communications director of the Senate Health, Education, Labor and Pensions Committee.
Last year, a number of bills to set up either state or federal medical-error databases were introduced in the Senate but failed to get out of committee. Karpinski said Jeffords favors a voluntary system that would use masked data from providers. Karpinski also said Jeffords' approach would include liability protection for providers.
"I think providers will have to look at the (database) project and evaluate it against their local and state laws," said summit participant Paul Conlon, vice president of clinical quality for Farmington, Mich.-based Trinity Health.
For now, however, provider groups are withholding judgment on the government's database initiative, expected to cost $15 million over several years.
The American Hospital Association favors making the database operation voluntary, confidential and nonpunitive to make sure it is "a system for learning," according to the AHA's Anne Berdahl, senior associate director of health policy development.
Hospitals may find ways around participating in federal data-collection efforts if disclosure puts providers at risk. Last year, the AHA admitted that some hospitals alter the way they discipline physicians to avoid reporting them to the National Practitioner Data Bank. While the database of malpractice settlements and disciplinary actions against physicians is accessible only to hospitals and insurers, there has been pressure to open it up to consumers.
The federal government is struggling without an integrated patient-safety information system. "We are flying by the seat of our pants," Eisenberg said.
Some existing databases to be integrated include the CDC's National Nosocomial Infections Surveillance System, the FDA's Medical Products Reporting Program and its Adverse Events Reporting System. Eighteen states have medical-errors reporting systems that also may be rolled into the database.
Private groups also maintain error-monitoring systems, such as the Joint Commission on Accreditation of Healthcare Organization's sentinel-event database, which may eventually be linked to HHS' new database. The JCAHO does not see the federal government's expanded role as a threat to the function it serves in tracking providers' adverse events, said Margaret VanAmringe, the JCAHO's vice president of external relations.
The federal government's current hodgepodge of error-tracking systems often results in providers filling out several government forms for the same incident. Government officials say their analysts have difficulty assessing cases from all the different systems and are likely to have some incidents go unexamined while others are evaluated multiple times.
Although providers will have access to analyses conducted on the database, they will not have access to patient information within the Internet-based system.
Eisenberg said he expects the infrastructure linking the federal databases to be completed within a year. The task force would then begin incorporating patient-safety databases from other parties.