Everyone’s for patient safety, but…

By Bernie Monegain
12:13 PM

IOM report draws mixed response from providers, policymakers, advocates

WASHINGTON – When the prestigious Institute of Medicine called for sweeping changes across healthcare to ensure health information technology is being used safely, the reaction from healthcare providers and policymakers was swift – and mostly positive.

However, Doug Duncan, MD, an orthopedic surgeon, who began his orthopedic practice in Springfield, Mo. in 1977 following his residency at the Mayo Clinic, responded by going to what he believes is the heart of the matter. Duncan argues that the timeline for achieving meaningful use is too demanding and too short.

“What’s the rush?” he asked. “The well-known IOM report of 1999 was called ‘To Err is Human,’” Duncan wrote in a comment on the Healthcare IT News website. “Allow me to predict that one of the conclusions of the new Health IT Safety Council will be: ‘To Rush is to Err.’”

“Providers already have too much on their plate trying to provide patient care with the current financial strains, coding challenges, keeping up with government regulations, demand for information and the medical legal climate,” he wrote.

Farzad Mostashari, MD, who as national coordinator for heath information technology, is charged with implementing the government’s meaningful use program, seemed to welcome input from the IOM on the matter of health IT.

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

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 government wants to be proactive in understanding risks and how we can mitigate the risks.”

Patient privacy advocate Deborah Peel also weighed in, opining (in a news release from her organization, Patient Privacy Rights), that “there is no question that widespread use of untested, unproven EHRs and health technologies will potentially cause injuries and deaths and different kinds of medical and human errors.”

The IOM report makes clear that the safe application of health information technology 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.

HIMSS weighed on the IOM’s work, calling the report “a notable contribution to the dialogue on how to make the American healthcare delivery system safer.”

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.

In its statement, HIMSS echoed the IOM’s own words in “To Err Is Human”: “Continuing to use paper records can place patients at unnecessary risk for harm and substantially constrains the country’s ability to reform healthcare.”

The IOM’s 10 recommendations:

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.