IOM calls for sweeping efforts on patient safety

By Bernie Monegain
10:37 AM
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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.

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.

“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.

The IOM’s 10 recommendations:

Recommendation 1: The Secretary of Health and Human Services (HHS) should publish an action and surveillance plan within 12 months that includes a schedule for working with the private sector to assess the impact of health IT on patient safety and minimizing the risk of its implementation and use.

Recommendation 2: The Secretary of HHS should ensure insofar as possible that health IT vendors support the free exchange of information about health IT experiences and issues and not prohibit sharing of such information, including details (e.g., screenshots) relating to patient safety.

Recommendation 3: ONC should work with the private and public sectors to make comparative user experiences across vendors publicly available.

Recommendation 4: The Secretary of HHS should fund a new Health IT Safety Council to evaluate criteria for assessing and monitoring the safe use of health IT and the use of health IT to enhance safety. This council should operate within an existing voluntary consensus standards organization.

Recommendation 5: All health IT vendors should be required to publicly register and list their products with ONC, initially beginning with EHRs certified for the meaningful use program.

Recommendation 6: The Secretary of HHS should specify the quality and risk management process requirements that health IT vendors must adopt, with a particular focus on human factors, safety culture, and usability.

Recommendation 7: The Secretary of HHS should establish a mechanism for both vendors and users to report health IT-related deaths, serious injuries, or unsafe conditions.

Recommendation 8: The Secretary of HHS should recommend that Congress establish an independent federal entity for investigating patient safety deaths, serious injuries, or potentially unsafe conditions associated with health IT. This entity should also monitor and analyze data and publicly report results of these activities.

Recommendation 9a: The Secretary of HHS should monitor and publicly report on the progress of health IT safety annually beginning in 2012. If progress toward safety and reliability is not sufficient as determined by the Secretary, the Secretary should direct the FDA to exercise all available authority to regulate EHRs, health information exchanges, and PHRs.

Recommendation 9b:
The Secretary should immediately direct the FDA to begin developing the necessary framework for regulation. Such a framework should be in place if and when the Secretary decides the state of health IT safety requires FDA regulation as stipulated in Recommendation 9a above.

Recommendation 10: HHS, in collaboration with other research groups, should support cross-disciplinary research toward the use of health IT as part of a learning health care system. Products of this research should be used to inform the design, testing and use of health IT.

Specific areas of research include:
a. User-centered design and human factors applied to health IT,
b. Safe implementation and use of health IT by all users,
c. Sociotechnical systems associated with health IT, and
d. Impact of policy decisions on health IT use in clinical practice.