Last month, an American College of Emergency Physicians report said a “rush to capitalize on the huge federal investment” has yielded “an alarming number of clinicians … anecdotally reporting a substantial increase in the incidence of wrong order/wrong patient errors” using IT. But the ACEP report, like several predecessors, noted there are “few consistent data on how commonly these errors occur, and few studies are actually focused on collecting evidence of these errors.”
In January, the Food and Drug Administration, working with the ONC and the Federal Communications Commission, is expected to release recommendations on establishing a “risk-based regulatory framework for health IT.” The FDA report, mandated by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) could lead to direct FDA regulation of health IT systems.
Since January 2011, more than $15.1 billion in federal spending under the electronic health-record incentive payment program has produced what Dr. Ron Wyatt, medical director of the healthcare improvement division at the Joint Commission, called “almost an explosion of health IT” adoption.
“You just look at the volume and you start thinking about what are the potentials and risks of something occurring with all that data,” Wyatt said. “One hospital I visited had three different, distinct systems just for medication reconciliation. You can see the risk of some type of error occurring.”
The Joint Commission, under the ONC plan, will investigate health-IT related adverse events, develop follow-up and corrective action plans and create a database of events for further research. “We want to look at where is health IT causing an unsafe condition, or a near miss or a close call, not just sentinel events,” Wyatt said.
Currently, there are no good data on the incidence of IT-related events, said Dr. William Munier, director of the Center for Quality Improvement and Patient Safety at HHS' Agency for Healthcare Research and Quality.
AHRQ has developed common formats for the standardized reporting of patient safety incident information by providers to federally chartered patient safety organizations.
Hospitals whose safety reporting systems use the latest AHRQ version of the standards, version 1.2, can report IT-linked cases to their PSOs now, he said.
The ONC plan also calls for AHRQ to gather IT-linked patient safety event data from the nation's 77 PSOs into a central data source. That national database is already functional and should be receiving de-identified data this year, Munier said.
Even so, the process is unlikely to produce a list of glitch-prone health IT vendors causing patient safety events. “Most IT-related events don't present the IT itself as the cause,” Munier said. They are typically reported as something else, maybe as an adverse drug event, or a patient fall, and “it takes some sleuthing after the event” to find an IT connection.
“If there is something inherently dangerous, a clear-cut glitch, about a piece of software, the vendor is going to find out about it and fix it,” Munier said. What the database is likely to gather is a slew of human factors linked to IT and contributing to patient safety problems, Munier said.
As stated in its plan, the ONC hasn't lost faith that “health IT has enormous potential to improve the quality and safety of care.”
One of the “most challenging” IOM recommendations—rejected by the ONC—was a call for HHS to create an independent federal entity to investigate health IT-linked patient safety incidents, said Dr. Paul Tang, chief innovation and technology officer at the Palo Alto (Calif.) Medical Foundation.
“It's interesting they picked on a private organization, the Joint Commission,” Tang said. “That covers hospitals; it doesn't cover the ambulatory sector. But that's a reasonable approach.”
Dr. Jacob Reider, chief medical officer at the ONC, will continue to lead implementation as overseer of the ONC Safety Program. He said the still-developing FDASIA framework “will be complementary” to the ONC effort, the plan's authors said.
Reider is unclear of the impact the FDASIA work group or the FDA report might have on possible revisions of the ONC plan. “It's a massive task we're starting to take on here, and FDASIA will be one of the many inputs into the final structure,” he said.
Physician informaticist Dr. Scot Silverstein said he's worried about how long it will take the Joint Commission to get up to speed on health IT and would rather see the FDA take over regulation of the health IT industry.
“Of all the organizations that have experience in IT validating, they are the best of the bunch,” he said.
Follow Joseph Conn on Twitter: @MHJConn
