Poorly designed records said to threaten safety
January 1, 2012 4 minutes read
Poorly designed records said to threaten safety
Poorly designed, hard-to-use electronic medical records (EMRs) are a threat to patient safety, according to a new federal study that also calls for an independent agency to investigate injuries and deaths linked to health information technology.
The report by the Institute of Medicine (IOM) cautions that the billions of dollars in incentive payments to encourage doctors and hospitals to adopt EMRs could undercut patient safety if the technology is not designed and used well. The Department of Health and Human Services (HHS) requested the study, in response to concerns from some doctors and public health experts that the drive for digital records might bring a wave of technology-induced medical errors. (The study is available for download online at http://tinyurl.com/7882h6w. The PDF download is free, and a printed copy costs $32.40.)
A new investigative agency should be modeled after the National Transportation Safety Board, which examines airline safety and accidents, says Gail L. Warden, MHA, president emeritus of Henry Ford Health System in Detroit and chair of the committee that wrote the report. The Institute of Medicine committee also called for tracking the safety performance of electronic health records in use. Results from studies done so far, the report said, are mixed. Success stories are offset by reports of patients harmed.
The advisory group also recommended that electronic health record suppliers drop "hold harmless" clauses from their sales contracts. The group says the language often limits the freedom of doctors and hospitals to publicly raise questions about software errors or defects.
The secretary of the HHS should publish a plan within 12 months to minimize patient safety risks associated with health IT and report annually on the progress being made, the report says. The plan should include a schedule for working with the private sector to assess the impact of health IT on patient safety. However, if the secretary determines that progress toward improving safety is insufficient within a year, the Food and Drug Administration should exercise its authority to regulate these technologies. Concurrently, the FDA should begin planning the framework needed for potential regulation so that the agency is ready to act if necessary.
"Just as the potential benefits of health IT are great, so are the possible harms to patient safety if these technologies are not being properly designed and used," Warden says. "To protect patients, industry and government have a shared responsibility to ensure greater transparency, accountability, and reporting of health IT-related medical errors."
The federal government is investing billions of dollars to encourage hospitals and other healthcare providers to adopt health IT so that all Americans can benefit from the use of electronic health records by 2014, but demonstrated improvements in care and safety are not yet established, the report says. Some of these technologies have significantly improved the quality of healthcare and reduced medical errors. However, concerns about potential harm are emerging as healthcare providers increasingly rely on health IT to deliver care.
Little published evidence exists that quantifies the magnitude of the risk associated with health IT problems, partly because many technology vendors discourage the free exchange of safety-related information in their contracts with healthcare providers. But serious errors involving these technologies including medication dosing errors, failure to detect fatal illnesses, and treatment delays due to poor human-computer interactions or loss of data have led to several reported patient deaths and injuries, the report says.
HHS should establish a mechanism for technology vendors and users to report health IT-related deaths, injuries, or unsafe conditions, the report says. Reporting events related to patient safety should be mandatory for vendors and voluntary, confidential, and nonpunitive for care providers. In addition, Congress should establish an independent federal entity to investigate patient deaths, injuries, or potential unsafe conditions associated with health IT, Warden says. Based on those investigations, the entity could make nonbinding recommendations, allowing flexibility for HHS, healthcare organizations, vendors, and other experts to determine the best course forward.
Health information technology researcher Dean Sittig, PhD, presented information to the panel that developed the IOM report. He is a professor at The University of Texas Health Science Center at Houston School of Biomedical Informatics and a member of the faculty of The University of Texas Memorial Hermann Center for Healthcare Quality and Safety. Sittig says the IOM's recommendations are in line with the improvements sought by many health IT leaders, particularly the call for a government agency to investigate errors.
"Right now we when we have these accidents, we're not learning from them. One organization is not telling others what they have learned and what they're doing in response," Sittig says. "Nobody thinks an accident like this is going to happen to them, but accidents happen. Backhoes cut power lines, coding errors cause havoc, and we need to know how to deal with these problems when they happen."
Sittig notes that risk managers have not been greatly involved with healthcare IT in a direct sense, and he urges risk managers to take an active role because of the potential for meaningful intervention.
"IT people don't really understand risk management. They understand how to make sure the system doesn't fail, but they don't understand the larger picture of how IT affects patient care and safety," Sittig says. "The risk manager can bring that perspective and help people understand the ramifications of IT issues, that they have a direct impact on patients. I think a lot of times when we have an accident or bad outcome, there's a role that health IT played in that."
Sources
Dean Sittig, Phd, Professor, The University of Texas Health Science Center at Houston School of Biomedical Informatics. Telephone: (713) 500-7977. E-mail: [email protected].
Gail L. Warden, MHA, President Emeritus, Henry Ford Health System, Detroit. Telephone: (313) 876-2882. E-mail:[email protected].
Poorly designed, hard-to-use electronic medical records (EMRs) are a threat to patient safety, according to a new federal study that also calls for an independent agency to investigate injuries and deaths linked to health information technology.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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