IOM calls for sweeping efforts on patient safety

A report on the use of health IT and its impact on patient safety, released at a news briefing Nov. 10 in the nation's capital, calls for funding a new Health IT Safety Council to evaluate criteria for assessing and monitoring the safe use of health IT.

[See also: Institute of Medicine report says FDA not fit to regulate HIT]

That recommendation is among 10 recommendations the IOM is making in its call for sweeping changes that touch every aspect of the industry – care providers, technology vendors, policymakers and officials at the highest levels of government.

"I think the report will bring more stakeholders together to improve quality and safety of care, and I think this committee will be an important part of that," ONC chief Farzad Mostashari, MD, said at a meeting of the federal Health IT Policy Committee meeting on Nov. 9.

Paul Tang, MD, CMIO of Palo Alto Medical Center and also a member of the Health IT Policy panel, agreed. "ONC takes safety very seriously," he said.

[See also: IOM finds healthcare data for children lacking]

“The governement wants to be proactive in understanding risks and how we can mitigate the risks," Tang added.

However, there may also be legal barriers, he noted; there may be laws that prohibit looking at safety risks. Some of the contracts providers make with vendors have an indemnity clauses, for instance.

Design of system is also a factor, Tang added; there is a certain amount of customization that is required.

The IOM report makes clear that the safe application of health information technoliogy is a life-or-death issue. And it urges Health and Human Services Secretary Kathleen Sebelius to call on Congress to establish an independent federal entity for investigating patient safety deaths, serious injuries or potentially unsafe conditions associated with health IT.

IOM, best known for its watershed 1999 report on medical errors, “To Err is Human,” is the health arm of the National Academy of Sciences. It is an independent, nonprofit organization that works outside of government to provide unbiased and authoritative advice to decision makers and the public.

This new report, “Health IT and Patient Safety: Building Safer Systems for Better Care,” examines a broad range of health information technologies and recommends actions the government, healthcare providers and technology vendors should take to improve patient safety.

Its call for an independent federal entity, however, comes at a time when the federal government is in gridlock – and apparently averse to what many view as “big government.”

On the vendor front, the IOM recommends that the secretary of HHS ensure that health IT vendors support the free exchange of information about health IT experiences and issues and also urges HHS to establish a mechanism for both vendors and users to report health IT-related deaths, serious injuries or unsafe conditions.

"We appreciate the focus this report places on patient safety," Allscripts executives told Healthcare IT News in a written response. "It is a top priority for Allscripts."

Officals from the EHR vendors said Allscripts supports IOM’s assertion "that the FDA should not regulate EHRs for the reasons cited in the report."

The IOM recommends setting up an independent federal entity, similar to the National Transportation Safety Board, to investigate deaths, serious injuries or unsafe conditions associated with health IT.

But Allscripts officials suggest a different approach.

"We instead suggest that Patient Safety Organizations (PSOs), as established in the 2005 Quality and Patient Safety Act, would be the appropriate structure for adverse event reporting, rather than the creation of an entirely new regulatory structure," the statement said. "PSOs are a model already familiar to many healthcare organizations and would achieve the aims of the desired event reporting without the cost of creating and maintaining a new government body.

"Further, we are in favor of having vendors participate in the adverse event reporting process, as we support all efforts to promulgate a learning health system that expands the associated benefits of improved patient care and decreased costs stemming from health information technology use."

Healthcare IT News Managing Editor Mike Miliard and Washington D.C.-based Healthcare IT News Senior Editor Diana Manos contributed to this report.

The IOM's 10 recommendations are on the next page.