Federal efforts to improve patient safety should recognize that IT tools can decrease the risk of adverse events...
rather than increase it, according to a new report from the Bipartisan Policy Center.
The paper, titled "An Oversight Framework for Assuring Patient Safety in Health Information Technology," lays out a set of priorities it says should be considered when regulatory bodies are drawing up new patient safety guidelines. It says regulations should consider the positive impact of IT systems on patient safety, ensure that responsibility for safety is shared among all stakeholders, support innovation, take advantage of existing quality standards and ensure that reporting of safety events is not punitive.
Federal agencies currently are considering ways to certify that technology, such as electronic health records (EHRs), doesn't interfere with care quality. The Department of Health and Human Services released its Health IT Patient Safety Action and Surveillance Plan for public comment in December 2012, and the Food and Drug Administration Safety and Innovation Act, signed into law last July, directs the FDA to develop a set of recommended regulations for ensuring EHR-related safety.
Health IT patient safety developments
Part 1: ONC's EHR patient safety plan
Part 2: Q&A on ONC's safety plan
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At an event announcing the release of the Bipartisan Policy Center (BPC) report, Farzad Mostashari, M.D., national coordinator for health IT, said that the new regulations bearing down on the industry need to be smart in order to take advantage of the full potential of IT systems to support patient safety. He acknowledged the growing chorus of detractors who feel that health IT systems could add new safety risks, but said that technology accounts for only a small portion of reported safety events.
"Technology can be a tool for better reporting of those safety events and to reduce those safety events," Mostashari said. "Technology must be seen to improve safety, not merely add to the safety issues." IT systems can help ensure patients receive the right medications, facilitate the use of surgical checklists and support greater standardization of care, he said.
But these benefits are not universal. Several high-profile cases in the last couple of years highlight how technology can play a role in dangerous care. Last August, an EHR system used at a Contra Costa correctional facility in California recommended that a nurse administer what could have been a lethal dose of heart medication to an inmate. In August 2011, the Lifespan hospital group of Rhode Island announced that a software glitch caused some patients to receive short-acting medications when they should have been given time-release drugs.
We know health IT can improve patient safety. The rest is all about redesigning how we deliver care and make it usable. That's the issue that health IT needs to address.
director, Agency for Healthcare Research and Quality
A report released this week by the ECRI Institute states that ensuring EHR system safety should be a top priority for health care executives, now that so many providers have adopted EHR systems. Nevertheless, the BPC paper cites information from the Institute of Medicine indicating that less than 1% of all reported treatment errors can be blamed directly on IT systems.
Carolyn Clancy, M.D., director of the Agency for Healthcare Research and Quality, who spoke at the BPC event, said this number, though small, is not insignificant. Still, she said, most safety events that ultimately are pinned on IT problems can be traced back further, to workflow or process problems. Errors are more likely to occur when a provider implements a system that is a poor match for its clinical needs or doesn't adjust its clinical processes to incorporate the system. "We know health IT can improve patient safety," she added. "The rest is all about redesigning how we deliver care and make it usable. That's the issue that health IT needs to address."
Doug Henley, M.D., executive vice president and CEO of the American Academy of Family Physicians, said this shift in focus from IT products to processes may be happening already as the nation increasingly transitions away from fee-for-service payment models. Accountable care organizations and other quality-based payment systems force physicians to rely heavily on IT systems to track patients' health, spot trends and collaborate with other doctors, all of which activities support patient safety. Accountable care is where IT and patient safety issues intersect, he said. However, accountable care projects are still unable to take full advantage of IT systems to support safety, primarily because systems don't communicate with each other effectively, he added. Providers are clamoring for interoperability.
"In the context of better integrated care, our members are telling us they need the process. They need interoperability," Henley said. "They are frustrated by the fact that it's now about populations, not just individual patients, and the technology needs to innovate and evolve rapidly."
The statement echoed earlier comments by Mostashari. He said ensuring that health IT tools are used to improve patient safety rather than add new risks is less about technology than it is about people and processes. For Mostashari, these "socio-technical" factors will be key drivers of quality going forward.